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Drug Eluting Stents
http://www.aievolution.com/tct0801 Drug Eluting Stents (Abstracts Nos 297-450) TCT-297 Long Term Clinical Follow-up Of Drug Eluting Coronary Stents After Successfull Treatment Of Bare Metal Stent Instent Restenosis
E L E C T RO N I C A B S T R AC T S
Alexander Kypta, Clemens Steinwender, Robert Hofmann, Klaus Kerschner, Simon Hönig, Jürgen Kammler, Franz Leisch Cardiovascular Division General and University Teaching Hospital Linz, Linz, Austria Background: Different trials have demonstrated a dramatic reduction in incidence of in-stent restenosis (ISR) following implantation of drug eluting stents (DES) compared with bare metal stents (BMS). The clinical outcome following successful (no re-restenosis after 6 months) implantation of a DES IRU%06,65LVOHVVZHOOGH¿QHG7KHDLPRIWKLVVWXG\ZDVWRDVVHVVWKHVDIHW\ DQGHI¿FDF\RI'(6 VLUROLPXVDQGSDFOLWD[HO LQWKHWUHDWPHQWRISDWLHQWVZLWK BMS ISR which had angiographicaly less than 50% restenosis at 6 month after implantation of DES. Methods and Results: $OOSDWLHQWV PHDQDJHIHPDOH male) who received a DES (120 sirolimus, 84 paclitaxel) for treatment of BMS ISR from May 2002 - December 2004 at a single institution were entered into a prospectively collected database. Six month angiographic follow-up and long term clinical outcomes (36 - 60 months) were collected. At baseline, the most common target vessel was the left anterior descending coronary artery (41%), and 3% of lesions were in the left main (LM). Multivessel disease was present in 82 (40%) of patients. Saphenous vein grafts were excluded. 7KH PHDQ UHIHUHQFH GLDPHWHU ZDV PP DQG WKH PHDQ OHVLRQ OHQJWKZDVPP7KHUHZDVRQHDFXWHOHWDOVWHQWWKURPERVLVWKUHH days after implantation of a sirolimus stent. No additional procedural or inhospital major adverse cardiac events (MACE - cardiac death, myocardial infarction or target lesion revascularisation) occurred. In patients who were V\PSWRPDWLFDWWKHWLPHRIFRQWUROODQJLRJUDSK\ KDGVLJQL¿FDQW ! UHVWHQRVLV,QDOORIWKHVHSDWLHQWVDQHZ'(6ZDVLPSODQWHG$WWKLV point of time, a paclitaxel eluting stent was implanted in pts. previously treated with a sirolimus eluting stent and vice versa. The six months MACE rate was 12.2%. Of the remaining 179 (100%) patients long term clinical follow-up (3660 months) was available in 177 (98.8%) patients. The 36-60 months MACE rate was 17.4%. Late stentthrombosis occurred in 4 (2.3%) of patients. There were 7 (4%) cardiac death and 3 (1.7%) non cardiac deaths. Conclusion: Stenting of restenosis after BMS using a DES evolves as an option with acceptable short-term and mid-term results. Whether a change of stent type (paclitaxel to sirolimus and vice versa) during treatment of reUHVWHQRVLVLVRIIXUWKHUEHQH¿WKDVWREHGH¿QHG TCT-298 Two-Year Follow-up of a New Zotarolimus-Eluting Stent Ian T Meredith1, Stephen Worthley2, Darren Walters3, Robert Whitbourn4, Peter J Fitzgerald5, Manuela Negoita6, Jeffrey J Popma7, On Behalf of the RESOLUTE Investigators 1 MonashHeart, Southern Health, Clayton, Victoria, Australia 2Royal Adelaide Hospital, Adelaide, Australia 3Prince Charles Hospital, Chermside, Queensland, Australia 4St Vincent’s Public Hospital Melbourne, Fitzroy, Victoria, Australia 5Standford University, Standford, CA; 6Medtronic CardioVascular, Santa Rosa, CA; 7St. Elizabeth Medical Center, Boston, MA Background:Year two of follow-up from drug-eluting stent (DES) clinical WULDOVKDVEHFRPHLPSRUWDQWLQDVFULELQJULVNEHQH¿WSUR¿OHV7KH(QGHDYRU Resolute is a zotarolimus-eluting stent (ZES), which incorporates the hydrophilic BioLinx polymer to maximize biocompatibility while minimizing
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LQÀDPPDWLRQ$W\HDUWKH5HVROXWHZDVDVVRFLDWHGZLWKRQO\7/5HYHQW DQG VLJQL¿FDQWO\ ORZ ODWH OXPHQ ORVV ZKHQ FRPSDUHG ZLWK DQ KLVWRULFDO control. Two-year follow-up will be completed in June 2008. Methods:7KLV ¿UVWLQKXPDQ HYDOXDWLRQ RI WKH (QGHDYRU 5HVROXWH =(6 enrolled 130 patients with documented ischemia and single and multi-vessel disease from 12 centers in Australia and New Zealand. Patients were to be treated for only a single de novo OHVLRQPPDQGPPLQOHQJWKLQ FRURQDU\DUWHULHVZLWKDUHIHUHQFHYHVVHOGLDPHWHUEHWZHHQPPDQG PP)RUSDWLHQWV4&$DQG,986ZHUHSHUIRUPHGDWPRQWKVDQG IRUSDWLHQWV4&$DQG,986ZHUHSHUIRUPHGDW PRQWKV7KHSULPDU\ endpoint was in-stent late lumen loss at 9 months post-procedure by QCA. The Endeavor II treatment cohort was used as a control. Key secondary endpoints included, MACE at 30 days, 4 (4-month subset patients only), 6, 9, and 12 months post-procedure; acute device, lesion and procedure success; DQJLRJUDSKLFLQVWHQWDQGLQVHJPHQWSDUDPHWHUV 79)DQG7/5DW PRQWKV DQGQHRLQWLPDOK\SHUSODVWLFYROXPHDQGSHUFHQWYROXPHREVWUXFWLRQLQ,986 subsets. Clinical follow-up is planned through 5 years. Results: Of 131 lesions treated (one patient had 2 lesions treated), mean OHQJWKZDV PP UDQJH ZHUH%&DQG of patients had multivessel disease. Mean late lumen loss at 9 months was PPLQVWHQWDQGPPLQVHJPHQW 1 $W\HDU WKHFXPXODWLYHLQFLGHQFHRI7/579)DQG0$&(ZHUHDQG 8.5%, respectively. Conclusion: The RESOLUTE study enrolled patients with longer and more complex lesions than in previous ZES randomized trials. There were no early RUODWHSURWRFROGH¿QHGVWHQWWKURPERVLVHYHQWV7KH(QGHDYRU5HVROXWH=(6 was shown to be safe and effective for the treatment of obstructive coronary GLVHDVHWKURXJK\HDUIROORZXS:HSODQWRUHSRUWWKHNH\\HDUFOLQLFDO outcomes in October 2008. TCT-299 Long Term Outcome After Des Implantation: Restenosis And Progression Of Atherosclerotic Disease Massimo Fineschi, Tommaso Gori, Giuseppe Sinicropi, Stefano Casini, Alessandro Iadanza, Arcangelo Carrera, Carlo Pierli U.O.Emodinamica Azienda Ospedaliera-Universitaria Senese, Siena, Italy Background: Drug eluting stents (DES) reduce intimal hyperplasia as well as clinical and angiographic restenosis improving event-free survival. However,recurrent angina after percutaneous coronary intervention remains a challenging problem especially in consideration of the increasing complexity of the revascularization procedures being performed in real-world practice. We examined DES outcome in unselected patients in order to identify the relative clinical importance of stented-segment lesion recurrence (in-segment restenosis or thrombosis) compared to the development of arterial lesions in other coronary segments (disease progression). Methods: Between May 2002 and December 2006, 3672 DES (sirolimus and paclitaxel-eluting stents) were implanted in 2626 patients in our tertiary center. Our registry enrolled all patients who had a clinically-driven new percutaneous procedure for restenosis or disease progression. A total of 166 patients (6.3%; 123 males, mean age 65+/-10years) were recruited at a minimum follow-up time of 12 months after the index procedure. Results: Of these patients who underwent a second procedure, 72% were diabetics, 63% were hypertensives, 68% had hypercholesterolemia. Seventy¿YHSDWLHQWV XQGHUZHQWWKHVHFRQGSURFHGXUHIRUGLVHDVHSURJUHVVLRQ the remaining ninety-one (55%) showed in-segment restenosis. Patients showing disease progression returned at a mean of 16+/-11 months. The large majority (61 patients, 81%) of these patients returned with stable angina and/ or a positive stress test. While patients with in-segment restenosis returned at a similar time after the index procedure (mean 15+/-12 months), their presentation was absolutely different, with a predominance of unstable coronary syndromes (70 patients or 77%) over stable angina or inducible ischemia (21 patients, 23%). This difference between groups was statistically VLJQL¿FDQW 3 E\&KLVTXDUH 7KHWLPLQJRIWKHSUHVHQWDWLRQIRUERWK
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with documented OSA (diagnosed by polysomnography) treated with contemporary PCI between 9/2002 and 4/2007 were enrolled and 126 CAD patients without OSA were grouped as controls. All patients were implanted ZLWK'(6VIRURYHUWFRURQDU\VWHQRVLV ! &OLQLFDOSDUDPHWHUVWKHVWHQW type, stent length, and number as well as lesion complexity were collected and all main adverse cardiac events (MACE) including cardiac death, heart failure, recurrent angina pectoris and myocardial infarction from PCI procedure to 1-year follow-up were recorded. Association of OSA with MACE was analyzed by multivariate logistic regression. Results: Plasma levels of triglyceride, white blood cell counts, body mass LQGH[DQGUDWLRRIGLDEHWHVZHUHVLJQL¿FDQWO\KLJKHULQ26$SDWLHQWVWKDQWKDW LQFRQWUROV 3 UHVSHFWLYHO\ 7KHSUHYDOHQFHRIK\SHUWHQVLRQVPRNLQJ family history of CAD, stent types, stent length, and numbers as well as OHVLRQ FRPSOH[LW\ ZHUH QRW VLJQL¿FDQWO\ GLIIHUHQW EHWZHHQ WZR JURXSV DOO S! 0$&(LQ26$DQGFRQWUROVZHUHFDUGLDFGHDWK KHDUWIDLOXUH (6,3), recurrent angina pectoris (14,4) and myocardial infarction (4,2). Patients ZLWK26$DIWHU3&,ZLWK'(6VKDGDVWDWLVWLFDOO\VLJQL¿FDQWLQFUHDVHGQXPEHU of recurrent angina pectoris (C2=5.983, p=0.014) and MACE (C2=8.296, p=0.004) on 1-year follow-up when compared with controls. Multivariate analysis revealed that OSA (OR:2.320, 95%CI 1.198~4.726, p=0.006) was an independent predictor of 1-year prognosis in CAD patients treated with DESs. Conclusion: At 1 year follow-up, CAD patients with OSA suffered from KLJKHU ULVN RI UHFXUUHQW DQJLQD SHFWRULV DQG FRPSOH[ 0$&( HYHQ WUHDWHG with DESs.
JURXSVRISDWLHQWVVKRZHGDELPRGDOSDWWHUQZLWKDSHDNDWPRQWKVDQG DQRWKHUSHDNDURXQGPRQWKVDIWHUWKHLQGH[SURFHGXUH Conclusion: The need for a new percutaneous procedure in patients treated with DES is relatively low (6.3%) in a real-world setting. In-segment restenosis and disease progression account to a similar extent although their clinical SUHVHQWDWLRQ LV VWULNLQJO\ GLIIHUHQW 7KH PRVW FRPPRQ SUHVHQWDWLRQ RI LQ VHJPHQWUHVWHQRVLVLVDQXQVWDEOHV\QGURPHFRQ¿UPLQJWKDWUHVWHQRVLVLQD DES is not a clinically benign entity. TCT-300 Low Incidence of Stent Thrombosis in Asian Races: Multicenter Registry in Asia 3 Years Follow-Up Result Sunao Nakamura1, Hisao Ogawa2, Shotaro Nakamura1, Jang-Ho Bae3, Yeo Hans Cahyadi4, Wasan Udayachalerm5, Damras Tresukosol6, Sudaratana Tansuphaswadikul7 1 New Tokyo Hospital, Chiba, Japan 2Kumamoto University Hospital, Kumamoto, Japan 3Konyang University Hospital, Daejeon, Republic of Korea 4Husada Hospital, Jakarta, Indonesia 5King Chulalongkorn Memorial Hospital, Bangkok, Thailand 6Her Majesty’s Cardiac Center, Siriraj Hospital, Bangkok, Thailand 7Chest Disease Institute, Bangkok, Thailand Background: There are limited data about stent thrombosis which is rare but devastating complication after drug-eluting stent (DES) implantation in unselected patients with a variety of coronary lesions. The aim of this study was to evaluate the frequency, predictors and the clinical outcome of stent thrombosis after DES implantation and bare metal stent (BMS) implantation in Asian races. Method: A total of 14,577 consecutive patients who underwent successful DES implantation (8,809 patients, 62% of the lesion with Sirolimus-eluting stent: SES, 38% of the lesion with paclitaxel-eluting stent: PES) and BMS implantation (5,768 patients) in 5 Asian high volume PCI center during March 2002 to March 2004 were included in this study. We evaluate the frequency, predictor and clinical outcome of stent thrombosis in our multi-center registry of Asian races. Results: $WDPHDQIROORZXSRIPRQWKVLQ'(6DQG PRQWKVLQ%067KHFXPXODWLYHLQFLGHQFHRIVWHQWWKURPERVLVZHUH subacute stent thrombosis (SAT): 0.5% with DES and 0.6% with BMS, late stent thrombosis (LAST): 0.2% with DES and no with BMS, very late stent WKURPERVLV 9/$67 SHU\HDUZLWK'(6DQGQR%06,QGHSHQGHQW predictors of stent thrombosis are bifurcation lesion (OR=1.90, 95% CI: 1.83 to 24.24, p=0.01) and ejection fraction (OR=0.90, 95% CI: 0.86 to 0.94, p=0.03). Only 0.2 % of the patients were died because of the myocardial infarction after stent thrombosis in both groups. Conclusion: The incidence of stent thrombosis in Asian races is relatively low (0.5 % with DES and 0.6% with BMS of SAT, 0.2% increase per year with DES of late stent thrombosis) at mean follow-up more than 3 years. Particular attention will need to be directed to this complication when the patients have bifurcation lesions or low ejection fraction.
TCT-302 Comparison of Stent Delivery Balloon Withdrawal Forces (Bare Metal vs. CYPHER vs. TAXUS Liberte): “Sticky” SIBS Polymer Causes Balloon Withdrawal Issues With TAXUS DES Tim Fischell, Marvee Turk Borgess Heart Institute, Kalamazoo, MI
TCT-301 Obstructive Sleep Apnea Predicts Prognosis in Patients Undergoing Percutaneous Coronary Intervention with Drug-eluting Stents chen zhong1, Genshan Ma1, Fangyi Xie2, Yi Feng1 'HSDUWPHQWRI&DUGLRORJ\WKH$I¿OLDWHG=KRQJ'D+RVSLWDORI Southeast University, Nanjing,Jiangsu, China 2Nanjing Medical University, Nanjing,Jiangsu, China 1
Background: Obstructive sleep apnea (OSA) is associated with an increased ULVN RI DGYHUVH FDUGLDF HYHQWV LQFOXGLQJ FDUGLRYDVFXODU PRUELGLW\ DQG mortality. But the prognostic value of OSA in patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DESs) remains unclear. We are presenting our medium-term following-up results Methods: 126 consecutive coronary artery disease (CAD) patients
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Introduction: 7KH 7$;86 /LEHUWp HOXWHV SDFOLWD[HO IURP SRO\ VW\UHQH ELVREXW\OHQHEVW\UHQH 6,%6 7KLV SRO\PHU LV ³WDFN\´ DQG KDV EHHQ DVVRFLDWHGZLWKQXPHURXVUHSRUWVRIFRPSOLFDWLRQVGXHWRGLI¿FXOW\UHPRYLQJ WKHGHÀDWHGVWHQWGHOLYHU\EDOORRQFDWKHWHU )'$0$8'( Objective: The purpose of this study was to determine whether the SIBS polymer ZDV³VWLFN\´DQGDVVRFLDWHGZLWKDQLQFUHDVHGIRUFHUHTXLUHPHQWWRUHPRYHWKH GHÀDWHGVWHQWGHOLYHU\EDOORRQDIWHUVWHQWGHSOR\PHQWFRPSDUHGWRWKH&<3+(5 '(6DQGWREDUHPHWDO/LEHUWpDQG%;9HORFLW\VWHQWVLQDQH[YLYRPRGHO Methods::HDQDO\]HGWKHEDOORRQSRO\PHUVWHQWLQWHUDFWLRQVZLWK7$;86 /LEHUWH /LEHUWH EDUHPHWDO VWHQW QR SRO\PHU FRQWURO &RUGLV¶ &<3+(5 '(6 3(9$ SRO\PHU DQG %; 9HORFLW\ :H PHDVXUHG UHDO WLPH WKHIRUFHUHTXLUHGWRUHPRYHWKHGHÀDWHGVWHQWGHOLYHU\EDOORRQIURP each of these stents in simulated straight (0 degree), curved (30 degree) and sharply curved (75 degree) vessels, in a water bath at 37° C. Results: 70 experiments were performed comparing these 4 stents. The PD[LPXP IRUFH PHDQ UHTXLUHG WR UHPRYH WKH EDOORRQ IURP D 7$;86 /LEHUWp VWHQW D /LEHUWp EDUH PHWDO VWHQW D &<3+(5 '(6 DQG %[ 9HORFLW\VWHQWZHUHOEVOEVOEVDQGOEVUHVSHFWLYHO\ LQ VKDUSO\FXUYHG³VLPXODWHG´YHVVHOV 3YDOXHVZHUHVLJQL¿FDQWIRU7$;86 /LEHUWp KDYLQJ JUHDWHU IRUFHV RI ZLWKGUDZDO LQ FXUYHG DQG YHU\ FXUYHG YHVVHOVFRPSDUHGWRERWKEDUHPHWDODQG&<3+(5'(6 S¶V DQG 0.00001, respectively)
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Conclusion:7KLVVWXG\GHPRQVWUDWHVDKLJKO\VLJQL¿FDQWLQFUHDVHLQIRUFH UHTXLUHGWRUHPRYHWKH7$;86/LEHUWpFRPSDUHGWRWKH/LEHUWpEDUH PHWDO VWHQW RU WKH &\SKHU VWHQW LQ FXUYHG ³YHVVHOV´ 7KHVH REVHUYDWLRQV RI³VWLFNLQHVV´RIWKH6,%6SRO\PHUPD\KHOSWRH[SODLQWKHFRPSOLFDWLRQV UHODWHGWREDOORRQ³ZLWKGUDZDO´LVVXHVREVHUYHGZLWKWKLVGHYLFH TCT-303 Intravascular Ultrasonic, Angioscopic and Histopathological Characterization of Heterogeneous Patterns of Restenosis After Sirolimus-Eluting Stent Implantation -Insights into Potential “Thromborestenosis” PhenomenonYuji Oikawa, Junji Yajima, Shunsuke Matsuno, Tadanori Aizawa The Cardiovascular Institute, Tokyo, Japan Background: Histopathological characterization of DES restenosis remains unclear. Objective To examine restenotic tissue characteristics after sirolimusHOXWLQJVWHQW 6(6 DQGFRPSDUHKLVWRORJLFDODQGFOLQLFDOLPDJH¿QGLQJVZLWK restenosis after bare-metal stent (BMS). Methods: ,986FRURQDU\DQJLRVFRS\ &$6 DQG'&$ZHUHSHUIRUPHGLQ consecutive patients who presented with restenosis after SES (n=13) and BMS (n=8). Histological analyses were performed in the atherectomy samples. Results: Mean time from implantation to restenosis was 10.8 months in the SES YHUVXVPRQWKVLQWKH%067\SLFDOCCEODFNKROH¶¶HFKROXFHQWDSSHDUDQFHE\ ,986ZDVREVHUYHGLQ6(6FDVHDQGFRUUHVSRQGHGWRD¿EULQULFKWLVVXHE\ histology which appeared translucent tissue by CAS (Figure). All restenosis DIWHU%06VKRZHGKRPRJHQRXVORZRULVRHFKRLFDSSHDUDQFHE\,986&$6 did not reveal red thrombus, but showed white thrombus in 6 SES versus 2 BMS (46.2 % vs. 25.0 %, p=0.597). Histology demonstrated various patterns after 6(6LQFOXGLQJWKURPEXV¿EULQLQÀDPPDWRU\LQ¿OWUDWHDQGFROODJHQPDWUL[ rich tissue, while thrombus component was not detected in BMS. Thrombus DQG¿EULQGHSRVLWLRQGHWHFWHGE\HLWKHU&$6RUKLVWRSDWKRORJ\ZHUHREVHUYHG more frequently in SES than in BMS group (92.3 % vs. 37.5 %, p=0.026).
Aim: of our study was to evaluate ST rate on a 5-year clinical follow-up after sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) implantation in daily clinical practice. Methods: We prospectively evaluated 867 patients undergoing DES implantation, 618 patients with SES and 249 with PES, in a single academic center, between april 2002 and April 2004. Results: Multivessel disease was present in 72% of patients, multivessel VWHQWLQJZDVSHUIRUPHGLQORQJ !PP OHVLRQVZHUHWUHDWHGLQ DQGPXOWLSOHVWHQWVSHUOHVLRQZHUHQHHGHGLQ2QDYHUDJHVWHQWV SHUSDWLHQWZHUHLPSODQWHG PHDQVWHQWHGVHJPHQWOHQJWK PPYHVVHO ,,E,,,D LQKLELWRUV ZHUH XVHG LQ ,QWUDYDVFXODU XOWUDVRXQG ,986 guidance was employed in 65% of SES and 50% of PES implantations, and the procedural success rate was 100% in SES and 99% in PES cases. Sixmonth follow-up was performed in all patients, whereas one-year follow-up was completed in 87% patients of the SES group and in 95% of the PES group, DQG¿YH\HDUIROORZXSZDVSHUIRUPHGLQ RI6(6DQG RI3(6SWV We considered that ST occurred when angiographic evidence of thrombus was available, or when patients experienced sudden cardiac death or either STelevation or non-ST-elevation MI through the follow-up period. The overall incidence of ST was 1.3% (0.97% in SES and 2.4% in PES, p=0.05). Of the 12 ST, 2 (16%) were acute, 4 (33%) subacute, 1 (8%) was a late event and 5 YHU\ODWHHYHQWV(OHYHQ67ZHUHFRQ¿UPHGE\DQJLRJUDSK\1R,986 guidance was used in 4/12 (33%) ST patients, while antiplatelet therapy was prematurely discontinued in 4/12 (33%). Among ST patients, mortality and non-fatal myocardial infarction rates were 25% and 42%, respectively. No ST ZDVGLDJQRVHGEHWZHHQVL[DQGWZHOYHPRQWKVZKLOH¿YHWKURPERVLVRFFXUUHG very late (range 390-720 days). Conclusion: The incidence of ST after DES use in daily clinical practice is low and similar to that observed in RCT. Longer lesions and smaller vessels WUHDWHGUHVXOWHGLQDKLJKHUSUHYDOHQFHRI67DPRQJ3(6SWVEXWQRVLJQL¿FDQW differences in cumulative MACE were obtained among SES and PES at 1- and 5-year follow-up. TCT-305
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Long Term Safety Results From the Endeavor Program: Four-Year Follow-up Laura Mauri1, Donald E Cutlip2, Martin B Leon3, David E Kandzari4, William Wijns5, Jean Fajadet6, Joseph M Massaro7, Wei Guo7, Ian T Meredith8 1 Brigham and Women’s Hospital, Harvard Medical School, Boston, MA; 2 Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; 3 Columbia University Medical Center, New York, NY; 4Scripps Clinic, LaJolla, CA; 5Cardiovascular Centre Aalst, Aalst, Belgium 6Clinique Pasteur, Toulouse, France 7Harvard Clinical Research Institute, Boston, MA; 8MonashHeart, Southern Health, Melbourne, Victoria, Australia Conclusion: Restenosis after SES and BMS have different histological patterns. SES restenosis is heterogeneous and frequently associated with thrombus component. TCT-304 Incidence Of Stent Thrombosis At Five-Year Follow-Up After Sirolimus- And Paclitaxel-Eluting Stent Implantation: A SingleCenter Registry Daniela Trabattoni, Franco Fabbiocchi, Stefano Galli, Piero Montorsi, Luca Grancini, Giovanni Teruzzi, Alessandro Lualdi, Paolo Ravagnani, Cristina Ferrari, Antonio L Bartorelli Centro Cardiologico Monzino, IRCCS, Milan, Italy Background: 7KH VDIHW\ SUR¿OH RI GUXJHOXWLQJ VWHQWV '(6 ZDV predominantly determined in randomized clinical trials (RCT) with narrow inclusion criteria. Concerns about stent thrombosis (ST) have been raised in unselected patients treated with DES.
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Background: Individual randomized controlled trials (RCT) of drug-eluting VWHQWV '(6 KDYHQRWKDGVXI¿FLHQWSRZHUWRFRPSDUHLPSRUWDQWFOLQLFDOHYHQWV beyond 1 year. We analyzed pooled data from 6 trials of the Endeavor DES to compare long term outcomes with the Driver bare metal stent (BMS). Methods: We pooled patient data from 6 trials to compare patients assigned to treatment with the Endeavor DES compared to BMS. Endeavor-treated SDWLHQWV ZHUH SRROHG IURP (1'($925 , Q D ¿UVWLQKXPDQ VWXG\ (1'($925 ,, DQ 5&7 FRPSDULQJ (QGHDYRU Q ZLWK %06 (1'($925,,&RQWLQXHG$FFHVV5HJLVWU\ Q (1'($925,,,DQ RCT comparing Endeavor (n = 323) with a sirolimus-eluting stent (Cypher) DQG(1'($925,9DQ5&7FRPSDULQJ(QGHDYRU Q ZLWKDSDFOLWD[HO HOXWLQJVWHQW 7D[XV DQG(1'($9253. Q IRUDWRWDORISDWLHQWV receiving the Endeavor DES and compared with BMS-treated patients from WKHFRQWURODUPRI(1'($925,, Q 7KHUHFRPPHQGHGPLQLPXP duration of dual antiplatelet therapy (DAPT) in these studies was 3-6 months. Results: The cumulative incidence of each endpoint is reported to 1440 days (4y) (Table). DAPT was extended to 1-2 y in the minority of patients studied in both groups (1 y 29% vs 29%; 2y 11.2 vs 13.5%, DES vs BMS, p=NS).
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$EEUHYLDWLRQV 795 WDUJHWYHVVHOUHLQWHUYHQWLRQ 795UHPRWH 795RXWVLGHWDUJHW OHVLRQ 7/5 7$;86UHODWHGWDUJHWYHVVHOUHLQWHUYHQWLRQ 0, P\RFDUGLDOLQIDUFWLRQ $5&67 $FDGHPLF5HVHDUFK&RQVRUWLXP'H¿QLWH3UREDEOH6WHQW7KURPERVLV Multivariate-adjusted Kaplan-Meier 2-year event rates are shown; unadjusted rates will also be shown at the time of presentation. 1RWHWKDWVLWHPRQLWRULQJLVRQJRLQJ ¿QDOGDWDZLOOEHDYDLODEOHDWWKHWLPHRI presentation. *Treated with oral hypoglycemics or insulin at time of enrollment. Patients with selfreported diabetes not medically treated are included in the non-diabetic cohort.
³+LJKHU5LVN´LQFOXGHVWKHIROORZLQJOHVLRQFKDUDFWHULVWLFVDQGSDWLHQWFRQGLWLRQV ZKLFKDUHH[FOXGHGIURPWKH³/RZHU5LVN´SRSXODWLRQ YHLQJUDIWOHIWPDLQ ELIXUFDWLRQFDUGLRJHQLFVKRFNVHYHUHFDOFL¿FDWLRQGLUHFWVWHQWLQJRIWRWDORFFOXVLRQ WKURPEXVVHYHUHO\WRUWXRXVYHVVHOVWRWDOVWHQWOHQJWK!PP
Table. Cumulative Incidence (%) of Adverse Events Endeavor DES n=2132
Driver BMS n=596
[95% CI]
[95% CI]
Death
4.6
[2.91,6.32]
5.2
[3.20,7.14]
Cardiac Death
1.8
[0.68,2.85]
2.6
[1.16,4.02]
MI
2.7
[1.33,4.01]
4.4
[2.53,6.28]
Cardiac Death/MI
4.3
[2.59,5.92]
7.0
[4.68,9.27]
ST (protocol)
0.5
[0.00, 1.04]
1.2
[0.19,2.16]
ST (ARC Def/Prob)
0.7
[0.01,1.39]
1.5
[0.41,2.64]
Conclusion: 7KLV VWXG\ GHPRQVWUDWHV WKDW WKH 7$;86 3(6 HVVHQWLDOO\ HOLPLQDWHV WKH HIIHFW RI GLDEHWHV RQ UHVWHQRVLV LQGHSHQGHQW RI SDWLHQW ULVN SUR¿OHDQGLVHTXDOO\VDIHDQGHIIHFWLYHLQWUHDWLQJFRURQDU\OHVLRQVLQ'0 and non-DM patients.
Conclusion: In a pooled analysis of over 2132 Endeavor DES-treated patients, 2093 with at least 1 year follow-up and 678 patients with 4 years follow-up, there was no increase in death, cardiac death, MI, or ST compared with BMS. 7KHUHZDVQRLQFUHDVHLQ67ULVNZLWKLQ\HDU YV$5&GHISURE or very late (year 1- 4, 0.1 vs 0.2%), despite low rates of prolonged DAPT in these studies. These analyses will be updated to include 2-year results for 773 additional Endeavor DES patients in October 2008.
TCT-307 Impact Of Stented Segment Length On Long Term Result Of Sirolimus Eluting Stent Implantation: From Two-Year Clinical Outcome Of The j-Cypher Registry
TCT-306
Shinichi Shirai1, Kenji Ando1, Yoshimitsu Soga1, Masahiko Goya1, Hiroyoshi Yokoi1, Masashi Iwabuchi1, Hitoshi Yasumoto1, Hideyuki Nosaka1, Masakiyo Nobuyoshi1, Takeshi Kimura2, Kazuaki Mitsudo3, on behalf of the j-CYPHER Registry investigators 1 Kokura Memorial Hospital, Kitakyusyu, Japan 2Kyoto University Hospital, Kyoto, Japan 3Kurashiki Central Hospital, Kurashiki, Japan
TAXUS Mitigates the Effect of Diabetes on Restenosis Independent RI3DWLHQW5LVN3UR¿OH
DQG ORZHUULVN JURXSV 7ZR\HDU HYHQWV ZHUH DVVHVVHG Multivariate adjustment was performed to correct for baseline differences. Results: Adjusted rates are shown (Table). TLR was similar across groups; in the KLJKHVWULVN'0SDWLHQWV7/5ZDVVLJQL¿FDQWO\lower compared to non-DM. PES yielded comparable MI and ST rates regardless of DM status. Mortality was increased in DM patients in accordance with increased comorbidity. Additional outcomes in subsets of patients with or without prior MI, small vessels, bifurcation lesions, left main and multivessel disease will also be reported. HIGHER-RISK** 795 7955HPRWH --TLR (%) -All Death (%) -MI (%) -ARC ST (%) LOWER-RISK** 795 7955HPRWH --TLR (%) -All Death (%) -MI (%) -ARC ST (%)
Non-Diabetes N=1901 11.3 2.0 8.7 4.6 3.4 2.8 N=3479 7.6 1.8 5.7 3.7 2.1 1.5
Medically-Treated Diabetes* N=702 9.5 1.9 7.3 8.8 4.4 3.3 N=1410 9.9 2.7 7.0 6.4 2.5 1.9
The American Journal of Cardiology®
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P value 0.01 0.53 0.03 <0.001 0.64 0.57 0.10 0.09 0.32 <0.001 0.33 0.15
October 12-17, 2008
Conclusion: Total stented segment length affected the restenosis rates and WKHQHHGIRU7/52QWKHRWKHUKDQGLQFLGHQFHRIVWHQWWKURPERVLVUDWHGLGQ¶W differ according to the total stent length.
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Background: A longer stented segment resulted in a high restenosis rate in Bare Metal Stent (BMS). The advent of Sirolimus Eluting Stent (SES) reduced the rate of restenosis as compared with BMS. In this sub-analysis of the j-Cypher registry, we evaluate the relation between the stent length and the incidence of restenosis and stent thrombosis. Method: Design of the j-Cypher Registry was multi-center prospective enrollment of consecutive patients (pts) receiving SES from 39 centers in Japan. By the end of March, 2008, two-year clinical follow-up data was completed in 11323 pts (14712 lesions) underwent successful implantation of SES. Lesions were devided into four groups according to the implanted VWHQWOHQJWK *URXS6 Q PP7RWDOVWHQW/HQJWK 76/ PP *URXS0 Q PP 76/PP *URXS/ Q PP 76/ PP DQG *URXS9/ Q PP76/ Results:$VFRPSDUHGZLWKWKHSDWLHQWVLQ*URXS6SDWLHQWVLQ*URXS9/ KDGDKLJKHUSUHYDOHQFHRISHULSKHUDODUWHU\GLVHDVHFKURQLFNLGQH\GLVHDVH diabetes and multivessel coronary disease. The restensosis rates through 2 years were 5.19% in Group S, 6.43% in Group M, 11.27% in Group L and LQ*URXS9/7DUJHW/HVLRQ5HYDVFXODUL]DLRQ 7/5 UDWHVDW\HDUV were 3.94% in Group S, 5.23% in Group M, 9.42% in Group L and 12.44% LQ*URXS9/7KHUHZDVQRVLJQL¿FDQWGLIIHUHQFHLQWKHLQFLGHQFHRIVWHQW thrombosis among the four groups (0.54% in Group S, 0.56% in Group M, LQ*URXS/DQG LQ*URXS9/S
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TCT-308 XIENCE™ V, TAXUS®, and ENDEAVOR® Drug Eluting Coronary Stent Systems: Comparison in the Rabbit Iliac Arterial Model Laura E Perkins1, Alexander J Sheehy2, Leslie A Coleman2, Renu Virmani3, Juan F Granada4 1 Abbott Vascular, Mattaponi, VA; 2Abbott Vascular, Santa Clara, CA; 3 CVPath Institute, Inc., Gaithersburg, MD; 4Abbott VascularThe Jack H. Skirball Center for Cardiovascular Research, Orangeburg, NY
E L E C T RO N I C A B S T R AC T S
Background: Commercially available drug eluting stent systems (DES) have GHPRQVWUDWHGSUHFOLQLFDOVDIHW\DQGFOLQLFDOHI¿FDF\+RZHYHUWKHVHGHYLFHV GLIIHUVLJQL¿FDQWO\LQWKHLUEDVHVWHQWDFWLYHGUXJSRO\PHUFDUULHUDQGHOXWLRQ SUR¿OHZKLFKFDQLPSDFWWKHYDVFXODUUHVSRQVHDVVRFLDWHGZLWKHDFKGHYLFH Comparison of these vascular responses in an established preclinical model can further our understanding as to the safety, biocompatibility, and projected HI¿FDF\RIWKHVHDQGQH[WJHQHUDWLRQ'(6 Methods: 6LQJOH [ PP HYHUROLPXV HOXWLQJ ;,(1&(TM 9 $EERWW 9DVFXODU 6DQWD &ODUD &$ ((6 SDFOLWD[HO HOXWLQJ 7$;86 /LEHUWp® %RVWRQ6FLHQWL¿F1DWLFN0$ 3(6 DQG]RWDUROLPXVHOXWLQJ(1'($925® 0HGWURQLF 9DVFXODU 6DQWD 5RVD &$ =(6 FRURQDU\ VWHQW V\VWHPV ZHUH implanted in rabbit iliac arteries at a 1.1:1 balloon:artery ratio. Arteries were explanted at either 28 days or 60 days (n = 2 for each arm at each time point) and evaluated by light microscopy. Results: 1HRLQWLPDOWKLFNQHVVDQGDUHDDQGVWHQRVLVWUHQGHGORZHUIRU((6 PP PP2 DVFRPSDUHGZLWK3(6 PP PP2 DQG=(6 PP PP2 )LEULQGHSRVLWLRQZDVJUHDWHUIRU((6 DQG3(6 DVFRPSDUHGZLWK=(6 DW GD\VDQGZDVODUJHO\UHVROYHGE\GD\V UHVSHFWLYHO\ $WERWKDQGGD\VLQÀDPPDWLRQZDVORZLQUHODWLRQWR ((6 DQG3(6 EXWZDVKLJKHU IRU=(6 GXHWRWKHSUHVHQFHRIPDFURSKDJHVDQG multinucleated giant cells associated with the delamination of PC polymer visible in histological sections. Conclusion: Histological evaluation of rabbit iliac arteries implanted with ;,(1&(TM 9 7$;86® DQG (1'($925® stents reveals noteworthy differences in their associated vascular responses. These differences can EH UHODWHG EDFN WR WKH LQWULQVLF GHVLJQ IHDWXUHV IRU HDFK RI WKHVH GHYLFHV HVSHFLDOO\ ZLWK UHVSHFW WR WKH HOXWLRQ SUR¿OH DQG SRO\PHU FDUULHU 7D[XV /LEHUWp® is neither approved nor available for sale in the U.S. TCT-309 The Unrestricted Use of Sirolimus-eluting Stents: 5-year Results of the RESEARCH Registry Ron T van Domburg1, Neville Kukreja1, Hector Garcia-Garcia2, Joost Daemen1, Yoshinobu Onuma1, Patrick W Serruys1 1 Erasmus Medical Center, Rotterdam, Netherlands 2Cardialysis, Rotterdam, Netherlands Background: Although the safety of drug-eluting stents (DES) has been under scrutiny, limited follow-up data up to 5 years are available, particularly among real-world patients. Therefore, we evaluated the 5-year clinical event rates in patients from the The Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) registry to establish the safety DQG HI¿FDF\ RI VLUROLPXVHOXWLQJ VWHQW 6(6 LQ DQ XQVHOHFWHG DOOFRPHU population. Methods: On April 16, 2002, our institution commenced the use of SES &\SKHU &RUGLV&RUSRUDWLRQ0LDPL/DNHV)ORULGD DVWKHGHIDXOWVWUDWHJ\IRU DOOSHUFXWDQHRXVFRURQDU\LQWHUYHQWLRQVDWRXULQVWLWXWLRQ,QWKH¿UVWPRQWKV of enrollment, 508 patients with de novo lesions were treated exclusively with SES (the SES group) and compared with a group of 450 consecutive patients treated with BMS for de novo lesions in the preceding 6 months (the preSES group), matched for stent diameter. Survival data was acquired from
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municipal civil registries. Questionnaires have been sent to all living patients to obtain data on adverse clinical events. Medical records will be reviewed and family doctors or referring cardiologists contacted as necessary. The primary end-point was composite major adverse events (MACE: all-cause death, P\RFDUGLDOLQIDUFWLRQRUWDUJHWYHVVHOUHYDVFXODUL]DWLRQ>795@ 6HFRQGDU\ HQGSRLQWVLQFOXGHGDOOFDXVHGHDWK795DQGVWHQWWKURPERVLV$SURSHQVLW\ score-adjustment will be performed to compensate for differences in baseline characteristics between the groups. Results: At 5 years follow-up survival status was available for 94% of the patients. The 5-year all-cause mortality rates were 14.0% for SES and 13.4% for BMS S &XPXODWLYH0$&(ZDVIRXQGWREHVLJQL¿FDQWO\ORZHULQWKH6(6JURXS YV DGMXVWHG+5 &,WR DVZHUHWKHUDWHVRI795 (12.2% vs 17.8%, adjusted HR 0.57, 95%CI 0.39 to 0.83). There was no difference in overall stent thrombosis(2.3% vs 2.2%), p=1.0). Conclusion: There is no difference in the 5-year survival rates in the realworld unselected patients treated with SES, compared with BMS. TCT-310 The Unrestricted Use of Everolimus-Eluting Stents for De-novo coronary lesions: The Xience V Stent Evaluated At Rotterdam Cardiology Hospital (X-SEARCH) Registry Ron T van Domburg, Yoshinobu Onuma, Neville Kukreja, Joost Daemen, Nieves Gonazapolez, Nicolo Piazza, Pim de Feijter, Wim van der Giessen, Evelyn Regar, Martin van der Ent, Peter de Jaegere, Patrick W Serruys Erasmus Medical Center, Rotterdam, Netherlands Objective: Everolimus-eluting stents (EES) have been shown to be effective in the context of randomized trials with selected patients. However, the effect of EES implantation in more complex, unselected patients cannot be directly H[WUDSRODWHG IURP WKHVH ¿QGLQJV :H VRXJKW WR HYDOXDWH WKHLPSDFWRIWKLV second generation DES in comparison to bare metal, sirolimus-eluting and paclitaxel-eluting stents (BMS, SES and PES respectively) on the short-term clinical outcomes in a real-life all-comer population. Methods: Since March 2007, our institution commenced the use of EES ;LHQFH9 $EERWW9DVFXODU DVWKHGHIDXOWVWUDWHJ\IRUHYHU\3&,%HWZHHQ 1st March and 31st October 2007, 649 consecutive patients presenting with de novo lesions were treated exclusively with EES. These patients were compared to 3 historical cohorts of consecutive patients; 450 patients treated with bare metal stents (BMS), 508 with sirolimus-eluting stents (SES) and 576 paclitaxel-eluting stents (PES) from the RESEARCH and T-SEARCH registries. Six month survival data is currently acquired from municipal civil registries and questionnaires are currently being sent to all living patients to obtain data on adverse clinical events. Medical records will be reviewed and referring cardiologists will be contacted if necessary. Results: ((6 SDWLHQWV ZHUH VLJQL¿FDQWO\ ROGHU %06 \UV 6(6 \UV PES:62 yrs, EES:64 yrs, p<0.01) and presented more frequently with STHOHYDWLRQ 0, YV YV YV S :LWKLQ WKH ¿UVW month, there were 50/2163 deaths (2.3%); the mortality rates in the BMS, SES, PES and EES groups were 2.0%, 1.6%, 1.6% and 3.8% respectively (p=0.03). Unadjusted analysis revealed that STEMI was a strong predictor of 30 day mortality (HR 10.7, 95%CI 5.4-21.3). Increasing age was also predictive (HR 1.03, 95%CI 1.00-1.08), whilst treatment with EES was associated with with DQRQVLJQL¿FDQWWUHQGWRZDUGVKLJKHUGD\PRUWDOLW\ +5 &, 0.8-6.9). After adjustment for STEMI and age, this trend was less apparent (HR1.3, 95% CI 0.7-2.3). Conclusion:$IWHUGD\VWKHUHZHUHQRVLJQL¿FDQWGLIIHUHQFHVLQPRUWDOLW\ between BMS, SES, PES and EES. Data on 6-month mortality and clinical events are currently being collected and will be presented at the time of the meeting.
The American Journal of Cardiology® |
October 12-17, 2008
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TCT-311
VDIHW\DQGHI¿FDF\RIEDUHPHWDOVWHQWV %06 DQG'(6 Methods: From 2000-2005, 5869 consecutive patients underwent PCI for de novo coronary stenoses. This single-center registry consists of 3 sequential groups of consecutive patients treated with BMS (n=2194; 2000-2002), sirolimus-eluting stents (SES, n=834; 2002-2003) and paclitaxel-eluting stents (PES, n=2841; 20032005). Annual follow-up on the occurrence of death (obtained from municipal civil registries) and clinical events were collected. The values for the 20th, 40th, 60th and 80th age percentiles were 51.8, 58.4, 65.4 and 73.0 years respectively. The patient SRSXODWLRQZDVVXEVHTXHQWO\VWUDWL¿HGLQWRDJHJURXSVXVLQJWKHVHFXWRIIYDOXHV The primary endpoint was all-cause mortality. Secondary endpoints included WDUJHWYHVVHOUHYDVFXODUL]DWLRQ 795 DQGFRPSRVLWHPDMRUDGYHUVHFDUGLDFHYHQWV 0$&(GH¿QHGDVDOOFDXVHGHDWKQRQIDWDOP\RFDUGLDOLQIDUFWLRQRU795 Results: Complete follow-up was available for 98.6%, with a median duration of follow-up of 1366 days (interquartile range [IQR]: 962-1797). The all-cause PRUWDOLW\ZDVVLJQL¿FDQWO\KLJKHULQWKHHOGHVWJURXSV *URXS*URXS *URXS*URXS *URXS 795UDWHVZHUHVLPLODU across all age groups, with similar reductions with DES compared to BMS: Group 1 adjusted HR 0.63 (95%CI 0.40-0.99), Group 2 HR 0.35 (95% CI 0.220.55), Group 3 HR 0.44 (95%CI 0.27-0.71), Group 4 HR 0.59 (95%CI 0.38-0.93) and Group 5 HR 0.64 (0.40-1.02). DES also reduced overall MACE and showed a trend towards reduced mortality in all age groups when compared to BMS. Conclusion: Although all-cause mortality rates are higher in older patients, DES are safe and effective when compared to BMS, irrespective of age.
The Impact Of The Number Of Off-Label Characteristics Per Patient On the MACE Rates In The Sort Out II Trial Anders M Galløe1, Jens F Lassen2, Henning Kelbæk3, Per Thayssen4, Klaus Rasmussen5, Niels Bligaard1, Leif Thuesen2, Ulrik Abildgaard1, Henning R Andersen2, Thomas Engstrøm1, Sten D Kristensen2, Jensen S Jensen1, Lars R Krusell2, Søren Galatius1, Hans E Bøtker2, Jan K Madsen1, Evald H Christiansen2, Sten Z Abildstrøm1, Ghita B Stephansen1, Peter R Hansen1 1 Gentofte University Hospital, Hellerup, Denmark 2Skejby University Hospital, Aarhus, Denmark 3Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark 4Odense University Hospital, Odense, Denmark 5Aalborg University Hospital, Aalborg, Denmark Background::KHQWKH¿UVWWZRGUXJHOXWLQJVWHQWVZHUHUHOHDVHGIRUJHQHUDO use the Food and Drug approval related to the use in certain patients and lesions - the so called on-label characteristics. In everyday clinical practice the stents are used on a much broader spectrum of patients and lesions - the so called off-label characteristics. The present investigation correlates the number of off-label characteristics in each patient to the rate of Major Adverse Cardiac Events (MACE). Methods:7KH SDWLHQWVDQGWKHGH¿QLWLRQRI0$&(LQWKH6RUW2XW,, trial have been extensively described in JAMA 2008; 299: 409-16. Patients had a follow up ranging from 1½ to 3½ years. 18 different off-label characteristics were registered in the trial at inclusion time. Results: Compared to patients with zero off-label characteristics, increasing numbers of off-label indications correlated to stepwise increasing MACE UDWHV ORJUDQN WHVW IRU WUHQG FKL VTXDUH S 7KH 0$&( UDWHV were 25.4% for patients with at least 5 off-label characteristics and 11.9% for SDWLHQWVZLWK]HURRIIODEHOFKDUDFWHULVWLFV ORJUDQNWHVW+D]DUG5DWLR 95% CI 1.30 to 4.00, p<0.04).
TCT-313 Clinical and Angiographic Outcomes of Cardiac Allograft Vasculopathy Treated With Drug-Eluting Stents Versus Bare-Metal Stents Tonga Nfor, Imraan Ansaarie, Mohammad Khalil, Anthony DeFranco, Anjan Gupta, Tanvir Bajwa, Suhail Allaqaband Aurora Sinai/Aurora St. Luke’s Medical Centers, University of Wisconsin School of Medicine and Public Health-Milwaukee Clinical Campus, Milwaukee, WI
Conclusion: With increasing number of off-label characteristics in each patient the MACE rates increased in a stepwise fashion. The number of off ODEHOFKDUDFWHULVWLFVLQHDFKSDWLHQWLVDSURJQRVWLFPDUNHUIRUWKHGHYHORSPHQW of MACE and may be used to determine the need for enhanced clinical follow up or prolonged anti platelet treatment. TCT-312 Contemporary Percutaneous Coronary Intervention in Different Age Groups Neville Kukreja, Yoshinobu Onuma, Hector Garcia-Garcia, Joost Daemen, Ron van Domburg, Patrick Serruys Thoraxcenter, Rotterdam, Netherlands Background: $OWKRXJK WKH EHQH¿W RI SHUFXWDQHRXV FRURQDU\ LQWHUYHQWLRQ 3&, LQWKHHOGHUO\LVZHOOHVWDEOLVKHGGDWDRQWKHVDIHW\DQGHI¿FDF\RIGUXJ eluting stents (DES) in these patients is limited. As the global population ages, this subgroup of patients will form an increasing proportion of patients undergoing PCI. We therefore analysed all patients undergoing PCI for de QRYRVWHQRVHVLQRXWLQVWLWXWLRQVWUDWL¿HGE\DJHWRLQYHVWLJDWHWKHUHODWLYH
The American Journal of Cardiology®
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October 12-17, 2008
Conclusion: This study suggests DES are more effective than BMS in SUHYHQWLQJ,65DIWHU3&,RQ&$9ZKHQYHVVHOGLDPHWHULVPP
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E L E C T RO N I C A B S T R AC T S
Background:&DUGLDFDOORJUDIWYDVFXORSDWK\ &$9 LVWKHOHDGLQJFDXVHRI GHDWK DIWHU WKH ¿UVW \HDU IROORZLQJ KHDUW WUDQVSODQW 'LIIHUHQFH LQ FOLQLFDO and angiographic outcome of drug-eluting stents (DES) vs bare-metal stents %06 LVXQNQRZQ:HFRPSDUHGUHVWHQRVLVWDUJHWYHVVHOUHYDVFXODUL]DWLRQ 795 DQGPRUWDOLW\LQWUDQVSODQWUHFLSLHQWVWUHDWHGZLWK'(6DQG%06 Methods: All patients from our heart transplant registry who had PCI with VWHQWLQJIRU&$9ZHUHLGHQWL¿HG:HWUDFNHGSURFHGXUDODQGEDVHOLQHFOLQLFDO characteristics and follow-up data on yearly coronary angiography, cardiac events and death. Primary outcome was 12-month in-stent restenosis (ISR). Secondary RXWFRPHVZHUHLQVHJPHQWUHVWHQRVLV795DQGDOOFDXVHPRUWDOLW\ Results: Total 40 DES (in 25 pts) were compared with 37 BMS (19 pts). There ZHUH QR VLJQL¿FDQW GLIIHUHQFHV LQ EDVHOLQH FKDUDFWHULVWLFV 7ZHOYHPRQWK incidence of ISR was 0% with DES vs. 12.9% with BMS (p=0.03). On longWHUPIROORZXSWKLVGLIIHUHQFHZDVVLJQL¿FDQWIRUYHVVHOVPPLQGLDPHWHU but ISR was uncommon, irrespective of stent type, in larger vessels. Rates of in-segment restenosis were similar, Cox regression hazard ratio DES vs. BMS +5 &,WR S 795UDWHVZHUHDOVRVLPLODU +5 &,WR S 7KHUHZDVQRVLJQL¿FDQWGLIIHUHQFHLQRYHUDOO mortality: HR 0.75 (95% CI 0.23 to 2.90) p=0.74.
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TCT-314 Differential Healing in Paclitaxel and Sirolimus-Eluting Stents in Combination with Oral PPAR Gamma Agents: The Importance of Drug Interaction in Delayed Healing Aloke V Finn1, Michael C John2, Gaku Nakazawa3, Chitra Raghunathan1, Tucker Ezell1, Scott Lajoie2, Xin Xu3, Qi Cheng3, Frank Kolodgie3, Renu Virmani3, Herman K Gold2 1 Emory University, Atlanta, GA; 2Massachusetts General Hospital, Boston, MA; 3CVPath, Gaithersburg, MD Drug eluting stents (DES) contain different pharmacologic agents, yet the clinical UHOHYDQFHRIWKLVLVXQNQRZQ2YHUODSH[LVWVEHWZHHQWKHPROHFXODUWDUJHWVRI sirolimus (SRL) (i.e. PI3K/mTOR) and many agents used to treat diabetes (DM). %HFDXVHSDFOLWD[HO 3$& ZRUNVWKURXJKRWKHUPHFKDQLVPVLWPLJKWDYRLGWKLV issue. The impact of interactions between eluted drug and commonly used DM PHGVRQKHDOLQJUHPDLQVXQNQRZQ,QUDEELWVUHFHLYLQJEDUH %06 3$&DQG SRL DES, we investigated the effect of oral PPAR gamma agents, rosiglitazone (RSG) and pioglitazone (Pio), on stent endothelialization (ENDO). Methods: Rabbits were randomized to SRL, PAC or BMS and to placebo (PLC) YHUVXV56* PJNJGD\ RU3LR PJNJGD\ $QLPDOVZHUHVDFUL¿FHGDW 28 days and arteries evaluated by scanning electron microscopy (SEM). Cell culture experiments used human aortic endothelial cells (HAEC). Results:56*VLJQL¿FDQWO\UHGXFHG(1'2RIWKHVWHQWE\6(0LQDQLPDOV receiving SRL vs. PLC, but no differences were seen in animals receiving PAC or BMS (table). Similar results were seen in animals randomized to Pio vs. PLC (table). QRT-PCR revealed that SRL inhibited upregulation of heme oxygenase, a PPAR target gene, by RSG and suggests that in addition translational regulation, sirolimus may inhibit PPAR activity.
infarction (STEMI). We compared the mid- to long-term outcomes of DES versus BMS in unselected patients with STEMI in a real-world setting. Methods: We analyzed 684 consecutive patients with STEMI that underwent percutaneous coronary intervention (PCI) at two centers in Korea from January 2003 to December 2006; 540 patients (78.9%) with DES and 144 (21.1%) with BMS. Patients were followed for the occurrence of target vessel IDLOXUH 79) DFRPSRVLWHRIFDUGLDFGHDWKQRQIDWDOP\RFDUGLDOLQIDUFWLRQ 0, DQGWDUJHWYHVVHOUHYDVFXODUL]DWLRQ 795 Results: Among baseline characteristics, dyslipidemia was more common, and implanted stents were smaller in diameter and longer in length in the DES JURXSWKDQLQ%06JURXS$IWHUDPHGLDQIROORZXSRIPRQWKVWKH 79)UDWHZDVVLJQL¿FDQWO\GHFUHDVHGLQWKH'(6JURXSFRPSDUHGZLWKWKH BMS group (16.8% vs. 36.5%; HR, 0.37; 95% CI, 0.24 to 0.60; P<0.001), ZKLFK ZDV PDLQO\ GXH WR D UHGXFWLRQ LQ 795 YV P<0.001). In particular, DES outperformed BMS in those with multivessel disease (18.8% vs. 45.6%, P DQGLQWKRVHZLWKVWHQWGLDPHWHUPP vs. 49.3%, P<0.001). Rigorous adjustment with the use of propensity sore PDWFKLQJFRQFRUGDQWO\LQGLFDWHGDEHQH¿WRI'(6ZLWKUHJDUGWR79) vs. 38.8%; HR, 0.42; 95% CI, 0.25 to 0.71; P=0.001). We also found that the stent thrombosis (ST) rates were comparable between the two groups (4.3% vs. 4.1%, P=0.748), however, 3 cases of very late ST occurred exclusively in the DES group. Furthermore, for STEMI patients receiving DES, interruption of dual antiplatelet therapy (DAT) within 6 months was a strong predictor of a composite of death and MI (HR, 7.19, 95% CI, 2.18 to 23.74; P=0.001). +RZHYHUWKHUHZDVQRVWDWLVWLFDOO\VLJQL¿FDQWEHQH¿WRISURORQJHGGXUDWLRQ of DAT over 12 months (HR, 0.51; 95% CI, 0.22 to1.19; P=0.118). Conclusion: In unselected patients with STEMI, DES compared with BMS, VKRZHGVXSHULRUPLGWRORQJWHUPHI¿FDF\LQZLWKUHJDUGWR79)PDLQO\ GULYHQE\DUHGXFWLRQRI795ZKLOHVKRZLQJFRPSDUDEOHVDIHW\SUR¿OHV TCT-316 ,QÀDPPDWLRQ,QKLELWRU\(IIHFWV3RO\PHUIUHH$QG3RO\PHUFRDWHG Paclitaxel-eluting Stents On Il-1beta Induced Coronary Artery Instent Restenosis In Pigs
E L E C T RO N I C A B S T R AC T S
Xuchen Zhou1,2, Rongchong Huang1, Qigang Guan2, Xizhuo Sun2, Z.L. Miao2, X.Z. He2, F.T. Han2, Y. Cheng2, L. Zhang2, Dingyin Zeng2 1 First Hospital,Dalian Medical University, Dalian, China 2First Hospital, China Medical University, Shenyang, China
Conclusion: 56* 65/ LQKLELWV HQGRWKHOLDOL]DWLRQ EHFDXVH RI VLJQL¿FDQW drug interaction. No effect of PPAR gamma agonists is seen in animals receiving BMS or PAC. Our data suggest that SRL should be avoided in DM receiving PPAR gamma agonists and that investigation of other DM agents in combination with SRL is needed. TCT-315 ‘Real World’ Comparison of Drug-Eluting Stents versus Bare Metal Stents in the Treatment of Unselected Patients with Acute STSegment Elevation Myocardial Infarction: Mid to Long Term Results from a Two Center Registry Kyung Woo Park1, Si-Hyuck Kang1, Hae-Young Lee1, Hyun-Jae Kang1, Tae-Jin Yeon2, Young-Seok Cho2, In-Ho Chae2, Dong-Ju Choi2, Seokyung Hahn3,4, ByungJoo Park3,4, Woo-Young Chung2, Hyo-Soo Kim1 1 Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea 2Department of Internal Medicine and Cardiovascular Center, Seoul National University Bundang Hospital, Seoul, Republic of Korea 3Medical Research Collaborating Center, Seoul, Republic of Korea 4Department of Preventive Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea Background:&RQFHUQVH[LVWUHJDUGLQJWKHORQJWHUPHI¿FDF\DQGVDIHW\RI drug-eluting stents (DES) in patients with ST-segment elevation myocardial
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Objective: Coronary artery in-stent restenosis (ISR) and Late thrombosis still UHSUHVHQWDSUREOHPLQSDWLHQWV7KHLQÀDPPDWLRQUHDFWLRQWRSRO\PHUDQG polymer-free paclitaxel-eluting stents were investigated in a swine stenosis PRGHOLQGXFHGE\LQWHUOHXNLQ Methods: 0LQLSLJV Q PRQWKVROGDQGZHLJKLQJNJ ZHUHVXEMHFWHG to thoracotomy. Segments (10 mm) of the mid left anterior descending coronary DUWHU\ DQG OHIW FLUFXPÀH[ FRURQDU\ DUWHU\ ZHUH XQGHUPLQHG DQG DVHSWLFDOO\ ZUDSSHGZLWKFRWWRQPHVKVRDNHGZLWK,/B (5 -J $IWHUZHHNVWKHDQLPDOV were anesthetized and quantitative coronary arteriography (QCA) was performed. The stenosis sites were randomized into three groups for stent insertion: a polymerfree Paclitaxel -eluting stent group (YINYI™, n=7), a polymer-coated Paclitaxel HOXWLQJVWHQWJURXS 7$;86TM, n=9), and a bare-metal stent (BMS) group (DT1TM, n=8). Three different stents were randomly implanted into stenosis segments. Expression of monocyte chemoattractant protein-1(MCP-1), tumor necrosis factoralpha (TNF-A 3VHOHFWLQDQGYDVFXODUFHOODGKHVLRQPROHFXOH 9&$0 ZDV determined by reverse transcription-PCR (RT-PCR). Results: QCA showed a severe stenosis in IL-1B-treated segments. after 4 ZHHNV )ROORZXS FRPSDUHG ZLWK %06 WKH 4&$ UHVXOWV LQ SRO\PHUIUHH Paclitaxel -eluting stent group and polymer-coated Paclitaxel -eluting stent group showed a lower 1-month angiographic late lumen loss (LLL) within the stent and the lesion (p<0.05). There were no difference between polymerfree and polymerized Paclitaxel stent group in LLL (P=0.16). The RT-PCR results of MPC-1,TNF-A3VHOHFWLQDQG9&$0VKRZHGWKHKLJKHUYDOXH in polymerized Paclitaxel stent group. Conclusion: Both of polymer-free and polymerized Paclitaxel stents were
The American Journal of Cardiology® |
October 12-17, 2008
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TCT Abstracts/ELECTRONIC
http://www.aievolution.com/tct0801
superior in reducing 1-month angiographic ODWHOXPHQORVVLQLQÀDPPDWLRQ lesions in pigs than that of BMSs. Polymer-free Paclitaxel stent showed a UDWKHUOLWWOHLQÀDPPDWLRQUHDFWLRQWKDQWKDWRISRO\PHUL]HG3DFOLWD[HOVWHQWV
following complex pt & lesion types: types B2/C 393 (79.5%), multivessel disease (+ left main stenosis) 183 (60.1%), small vessel < 2.5 mm 154 (51.0%), ORQJOHVLRQ !PP FDOFL¿FDWLRQ GLDEHWHVPHOOLWXV 83 (27.5%), bifurcation lesion 69 (22.8%), chronic total occlusion 29 (9.6%), WKURPEXV OHIWPDLQVWHQRVLV ROGVDSKHQRXVYHLQJUDIW 12 (4%), instent restenosis 10 (3.3%). Procedural and device success was 795ZDVLQDWPRQWKV DWPRQWKVDQG DW yrs. The rates of cardiac deaths, myocardial infarction, stent thrombosis and cumulative MACE were 1 (0.3%), 1 (0.3%), 0 and 1 (0.3%) at 6 months and 3 (1%), 1 (0.3%), 1 (0.3%) and 9 (3%) at 2 yrs. QCA at 6 months (105 patients, 163 lesions and 198 stents) showed in-segment late loss, restenosis of 0.07 mm and 4.3 % respectively; in-stent late loss, restenosis of 0.16 mm and 3.1%, respectively. Conclusion: At follow-up of up to 2 years the low incidence of clinical 0$&(7/5DVZHOODVORZODWHORVVDQGUHVWHQRVLVFRQ¿UPHGWKHVDIHW\DQG HI¿FDF\RIXVLQJ%LRPDWUL[TM stent even in real word patients. Further study in a larger number of pts is underway.
TCT-317 The Risk of Stent Thrombosis in Patients with Acute Coronary Syndromes Treated with Bare Metal and Drug-eluting Stents Neville Kukreja, Yoshinobu Onuma, Hector Garcia-Garcia, Joost Daemen, Ron van Domburg, Patrick Serruys Thoraxcenter, Rotterdam, Netherlands Background: Although dug-eluting stents (DES) reduce the rates of repeat revascularization compared to bare metal stents (BMS), there remain concerns DERXWWKHULVNRIODWHDQGYHU\ODWHVWHQWWKURPERVLV0DQ\IDFWRUVKDYHEHHQ IRXQGWREHDVVRFLDWHGZLWKWKLVULVNLQFOXGLQJDFXWHFRURQDU\V\QGURPH $&6 DWSUHVHQWDWLRQ GH¿QHGDV67HOHYDWLRQ0,QRQ67HOHYDWLRQ0,RUXQVWDEOH DQJLQDDFFRUGLQJWRWKH%UDXQZDOGFODVVL¿FDWLRQ :HDLPHGWRHYDOXDWHWKH ULVNRIGH¿QLWHVWHQWWKURPERVLVZLWKEDUHPHWDODQGGUXJHOXWLQJVWHQWV %06 and DES respectively) in patients treated for acute coronary syndromes. Methods: Between January 2000 and December 2005, 5823 consecutive patients underwent PCI for de novo lesions with a single stent type. These patients consisted of 3 sequential groups of BMS (n=2248), sirolimus-eluting stents (n=822) and paclitaxel-eluting stents (n=2746). Annual follow-up on the occurrence of death (obtained from municipal civil registries) and clinical events were collected. Propensity score-adjustment was performed to compensate for differences in baseline characteristics. Results: In total, 3485 patients presented with an ACS. After a median followXSRI GD\VSDWLHQWVZLWK$&6KDGDGH¿QLWHVWHQWWKURPERVLVUDWHRI 2.5% vs. 1.0% in patients with stable angina (propensity score-adjusted HR 2.80, 95% CI 1.72-4.56). In stable patients, any stent thrombosis resulted in a VLJQL¿FDQWLQFUHDVHLQPRUWDOLW\ DGMXVWHG+5 &, DOWKRXJK this was particularly evident for late or very late stent thrombosis; in contrast RQO\HDUO\VWHQWWKURPERVLVVLJQL¿FDQWO\LQFUHDVHGPRUWDOLW\LQSDWLHQWVZLWK acute coronary syndromes (adjusted HR 2.0, 95% CI 1.0-2.8). The only independent predictor of very late stent thrombosis was the use of bare metal stents (adjusted HR 0.11, 95% CI 0.02-0.54). Conclusion: 3DWLHQWV ZLWK DFXWH FRURQDU\ V\QGURPHV DUH DW KLJKHU ULVN RI early and late stent thrombosis with either BMS or DES, although very late stent thrombosis seems to be uniquely associated with DES. The clinical sequelae of late and very late stent thrombosis are more pronounced in stable patients.
TCT-319 Impact of Sirolimus-Eluting Stent and Paclitaxel-Eluting Stent on the Outcome of Patients with Sirolimus-Eluting Stent Failure: Multicenter Registry in Asia Sunao Nakamura1, Hisao Ogawa2, Jang-Ho Bae3, Yeo Hans Cahyadi4, Wasan Udayachalerm5, Damras Tresukosol6, Sudaratana Tansuphaswadikul7 1 New Tokyo Hospital, Chiba, Japan 2Kumamoto University Hospital, Kumamoto, Japan 3Konyang University Hospital, Daejeon, Republic of Korea 4Husada Hospital, Jakarta, Indonesia 5King Chulalongkorn Memorial Hospital, Bangkok, Thailand 6Her Majesty’s Cardiac Center, Siriraj Hospital, Bangkok, Thailand 7Chest Disease Institute, Bangkok, Thailand
TCT-318 Single Centre Registry Of A Biodegradable Polymer Based Biolimus A9-eluting Stent : Two-year Clinical And Angiographic Follow-up Teguh Santoso , Aaron Wong , Tian-Hai Koh University of Indonesia Medical School, Medistra Hospital, Jakarta, Indonesia 2National Heart Center, Singapore , Singapore 1
2
PES
256/314
264/295
Procedural success (%)
100
100
MACE at 30 days (%)
0.6
1.1 (Stent thrombosis 2 cases)
Proximal reference diameter (mm)
2
1
Background. 5HFHQW GDWD KDYH DWWHVWHG WKH VDIHW\ DQG HI¿FDF\ RI biodegradable polymer based biolimus A9-eluting stent (BiomatrixTM) used in selected patients (pts). The aim of this study was to report the of the clinical outcome following PCI using BiomatrixTM in real world cases being followedup for 2 years (yrs). Methods: Included in this study were 302 all comers who underwent BiomatrixTM stent implantations to treat 638 lesions. Double antiplatelet regimen (aspirin and clopidogrel) was given for 6 months, followed by chronic DVSLULQRQO\7KHSULPDU\HQGSRLQWZDVWDUJHWYHVVHOUHYDVFXODUL]DWLRQ 795 at 6 and 12 months. Secondary End-Points were Major Adverse Cardiac (YHQWV 0$&( GHDWK40, RU795@DQGPRQWKLQVHJPHQWUHVWHQRVLV rate and in-segment late loss. Results: Male:female ratio was 210/92, mean age was 59.5 + 10.0 yrs. Number of stents per patient (pt) 1.95. BiomatrixTM stents were implanted in the
The American Journal of Cardiology®
SES Number of patients/lesions
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October 12-17, 2008
Minimum lumen diameter post procedure (mm) Minimum lumen diameter at 6 months (mm)
Minimum lumen diameter at 12 months (mm)
Restenosis rate (%)
7.0
15.2*
Target lesion revascularization (%)
6.6
15.2*
MACE at 12 months (%)
7.0
17.4*
*p<0.05 vs SES
Conclusion: The use of SES and PES in patients with restenosis after SES implantation was safe with low complications. Patients treated with SES showed lesser rate of restenosis compared with PES.
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Purpose: To evaluate the Sirolimus-eluting stent (SES) and Paclitaxel-eluting stent (PES) on the outcome of patients with SES failure (SES-F). Methods: A total of 520 patients with 609 SES-F lesions (male 74.8%, mean DJH\UV/07/$'/&;5&$69* ZHUHWUHDWHGZLWK6(6 PHDQOHVLRQOHQJWKPPPHDQVWHQWOHQJWK PP DQG 3(6 PHDQOHVLRQOHQJWKPPPHDQVWHQWOHQJWK PP :HHYDOXDWHLPPHGLDWHDQGORQJWHUPFOLQLFDOUHVXOWVE\ and 12 months angiography. Results: The baseline clinical characteristics between 2 groups were similar. See table for clinical results.
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TCT-320 Drug-Eluting Stents for the Treatment of Very Long Coronary Artery Stenosis: A Comparison with Sirolimus, Paclitaxel, Zotarolimus, EPC Capture and Everolimus-Eluting Stent: Multicenter Registry in Asia Sunao Nakamura1, Hisao Ogawa2, Jang-Ho Bae3, Yeo Hans Cahyadi4, Wasan Udayachalerm5, Damras Tresukosol6, Sudaratana Tansuphaswadikul7 1 New Tokyo Hospital, Chiba, Japan 2Kumamoto University Hospital, Kumamoto, Japan 3Konyang University Hospital, Daejeon, Republic of Korea 4Husada Hospital, Jakarta, Indonesia 5King Chulalongkorn Memorial Hospital, Bangkok, Thailand 6Her Majesty’s Cardiac Center, Siriraj Hospital, Bangkok, Thailand 7Chest Disease Institute, Bangkok, Thailand Aim:7KHDLPRIWKLVVWXG\LVWRFRPSDUHWKHVDIHW\DQGHI¿FDF\RI6LUROLPXV (SES), Paclitaxel (PES), Zotarolimus (ZES), EPC capture (ECS) and Everolimus-eluting stent (EES) on the outcome of stenting in patients with YHU\ORQJFRURQDU\OHVLRQ 9// OHVLRQOHQJWKPP Methods:$SURVSHFWLYHDQDO\VLVRI SDWLHQWVZLWK9// 6(6 PES, 151 ZES, 39 ECS, 54 EES) was performed. The study endpoints were major adverse cardiac events (MACE) at 9 months, restenosis rate and target lesion revascularization (TLR) at 9 months. Results: See table for clinical results. SES
PES
ZES
ECS EES
Number of patients/lesions
368/408 288/322 151/164 39/42 54/58
Lesion length (mean: mm)
47.8
46.3
42.8
Stent length (mean: mm)
57.9
59.9
53.9
50.8 53.9
In-hospital MACE (%)
0.8
1.2
0.7
0
0
Subacute thrombosis (%)
0.3
0.7
0.7
0
0
Proximal reference diameter (mean: mm) Minimum lumen diameter post procedure (mean: mm) Minimum lumen diameter at 9 months (mean: mm) Restenosis rate at 9 months (%)
2.88
2.80
2.8
2.89 2.83
2.60
2.52
2.58
2.64 2.54
2.51
2.19
1.89
2.09 2.40
7.6*
9.0
19.2
15.2 5.6*
TLR at 9 months (%)
7.6*
9.0
16.6
10.3 3.7*
43.9 47.8
E L E C T RO N I C A B S T R AC T S
*p<0.05 vs ZES, TES
Conclusion: 7KHXVHRIGUXJHOXWLQJVWHQWVLQSDWLHQWVZLWK9//VHHPVWR be favorable in terms of in-hospital clinical outcome and long-term results. (2) Patients treated with SES and EES showed lesser restenosis rate and TLR compared with other drug-eluting stents. TCT-321 &RPSDULVRQRI
130i
/&;5&$&RPSOHWHFOLQLFDOIROORZXSWR\HDUVLV being analyzed for all patients. Results: The baseline clinical characteristics between 2 groups were similar. At 4 years overall cardiac events of SES (16.3%) were lower than PES (24.0%) (p=0.03). See table for clinical results. Number of patients
SES
PES
p
368
288
-
Age (mean: yrs)
69.6
71.5
NS
MACE at 30 days (%)
1.1
1.7
NS
Proximal reference diameter (mm)
NS
MLD post (mm)
NS
MLD at 12 months (mm)
0.03
Restenosis rate at 12 months (%)
10.1
18.8
0.01
TLR at 12 months (%) 6WHQWWKURPERVLV 6$7/$679/$67
6.6 (0.8 /0.3 /0.5)
14.9 (1.0/ 0.3/ 0.7)
0.01 NS
MACE at 48 months (%)
15.2
24.3
0.03
Conclusion: The use of SES and PES in patients with very long coronary lesion was safe and feasible with low acute complication and low incidence of restenosis. SES showed lesser incidence of cardiac events (death, myocardial infarction, CABG and PCI) at 4 years clinical follow up. SAT (sub acute stent thrombosis), LAST (late stent thrombosis: ~1year), 9/$67 YHU\ODWHVWHQWWKURPERVLV \HDUa\HDUV 0$&( GHDWKP\RFDUGLDO infarction, CABG and PCI). TCT-322 WITHDRAWN TCT-323 WITHDRAWN TCT-324 WITHDRAWN TCT-325 First -in-Man Study of the Endeavor Zotarolimus-Eluting Stent: Final 5-Year Follow-up Ian T Meredith1, John Ormiston2, Robert Whitbourn3, I Patrick Kay4, David Muller5, Manuela Negoita6, Richard E Kuntz7, Peter J Fitzgerald8, On Behalf of the ENDEAVOR I Investigators 1 MonashHeart, Southern Health, Clayton, Victoria, Australia 2Auckland City Hospital, Auckland, Australia 3St Vincent’s Public Hospital Melbourne, Melbourne, Australia 4University of Auckland, Auckland, New Zealand 5Public Hospital Sydney, Sydney, Australia 6Medtronic CardioVascular, Santa Rosa, CA; 7Medtronic, Inc., Minneapolis, MN; 8 Stanford University Medical Center, Stanford, CA Background: (1'($925 , ZDV WKH ¿UVWLQKXPDQ VWXG\ WR HYDOXDWH WKH Endeavor zotarolimus-eluting stent (ZES), which consists of a cobalt-alloy ORZSUR¿OH VWHQW ZLWK D ELRFRPSDWLEOH SKRVSKRU\OFKROLQH SRO\PHU DQG WKH highly lipophilic anti-proliferative rampamycin analog, zotarolimus. Through 4 years follow-up, treatment of symptomatic coronary artery disease (CAD) ZLWKWKH(QGHDYRU=(6LVDVVRFLDWHGZLWKVXVWDLQHGHI¿FDF\7KH¿QDO\HDU follow-up will be completed in June, 2008, which represents the longest available follow-up for this device. Methods: 7KH (1'($925 , WULDO ZDV D SURVSHFWLYH PXOWLFHQWHU nonrandomized, single-arm study that enrolled 100 patients with symptomatic CAD at 8 centers in Australia and New Zealand. Patients were treated for a single de novoOHVLRQZLWKDUHIHUHQFHYHVVHOGLDPHWHU 59' RIWR PPDQGPPLQOHQJWK7KHSULPDU\HQGSRLQWZDV0$&(DWGD\VDQG LQVWHQWODWHOXPHQORVVDWPRQWKV$QJLRJUDSKLFIROORZXSZLWK,986ZDV performed at 4 and 12 months. Clinical follow-up occurred at 30 days, 4, 9, and 12 months, and annually through 5 years.
The American Journal of Cardiology® |
October 12-17, 2008
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Results: Mean age was 59 years, 79% were male, 47% had a previous MI, and 16% had a history of diabetes. Acute lesion, device, procedure, and GHYLFHVSHFL¿FSURFHGXUHVXFFHVVUDWHVZHUHDOO7UHDWHGOHVLRQVZHUH WKH/$' 5&$ DQG/&; ZLWKDPHDQ59'RI PP0/'RIPPDQGPHDQOHQJWKRI PP7KUHH patients have been lost to follow-up (3%) at the 4-year follow-up. At 4-years, WKH FXPXODWLYH 7/5 79) DQG 0$&( UDWHV ZHUH DQG respectively. Freedom from MACE was 92.5% (95% CI; 87.8 % -98.0%), and IUHHGRPIURP79)ZDV &, 2QHSDWLHQWKDGDQRQ Q-wave MI at 10 days, and 4 patients died during the study; all non-cardiac (cancer). One TLR event occurred between year 1 - 4, and 1 stent thrombosis (ST) occurred at 10 days, with no subsequent ST events. Conclusion: With data available for 97% of patients, the Endeavor ZES has been shown to be safe and effective through 4 years of follow-up with ORZ7/5QRFDUGLDFGHDWKVDQGQRODWHWKURPERWLFHYHQWV7KH¿QDO\HDU follow-up results will be reported in October 2008.
LQDOOVWHQWJURXSVDWPRQWKVIROORZXS7KHUHZDVQRGLIIHUHQFHLQ795 rate and stent thrombosis remains a low event occurrence. TCT-327 COMPARE-AMI : Preliminary Results of 6 Months Follow-Up, Comparing the Everolimus - Eluting Stent, XIENCE V, with the Paclitaxel - Eluting Stent, Taxus Liberte’, in Patients with STElevation Myocardial Infarction Elvin Kedhi, Jochem G P Wassing, Carlos A G Van Mieghem, Kayum SheikJoesoef, Eugene P McFadden, Peter C Smits MCRZ, Rotterdam, Netherlands
TCT-326 Comparison of 24-Month Clinical Outcomes of Endothelial Progenitor Cell Capture Stent versus Sirolimus-Eluting Bioabsorbable PolymerCoated Stent versus Bare Metal Stents In Patients Undergoing Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction Eric Chong1, Kian Keong Poh2, Liang Shen3, Chao Yang Soon1, Hean Yee Ong1, Ronald Chi Hang Lee2, Swee Guan Teo2, Adrian Low2, Huay Cheem Tan2 1 Cardiology Department, Alexandra Hospital, Singapore , Singapore 2 Cardiology Department, National University Hospital, Singapore , Singapore 3Biostatistics Department, National University, Singapore , Singapore Background: Endothelial progenitor cell (EPC) capture stent (Genous™, OrbusNeich), is designed to promote rapid endothelization and healing. It is potentially useful in patients undergoing primary percutaneous coronary intervention (PPCI) for acute ST-segment elevation myocardial infarction 67(0, :HFRPSDUHLWVFOLQLFDOHI¿FDF\DQGVDIHW\ZLWKDVLUROLPXVHOXWLQJ (SES) bioabsorbable polymer-coated stent (Cura™, OrbusNeich) and a bare metal stent (BMS) (Liberte™%RVWRQVFLHQWL¿F LQSDWLHQWVZLWK67(0, Methods: All patients presented to our center with STEMI and received PPCI with either EPC, SES or BMS stents from Jan 2004 to June 2006 were enrolled in the cohort study. The study endpoints were stent thrombosis and PDMRU DGYHUVH FDUGLDF HYHQWV 0$&( GH¿QHG DV FRPSRVLWH HQG SRLQWV RI GHDWKP\RFDUGLDOLQIDUFWLRQ 0, DQGWDUJHWYHVVHOUHYDVFXODUL]DWLRQ 795 at 24 months. Results: A total of 366 patients (EPC=95, SES=53, BMS 218) were enrolled. Baseline demographics in terms of age, gender, diabetes, renal impairment, SUHGLVFKDUJH OHIW YHQWULFXODU HMHFWLRQ IUDFWLRQ FDUGLRJHQLF VKRFN ZHUH comparable among the 3 groups. Procedural success rate was high at a mean RI 3RVWSURFHGXUDO 7,0, ÀRZ ZDV DFKLHYHG LQ (3& 6(6 96.2% and BMS 88.5%. The MACE results at 24-months were shown: Events
EPC (n=95)
SES (n=53)
BMS (n=218)
MACE (%)
13 (13.7%)
8 (15.1%) 43 (19.7%)
TCT-328 Unrestricted Use Of Paclitaxel-eluting Stents: Four-year Results Of The T-search Registry
p value
Yoshinobu Onuma, Neville Kukreja, Joost Daemen, Hector M GarciaGarcia, Ron van Domburg, Patrick W J C Serruys Thorax center, Rotterdam, Netherlands
0.383
Death (%)
9 (9.5%)
2 (3.8%)
27 (12.4%) 0.173
Non-fatal MI (%)
1 (1.1%)
2 (3.8%)
9 (4.1%)
0.364
795
4 (4.2%)
5 (9.4%)
13 (6.0%)
0.439
Acute stent thrombosis
1 (1%)
0 (0%)
0 (0%)
0.404
Subacute stent thrombosis (SAT)
0 (0%)
0 (0%)
0 (0%)
1.00
Late stent thrombosis (LST)
0 (0%)
0 (0%)
2 (0.9%)
1.00
9HU\/DWHVWHQWWKURPERVLV 9/67
0
0
0
1.00
Objectives: Although drug-eluting stents (DES) reduce the rate of repeat revascularization compared with bare metal stents (BMS) in carefully selected patients, the long-term safety of DES remains a concern, particularly amongst real-world patients. Furthermore, long-term comparisons between different DES types in a real-world setting are scarce. We therefore evaluated the 4-year clinical event rates in patients from the Taxus Stent Evaluated At Rotterdam Cardiology Hospital (T-SEARCH) registry, to establish the safety DQGHI¿FDF\RIGLIIHUHQW'(6LQDQXQVHOHFWHGDOOFRPHUSRSXODWLRQ Methods: On 16th February 2003, the paclitaxel-eluting stent (PES, Taxus)
Conclusion: The MACE rates in patients who underwent PPCI were similar
The American Journal of Cardiology®
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October 12-17, 2008
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TCT Abstracts/ELECTRONIC
131i
E L E C T RO N I C A B S T R AC T S
Context: Results from the SPIRIT I-III trials showed consistent clinical DQGDQJLRJUDSKLFEHQH¿WVRIWKH(YHUROLPXV(OXWLQJ&RURQDU\6WHQW6\VWHP ;LHQFH96DQWD&ODUD&$86$FRPSDUHGWRWKHZLGHO\XVHG3DFOLWD[HO (OXWLQJ &RURQDU\ 6WHQW 6\VWHP 7D[XV %RVWRQ 6FLHQWL¿F 1DWLFN 0$ USA. However, to date there are no data available for the use of the novel second-generation everolimus-eluting stent system in the setting of the STElevation Myocardial Infarction (STEMI). Objective:7RLQYHVWLJDWHWKHVDIHW\DQGHI¿FLHQF\RI;LHQFH9VWHQWIRUWKH WUHDWPHQWRI67(0,LQ³UHDOZRUOG´SDWLHQWV Methods: COMPARE is a prospective, randomised, single center trial FRPSDULQJWKHFOLQLFDORXWFRPHRIWKH;LHQFH9VWHQW6DQWD&ODUD&$86$ YHUVXVWKH7D[XV/LEHUWH¶VWHQW%RVWRQ6FLHQWL¿F1DWLFN0$86$LQ³UHDO OLIH´SDWLHQWV$OOSDWLHQWVEHWZHHQ\HDUVZLWKQRFRQWUDLQGLFDWLRQVIRU 12-months dual antiplatlet therapy, with lesions judged feasible for treatment with PCI are progressively being randomised on a 1:1 basis for treatment ZLWK7D[XVRU;LHQFH9&RPSOHWHUHYDVFXODULVDWLRQLQPXOWLYHVVHOGLVHDVH is strongly encouraged. The primary end point is a composite of death, non fatal AMI and clinically driven target vessel revascularisation at 1 year. COMPARE AMI is subgroup analysis of patients from the COMPARE database presenting with STEMI. Results: From Feb 2007 to oct 2007, 185 consecutive patients presenting with 67(0, ZHUH UDQGRPLVHG DQG UHVSHFWLYHO\ LQ ;LHQFH 9 DQG 7D[XV /LEHUWH¶ DUPV %DVHOLQH FOLQLFDO DQG DQJLRJUDSKLF FKDUDFWHULVWLFV VKRZHG QR VWDWLVWLFDOO\ VLJQL¿FDQW GLIIHUHQFHV DOWKRXJK WKHUH ZDV D WUHQG IRU PRUH PXOWLYHVVHO GLVHDVH LQ ;LHQFH 9 JURXS $QJLRJUDSKLF VXFFHVV GH¿QHG DV 7,0,,,,ÀRZDQG VWHQRVLVRQYLVXDOHVWLPDWLRQZDVDFKLHYHGLQ DQGLQ LQWKH7D[XVDQG;LHQFH9DUPVUHVSHFWLYHO\ S 7KH SULPDU\HQGSRLQWZDVUHDFKHGLQ LQWKH;LHQFH9DUPDQGLQLQ WKH7D[XVDUP S 1R795DQGQRVSRQWDQHRXV0,RFFXUUHGGXULQJWKH 6-month follow-up, so the end point in both groups was driven by in-hospital mortality en peri-procedural AMI that occurred during non-culprit leasion treatments. Conclusions: 7KH ;LHQFH 9 VWHQW IRU WKH WUHDWPHQW RI 67(0, LV VDIH DQG VKRZHGHTXDOHI¿FLHQF\ZLWKWKH7D[XV/LEHUWH¶VWHQWDWPRQWKIROORZXS
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JDLQHG &RQIRUPLWp (XURSpHQQH DSSURYDO DQG ZDV LPPHGLDWHO\ DGRSWHG DV the default stent for all percutaneous coronary interventions at our institution. 7KH¿UVWSDWLHQWVWUHDWHGH[FOXVLYHO\ZLWK3(6IRUGHQRYROHVLRQVZHUH enrolled in the T-SEARCH registry. These patients were compared with 508 consecutive patients treated with sirolimus-eluting stents (SES, Cypher) from 16th April 2002 onwards from the RESEARCH registry. Annual survival status was acquired from municipal civil registries and questionnaires sent to all living patients to obtain data on adverse clinical events. Medical records will be reviewed and family doctors or referring cardiologists contacted as necessary. The primary endpoint was composite major adverse events (MACE: all-cause death, any myocardial infarction or target vessel revascularization >795@ 6HFRQGDU\ HQGSRLQWV LQFOXGHG DOOFDXVH GHDWK 795 DQG VWHQW thrombosis. Cox proportional hazards regression analysis will be performed to compensate for differences in baseline characteristics between the groups. Results: Four-year follow-up data is currently available for 95% of the patients after 4 years. The 4-year cumulative MACE rates were 30.5% and 30.7% for SES and PES(p=0.9). The 4-year cumulative all-cause mortality rates were 10.9% for SES and 10.1% for PES (p=0.7). Conclusion: Four-year survival and event-free survival rates are similar in real-world all-comer patients treated with SES or PES.
TCT-331 Is It Possible To Predict Stent Thrombsosis with Sirolimus- And Paclitaxel-Eluting Stents After Percutaneous Coronary Intervention? The DERIVATION Score Davide Capodanno, Piera Capranzano, Gianpaolo Ussia, Alfredo R Galassi, Corrado Tamburino Ferrarotto, Catania, Italy
TCT-329 WITHDRAWN TCT-330 Stent Fracture-Associated Restenosis In Bare-Metal Stents Compared With Drug-Eluting Stents Paul S. Pienkos, S. Hinan Ahmed, Imraan Ansaarie, Babak Haddadian, Mubashir Ahmed, Tonga Nfor, Masood Ahmed, Nadeem Najam, Adnan Nazir, Mohamed Rahman, Mohamed Djelmami-Hani, Anthony DeFranco, Neil Oldridge, Masood Akhtar, Anjan Gupta, Suhail Allaqaband, Tanvir Bajwa Aurora Sinai/Aurora St. Luke’s Medical Centers, University of Wisconsin School of Medicine and Public Health-Milwaukee Clinical Campus, Milwaukee, WI
E L E C T RO N I C A B S T R AC T S
Conclusion: &RPSDUHG ZLWK %06 '(6 KDYH VLJQL¿FDQWO\ KLJKHU UDWHV RI stent fracture-associated restenosis. Additionally, closed-cell design stents have VLJQL¿FDQWO\KLJKHUUDWHVRIVWHQWIUDFWXUHFRPSDUHGZLWKRSHQFHOOGHVLJQ
Background 6WHQW IUDFWXUH KDV EHHQ LQFUHDVLQJO\ LGHQWL¿HG LQ SDWLHQWV found to have angiographic in-stent restenosis in drug-eluting stents (DES). However, association between stent fractures and in-stent restenosis in barePHWDOVWHQWV %06 LVXQNQRZQ7RGHWHUPLQHVLJQL¿FDQFHRIVWHQWGHVLJQ type and drug-coating variables in particular, we compared stent fracture rates in BMS and DES. Methods :HLGHQWL¿HGSDWLHQWVZKRXQGHUZHQWUHSHDWFDWKHWHUL]DWLRQ between January 2006 and December 2007 because of acute coronary syndrome or positive functional test. Of these patients, 310 were noted to have HYLGHQFHRIDQJLRJUDSKLFLQVWHQWUHVWHQRVLV7KHVH¿OPVZHUHLQGHSHQGHQWO\ reviewed by two experienced interventional cardiologists and 62 stent IUDFWXUHV ZHUH LGHQWL¿HG )UDFWXUH UDWHV ZHUH FRPSDUHG EHWZHHQ %06 paclitaxel-eluting (PES), and sirolimus-eluting (SES) stents. Results:6L[W\WZRVWHQWIUDFWXUHVZHUHLGHQWL¿HG IUDFWXUHLQFLGHQFHLQ%06 was 11/1,561 (0.7%), PES 16/998 (1.6%), and SES 35/1,208 (2.8%). Fracture UDWH ZDV VLJQL¿FDQWO\ ORZHU LQ %06 WKDQ '(6 >S 25 &, 1.72-6.24)], and also when compared with either SES [p <0.0001, OR 4.11 (CI 2.11-8.03)], or PES [p = 0.046, OR 2.26 (CI 1.07-4.84)]. Fracture rate was VLJQL¿FDQWO\ORZHUZLWKRSHQFHOOGHVLJQ %063(6 FRPSDUHGZLWKFORVH cell design (SES) [p < 0.0001, OR 2.75 (CI 1.66-4.53)]. Additionally, fracture rate trended towards being lower in PES compared with SES [p = 0.063, OR 1.81 (CI 1.00-3.26)].
Aims: Recent studies of drug-eluting stents (DES) use in routine clinical practice have led to concern regarding their long-term safety and to questions about the adequacy of current antiplatelet therapy guidelines. We sought WR GHULYDWH D ULVN VFRUH IRU SUHGLFWLQJ VWHQW WKURPERVLV DIWHU GUXJ HOXWLQJ stenting. Methods and Results: The score was derived from the large single FHQWHU '(6 5HDOZRUOG ,QFUHPHQWDO 9DOXH LQ WKH HU$ RI SHUFXWDQHRXV UHYDVFXODUL]D7,21 '(5,9$7,21 GDWDEDVH FROOHFWLQJ GDWD DERXW patients of any age undergoing PCI with DES as treatment for symptomatic coronary artery disease. Logistic regression and boostrap procedure were used to select correlates of stent thrombosis that were subsequently weighted and integrated into an integer scoring system. Five variables selected from the initial multivariate model were weighted proportionally to their respective odds ratio for stent thrombosis (thienopyridines discontinuation [6 points], baseline left ventricular ejection fraction < 50% [4 points], bifurcation lesion [3 points], angioplasty in the setting of acute coronary syndromes [3 points], OHIWDQWHULRUGHVFHQGLQJDVWDUJHWYHVVHO>SRLQWV@7KUHHVWUDWDRIULVNZHUH GH¿QHG ORZULVNWR LQWHUPHGLDWHULVNWR KLJKULVN ZLWKJRRG prognostic accuracy for early, late and very late thrombosis (c statistic = 0.75, 0.72 and 0.74, respectively) in the derivation set. Conclusion: 7KH '(5,9$7,21 VFRUH PD\ EH XVHG DV D VLPSOH FOLQLFDO WRROIRUWKHLGHQWL¿FDWLRQRIDVL]DEOHFRKRUWLQZKRPFORVHPRQLWRULQJDQG DJJUHVVLYHWKHUDS\PD\EHEHQH¿FLDO TCT-332 5HDO:RUOG6DIHW\$QG(I¿FDF\2I7KH-DQXV7DFUROLPXV(OXWLQJ Stent: Long-Term Clinical Outcome And Angiographic Findings From The Tacrolimus-Eluting Stent (TEST) Registry Corrado Tamburino1, Maria E Di Salvo1, Davide Capodanno1, Piera Capranzano1, Rosario Parisi1, France sca Mirabella1, France sco Scardaci1, Gianpaolo Ussia1, Alfredo R Galassi1, Damiana Fiscella1, Roxana Mehran2, George Dangas2 1 Ferrarotto, Catania, Italy 2Columbia University Medical Center, New York, NY Objectives: We sought to evaluate the safety and performance of the Janus Tacrolimus-Eluting stent (TES) in an unselected population of patients, without application of restrictive clinical or angiographic criteria. Background:&RQWLQXHGDWWHQWLRQWRWKHVDIHW\HI¿FDF\DQGGHOLYHUDELOLW\ RI¿UVWJHQHUDWLRQ'(6KDVOHGWRWKHGHYHORSPHQWRIQHZDQWLSUROLIHUDWLYH
132i
The American Journal of Cardiology® |
October 12-17, 2008
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TCT Abstracts/ELECTRONIC
http://www.aievolution.com/tct0801
agents with alternative stent platforms and different drug carrier vehicles. Methods: The TEST (Tacrolimus Eluting STent) registry is a prospective, nonrandomized single-center registry in which 140 consecutive patients who underwent single- or multi-vessel percutaneous coronary intervention between February 2005 and August 2005 were enrolled. Results: The composite rate of major adverse cardiac events (MACE) at twenty-two months clinical follow-up was 40.9%. The rate of mortality, myocardial infarction and target lesion revascularization (TLR) were 5.5%, 11% and 31.5%, respectively. Angiographic follow-up at 8 months was achieved in 74% of patients; binary restenosis occurred in 39.4% of lesions. Most restenosis lesions (94.6%) had a diffuse pattern, while focal restenosis ZDV REVHUYHG LQ RI FDVHV 'H¿QLWH RU SUREDEOH VWHQW WKURPERVLV ZDV observed in 2.4% of patients. Neither TLR nor MACE statistically varied relative to diabetes, vessel diameter or lesion length. Conclusion: The present prospective, nonrandomized, TEST registry indicated high MACE and restenosis rates, and thereby rather discouraging ORQJWHUPRXWFRPHVZLWKXVHRIWKH-DQXV7(6LQDQXQVHOHFWHG³UHDOZRUOG´ population of patients who underwent single- or multi-vessel percutaneous coronary intervention.
NonDM (N = 5269) 6.4 9.7 (248) (339)
DM (N = 2563) MACE, %(n)
p-value <.001
Death, %(n)
4.1 (104) 1.7 (87) <.001
Cardiac death, %(n)
2.7 (70) 1.2 (65) <.001
MI (all), %(n)*
1.8 (47) 1.5 (81) 0.343
Q-wave MI, %(n)*
0.5 (12) 0.4 (19) 0.565
Non Q-wave MI, 1.4 (35) 1.2 (630 0.518 %(n)* Stent thrombosis (all), 1.6 (41) 0.8 (41) 0.001 %(n) 5.3 TLR, %(n) 4.0 (213) 0.012 (136) TLR (non-TL), %(n) 0.6 (15) 0.7 (37) 0.657 795 Q 79) Q
4.6 5.7 (147) 0.026 (240) 8.7 6.5 (341) <.001 (224)
IDDM (N = 644)
Non-IDDM (N = 1919)
12.6% (81/644) 6.7% (43/644) 4.5% (29/644) 1.7% (11/644) 0.2% (1/644) 1.6% (10/644) 2.3% (15/644) 6.5% (42/644) 0.5% (3/644) 7.0% (45/644) 11.0% (71/644)
8.7% (167/1919) 3.2% (61/1919) 2.1% (41/1919) 1.9% (36/1919) 0.6% (11/1919) 1.3% (25/1919) 1.4% (26/1919) 4.9% (94/1919) 0.6% (12/1919) 5.3% (102/1919) 8.0% (153/1919)
p-value 0.005 <.001 0.003 0.867 0.315 0.695 0.102 0.127 0.774 0.118 0.019
TCT-333
YHUL¿HGE\(&*DQGHQ]\PHV
12 -Month Outcomes In Patients With Diabetes Implanted With A Zotarolimus Drug-Eluting Stent: Results From The E-FIVE Registry
Conclusion: 7KH (),9( 5HJLVWU\ HQUROOHG KLJK ULVN SDWLHQWV WKDW ZRXOG have been excluded from randomized controlled trials. In this diabetic cohort including 36% of patients with unstable angina, 19% with a recent MI, treated with multiple stents, 12-month MACE rates were highly comparable to other reported results. These data represent a real-world report of the use RI WKH (QGHDYRU =(6 LQ KLJKULVN GLDEHWLF SDWLHQWV IURP DQ ³DOOFRPHUV´ population.
Martin T Rothman1, Ian T Meredith2, Minglei Liu3, Chaim Lotan4, For the E-FIVE Registry Investigators 1 Barts and The London National Health Service Trust, London, United Kingdom 2Monash Medical Centre, Southern Health, Melbourne, Victoria, Australia 3Medtronic CardioVascular, Santa Rosa, CA; 4 Hadassah-Hebrew University Medical Center, Jerusalem, Israel Background:'LDEHWLFSDWLHQWVKDYHDQLQFUHDVHGULVNRIUHVWHQRVLVDQGRWKHU major adverse cardiovascular events. The Endeavor zotarolimus-eluting stent (ZES) has been shown to be safe and effective for the treatment of single, de novo lesions, in randomized controlled trials that included patients with diabetes mellitus (DM). We evaluated the effectiveness of the Endeavor ZES LQGLDEHWLFSDWLHQWVLQDUHDOZRUOGSRSXODWLRQLQWKH(),9(5HJLVWU\ Methods:7KH(),9(5HJLVWU\LVDSURVSHFWLYHPXOWLFHQWHUQRQUDQGRPL]HG global registry that enrolled 8314 patients at 188 centers in Europe, South America, Australia, New Zealand and Asia. All patients presenting with symptomatic coronary artery disease amenable to stent implantation were eligible for the study. Event data at 12 months was compared between DM and non-DM patients, and between insulin-dependent (IDDM) and nonIDDM (NIDDM) patients. All MACE events were adjudicated by a Clinical Events Committee. Results:2IWKHSDWLHQWVZLWKPRQWKIROORZXSDVLJQL¿FDQWSURSRUWLRQ ZHUHKLJKULVNZLWKFRPSOH[OHVLRQVLQFOXGLQJZLWK'0RIZKLFK had IDDM. Key baseline characteristics and clinical outcomes are presented in Table. Non-DM (n = 5593 patients/ 6884 lesions)
p-value
30.7 35.6 19.4 78.6 67.7 44.7 60.8 16.0
19.8 33.1 23.0 63.7 60.8 47.5 60.0 16.7
<.001 <.001 0.023 <.001 <.001 <.001 0.007 0.418 0.369
0.319
Long-term Use of Clopidogrel Is Associated with a Reduced Risk for Very Late Stent Thrombosis Following Drug-eluting Stent Implantation in Real-world Registry Jin Won Kim, Jae Hyoung Park, Jin Oh Na, Cheol Ung Choi, Sang-Gi Moon, Byung Won Cheon, Eung Ju Kim, Seung-Woon Rha, Chang Gyu Park, Hong Seog Seo, Dong Joo Oh Cardiovascular Center, Korea University Guro Hospital, Seoul, Republic of Korea Background: There is mounting evidence that delayed endothelialization after drug-eluting stent (DES) implantation may lead to very late stent WKURPERVLV 67 DQGUHODWHGFDWDVWURSKLFHYHQWV+RZHYHUWKHULVNRIYHU\ late ST following cessation of clopidogrel in patients with DES in real-world SUDFWLFHUHPDLQVOHVVGH¿QHG Methods: A total of 1031 consecutive patients (male 66.6 %, mean age 62.2 \HDUVGLDEHWHV WUHDWHGZLWKDWOHDVW'(6 &\SKHUTM 64 %, TaxusTM 16 %, EndeavorTM 13.0 %, combination 7 %) from January 2003 to May 2007, were analyzed in a single academic center. Stent thrombosis was GH¿QHGDFFRUGLQJWR$FDGHPLF5HVHDUFK&RQVRUWLXP $6& GH¿QLWLRQ Results: Clopidogrel was discontinued after 1-year of DES implantation in 24.8 %, 256/1031 of patients. The complex lesions (aorto-ostial, multiple stent, chronic total occlusion, and bifurcation using two stents) were more common LQFORSLGRJUHOVWD\JURXSWKDQLQZLWKGUDZDOJURXS S :HLGHQWL¿HG SDWLHQWV RIWKHWRWDOSDWLHQWVWUHDWHGZLWK'(6 ZLWKGH¿QLWHYHU\ ODWH67 PDOHPHDQDJH\HDUV 7KHLQFLGHQFHRIYHU\ODWH 67ZDVVLJQL¿FDQWO\KLJKHULQSDWLHQWVZKRZLWKGUHZFORSLGRJUHODIWHU\HDU administration compared to those who stayed on clopidogrel (3.13 %, 8/256 vs. 0.26 %, 2/775, p<0.001) (Figure 1). Among the patients with very late ST, the single agent (aspirin 2, cilostazol 3, sarpogrelate 1) were used in 6 patients (6/10, 60 %) (Figure 2).
Clinical Outcomes
The American Journal of Cardiology®
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October 12-17, 2008
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$JHPHDQ6' Female, % Unstable angina, % Recent MI (< 72 hrs), % Hypertension, % Hyperlipidemia, % Target vessel: LAD, % B2/C Lesions Bifurcations, % Number of stents LPSODQWHGPHDQ6'
DM (n = 2721 patients/ 3455 lesions)
TCT-334
http://www.aievolution.com/tct0801
Conclusion: Long-term use of dual anti-platelet regimen of aspirin and clopidogrel beyond 1-year in patients with DES could be associated with a UHGXFHGULVNIRUYHU\ODWH67LQUHDOZRUOGSUDFWLFH TCT-335 &RPSDULVRQRI/RQJ7HUP&OLQLFDO2XWFRPHVLQ3DWLHQWV5HFHLYLQJ 30mm of Drug Eluting Stent(s) versus Bare Metal Stent(s) in a Single Coronary Vessel
E L E C T RO N I C A B S T R AC T S
Hong S Jeong, Anthony J Minisi Virginia Commonwealth University, Glen Allen, VA Objective: Multiple or long stents are often needed to treat multi-focal or diffuse lesions. Purpose of this study was to compare long-term clinical RXWFRPHVLQSDWLHQWVWUHDWHGZLWKPPRIHLWKHUEDUHPHWDOVWHQW V %06 or drug eluting stent(s) (DES) in a single coronary vessel. Methods:$WRWDORIFRQVHFXWLYHSDWLHQWVZKRUHFHLYHGPPRIVWHQW V LQDVLQJOHFRURQDU\YHVVHOZHUHLGHQWL¿HGWKURXJKUHWURVSHFWLYHUHYLHZRI UHFRUGVIURP-DQWR'HFDWD9HWHUDQV$IIDLUPHGLFDOFHQWHU of these patients received BMS and 175 patients received DES. 19 patients who received both BMS and DES were excluded from the study. Average IROORZXSGXUDWLRQIRU%06JURXSZDVPRQWKVDQGDYHUDJHIROORZXS GXUDWLRQIRU'(6JURXSZDVPRQWKV&OLQLFDORXWFRPHV GHDWKDFXWH myocardial infarction, target vessel revascularization, and cardiac admission) post index procedures were recorded for analysis. Results: DES group had higher prevalence of diabetes, hyperlipidemia, and peripheral vascular disease. BMS group had higher frequency of prior myocardial infarction. Cardiac mortality rate for DES group was 3.4% compared to 9.3% for %06JURXS S 7KHUHZDVDVLJQL¿FDQWUHGXFWLRQRIDFXWH0,LQ'(6JURXS (5.1% vs. 14.0%; p=0.009). Target vessel revascularization was also reduced in '(6JURXS YV S '(6JURXSKDGVLJQL¿FDQWOHVVFDUGLDF admission post index procedure (33.1% vs. 61.9%; p<0.0001), as well as, less episodes of recurrent angina (37.7% vs. 51.3%; p=0.02). Conclusion: )RU SDWLHQWV UHFHLYLQJ PP RI VWHQW V IRU WUHDWPHQW RI multi-focal or diffuse lesion in a single coronary vessel, implantation of DES lead to decreased cardiac mortality, myocardial infarction, target vessel revascularization, cardiac admission, and recurrent angina over BMS. TCT-336 (LJKWHHQPRQWK06&7IROORZXSUHVXOWVRID¿UVWLQPDQXVHRID Bioabsorbable Everolimus Eluting Stent Design Nico Bruining, Masato Otsuka, Yoshi Onuma, Evelyn Regar, Annick Weustink, Koen Nieman, Patrick J W C Serruys Erasmus MC, Rotterdam, Netherlands Objective: Bioabsorbable drug-eluting stents (DES) could theoretically overcome problems related to permanent metallic DES (no remodeling, no vasomotion, no dual antiplatelet therapy, fracture, etc.). One of the problems UHODWHG WR PHWDO VWHQWV LV WKH GLI¿FXOW\ WR YLVXDOL]H WKH OXPHQ LQ VWHQWHG segments by non-invasive multi-slice computed tomography (MSCT) imaging. This study explores the feasibility to apply quantitative MSCT in a ¿UVWLQPDQVWXG\RIDQHZJHQHUDWLRQRIELRDEVRUEDEOHVWHQWGHVLJQV %96 $EERWW9DVFXODU6DQWD&ODUD&$86$ Methods and results: ,QSDWLHQWV%96VWHQWVZHUHLPSODQWHGLQVLQJOHOHVLRQV
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(15 * 12mm and 1 * 18 mm length) of which in 10 quantitative MSCT was DYDLODEOH'URSRXWVZHUHFDXVHGE\ FRQWUDVWDOOHUJ\ SRRUNLGQH\IXQFWLRQ (1), motion artifacts on MSCT (1) and not returning for follow-up (FUP) (3). 4XDQWLWDWLYH 06&7 DQDO\VLV ZDV SHUIRUPHG XVLQJ GHGLFDWHG VRIWZDUH 9HVVHO DQDO\VLV &85$' :LMN ELM 'XXUVWHGH 1HWKHUODQGV 6WHQW OHQJWKV PHDVXUHG ZHUHPPDWEDVHOLQH %/ YV PPDW)83S /XPHQ YROXPHVZHUH PP3 %/ YV PP3 (FUP), p=0.11 (-10.33%), UHVSHFWLYHO\0HDQOXPHQDUHDV 0/$ PP2YV PP2, p=0.1 DQGPHDQOXPHQGLDPHWHUV 0/' PPYV PP S 7KHPHDQYHVVHODUHDZDVPP2YV PP2, S DQGWKHPHDQSODTXHDUHD PP2YVPP2, p=0.74 &RPSDUHGWRTXDQWLWDWLYH,986PHDVXUHGDW%/DQGPRQWKV 0 )83 LQWKHVDPHSDWLHQWVQRVLJQL¿FDQWGLIIHUHQFHLQPHDVXUHPHQWVRUDFKDQJHLQ PHDVXUH FRXOG EH GRFXPHQWHG 7KH ,986 PHDVXUHPHQWV DW %/ ZHUH 0/$ PP2 DQG 0/' PP DQG DW 0 0/$ PP2 and 0/'PPUHVSHFWLYHO\ Conclusion: Non-invasive imaging of bioabsorbable stents seems feasible without artifacts as encountered with metallic stent designs. Compared to 0,986DUHODWLYHVLPLODUOXPHQUHGXFWLRQZDVIRXQGGHVSLWHDPRQWK GLIIHUHQFHEHWZHHQWKHPHDVXUHPHQWV$PRQWKV,986)83LVLQSURJUHVV DQGFRXOGFRQ¿UPWKHTXDQWLWDWLYH06&7UHVXOWVDWPRQWKV TCT-337 12-Month Clinical Outcome with the Endeavor™ ABT-578 Eluting Coronary Stent System in Patients Undergoing Primary PCI For ST Elevation Myocardial Infarction (STEMI): THE ENDEAVOR™ PRIMARY PCI STUDY (E-PPCI) Kamal Chitkara, Ravi Singh, Mischa Dorsch, Kathryn Somers, Claire Priestley, Jim Mclenachan, Jonathan Blaxill, Steve Wheatcroft, Dan Blackman, John Greenwood Yorkshire Heart Centre, Leeds, United Kingdom Background: Primary percutaneous coronary intervention (PPCI) is superior to thrombolysis in patients with STEMI. Drug-eluting stents (DES) have been shown to be superior to bare metal stents for reduction of instent-restenosis. 'DWD RQ ODWH VWHQW WKURPERVLV ! GD\V KDV UDLVHG FRQFHUQV UHJDUGLQJ '(6SODFHPHQWLQSDWLHQWVZLWK$&6:HUHSRUWWKH¿UVWPRQWKFOLQLFDO evaluation of the Medtronic Endeavor™ ABT-578 eluting coronary stent system in patients undergoing PPCI. Methods: A prospective, single-centre registry of consecutive patients admitted with STEMI was performed. All underwent PPCI within 12 hours of symptoms; each received one or more Endeavor™ stents in one or more target lesions. All received clopidogrel 600mg and aspirin 300mg pre-procedure followed by 75mg each for 12 months. All patients received abciximab and XQIUDFWLRQDWHGKHSDULQ ,8NJ Results: 102 STEMI patients (76 male) received 162 Endeavor™ stents (mean VWHQWVSDWLHQW $JHUDQJH\UV PHDQ\UV 5LVNIDFWRUSUR¿OH comprised 29% hypertension, 25% hyperlipidaemia and 11% diabetes. Mean call-to-balloon time was 112 (+/-45) minutes. The infarct related artery was the LAD in 49%, LCx in 16% and RCA in 35% of patients. Major Adverse &DUGLRYDVFXODU(YHQWUDWH 0$&( ZDVGH¿QHGDVDFRPSRVLWHHQGSRLQWRI death, recurrent MI and target lesion revascularization (TLR). Thirty-day 0$&(UDWHZDV Q FRPSULVLQJGHDWKV GD\ DQG7/5¶VDV a result of sub-acute stent thrombosis (days 9 & 11). One early stent thrombosis was associated with aspirin and clopidogrel non-compliance. MACE rate at PRQWKVZDV Q 7KHUHZHUHDGGLWLRQDO7/5¶VDWGD\V IRU late stent thrombosis) and 267 (for instent restenosis) respectively. There was 1 death on day 345 related to a non-cardiac cause. Conclusion: 7KLVLVWKH¿UVW\HDUUHSRUWRIWKHXVHRIWKH(QGHDYRU'(6 platform in an unselected, consecutive PPCI population. The low occurrence of MACE (6.9%) at 12-month follow-up is comparable to that of sirolimus (Cypher™; TYPHOON study - 7.3%) and paclitaxel (Taxus™; PASSION study - 8.8%) eluting stents. Longer-term follow-up is necessary to monitor rates of very late stent thrombosis.
The American Journal of Cardiology® |
October 12-17, 2008
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TCT Abstracts/ELECTRONIC
http://www.aievolution.com/tct0801
TCT-338
TCT-339
Acute and 1-year Outcomes of Endeavor TM and Xience VTM Stents in the Real World
A Randomized Comparison of Sirolimus-Eluting Stent and Paclitaxel-Eluting Stent in Diabetic Patients: 2-year Clinical Outcomes of DES-DIABETES Trial
Franco Fabbiocchi, Margherita Pirondini, Stefano De Martini, Giuseppe Calligaris, Daniela Trabattoni, Paolo Ravagnani, Stefano Galli, Alessandro Lualdi, Piero Montorsi, Antonio L Bartorelli Centro Cardiologico Monzino IRCCS, Milan, Italy
Seong-Wook Park1, Seung-Whan Lee1, Young-Hak Kim1, Sung-Cheol Yun1, Duk-Woo Park1, Cheol Whan Lee1, Myeong-Ki Hong1, Kyoung-Suk Rhee2, Jei Keon Chae2, Jae-Ki Ko2, Jae-Hyeong Park3, Jae-Hwan Lee3, Si Wan Choi3, Jin-Ok Jeong3, In-Whan Seong3, Yoon Haeng Cho4, NaeHee Lee4, June Hong Kim5, Kook-Jin Chun5, Hyun-Sook Kim6, SeungJung Park1 1 Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea 2Chonbuk National University Hospital, JeonJoo, Republic of Korea 3Chungnam National University Hospital, DaeJeon, Republic of Korea 4Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea 5Busan National University Hospital, Busan, Republic of Korea 6Hallym University Sacred Heart Hospital, Pyeongchon, Republic of Korea
Background: Second generation DES deliver sirolimus-analogue drugs by PRUHELRFRPSDWLEOHSRO\PHUVDQGÀH[LEOHFREDOWFURPLXPSODWIRUPV,QVSLWH of potential improvement in PCI acute results and safety, few data substantiate VHFRQG JHQHUDWLRQ '(6 HI¿FDF\ LQ WKH UHDO ZRUOG Purpose. To analyze acute and 1-year outcomes of EndeavorTM-zotarolimus-eluting (Medtronic, 0LQQHDSROLV01 ( DQG;LHQFHTM9HYHUROLPXVHOXWLQJ $EERW9DVFXODU 6DQWD&ODUD&$ ; VWHQWLPSODQWDWLRQLQFRPSOH[OHVLRQVSDWLHQWV Methods: Between October 2006 and May 2007, 400 unselected pts. with symptomatic coronary artery disease were enrolled: 200 consecutive pts. KDG ( DQG FRQVHFXWLYH SWV KDG ; VWHQWV 'HPRJUDSKLFV DQG FOLQLFDO presentations were similar in both groups, with no difference in diabetes (YV; PXOWLYHVVHOGLVHDVH (YV; %&OHVLRQV LQ(YVLQ; VWDEOH (YV; DQGXQVWDEOHDQJLQD (YV ; $0, (YV; Results: 7ZR KXQGUHG ¿IW\RQH FRURQDU\ OHVLRQV ZHUH WUHDWHG ZLWK ( VWHQWVDQGOHVLRQVZLWK;VWHQWV VWHQWOHVLRQUDWLRZDV(YV; PHDQVWHQWOHQJWKZDV PPLQ(YV PPLQ;RYHUODSSLQJZDV SHUIRUPHGLQ (YV;OHVLRQV DOOS QV ,QKRVSLWDO0$&(ZHUH QRQ40,LQ(YV LQ; SWZLWKFDUGLRJHQLFVKRFNDWSUHVHQWDWLRQ GLHGLQ;7DEOH,VKRZV\HDUSRVWGLVFKDUJHQHZ0$&( Table I All Death
EndeavorTM stent
;LHQFH709VWHQW
p value
6 (3%)
0 (0%)
0.014
Cardiac Death
3 (1.5%)
0 (0%)
ns
AMI
7 (3.5%)
0 (0%)
0.008
TLR
14 (7%)
4 (2%)
0.016
Re-PCI
12 (6%)
4 (2%)
0.041
CABG
2 (1%)
0 (0%)
ns
LST
1 (0.5%)
1 (0.5%)
ns
Composite MACE
19 (9.5%)
4 (2%)
0.001
One-year post-discharge new MACE
Conclusion:%RWK(DQG;VWHQWVVKDUHVLPLODUH[FHOOHQWDFXWHUHVXOWVLQWKH UHDOZRUOGFRPSOH[OHVLRQVSDWLHQWV$W\HDUIROORZXS;VWHQWLVDVVRFLDWHG ZLWKDVLJQL¿FDQWORZHUUDWHRI$0,7/5DQGFRPSRVLWH0$&(
TCT-340 Comparison of Therapeutic Strategy for the Treatment of SirolimusEluting Stent Restenosis Kiyotake Ishikawa1, Yutaka Aoyama1, Hirayama Haruo1, Katsuhiro Katou2,3, Masayoshi Ajioka3, Akihito Tanaka4, Toshikazu Tanaka4, Mizuho Hiramatsu5, Haruo Kamiya5, Toyoaki Murohara2 1 Nagoya Daini Red Cross Hospital, Nagoya, Japan 2Nagoya University School of Medicine, Nagoya, Japan 3Tousei Hospital, Seto, Japan 4 Okazaki City Hospital, Okazaki, Japan 5Nagoya Daiichi Red Cross Hospital, Nagoya, Japan Background: The optimal treatment for Sirolimus-eluting stents (SES) UHVWHQRVLVLVXQNQRZQ:HVRXJKWWRLQYHVWLJDWHWKHRXWFRPHVRIUHSHDWLQJ revascularization for SES restenosis and the difference between the procedures. Methods: Revascularizations to SES restenosis in 4 cardiovascular centers in $LFKLSUHIHFWXUH-DSDQZHUHLGHQWL¿HGUHWURVSHFWLYHO\ Results: One hundred seventy-seven SES restenosis in 151 patients (mean age 66.4 +/- 9.5, 77% male) was treated by balloon angioplasty (BA), bare
The American Journal of Cardiology®
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TCT Abstracts/ELECTRONIC
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E L E C T RO N I C A B S T R AC T S
Background: 'UXJHOXWLQJ VWHQW LPSODQWDWLRQ VLJQL¿FDQWO\ LPSURYHG WKH angiographic and long-term clinical outcomes compared with bare-metal stent implantation in diabetic patients, mainly driven by reduced target lesion revascularization. However, comparison of long-term clinical outcomes between sirolimus-eluting stent (SES) with paclitaxel-eluting stent (PES) in GLDEHWLFSDWLHQWVKDVQRWEHHQVXI¿FLHQWO\HYDOXDWHG Methods: This prospective, multicenter, randomized study compared SES (n=200) and PES implantation (n=200) for diabetic patients (n=400). We compared the long-term clinical outcomes (death, myocardial infarction, and target lesion revascularization) between two groups. Results: The 2 groups had similar baseline clinical and angiographic characteristics. Six-month angiographic restenosis (4.0% vs. 20.8%, p<0.001), 9-month target lesion revascularization (2.0% vs. 7.5%, p=0.017) and major adverse cardiac events (2.0% vs. 8.0%, p=0.010) including death, myocardial LQIDUFWLRQDQGWDUJHWOHVLRQUHYDVFXODUL]DWLRQZHUHVLJQL¿FDQWO\ORZHULQ6(6 versus PES group. At 2 years, there was no difference in the incidence of death (0% vs. 1.5%, p=0.248) and myocardial infarction (0.5% vs. 1.0%, p=0.999). However, the target lesion revascularization (3.5% vs. 11.0%, p=0.004) and PDMRU DGYHUVH FDUGLDF HYHQWV YV S ZHUH VLJQL¿FDQWO\ lower in SES versus PES group. Two stent thromboses (1 acute, 1 very late) occurred in the SES group during dual antiplatelet therapy and none in the PES group. Conclusion: SES implantation is superior to reducing 2-year target lesion revascularization and improving 2-year clinical outcomes in patients with DM and coronary artery disease compared to PES implantation.
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metal stent implantation (BMS), repeated drug eluting stent implantation (DES) or coronary artery bypass graft (CABG) (55 (31.1%), 3 (1.7%), 101 (57.1%), 17(9.6%); respectively). In total follow up period of 361 +/- 270 days, 28 major advanced cardiovascular events were seen (2 cardiac death, 4 noncardiac death, 2 thrombosis, 20 target lesion revascularization) and follow up coronary angiography was performed in 110 cases (BA 42, BMS 3, DES 59, CABG 13). The proportion of re-restenosis, re-target legion revascularization, and re-target vessel revascularization was lower in CABG group (7.7%, 7.7%, 7.7%, respectively; P=0.007) compared with BA group (45.2%, 26.2%, 26.2%, respectively), or DES group (55.9%, 25.4%, 35.6%, respectively). No VLJQL¿FDQWGLIIHUHQFHUHJDUGLQJEDFNJURXQGVDQGOHVLRQFKDUDFWHULVWLFVZDV seen between patients with and without re-restenosis. Conclusion: SES restenosis presents quite high rate of re-restenosis with percutaneous coronary intervention (PCI) and CABG seems to be the best way to avoid repeat revascularization. Implanting another DES has no advantage to BA when treated with PCI. TCT-341 Prognostic Impact of Preprocedural Levels of C-Reactive Protein on Stent Thrombosis After Coronary Stent Implantation
E L E C T RO N I C A B S T R AC T S
Keiji Inoue, Naoki Makita, Kiyonari Matsuo, Yasutsugu Shiono, Kento Tateishi, Yoshiharu Nishibori, Akiko Matsuo, Tetsuya Tanaka, Hiroshi Fujita, Makoto Kitamura Kyoto Second Red Cross Hospital, Kyoto, Japan Background: Stent thrombosis (ST) is the most concerning adverse outcome of coronary stent placement, frequently presenting as acute myocardial infarction or death. Although the safety concerns regarding ST have EHHQ UDLVHG WKH DFFXUDWH ULVN SUHGLFWLRQ DQG VWUDWL¿FDWLRQ IRU WKHVH HYHQWV after percutaneous coronary intervention (PCI) still remain challenging. ,QÀDPPDWRU\PHFKDQLVPVPD\SOD\DFUXFLDOUROHLQWKHVWHQWWKURPERVLV &UHDFWLYH SURWHLQ &53 D PDUNHU RI V\VWHPLF LQÀDPPDWLRQ KDV EHHQ FRQVLVWHQWO\DVVRFLDWHGZLWKDQLQFUHDVHGULVNRIFDUGLRYDVFXODUHYHQWV:H therefore evaluated whether elevated preinterventional CRP levels were UHODWHGWRDQLQFUHDVHGULVNRI67DIWHUVWHQWLPSODQWDWLRQ Methods::HVWXGLHGFRQVHFXWLYHSDWLHQWV PHDQDJH \UV ZKR XQGHUZHQW VXFFHVVIXO VWHQW LPSODQWDWLRQ %ORRG VDPSOHV ZHUH WDNHQ EHIRUH PCI to evaluate baseline CRP. The subjects were divided into two groups of elevated CRP group (group E) and non-elevated CRP group (group N) according to the median value of baseline CRP for data analysis. The primary HQGSRLQWRIWKHVWXG\ZDVGH¿QLWH677KHVHFRQGDU\HQGSRLQWZDVGH¿QHG as cardiac death due to ST. Results: The median value of baseline CRP was 2.09mg/L in all patients. 'XULQJWKH\HDUIROORZXSGH¿QLWH67ZDVREVHUYHGLQ FDVHV DQG67UHODWHGGHDWKZDVVHHQLQFDVHV 7KHUHZDVQRVLJQL¿FDQW difference of ST rate between bare metal stent cases and drug eluting stent FDVHV3DWLHQWVRIJURXS( Q ZLWKKLJKHUVHUXPOHYHOVRI&53 PJ/ KDGDVLJQL¿FDQWO\KLJKHULQFLGHQFHRIVWHQWWKURPERVLVDVFRPSDUHGWR those of group N (n=1,256) with lower serum levels of CRP (1.83% vs. 0.48%, S $OVRWKHUDWHRIGHDWKDIWHU67RIJURXS(ZDVVLJQL¿FDQWO\KLJKHU than those of group N (0.71% vs. 0.16%, p=0.0349). Conclusion: (OHYDWHG SUHSURFHGXUDO OHYHOV RI &53 ZHUH VLJQL¿FDQWO\ associated with the development of ST and ST related death. Baseline CRP OHYHOV PD\ EH XVHIXO WR SUHGLFW FOLQLFDO ULVN RI 67 LQ SDWLHQWV WUHDWHG ZLWK coronary stents.
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TCT-342 Predictive Value of Preinterventional C-reactive Protein Levels on Long Term Angiographic and Clinical Outcomes after SirolimusEluting Stent Implantation Keiji Inoue, Naoki Makita, Kiyonari Matsuo, Yasutsugu Shiono, Kento Tateishi, Yoshiharu Nishibori, Akiko Matsuo, Tetsuya Tanaka, Hiroshi Fujita, Makoto Kitamura Kyoto Second Red Cross Hospital, Kyoto, Japan Background:$IWHUSHUFXWDQHRXVFRURQDU\LQWHUYHQWLRQ 3&, LQÀDPPDWRU\ mechanisms play a crucial role in the restenosis. However, possible role of LQÀDPPDWLRQLQUHVWHQRVLVDIWHUGUXJHOXWLQJVWHQWVKDVQRWEHHQHVWDEOLVKHG We assessed the association of preprocedural C-reactive protein (CRP) levels with angiographic restenosis and adverse clinical events after Sirolimuseluting stent (SES) implantation. Methods: :H VWXGLHG FRQVHFXWLYH SDWLHQWV PHDQ DJH \UV ZKR XQGHUZHQWVXFFHVVIXO6(6LPSODQWDWLRQ%ORRGVDPSOHVZHUHWDNHQEHIRUH3&, to evaluate CRP and patients were grouped into quartile according to baseline &53YDOXHVIRUGDWDDQDO\VLV7KHSULPDU\HQGSRLQWZDVDPDMRUHYHQWGH¿QHG as cardiac death or Q-wave myocardial infarction. The secondary end point was GH¿QHGDVUHVWHQRVLVUHTXLULQJUHSHDWUHYDVFXODUL]DWLRQDWPRQWKIROORZXS Results: Baseline clinical and angiographic characteristics were similar between the quartile groups. At 1-year follow-up, primary end point occurred in 1 (1.3%) patient of the third quartile and in 5 (6.5%) patients of the highest quartile whereas no major cardiac event occurred in the lowest quartile and second quartile (p<0.005). Restenosis were observed in 38 patients (12.3%) of total subjects at PRQWK IROORZXS %LQDU\ UHVWHQRVLV UDWHV ZHUH UHPDUNDEO\ ORZHU LQ WKH ¿UVW quartile group compared with the second, third and fourth quartile groups (3.8% in quartile I vs. 12.2% in quartile II vs. 16.7% in quartile III vs 16.9% in quartile ,9UHVSHFWLYHO\S ,QVWHQWODWHORVVZHUHORZHULQWKH¿UVWTXDUWLOHDPRQJ JURXSV YV YVYV UHVSHFWLYHO\S The correlation between late loss index and pre-procedure CRP showed positive proportion (y=0.2691x + 0.0103; R=0.202, p<0.001). In multivariate analysis, the higher quartile of CRP levels was an independent predictor of a major cardiac event and subsequent restenosis. Conclusion: 3UHSURFHGXUDO &53 OHYHOV DUH VLJQL¿FDQWO\ DVVRFLDWHG ZLWK cardiac events and angiographic restenosis after SES implantation. Baseline &53OHYHOVPD\EHXVHIXOWRSUHGLFWFOLQLFDOULVNLQSDWLHQWVWUHDWHGZLWK6(6 TCT-343 Biolimus A9 Eluting Self Expandable Designated Bifurcation Stent in a Porcine Coronary Model: Structural Integrity and Biocompatibility in Comparison to Overlapping Cypher Stents Greg L Kaluza1, Gerard B Conditt1, Akira Murata1, Shigenobu Inami1, David Wallace-Bradley1, Kai Xu1, Geng Hua Yi1, Jennifer C McGregor1, Armando Tellez1, Brett Trauthen2, Frank Kolodgie3, Renu Virmani3, Juan F Granada1 1 Cardiovascular Research Foundation, Orangeburg, NY; 2Devax, Inc., Menlo Park, CA; 3CV Path, Gaithersburg, MD Background:7KH$;;(66VWHQW $[%$ LVDQRYHOVHOIH[SDQGDEOHGHYLFH aiming at more anatomically correct reconstruction of the bifurcation than the current techniques using overlapping tubular stents. It features a conical shape covering the entire proximal bifurcation area down to the carina, and can be complemented with conventional stents in the distal parent vessel and in the side branch. It is coated with a bioresorbable (polylactic acid) top coat eluting Biolimus A9 (~22 -g/mm of stent length). Methods: This study evaluated the structural integrity of AxBA9 deployed in a bifurcation and overlapped by Cypher (SES) in a distal parent vessel. Furthermore, it compared the mechanical and biological consequences of stent-stent interaction of 2 different overlapped stents (AxBA9-SES) to 2 identical overlapped (SES) stents. In 11 Yucatan miniswine, overlapping $[%$ 6(6VWHQWVZHUHSODFHGLQELIXUFDWLRQVRI/$'RU/&;ZKLOH
The American Journal of Cardiology®
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October 12-17, 2008
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TCT Abstracts/ELECTRONIC
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TCT-345
other single straight arteries received 2 sequentially overlapped SES. At 90 days, angiography was performed and arteries were harvested for histology. Results: Two stent fractures in the SES-SES combinations were found as RSSRVHGWRQRQHLQWKH$[%$ 6(6FRPELQDWLRQV,QÀDPPDWRU\UHVSRQVH was slightly lower in the AxBA9-SES combination (39% of struts had presence of granulomas) than in the SES-SES combination (61% of struts had presence of granulomas). Granulomas were associated with the presence of SES as the struts with granulomas were found predominantly in the overlap sections, and with similar frequency in both stent combinations. Whereas, WKHUHZHUHVLJQL¿FDQWO\OHVVJUDQXORPDVLQWKHSUR[LPDOVHFWLRQVRIWKH$[[HVV BA9 sections when compared to all the SES-SES stented sections. AxBA96(6FRPELQDWLRQVIHDWXUHGVLPLODUQHRLQWLPDOWKLFNQHVVHVWRWKH6(66(6 combination in the overlapping zone. The remaining sections proximal and distal to the overlap for the AxBA9-SES groups as well as the Cypher-Cypher combination showed similar area measurements. Conclusion: The $;;(66%LROLPXV$ VHOIH[SDQGLQJQLWLQROELIXUFDWLRQ stent overlapped distally with Cypher demonstrated excellent structural integrity (no fractures), while showing at least comparable biocompatibility WRWKHRYHUODSSHGEHQFKPDUN&\SKHUVWHQWVRXWWR GD\V
Pooled Analysis of CUSTOM II and III Trials: Six-Month IVUS Analysis of Very Long Lesions Treated with the Custom NX Biolimus-A9 Eluting Stent Takao Shimohama1, Junya Ako1, Daisaku Nakatani1, Katsuhisa Waseda1, Hyeonsoo Chang1, Paul G. Yock1, Yasuhiro Honda1, Bernard De Bruyne2, Eberhard Grube3, Peter J. Fitzgerald1 1 Stanford University Medical Center, Stanford, CA; 2Cardiovascular Center, OLV Clinic, Aalst, Belgium 3HELIOS Heart Center Siegburg, Siegburg, Germany Background:7KH&XVWRP1;V\VWHPFRQVLVWVRID%LROLPXV$ HOXWLQJVWHQW on a bioabsorbable polymer with interdigitating design which allows operators to customize stent length in 6 mm cobalt-chromium modular units up to 60 mm. The DLPRIWKLV,986VWXG\ZDVWRHYDOXDWHWKHHI¿FDF\RIWKH&XVWRP1; ;7(17 ,QF LQWKHWUHDWPHQWRIYHU\ORQJOHVLRQV OHVLRQOHQJWK!PP Methods: Data were obtained from the CUSTOM II and III trials; prospective, PXOWLFHQWHUVWXGLHVGHVLJQHGWRDVVHVVVDIHW\DQGHI¿FDF\RIWKLVVWHQWV\VWHP 6L[PRQWKVIROORZXSYROXPHWULF,986DQDO\VLVZDVDYDLODEOHLQSDWLHQWV OHVLRQV /HVLRQVZHUHGLYLGHGLQWRJURXSV /RQJ !PPQ DQG 6KRUW PP Q 9ROXPH LQGH[ YROXPHOHQJWK ZDV FDOFXODWHG IRU YHVVHOOXPHQVWHQWDQGQHRLQWLPD 1,9 Results:'HVSLWHYHU\ORQJOHVLRQVDQGVWHQWOHQJWK1,9 1,9VWHQWYROXPH was <10% in the Long group. There was no difference in minimum lumen area at follow-up between the 2 groups. There were 5 cases of stent strut discontinuity (Long: n=1, Short: n=4) between the segments yet no lumen loss was observed at that location in any of the cases. Late-acquired incomplete stent apposition was not observed in either group.
TCT-344 Directional Sirolimus Biodegradable Abluminal Coating and Anti&'6XUIDFH0RGL¿FDWLRQ (DUO\$QLPDO'DWDRQ9DVFXODU+HDOLQJ and Restenosis Juan F Granada1, Carlos L Alviar1, Martin B Leon2, Greg L Kaluza1, Armando Tellez1, David Wallace-Bradley1, Stephen Rowland3, Sherry P Parker3, Frank Kolodgie4, Gaku Nakazawa4, Renu Virmani4 1 Cardiovascular Research Foundation, Orangeburg, NY; 2 Cardiovascular Research Foundation, New York, NY; 3Orbus Neich, Fort Lauderdale, FL; 4CV Path, Gaithersburg, MD
Lesion length, mm
Background: Previous studies with anti-CD34 coating on sirolimus-eluting stents resulted in enhanced endothelialization, but not expression of functional HQGRWKHOLDOPDUNHUV 3(&$0 GXHWRWKHHIIHFWVRIVLUROLPXVRQFDSWXUHG cells. The hypothesis is that separation of the EPC capture effect from drug delivery (i.e. by applying the drug and polymer to the abluminal surface of the stent) would result in both enhanced endothelialization and function (expression of PECAM at endothelial junctions); and still preserve the effect of sirolimus on neointimal proliferation. Methods: A total of 35 stents: 18 R stents with preferential sirolimus ELRGHJUDGDEOH DEOXPLQDO FRDWLQJ DQG DQWL&' VXUIDFH PRGL¿FDWLRQ $E& stent) and 17 R stents with uniform sirolimus biodegradable abluminal coating DQGDQWL&'VXUIDFHPRGL¿FDWLRQ FRQWUROVWHQWV ZHUHGHSOR\HGLQSLJV $QLPDOVZHUHVDFUL¿FHGDW VWHQWV$E&VWHQWVFRQWUROV $E& stents, 6 controls) and 28 (6 AbC stents, 6 controls) days. Stents harvested at 3 and 14 days were used for SEM evaluation and confocal microscopy (with PECAM staining). Stents harvested at 28 days were used for Morphometric evaluation using light microscopy. Results: Stent endothelialization rates evaluated by SEM were comparable at 3 (47% +/-13% AbC stent versus 45%+/-21% control stent) and at 14 (97%+/-2.4% AbC stent versus 96%+/-2.6% control stent) days. However, endothelialization rates evaluated by confocal microscopy (CD31/PECAM-1 positive cells) demonstrated a trend in improved endothelialization in the AbC stent at 3 (AbC 0.6%+/-1.4%, control 0.2%+/-0.4%, p=0.55) and at 14 (AbC FRQWUROS $WGD\VQHRLQWLPDOWKLFNQHVV $E& FRQWURO PHDQ¿EULQVFRUH $E& 16%, control 15%+/-18%) and the intimal score (AbC 0.56+/-0.62, control 0.94%+/-1.14) were similar between both stent groups. Thus, despite almost identical endothelial cell coverage seem by SEM, AbC stents trended toward superior endothelial cell viability at 3 and 14 days. Conclusion: In two similarly designed drug eluting stents using anti-CD34 coating, the preferential abluminal deposition of sirolimus delivery maintained DQ HI¿FDFLRXV FRQWURO RQ QHRLQWLPDO JURZWK EXW VKRZHG D PRUH IDYRUDEOH YDVFXODUKHDOLQJSUR¿OHWKDQWKHFRQYHQWLRQDOO\XQLIRUPFRDWLQJRIVLUROLPXV
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October 12-17, 2008
Short (n=48)
39DOXH
<0.0001
Stent length, mm
<0.0001
Reference diameter, mm
0.81
Baseline MLA, mm2
0.71
Follow up MLA, mm2
0.60
1,9
0.05
Max CSN, %
0.004
Late acquired ISA, %
0
0
-
0/$ PLQLPXPOXPHQDUHD 1,9 SHUFHQWQHRLQWLPDOYROXPH CSN: cross sectional narrowing; ISA: incomplete stent apposition
Conclusion: 7KH &XVWRP 1; GHPRQVWUDWHG H[FHOOHQW VXSSUHVVLRQ RI neointimal hyperplasia in very long lesions at 6 months. Compared to other DES trials, longer average lesion lengths were enrolled and treated successfully. This novel stent system may offer a customized option for treatment of long diffuse lesion molphology. TCT-346 The Impact of Non-Stent Related Progression of Underlying Coronary Artery Disease on Late Clinical Outcomes after PaclitaxelEluting Stents Dominic J. Allocco1, Keith D. Dawkins1, Donald S. Baim1, Martin B. Leon2 %RVWRQ6FLHQWL¿F&RUSRUDWLRQ1DWLFN0$ 2Columbia University Medical Center, New York, NY
1
Background: &OLQLFDOHYHQWVLQWKH¿UVW\HDUDIWHUEDUHPHWDOVWHQW %06 implantation are predominantly stent-related, while clinical events in years 2-5 are more often related to disease activity outside the stented segment. It is QRWNQRZQLIWKHVDPHLVWUXHIRUSDFOLWD[HOHOXWLQJVWHQWV 3(6 Methods::HORRNHGDW7$;8665SDWLHQWVDQG %06SDWLHQWV IURPWKH7$;86,,,,9DQG9WULDOVDQGFDOFXODWHGDQQXDOKD]DUGUDWHV (HR) for major adverse events through a median 4.8 year follow-up. Results: Annualized HR for major adverse events beyond 1 year were relatively
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The American Journal of Cardiology®
Long (n=20)
http://www.aievolution.com/tct0801
constant and similar for PES and BMS (Table). Event rates after 1 year were KLJKHULQSDWLHQWVZLWKPDUNHUVRIDJJUHVVLYHGLVHDVH VXFKDVGLDEHWHVRUORQJ OHVLRQVGDWDQRWVKRZQ :KLOHWDUJHWYHVVHOUHYDVFXODUL]DWLRQ 795 HYHQWV at 1 year consisted mostly of target lesion revascularization (TLR); TLR and QRQ7/5HYHQWVFRQWULEXWHGHTXDOO\WRRYHUDOO795DIWHU\HDU7KHDQQXDO VWHQWWKURPERVLV+5IURPWR\HDUVZDVORZDQGGLGQRWGLIIHUVLJQL¿FDQWO\ between BMS and PES (0.25 and 0.35%/year, respectively). Year 1 Annual Hazard Rate per 100 pt-yrs
Years 2 to 5 Annual Hazard Rate per 100 pt-yrs
BMS n=1397
PES n=1400
P value
BMS n=1349
PES n=1345
P value
795
20.36%
11.21%
<0.0001
3.83%
3.22%
0.16
-TLR
17.57%
7.45%
<0.0001
2.02%
1.61%
0.19
Table
1RQ7/5795 4.45%
4.31%
0.87
2.09%
1.78%
0.32
MI
4.76%
4.24%
0.52
0.68%
0.94%
0.20
-QWMI
0.37%
0.66%
0.28
0.20%
0.23%
0.80
7DUJHW9HVVHO --Non-target 9HVVHO -NQWMI
0.29%
0.44%
0.53
0.07%
0.15%
0.32
0.07%
0.22%
0.32
0.12%
0.07%
0.48
4.37%
3.54%
0.28
0.53%
0.73%
0.25
Death
1.90%
1.97%
0.89
1.94%
1.87%
0.84
Death or MI ARC ST-Def/ Probable ARC ST'H¿QLWH
6.42%
5.99%
0.64
2.59%
2.69%
0.79
0.81%
0.88%
0.83
0.25%
0.35%
0.40
0.66%
0.73%
0.82
0.17%
0.23%
0.61
Conclusion: Given the late stability of the stented segment beyond 1 year for both BMS and PES and evidence of ongoing disease activity outside the stented segment, many of the observed late events with PES (death and MI) may be due to underlying disease activity rather than stent-related events. Analyses of PES outcomes should recognize and attempt to correct for this EDFNJURXQGHYHQWUDWHE\WKHXVHRIVXLWDEOH%06FRQWUROV TCT-347
E L E C T RO N I C A B S T R AC T S
IVUS Analysis in the SPIRIT III Japan Treated with XIENCETM V Everolimus-Eluting Stent Compared to the SPIRIT III US Arm Takao Shimohama1, Hiromasa Otake1, Junya Ako1, Masao Yamasaki1, Ichizo Tsujino1, Katsuhisa Waseda1, Takao Hasegawa1, Ryota Sakurai1, Daisaku Nakatani1, Hyeonsoo Chang1, Paul G. Yock1, Yasuhiro Honda1, Hajime Kusano2, Krishnankutty Sudhir2, Shigeru Saito3, Gregg W. Stone4, Peter J. Fitzgerald1 1 Stanford University Medical Center, Stanford, CA; 2Abbott Vascular, Santa Clara, CA; 3Shonan Kamakura General Hospital, Kamakura, Japan 4Columbia University Medical Center, New York, NY Background: ;,(1&(TM 9 DQ HYHUROLPXVHOXWLQJ FREDOW FKURPLXP VWHQW RQDGXUDEOHÀXRURSRO\PHU ((6 KDVVKRZQSURPLVHLQLPSURYLQJFOLQLFDO and angiographic outcomes in patients with coronary artery disease. The aim RIWKLV,986VWXG\ZDVWRHYDOXDWHYHVVHOUHVSRQVHVWR((6LPSODQWDWLRQLQ SPIRIT III Japan, and compare them with the US arm. Methods: The SPIRIT III Japan is a prospective, multicenter, non-randomized arm using EES in Japan. In this study, we compared SPIRIT III Japan (JAPAN) and SPIRIT III US (EES, PES: paclitaxel-eluting stent). Eight months followXSYROXPHWULF,986GDWDZHUHDYDLODEOHLQ OHVLRQV -$3$1 ((6 3(6 9ROXPH LQGH[ YROXPHOHQJWK ZDV FDOFXODWHG IRU YHVVHO SODTXH QHRLQWLPD 1,9 DQG OXPHQ /9, &URVVVHFWLRQDO QDUURZLQJ &61 ZDV GH¿QHGDVQHRLQWLPDODUHDGLYLGHGE\VWHQWDUHD Results: There was a trend toward larger minimum lumen area (MLA) at baseline and follow-up in JAPAN (Table), although no difference was observed LQYHVVHOVL]HLQWKHUHIHUHQFHVHJPHQWDPRQJWKHDUPV,Q-$3$11,9 1,9VWHQWYROXPH DQGPD[&61ZHUHVLJQL¿FDQWO\ORZHUDWPRQWKVIROORZ XS S E\$129$ 7KHUHZDVDWUHQGWRZDUGORZHUEDVHOLQHLQFRPSOHWH stent apposition (ISA), while there were no differences in tissue prolapse or edge dissection in JAPAN. Late acquired ISA was infrequent in each arm.
138i
JAPAN
EES
PES
39DOXH
/9,LQ3UR[LPDO5HIHUHQFHPPPP
0.78
/9,LQ'LVWDO5HIHUHQFHPPPP
0.66
Baseline MLA, mm2
0.08 0.08
Follow-up MLA, mm2
1,9
<0.0001
Max CSN, %
<0.0001
Baseline ISA, %
19.4
32.9
29.0
0.07
Late acquired ISA, %
1.2
1.7
4.5
0.42
E\$129$
Conclusion:;,(1&(TM9GHPRQVWUDWHGVLJQL¿FDQWVXSSUHVVLRQRIQHRLQWLPDO hyperplasia in the Japanese population up to 8 months as compared with EES and PES in the US arm. TCT-348 Long-Term Outcomes of Drug-Eluting Stents Versus Bare-Metal Stents in Saphenous Vein Graft Disease: Results from the Prairie “Real World” Stent Registry Nilesh J Goswami10DWWKHZ*DI¿JDQ2, Amanda M Pfeiffer3, Anna L. Moore3, Stephen J. Markwell2, Marc E. Shelton1, Gregory J. Mishkel1 1 3UDLULH+HDUW,QVWLWXWHDW6W-RKQ¶V+RVSLWDO6SULQJ¿HOG,/ 2Southern ,OOLQRLV8QLYHUVLW\6FKRRORI0HGLFLQH6SULQJ¿HOG,/ 3Prairie (GXFDWLRQ 5HVHDUFK&RRSHUDWLRQ6SULQJ¿HOG,/ Background: Drug eluting stent (DES) implantation in native coronary arteries has proven to effectively reduce restenosis and even mortality relative WR EDUH PHWDO VWHQWV %06 +RZHYHU WKH HI¿FDF\ RI '(6 LQ VDSKHQRXV YHLQJUDIWV 69* UHPDLQVXQFHUWDLQDQGVRPHVWXGLHVVXJJHVWDQH[FHVVRI PRUWDOLW\LQ'(669*SDWLHQWV:HVRXJKWWRHYDOXDWHORQJWHUPRXWFRPHVRI '(6FRPSDUHGWR%06IRU69*GLVHDVH Methods: Data were obtained on patients undergoing a 1st DES or BMS SODFHPHQWLQD69*IURPWR&OLQLFDOIROORZXSZDVREWDLQHG at regular intervals. We report 3-year major adverse cardiac events (MACE) GH¿QHGDVDFRPSRVLWHRIDOOFDXVHPRUWDOLW\QRQIDWDOP\RFDUGLDOLQIDUFWLRQ (MI), or target segment revascularization (TSR). Propensity scores were generated using pertinent baseline variables. Multivariable Cox regression ZDVXWLOL]HGWRDQDO\]HWKHULVNDVVRFLDWHGZLWK%06YV'(6LPSODQWDWLRQ Results: Our study group included 432 patients (104 BMS; 328 DES) with OHVLRQV&OLQLFDOIROORZXSZDVREWDLQHGRQ RISDWLHQWV PHDQ 449 days). Demographics were similar at baseline except that BMS were used more often in patients with STEMI presentation (12.5% vs 3.0%; p<0.001) DQGLQODUJHUGLDPHWHUYHVVHOV YV S %LYDOLUXGLQZDV used more often in DES procedures (32.9% vs 20.2%; p=0.014). In-hospital outcomes were similar between groups except that death occurred more often in BMS patients (2.9% vs 0.3%; p=0.05). Three-year Kaplan-Meier event rates were similar between cohorts. Cox regression showed similar results between cohorts, even after propensity score adjustment (see table). Unadjusted (BMS vs DES) Hazard Ratio p value &RQ¿GHQFH,QWHUYDO 1.142 Mortality 0.6265 (0.669 - 1.948) 0.373 MI 0.1093 (0.112 - 1.247) 1.029 TSR 0.9270 (0.564 - 1.876) 0.920 Mortality + MI 0.7410 (0.562 - 1.506) 0.948 MACE 0.7890 (0.641 - 1.401)
Adjusted (BMS vs DES) Hazard Ratio p value &RQ¿GHQFH,QWHUYDO 1.604 0.1320 (0.867 - 2.966) 0.323 0.0931 (0.086 - 1.208) 1.336 0.3985 (0.682 - 2.620) 1.045 0.8784 (0.596 - 1.833) 1.150 0.5320 (0.742 - 1.782)
Conclusion: Although our data shows that long-term MACE rates are comparable EHWZHHQ'(6DQG%06LQ69*OHVLRQVZLWKQRH[FHVVPRUWDOLW\ULVNWKHUHGRHV QRWDSSHDUWREHDQ\EHQH¿WLQWKHUHGXFWLRQRIFOLQLFDOUHVWHQRVLV
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TCT-349
loaded with 85-g of Novolimus, as compared to 150-g of Sirolimus loaded on the Cypher stent (Cordis Corp, Miami, Fl, USA) and VLJQL¿FDQWO\ OHVV SRO\PHUWKDQRWKHUPDUNHWDSSURYHG'(6V\VWHPV7KHVDIHW\DQGHI¿FDF\ of this novel device was evaluated in reducing neointimal hyperplasia as DVVHVVHGE\4&$DQG,986 Methods: A consecutive cohort of 15 patients with de novo lesions <14 mm in length, located in native coronary arteries ranging in diameter from 3.0 WRPPZHUHHQUROOHGLQWKLV)LUVW,Q0DQVWXG\$QJLRJUDSK\DQG,986 were completed at baseline and repeated at 4 and 8 months. Dual antiplatelet therapy was maintained for 12 months. The primary endpoint was in-stent late lumen loss at 4-months as assessed by QCA. Secondary endpoints included 0$&(LQVWHQWQHRLQWLPDOREVWUXFWLRQE\,986DQGGHYLFHVXFFHVV Results: A total of 15 patients were enrolled with 67% females and 47% diabetics. Angiographic and procedural success were achieved in all cases. At WKHPRQWKIROORZXSWKHPLQLPXPLQVWHQWODWHOXPHQORVVZDV PPE\DQJLRJUDSK\DQGYROXPHREVWUXFWLRQZDVE\,986$WWKH PRQWKIROORZXSSHULRGWKHLQVWHQWODWHOXPHQORVVZDVPPE\ 4&$DQGWKHYROXPHREVWUXFWLRQZDVE\,9869DVFXODUSRVLWLYH remodeling and late ISA were not present among these patients. There were no 0$&(HYHQWVWKURXJKWKH¿UVW\HDUFOLQLFDOIROORZXSSHULRG Conclusion: ,Q WKLV ¿UVWLQPDQ VWXG\ LPSODQWDWLRQ RI WKH (OL[LU 0HGLFDO Novolimus-Eluting Stent with Durable Polymer was safe and effective exhibiting minimal neointimal proliferation. Additional large clinical trials DUHUHTXLUHGWRFRQ¿UPWKHVHSURPLVLQJUHVXOWV
Treatment of DES In-stent Restenosis with Paclitaxel Eluting Balloon: a Multicenter, Prospective Registry Fabrizio Clementi1, Fina Mauri2, Riccardo Colantonio3, Alessandro Aprile1, Oriol Rodriguez2, Eugenio Martuscelli1, France sco Romeo1, Gennaro Sardella3, Massimo Sangiorgi1 1 University of Rome Tor Vergata, Roma, Italy 2University Hospital Germans Trias i Pujol, Barcelona, Spain 3University of Rome La Sapienza, Roma, Italy Background: DES restenosis, albeit presenting with less aggressive pattern, is more challenging in terms of treatment results both angiographically and clinically. Treatment strategy reported in literature encompass brachitherapy DQG'(6LQ'(6EXWRXWFRPHVDUHQRWVXI¿FLHQWO\HQFRXUDJLQJ PRQWKV MACE ranging from 25% to 40%). Recently the use of paclitaxel eluting balloon (PEB) for BMS restenosis has been reported with encouraging results even when compared with DES treatment. We report here results of a multicenter prospective registry about the use of PEB (DIOR© , EuroCore, Dusseldorf, Germany) for treatment of DES in-stent restenosis. Methods: Between August 2007 and February 2008 we prospectively enrolled 35 patients (38 lesions) with angiographically documented DES inVWHQWUHVWHQRVLV GLDPHWHUVWHQRVLV!ZLWKV\PSWRPVRIRUGRFXPHQWHG cardiac ischemia). Treatment protocol required pre-dilation of the lesion with a non-compliant balloon to reach less than 20% residual stenosis prior to WUHDWPHQWZLWKWKH3(%ZKLFKZDVLQÀDWHGDWOHDVWWRQRPLQDOSUHVVXUH DWP for 60 seconds. After treatment all patients was discharged with 1 months double antiplatelet therapy if not else required. Primary end-point of the study was late-lumen loss at 6 months. Secondary end-points were incidence RI0$&(DQGELQDU\UHVWHQRVLV GLDPHWHUVWHQRVLV! DWPRQWKV'DWD management and QCA analysis was centralized and independent. Results: Restenosis pattern was diffuse in 41,8 % of cases. Diabetic patients ZHUH UHÀHFWLQJWKHKLJKHUULVNRIUHVWHQRVLVLQWKLVSDWLHQWVXEVHW3UH WUHDWPHQWUHIHUHQFHYHVVHOGLDPHWHUZDV PPPHDQ6' OHVLRQ OHQJWKPLQLPDOOXPHQGLDPHWHUZDV DQGSHUFHQWDJH VWHQRVLV ZDV $IWHU SURFHGXUH UHVLGXDO VWHQRVLV ZDV with an acute gain of 1,91 mm. 6 months clinical follow-up is available for 29 patients with an incidence of MACE of 20,6 % (Q-wave MI 3.4%, TLR 17.2%, Death 0%). 1 subacute stent thrombosis was observed in the study interval. Results for angiographic follow-up will be available in late August 2008. Conclusion: Treatment of DES in-stent restenosis with PEB is safe with 6 PRQWKVHI¿FDF\DWOHDVWDVJRRGDVDOWHUQDWLYHVWUDWHJLHVFXUUHQWO\SURSRVHG (DES in DES and brachitherapy). Moreover only 1 month dual antiplatelets therapy is required with low incidence of stent thrombosis.
TCT-351 Six-Month IVUS Analysis of Pimecrolimus and Dual Pimecrolimus/ Paclitaxel Eluting Stents: Results of the GENESIS Trial Takao Shimohama1, Ichizo Tsujino1, Junya Ako1, Takao Hasegawa1, Hyeonsoo Chang1, Paul G. Yock1, Yasuhiro Honda1, Keith D. Dawkins2, Stefan Verheye3, Peter J. Fitzgerald1 1 Stanford University Medical Center, Stanford, CA; 2Southampton University Hospital, Southampton, United Kingdom 3Antwerp Cardiovascular Institute, Antwerp, Belgium
TCT-350 Single Center, First-In-Man Study of the Elixir Novolimus-Eluting Coronary Stent System with Durable Polymer: Twelve Month &OLQLFDO6DIHW\DQG(I¿FDF\5HVXOWV José de Ribamar Costa, Jr.1, Alexandre Abizaid1, Fausto Feres1, Ricardo Costa1, Ana Cristina Seixas1, Rodolfo Staico1, Dimytri Siqueira1, Lynn Meredith2, Vinayak Bhat2, John Yan3, John Ormiston4, Amanda Sousa1, J Eduardo Sousa1, Peter Fitzgerald5 1 Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil 2Elixir Medical, Sunnyvale, CA; 3Elixir Medical, Sunyvale, CA; 4Auckland City Hospital,, Auckland, New Zealand 5Stanford University Medical Center, Stanford, CA
PLES (n=15) PL/PES (n=23) PES (n=16) Baseline 6 Months Baseline 6 Months Baseline 6 Months 9HVVHO9,PPP /XPHQ9,PPP
3ODTXH9,PPP 1,9 Max CSN†, % Late ISA, % 0 0 0
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Background: The Elixir Medical Novolimus-Eluting Stent with Durable Polymer is a novel DES that combines a cobalt chromium alloy stent platform with Novolimus (a unique, antiproliferative macrocyclic lactone similar to sirolimus) and a thin, single-layer methacrylate polymer. The innovative design of this stent system enables drug delivery using a substantially reduced amount of polymer and drug. The Elixir Medical Novolimus Eluting DES is
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Background: Pimecrolimus and dual pimecrolimus/paclitaxel eluting stents KDYHEHHQVKRZQWRGHFUHDVHLQÀDPPDWLRQDQGQHRLQWLPDOSUROLIHUDWLRQLQDQ DQLPDOPRGHO7KHDLPRIWKLV,986VWXG\ZDVWRHYDOXDWHWKHHI¿FDF\RIWKH Conor cobalt-chromium reservoir-based coronary stent system eluting either pimecrolimus (PLES) or a dual drug delivery of pimecrolimus/paclitaxel (PL/ PES) compared with CoStar paclitaxel-eluting stents (PES) in human de novo native coronary lesions. Methods: Data were obtained from the GENESIS Trial, a multicenter, randomized clinical trial comparing PLES or PL/PES coronary stent system WRWKH3(6FRQWURODUP6L[PRQWKVIROORZXSYROXPHWULF,986DQDO\VHVZHUH DYDLODEOHIRUSDWLHQWV 3/(6 3/3(6 3(6 9ROXPHLQGH[ 9, volume/length) was calculated for vessel, lumen, plaque, stent and neointima 1,9 3HUFHQW QHRLQWLPDO YROXPH 1,9 ZDV FDOFXODWHG DV 1,9VWHQW YROXPH ;&URVVVHFWLRQDOQDUURZLQJ &61 ZDVGH¿QHGDVQHRLQWLPDO area divided by stent area. Results:$WPRQWKVIROORZXS1,9DQGPD[&61RI3/(6DQG3/3(6 JURXSVZHUHVLJQL¿FDQWO\KLJKHUWKDQWKRVHRI3(6FRQWUROJURXS S E\ $129$ 9HVVHOYROXPHVLJQL¿FDQWO\LQFUHDVHGLQ3/(6DQG3(6JURXSVGXULQJ 6 months follow up. Peri-stent plaque progression was observed in the PES group. There was no late-acquired incomplete stent apposition (ISA) in each group.
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Conclusion: These results suggest that PLES and PL/PES do not suppress neointimal hyperplasia in humans compared with PES. TCT-352 Paclitaxel-Eluting Stent Induces Endothelial Dysfunction Associated with Local Oxidative Stress in Pig Coronary Model Lakshmana K Pendyala, Jinsheng Li, Toshiro Shinke, Jack P Chen, Nicolas A Chronos, Keith Robinson, Dongming Hou Saint Joseph’s Research Institute, Atlanta, GA
E L E C T RO N I C A B S T R AC T S
Background: Drug-eluting stent (DES) implantation appears to elicit epicardial artery vasomotor dysfunction in human patients and experimental DQLPDOV+RZHYHUWKHPHFKDQLVPLVQRW\HWNQRZQ:HHYDOXDWHGHQGRWKHOLDO function and local superoxide anion production after overlapping paclitaxeleluting stents (PES) implantation in porcine coronary arteries. Methods: Pigs (n=9) received overlapping PES and bare metal stents (BMS). &RURQDU\YDVRPRWRUIXQFWLRQSUR[LPDODQGGLVWDO PP WRWKHVWHQWVZDV measured angiographically in vivo and on harvested tissue in vitro in an organ chamber apparatus 1-month post-implant, and superoxide (O.2 ) production of adjacent segments was estimated by lucigenin chemiluminescence. Results: PES had less late lumen loss than BMS (P=0.01). In vivo, angiographic %diameter change following intracoronary (IC) endothelium-dependent UHOD[DWLRQ ('G5 WRVXEVWDQFH3 V3QJNJ ZDVGLPLQLVKHGLQ3(6 SUR[ GLVW FRPSDUHGWR%06 SUR[GLVW 3 DQGQDwYH SUR[GLVW 3 %XWHQGRWKHOLXPLQGHSHQGHQWUHOD[DWLRQ (EdiR) response to NTG (IC, 200-g) was not different between the two stent types. Similarly, in vitro organ chamber revealed that EDdR response to sP DQG$LQERWKSUR[LPDODQGGLVWDOVHJPHQWVZDVVLJQL¿FDQWO\LPSDLUHGLQ PES versus BMS and naive (p<0.001), but EdiR to SNP was preserved (P=NS). O.2 SURGXFWLRQZDVKLJKHUSUR[LPDODQGGLVWDOWR3(6WKDQ%06DQGQDwYH YVDQG5/8VPJWLVVXH3 DQGYV DQG 5/8VPJWLVVXH3 Conclusion: PES was effective in decreasing neointimal formation. However, a profound adverse effect of PES on endothelium-dependent vasomotor relaxation in conduit vessel segments both proximal and distal to overlapping implants, was observed both in vivo and in vitro, and is associated with local enhancement of oxidative stress. Endothelial dysfunction after implantation of PES may contribute to adverse clinical sequelae through similar pathophysiological mechanisms. TCT-353 Long-term Clinical Outcomes of DES for the Treatment of Complex versus Non-complex Lesions in the DESIRE Registry José de Ribamar Costa, Jr., Amanda Sousa, Adriana Moreira, Ricardo Costa, Manuel Cano, Galo Maldonado, Mariana Carballo, Otavio Berwanger, Luiz Alberto Mattos, Alexandre Abizaid, Edson Romano, J Eduardo Sousa Instituto de Ensino e Pesquisa - Hospital do Coração, São Paulo, Brazil Background: Regardless of the FDA strict indications for DES use, cardiologists have expanded the formal recommendations and treated more complex pts and lesions not previously included in randomized trials. We sought to evaluate the clinical outcomes of DES in the off-label scenario. Methods: Between May 2002 and December 2007 all consecutive pts treated solely with DES were prospectively enrolled in the single center DESIRE UHJLVWU\DQGJURXSHGDFFRUGLQJWRWKHLU³ODEHO´VWDWXV2QODEHOSWVKDGVWDEOH angina or silent ischemia caused by a single, de novo lesion <30mm in length and located in a native coronary artery of 2.5 to 3.5mm in diameter. All UHPDLQLQJSWVZHUHFODVVL¿HGDVRIIODEHO2XUSULPDU\JRDOZDVWRFRPSDUH the incidence of long-term MACE and stent thrombosis (ST) in the 2 groups. Pts were clinically evaluated at 1, 6 and 12 months and then yearly up to 6 years. After conducting bivariate analysis, a model was built to identify subgroup characteristics associated with MACE, TLR and ST, including Cox
140i
Proportional Hazard Regression. Results: Most of the enrolled pts were off-label [1,533 (76%) of 2,014]. During WKH LQKRVSLWDO SKDVH RIIODEHO SWV KDG VLJQL¿FDQW PRUH QRQ4 ZDYH 0, (2.3% vs. 1.2%, p = 0.02) but equivalent ST and combined MACE rates when compared to on-label pts. Long-term FU was obtained in 98.3% of the cases (median 3.6 years). Survival-free of MACE and ST curves are displayed in the chart. Off-label use of DES was an independent predictor of MACE (HR 2.5; 95% IC 1.7 - 4.9) and TLR (HR 3.6; 95% IC 2.8-5.1) but did not impact ST rate in this registry.
Conclusion: In the DESIRE registry, DES in pts with increased complexity SUR¿OH RIIODEHOLQGLFDWLRQ ZDVDVVRFLDWHGZLWKORZUDWHVRI0$&( and ST (<2.0%) up to 6 year of FU; however, the outcomes in this subset are still inferior compared to those with strict indications for DES (on-label). TCT-354 Do Bare-metal And Drug-eluting Stent Restenosis Have Similar Outcomes When Treated With Drug-eluting Stent Implantation?: Insights From The Desire-ISR Registry José de Ribamar Costa, Jr., Amanda Sousa, Adriana Moreira, Ricardo Costa, Galo Maldonado, Manuel Cano, Cantidio Compos, Neto, Mariana Carballo, Enilton Egito, Fausto Feres, Rodolfo Staico, Otavio Berwanger, J Eduardo Sousa Instituto de Ensino e Pesquisa - Hospital do Coração, São Paulo, Brazil Background: Right after their introduction into clinical practice, drugHOXWLQJVWHQWV '(6 EHFDPHWKH¿UVWFKRLFHWRWUHDWEDUHPHWDOVWHQW %06 restenosis, replacing brachterapy and all other available percutaneous DSSURDFKHV $OWKRXJK PDUNHGO\ UHGXFHG '(6 UHVWHQRVLV VWLOO RFFXUV DQG has been frequently treated with another DES deployment, despite a clear GHPRQVWUDWLRQ RI WKH HI¿FDF\ DQG VDIHW\ RI WKLV DSSURDFK :H VRXJKW WR compare the long-term outcomes of pts with BMS and DES restenosis treated with the implantation of DES. Methods: Between May 2002 and Jan 2008, a total of 158 pts with BMS restenosis and 58 pts with DES restenosis were consecutively treated with '(6 DQG HQUROOHG LQWR WKLV VLQJOHFHQWHU UHJLVWU\ 2QO\ SWV ZLWK ¿UVW VWHQW UHVWHQRVLVZHUHLQFOXGHG3DWLHQWVWUHDWHGLQWKHVHWWLQJRI0,DQGZLWK69* lesions were excluded. Primary endpoint included long-term MACE and stent WKURPERVLV 67 UDWH DFFRUGLQJ WR WKH $5& GH¿QLWLRQ &OLQLFDO IROORZXS (FU) was obtained at 1, 6 and 12 months and then annually, up to 6 years. Results: %DVHOLQH FOLQLFDO FKDUDFWHULVWLFV GLG QRW VLJQL¿FDQWO\ GLIIHU EHWZHHQ the 2 groups with a high prevalence of DM in both cohorts (33% in the BMS group and 35% in the DES group, p = 0.7). Unstable angina was the initial clinical presentation in 32.9% of BMS pts and 31.1% of DES pts (p=0.9). LAD was the most frequent treated vessel (36.7% in the BMS group vs. 38% in the DES, S '(6UHVWHQRVLVRFFXUUHGLQYHVVHOVRIVPDOOHUGLDPHWHU PPYV PPS ,QWKH%06FRKRUWUHVWHQRVLVSDWWHUQZDVGLIIXVHLQPRVW cases (51%) while in the DES group, focal restenosis was predominant (82%, S /RQJHU'(6ZHUHXVHGWRWUHDW%06UHVWHQRVLV PPYV PPS 2YHUDOO)8ZDVREWDLQHGLQ RIWKHFDVHV PHGLDQ \HDUV '(6 UHVWHQRVLV JURXS SUHVHQWHG VLJQL¿FDQW PRUH 0$&( YV 7.5%, p<0.001), mainly at the expenses of higher rates of new revascularization
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Conclusion:,QWKLV³UHDOZRUOG´SDWLHQWFRKRUWWKHPRQWK0$&(UDWHZDV 7.5%; 3.8% in the simple group, which were more representative of those enrolled in randomized trials, compared with 7.8% in the complex patient group. With ORZ$5&GH¿QLWHSUREDEOH67UDWHVRI FRPSOH[ DQG VLPSOH WKHVH results support the safe use of the Endeavor ZES in standard practice.
procedure (13.3% vs. 3%, p<0.001). Myocardial infarction ( 1.9% for BMS vs. 0% for DES, p=0.8) and cardiac death (2.8% for BMS vs. 0% for DES, p = 0.4) were very low and equivalent in the two groups. There was a single case of ST in the BMS cohort (0.6%) vs. none in the DES group (p=0.9). Conclusion: With the advent of DES, percutaneous treatment of both BMS RU '(6 UHVWHQRWLF OHVLRQV EHFDPH VLPSOH HI¿FLHQW DQG VDIH ZLWK H[FHOOHQW and sustained long-term results. However, the probability of recurrence of restenosis is considerably higher among pts with prior DES restenosis.
TCT-356 /RQJ7HUP)ROORZ8SRI3DWLHQWVZLWK'UXJ(OXWLQJ6WHQWV '(6 Implications for Contemporary Interventional Practice
TCT-355
Robert T Gerber1,2, Alfonso Ielasi2, Azeem Latib2, Luca Ferri2, Giorgio Bassanelli2, Ricardo Colantonio2, Cosmo Godino2, Flavio Airoldi2, Alaide Chieffo2, Mauro Carlino2, Matteo Montorfano2, Iassen Michev2, Giuseppe Sangiorgi1, Antonio Colombo1,2 1 EMO Centro Cuore Columbus, Milan, Italy 2San Raffaele, Milan, Italy
Twelve-Month Results from the Real-World Use of the Endeavor Zotarolimus -Eluting Stent in the E-FIVE Registry Martin T Rothman1, Chaim Lotan2, Manuela Negoita3, Ian T Meredith4, For the E-FIVE Registry Investigators 1 Barts and The London NHS Trust, London, United Kingdom 2 Hadassah-Hebrew University Medical Center, Jerusalem, Israel 3 Medtronic CardioVascular, Santa Rosa, CA; 4Monash Medical Centre, Southern Health, Melbourne, Victoria, Australia
Introduction: There is limited evidence concerning clinical outcomes for multiple stent insertion in the DES era. Stent thrombosis (ST) and restenosis are always concerns when implanting several stents. We present long-term IROORZXSRISDWLHQWVZKRKDG'(6LPSODQWHG Methods: )URP $SULO DOO SDWLHQWV ZLWK '(6 ZHUH LGHQWL¿HG DQG separated according to whether treatment was for de-novo or restenotic lesions. Results: SDWLHQWV ZHUH LGHQWL¿HG FRPSULVLQJ GHQRYR DQG UHVWHQRWLF '(6 ,QWKHGHQRYRJURXSWKHUHZHUH GH¿QLWHVWHQW thrombosis (ST): 1 acute (0.2%), 3 sub-acute (0.6%), 2 late (0.4%) and 0 very ODWH,QFRQWUDVWWKHUHZHUH GH¿QLWH67LQWKHUHVWHQRWLFJURXS acute (1.9%), 2 sub-acute (1.9%), 3 late (2.9%) and 2 (1.9%) very late.
Background:The Endeavor zotarolimus-eluting stent (ZES) has been shown WREHVDIHDQGHI¿FDFLRXVIRUWUHDWPHQWRIVLQJOHde novo lesions in patients with stable coronary artery disease (CAD). We assessed the effectiveness of WKLV=(6LQDUHDOZRUOGSDWLHQWSRSXODWLRQLQWKH(),9(5HJLVWU\ Methods: (),9( LV D SURVSHFWLYH PXOWLFHQWHU QRQUDQGRPL]HG JOREDO registry designed toevaluate the use of the Endeavor stent in routine treatment RISDWLHQWVLQGLFDWHGIRU3&,DQGWRHYDOXDWHFOLQLFDORXWFRPHVLQKLJKULVN patient groups, e.g. those with diabetes mellitus (DM), longer lesions and small diameter vessels. The study enrolled over 8000 patients at 200 centers in Europe, South America, Australia, New Zealand and Asia. All patients presenting with symptomatic CAD amenable to stent implantation were eligible for the study. All MACE events, death, myocardial infarction (MI), and stent thrombosis (ST) events using ARC criteria, were adjudicated by a Clinical Events Committee. We compared outcomes between patients with simple vs. complex lesions and clinical characteristics. Complex patients included those with at least 1 of the following; AMI (< 24h), unstable angina, '0OHVLRQVPP59'RIPPDQGELIXUFDWLRQOHVLRQV Results: Of 7832 (94.2%) patients with 12-month follow-up, 91.6% had FRPSOH[OHVLRQDQGFOLQLFDOFKDUDFWHULVWLFVDQGZHUHFRQVLGHUHGKLJKULVN Characteristic
Clinical Outcomes MACE, % (n) Death-all % (n) Cardiac, % MI (all), % (n) Q-wave, % (n) Non Q-wave, %(n) Death (cardiac) + MI (all), %(n) Def + Prob ARC ST, %(n) Def ARC ST, %(n) TLR, % (n) TLR (non-TL), %(n) 795 Q 79) Q
TOTAL (3120 Lesions) De Novo (2525 Lesions) Follow-up Median (IQR)
Death (total) [cardiac] 33 (6.5%) [3.4%]
October 12-17, 2008
5 (4.8%) [4.8%] 4 (3.8%)
177 (35%)
65 (61%)
TLR per patient
142 (28%)
60 (57%)
Restenosis per lesion
419/1891 (22%)
191/533 (36%)
795SHUYHVVHO
636/2525 (25%)
295/595 (50%)
TLR per lesion
461/2525 (18%)
231/595 (39%)
MACE 0,7/5795 Cardiac Death)
164 (33%)
63 (60%)
Conclusion: This study demonstrates an acceptable occurrence of MI, death, repeat revascularization and ST in patients with de novo lesions and PXOWLYHVVHOGLVHDVHWUHDWHGZLWK'(6+RZHYHULQSDWLHQWVZLWKUHVWHQRVLV DKLJKFRPSOLFDWLRQUDWHLVH[SHFWHGZKLFKUHÀHFWVWKHFRPSOH[QDWXUHRIWKLV cohort of patients. TCT-357 Anemia Predicts Long-Term Mortality Following PCI with DrugEluting Stents in Real World Clinical Practice Dmitriy N. Feldman, Christopher L. Gade, Linda J. Cuomo, Robert M. Minutello, Issam Moussa, Geoffrey Bergman, S. Chiu Wong New York Presbyterian Hospital - Weill Medical College of Cornell University, New York, NY Background:$QHPLDLVDVVRFLDWHGZLWKLQFUHDVHGULVNRIVKRUWDQGORQJ term mortality after PCI with bare metal stents. Impact of anemia on longterm prognosis in current clinical practice of revascularization with DES is XQNQRZQ Methods: Using the 2004/2005 Cornell Angioplasty Registry, we studied 2,837 consecutive patients undergoing urgent or elective PCI based on the
% = percent of patients unless noted. *Simple includes any patient not meeting FRPSOH[GH¿QLWLRQ
|
Restenotic (595 Lesions) 32 (19-43) months (Clinical 100%; Angiographic 83%)
Myocardial Infarction 18 (3.6%) 795SHUSDWLHQW
(),9($// N = 8314 patients/10339 lesions 76.7 32.2 25.3 32.7 33.9 21.8 46.6 (4817/10339) 42.6 (3336/7832) 43.4 (3402/7832) Simple* Complex p-value N = 655 N = 7177 3.8 (25) 7.8 (562) <0.001 1.1 (7) 2.6 (184) 0.016 0.8 (5) 1.8 (130) 0.057 0.9 (6) 1.7 (122) 0.148 0.0 0.4 (31) 0.107 0.9 (6) 1.3 (92) 0.580 1.5 (10) 3.2 (228) 0.017 0.3 (2) 1.2 (86) 0.032 0.3 (2) 0.7 (47) 0.434 2.3 (15) 4.7 (334) 0.004 0.6 (4) 0.7 (48) 1.000 2.7 (18) 5.1 (369) 0.006 4.0 (26) 7.5 (539) <0.001
The American Journal of Cardiology®
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Male (%) Age (yrs) Previous MI (%) Previous PTCA (%) DM (%) Unstable angina (%) Recent MI [within 72 hrs] (%) LAD (% of lesions) 59'PP /HVLRQOHQJWKPP
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hemoglobin (Hb) value prior to PCI. Patients were divided into 3 groups based RQWKHEDVHOLQH+EOHYHO JO +E VHYHUHDQHPLD +E PLOGDQHPLD +E QRDQHPLD :HH[FOXGHGSDWLHQWVSUHVHQWLQJZLWKDQDFXWH0, KRXUVKHPRG\QDPLFLQVWDELOLW\VKRFNWKURPERO\WLFWKHUDS\GD\VRUUHQDO LQVXI¿FLHQF\0HDQFOLQLFDOIROORZXSZDVGD\V UDQJH GD\V Results: We studied 146 pts (5.1%) with severe anemia, 637 pts (22.5%) with mild anemia, and 2,054 pts (72.4%) without anemia. DES were used in 87% of PCI. The incidence of in-hospital mortality (0% vs. 0.5% vs. 1.4%, p=0.001), non-Q-wave MI (9.3% vs. 10.8% vs. 13.7%, p=0.160), and MACE GHDWKVWURNHHPHUJHQW&$%*3&,0, YVYVS increased incrementally by degree of anemia. By follow-up, there were 40 (1.9%) deaths in pts without anemia, 34 (5.3%) in pts with mild anemia (HR 2.7, 95% CI 1.7-4.3, p<0.001), and 14 (9.6%) in pts with severe anemia (HR 4.6, 95% CI 2.5-8.4, p<0.001) (Figure). After multivariate Cox analysis, severe anemia (HR 2.3, 95%CI 1.1-4.6, p=0.02), and not mild anemia (HR 1.6, 95%CI 1.0-2.5, p=0.08) remained an independent predictor of long-term mortality.
Conclusion: Severe anemia is an independent predictor of long-term mortality after PCI with DES and is associated with higher short-term adverse procedural events. A randomized clinical trial is needed to determine whether RSWLPL]DWLRQRIKHPRJORELQSULRUWR3&,PD\EHRIFOLQLFDOEHQH¿W TCT-358
E L E C T RO N I C A B S T R AC T S
'XUDEOH%HQH¿WRI7$;86/LEHUWpYHUVXV7$;86([SUHVVLQ6PDOO Vessels and Long Lesions in the TAXUS ATLAS SMALL VESSEL and TAXUS ATLAS LONG LESION Trials John A. Ormiston1, Mark A. Turco2, Lazar Mandinov3, Jack J. Hall4, Tift Mann5, Louis A. Cannon6, Mark W. I. Webster7, Gregory J. Mishkel8, Charles D. O’Shaughnessy9, Thomas F. McGarry10, Keith D. Dawkins3, Donald S. Baim3 1 Mercy Hospital, Auckland, New Zealand 2Washington Adventist Hospital, Takoma Park, MD; 3%RVWRQ6FLHQWL¿F1DWLFN0$ 4St. Vincent’s Hospital, Indianapolis, IN; 5Wake Medical Center, Raleigh, NC; 6Northern Michigan Regional Hospital, Petoskey, MI; 7Auckland City Hospital, Auckland, New Zealand 86W-RKQ¶V+RVSLWDO6SULQJ¿HOG,/ 9Elyria Memorial Hospital, Elyria, OH; 10Oklahoma Heart Hospital, Oklahoma City, OK Background: 7KH7$;86/LEHUWp 7/ VWHQW %RVWRQ6FLHQWL¿F1DWLFN0$ 86$ ZDVVSHFL¿FDOO\GHVLJQHGZLWKWKLQQHUVWUXWVDQGXQLIRUPYHVVHOVFDIIROGLQJ to provide more uniform drug distribution. Additionally, the repeating cell design DOORZVIRULQFUHDVHGÀH[LELOLW\DQGFRQIRUPDELOLW\7KH7$;86$7/$66PDOO 9HVVHO 69 DQG/RQJ/HVLRQ // JOREDOVWXGLHVFRPSDUHWKHSHUIRUPDQFHRIWKH 7/PPDQGPPVWHQWVZLWK7$;86([SUHVV 7( DVWJHQHUDWLRQVWHQW ZLWKLGHQWLFDOSRO\PHUFRDWLQJGUXJGRVDJHDQGUHOHDVHNLQHWLFVEXWGLIIHUHQW JHRPHWU\DQGWKLFNHUVWUXWV The primary 9-month non-inferiority endpoint of % diameter stenosis (in-segment) was met in both studies. Long-term outcomes are being evaluated in the two studies. Methods: 7$;86 $7/$6 69 DQG // DUH PXOWLFHQWHU VLQJOH DUP VWXGLHV comparing outcomes of the TL 2.25 mm (N=261) and TL 38 mm (N=150) VWHQWVWROHVLRQPDWFKHG7(KLVWRULFDOFRQWUROVGHULYHGIURP7$;86,9DQG 7$;869%RWKWULDOVDUHIXOO\PRQLWRUHGDQGDOO0$&(DUHDGMXGLFDWHGE\DQ independent CEC. Results: At 1 year, the 69WULDOGHPRQVWUDWHGDPDUNHGGHFUHDVHLQ7/5 for the TL 2.25 mm stent versus TE control, and the LL trial demonstrated
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DVLJQL¿FDQWGHFUHDVHLQ0,UDWHVIRUWKH7/PPORQJVWHQWYHUVXV TE control (Table). Assessment of 2 year clinical outcomes will be available July/August 2008. 1-Year Clinical Outcomes, Per Protocol 7$;86$7/$66PDOO9HVVHO 7$;86$7/$6/RQJ/HVLRQ 7$;86 7$;86 7$;86 7$;86 Express /LEHUWp p Express /LEHUWp Clinical Outcome p value Control 2.25 mm value Control 38 mm (N=73) (N=254) (N=145) (N=150) 26.8 13.4 16.5 10.9 MACE (%) 0.0071 0.16 (19/71) (33/247) (23/139) (16/147) ...Cardiac 4.2 (3/71) 1.2 (3/247) 0.13* 3.6 (5/139) 0.0 (0/147) 0.0261* ...Death (%) ...MI (%) 4.2 (3/71) 2.4 (6/247) 0.42* 6.5 (9/139) 1.4 (2/147) 0.0246 ......Q-Wave 1.4 (1/71) 0.8 (2/247) 0.53* 1.4 (2/139) 0.0 (0/147) 0.24* ......MI (%) ......Non-Q2.8 (2/71) 1.6 (4/247) 0.62* 5.0 (7/139) 1.4 (2/147) 0.10* ......Wave MI (%) 795 22.5 10.5 10.1 10.2 0.0084 0.97 ...Overall (%) (16/71) (26/247) (14/139) (15/147) 7.5 ......TLR (%) 16.9 (12/71) 6.1 (15/247) 0.0039 8.6 (12/139) 0.72 (11/147) 795 8.5 (6/71) 6.9 (17/247) 0.65 1.4 (2/139) 3.4 (5/147) 0.45 ......Remote (%) 3URWRFROGH¿QHG Stent Thrombosis 1.5 (1/67) 0.4 (1/243) 0.39* 0.7 (1/135) 0.0 (0/146) 0.48* (%) $5&GH¿QLWHRU probable Stent 1.5 (1/67) 0.4 (1/243) 0.39* 0.7 (1/135) 0.0 (0/146) 0.48* Thrombosis (%) Total Death (%) 4.3 (3/69) 2.8 (7/249) 0.46* 3.6 (5/139) 0.7 (1/147) 0.11* Numbers shown are % (count/total) Default p value for comparing two proportions is from the chi-square test. *p values were calculated by Fisher exact test. $EEUHYLDWLRQV 0$&( PDMRUDGYHUVHFDUGLDFHYHQWV FDUGLDFGHDWK0,795 0, P\RFDUGLDOLQIDUFWLRQ 795 WDUJHWYHVVHOUHYDVFXODUL]DWLRQ 7/5 WDUJHWOHVLRQ revascularization; ARC: Academic Research Consortium; CEC: clinical events committee
Conclusion: 7$;86 /LEHUWp LPSURYHG RXWFRPHV FRPSDUHG ZLWK 7$;86 ([SUHVV LQ VPDOO YHVVHOV DQG ORQJ OHVLRQV 7KLV PD\ UHODWH WR /LEHUWp¶V improved geometry and thinner strut design. TCT-359 A Randomized Comparison of Triple Antiplatelet Therapy with Dual Antiplatelet Therapy after Drug-Eluting Stent Implantation in Long Coronary Lesions: 2-year Clinical Outcomes of DECLARE-LONG Trial Jae-Hwan Lee1, Seong-Wook Park2, Seung-Whan Lee2, Young-Hak Kim Kim2, Jong-Young Lee2, Jeong-Woo Lee2, Won-Jang Kim2, Sung-Cheol Yun2, Cheol Whan Lee2, Myeong-Ki Hong2, Jae-Ki Ko3, Jae-Hyeong Park1, Si Wan Choi1, Jin-Ok Jeong1, In-Whan Seong1, Yoon Haeng Cho4, Nae-Hee Lee4, June Hong Kim5, Kook-Jin Chun5, Hyun-Sook Kim6, Seung-Jung Park2 1 Chungnam National University Hospital, Daejeon, Republic of Korea 2 Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea 3Chonbuk National University Hospital, Jeonjoo, Republic of Korea 4Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea 5Busan National University Hospital, Busan, Republic of Korea 6Hallym University Sacred Heart Hospital, Pyeongchon, Republic of Korea Background: Although cilostazol reduced angiographic restenosis after baremetal stent or drug-eluting stent (DES) implantation, its long-term clinical impact on the performance of DES has not been evaluated. Methods: This randomized, multicenter, prospective study compared triple antiplatelet therapy (aspirin, clopidogrel and cilostazol, triple group, n=250) and dual antiplatelet therapy (aspirin and clopidogrel, standard group, n=250) for 6 months in patients with long coronary lesions receiving DES. We evaluated long-term clinical outcomes (death, myocardial infarction, and target lesion revascularization) at 2 years. Results: Baseline clinical and angiographic characteristics were comparable between groups. At 2 years, the incidence of death (1.2% vs. 2.0%, p=0.724) and myocardial infarction (0.8% vs. 0.4%, p=0.999) was not statistically different
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TCT-361
EHWZHHQ WKH WZR JURXSV +RZHYHU WULSOH WKHUDS\ VLJQL¿FDQWO\ UHGXFHG WKH 2-year target lesion revascularization compared to standard group (4.0% vs. 8.4%, p=0.041). Major adverse cardiac events including death, myocardial LQIDUFWLRQDQGWDUJHWOHVLRQUHYDVFXODUL]DWLRQZDVDOVRVLJQL¿FDQWO\UHGXFHG in the triple than in the standard group (5.6% vs. 10.4%, p=0.048). During study period, 1 subacute stent thrombosis occurred in the triple therapy and 2 stent thromboses (1 late, 1 very late) in the standard group. Conclusions: Triple antiplatelet therapy after DES implantation is superior WRLQUHGXFLQJ\HDUULVNRIWDUJHWOHVLRQUHYDVFXODUL]DWLRQDQGPDMRUDGYHUVH cardiac events in long coronary lesions compared to dual antiplatelet therapy, which suggests that adding cilostazol on the dual antiplatelet regimen provides WKHLPSURYHGHI¿FDF\RI'(6LQOHVLRQVRUSDWLHQWVDWKLJKULVNRIUHVWHQRVLV
Drug Eluting Stents Do Not Delay Early Endothelialization, But Show Distinct Differences In Endothelial Function Heleen M M van Beusekom1, Yoshinobu Onuma1, Ilona KrabbendamPeters1, Willem J van der Giessen2 1 Erasmus MC, Rotterdam, Netherlands 2Erasmus MC and ICIN-KNAW, Rotterdam, Utrecht, Netherlands Late stent thrombosis and impaired endothelium-dependent vasodilation in Cypher and Taxus are often attributed to delayed re-endothelialization. Data to support this hypothesis is scarce and the functional status of the HQGRWKHOLXP ZLWKLQ WKHVH GUXJ HOXWLQJ VWHQWV LV XQNQRZQ :H FRPSDUHG drug eluting stents (eluting Paclitaxel, Sirolimus (-limus via mTOR) and Tacrolimus (-limus via calcineurin) to bare metal stents in swine coronary arteries with respect to early re-endothelialization at 5 days and endothelial function as assessed by immunocytochemistry for eNOS and vWF expression at 28 days (semiquantitative score). Results:7KHUHZHUHQRVLJQL¿FDQWGLIIHUHQFHVLQUHHQGRWKHOLDOL]DWLRQEHWZHHQ drug eluting stents and bare stents at 5 days (Anova, p=0.7). While vWF expression was similar for all drug eluting stents, paclitaxel did show diminished eNOS expression at 28 days ( † p=0.00002 and ‡ p=0.002 vs PES).
TCT-360 Comparison of Clinical Characteristics and Long-term Outcomes after Sirolimus-eluting stent implantation between Hemodialysis Patients and Non-hemodialysis Patients Insight from Japan Multicenter Post Marketing Surveillance Registry Yoritaka Otsuka1, Sugao Ishiwata2, Tsukasa Inada3, Yasuhiko Hayashi4, Hiroshi Fujita5, Ichiro Michishita6 1 National Cardiovascular Center, Suita, Osaka, Japan 2Toranomon Hospital, Tokyo, Japan 3Osaka Red Cross Hospital, Osaka, Japan 4Tsuchiya General Hospital, Hiroshima, Japan 5Kyoto Second Red Cross Hospital, Kyoto, Japan 6 Yokohama Sakae Kyosai Hospital, Yokohama, Japan Background: 6LUROLPXVHOXWLQJ VWHQW 6(6 KDV PDUNHGO\ UHGXFHG LQVWHQW restenosis compared to bare metal stent in spite of on-label or off-label uses in SDWLHQWVZLWKFRURQDU\DUWHU\GLVHDVH+RZHYHUWKHHI¿FDF\RISHUFXWDQHRXV coronary interventions (PCI) with SES in hemodialysis (HD) patients has remained controversial due to consistent exclusion of these populations from major clinical trials. Methods: We analyzed the data on 2,050 patients who underwent PCI with SES implantation and enrolled in multi-center of Japan. Clinical characteristics, 8-month angiographic results and 2-year clinical outcomes were compared between HD group (n = 106) and non-hemodialysis (NH) group (n = 1,944). Those between HD group and NH group with diabetes mellitus were also compared. Results: Clinical characteristics in HD group revealed higher prevalence of diabetes mellitus and multivessel disease, lower ejection fraction, and lower prevalence of hyperlipidemia and obesity. For PCI, HD group needed more GHEXONLQJ VWUDWHJ\ XVLQJ D URWDEODWRU DWKHUDFWRP\ DQG KLJKHU GHSOR\PHQW SUHVVXUHGXHWRFRPSOH[OHVLRQV$WPRQWKV+'JURXSKDGDVLJQL¿FDQW ODUJHU ODWH ORVV +' PP YV 1+ PP S DQG D VLJQL¿FDQW higher binary restenosis rate (HD: 26.4% vs NH: 8.2%, p<0.001) compared to NH group. At 2-year clinical follow-up period, there were higher mortality and target lesion revascularization (TLR) (HD: 18.2% vs NH: 5.3%, p<0.001) in HD group compared to NH group but no difference in stent thrombosis rate between 2 groups (HD: 2.0% vs NH: 0.6%, p=NS). In diabetic patients, HD JURXSKDGDVLJQL¿FDQWKLJKHULQFLGHQFHRI7/5FRPSDUHGWR1+JURXS +' 21.7% vs NH: 6.4%, p<0.001). Conclusions: 3&,ZLWK6(6LQ+'SDWLHQWVLVVDIHEHFDXVHRIQRVLJQL¿FDQW difference in stent thrombosis rate but not comparable with a higher incidence of repeat revascularization and mortality when compared with NH patients. +LJKPRUWDOLW\LQ+'SDWLHQWVLQÀXHQFHVE\FRQWULEXWLQJFRPRUELGLWLHVDQG more severe conditions such as the low ejection fraction. HD is suggested to be a strong predictor of repeat revascularization after SES implantation not only in the general population but also in the diabetic subset.
SEM and immunocytochemistry eNOS at 28 days
vWF at 28 days
n.d.
n.d.
Tacrolimus (n=7+14
Paclitaxel (n=3+16)
Sirolimus (n=4+15)
Á
eNOS and vWF score between 0 (no EC) 1 (-10%) 2 (10-40%), 3 (40-70%, 4 (70-90%) 5 (90-100%EC).
Conclusion: Drug eluting stents show no differences in re-endothelialization as compared to bare metal stents. Only Paclitaxel induced diminished eNOS expression at 28 days as compared to the other drug eluting stents. TCT-362 ,PSDFWRI/HVLRQ&DOFL¿FDWLRQRQ&OLQLFDODQG$QJLRJUDSKLFRXWFRPH after Sirolimus-Elutimg Stent Implantation in Real-World Patients Ren Kawaguchi, Shigeru Oshima, Takuji Toyama, Hiroshi Hoshizaki Gunma Prefectural Cardiovascular Center, Maebashi, Japan Background: 3UHYLRXV VWXGLHV KDYH GHPRQVWUDWHG VLPLODU HI¿FDF\ RI WKH GUXJHOXWLQJ VWHQW LQ SDWLHQWV ZLWK DQG ZLWKRXW FDOFL¿HG OHVLRQV +RZHYHU PRVW RI WKH UDQGRPL]HG WULDOV KDYH H[FOXGHG SDWLHQWV ZLWK VHYHUH FDOFL¿HG lesions. We aimed to examine the impact of lesion calcium on clinical and angiographic outcome after Sirolimus-Eluting Stent (SES) implantation in real-world patients. Methods: Consecutive 380 patients with 556 lesions treated with SES
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% EC at 5 days Bare stents (n=4)
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were enrolled. Lesions were divided into Calc lesions (moderate or sever FDOFL¿FDWLRQ OHVLRQV DQGQRQ&DOFOHVLRQV QRQHRUPLOGFDOFL¿FDWLRQ lesions) according to the lesion calcium. Quantitative coronary angiography (QCA) parameters, binary restenosis rate (%restenosis), target lesion revascularization (TLR) rate, and major adverse cardiac events (MACE) during follow-up were compared between the two groups. All patients were contacted at 1, 6, and 12 months after the procedure. Results: Lesion success rate was similar in the two groups. %Restenosis YV S DQG7/5 YV S ZHUHVLJQL¿FDQWO\ higher in Calc lesions. Stent thrombosis was observed in 0.7% of overall lesions with no difference between the two groups. The MACE rate in Calc SDWLHQWV ZDV VLJQL¿FDQWO\ KLJKHU WKDQ LQ QRQ&DOF SDWLHQWV By multivariateanalysis, hemodialysis (HD) (OR: 9.84, 95%CI: 2.86 to 36.7, p=0.0003) and requirement of rotational atherectomy (RA) ((OR: 10.14, 95%CI: 2.57 to 41.03, p=0.0008) were predictive factors of TLR in the Calc lesions. Conclusion:&RURQDU\OHVLRQVZLWKFDOFL¿FDWLRQFRPSULVHDKLJKULVNFRKRUW and are associated with a higher TLR and binary restenosis rates in real-world SDWLHQWVWUHDWHGZLWK6(60RUHRYHUSDWLHQWVZLWKFDOFL¿HGOHVLRQVDQGRQ+' are associated with higher MACE rate. TCT-363 /RQJWHUP&OLQLFDO2XWFRPHVLQ3DWLHQWV:LWK5HQDO,QVXI¿FLHQF\ After Sirolimus-eluting Stents Implantation: Two-year Follow-up Results of the j-Cypher Registry
E L E C T RO N I C A B S T R AC T S
Yasushi Fuku, Kazuaki Mitsudo, Kazushige Kadota, Tsuyoshi Goto, Hiroyuki Yamamoto, Shingo Hosogi, Hiroyuki Tanaka, Takeshi Kimura, on behalf of the j-Cypher Registry investigators Kurashiki Central Hospital, Kurashiki City, Japan Background: Previous randomized trials of sirolimus-eluting stents (SES) H[FOXGHGSDWLHQWVZLWKVHYHUHUHQDOLQVXI¿FLHQF\:HVRXJKWWRHYDOXDWHWKH impact of baseline renal function on clinical outcomes in SES recipients in the real-world registry. Methods: The design of the j-Cypher Registry was multicenter prospective enrollment of consecutive patients who underwent SES implantations from 41 centers in Japan. We reviewed 2-year clinical outcomes of 12 809 patients who underwent successful implantation of SES between August DQG'HFHPEHU3DWLHQWVZHUHVWUDWL¿HGLQWRJURXSVDFFRUGLQJ WRWKHLUHVWLPDWHGJORPHUXODU¿OWUDWLRQUDWH H*)5 *URXS,H*)5PO min/1.73m2 QRUPDO IXQFWLRQ RU PLOG LQVXI¿FLHQF\ *URXS ,, H*)5 DQGPOPLQP2 PRGHUDWHLQVXI¿FLHQF\ *URXS,,,H*)5 PO min/1.73m2DQGQRWRQKHPRGLDO\VLV +' VHYHUHLQVXI¿FLHQF\ DQG*URXS ,9UHQDOIDLOXUHWUHDWHGZLWK+' Results: The baseline characteristics and two-year clinical outcomes are shown in the table. The overall mortality rates were 21.0% in Group III and LQ*URXS,9ZKLFKZHUHVLPLODU S %\PXOWLYDULDWHDQDO\VLV *URXS,9DQG*URXS,,, 25 DQG S ZHUHVWURQJSUHGLFWRUV of death.
Conclusion: The target lesion revascularization (TLR) rate of each non-HD JURXS ZDV ORZ DQG VLPLODU UHJDUGOHVV RI WKH GHJUHH RI UHQDO LQVXI¿FLHQF\ However, low rates of TLR were countered by high rates of major adverse cardiac and cerebrovascular events (MACCE) and death among renally LQVXI¿FLHQWSDWLHQWVDW\HDUVDIWHU6(6LPSODQWDWLRQ TCT-364 “Late catch-up” in Restenosis Following Sirolimus-Eluting Stent Implantation Osamu Mastuda, Masashi Kimura, Mitsuyasu Terashima, Kenya Nasu, Yoshihisa Kinoshita, Mariko Ehara, Etsuo Tsuchikane, Hitoshi Matsuo, Tetsuo Matsubara, Keiko Asakura, Yasushi Asakura, Osamu Katoh, Takahiko Suzuki Toyohashi Heart Center, Toyohashi, Japan Background: Despite the suppression of intimal hyperplasia (IH) in coronary arteries with drug eluting stent (DES) compared with bare-metal stents at 6 PRQWKVDIWHUWKHSURFHGXUHWKHUHDSSHDUVWREHD³ODWHFDWFKXS´LQ,+JURZWK among patients treated with DES after 1 year. However, late restenosis after 6(6LPSODQWDWLRQKDVQRWEHHQVXI¿FLHQWO\HYDOXDWHG7KHDLPRIRXUVWXG\ ZDVWRGHWHUPLQHZKHWKHULQVWHQWUHVWHQRVLVRFFXUULQJ!\HDU ³ODWHFDWFK XS´ DIWHUVLUROLPXVHOXWLQJVWHQWLPSODQWDWLRQLVDUHDOFOLQLFDOHQWLW\ Methods: We analyzed data on all sirolimus-eluting stents implanted in our institution ffrom June 2004 to April 2007 and evaluated the incidence, clinical presentation, and angiographic instent restenosis (ISR) pattern after VLUROLPXVHOXWLQJVWHQW 6(6 LPSODQWDWLRQ:HFRQVLGHUHGUHVWHQRVLV³HDUO\´ LILWRFFXUUHGGXULQJWKH¿UVW\HDUDQG³ODWHFDWFKXS´LIDIWHU\HDU³/DWH FDWFKXS´ UHTXLUHG GHPRQVWUDWLRQ RI D SDWHQW VWHQW DW WR PRQWKV ZLWK repeat angiography after 1 year demonstrating restenosis. Results: Of 3420 lesions in 2414 patients treated with SES. Angiographic follow-up was performed in 1763 patients (73.0%) with 2506 lesions (73.3%). Angiography DIWHU\HDUZDVSHUIRUPHGEHFDXVHRISDWLHQWV¶V\PSWRPRUWUHDWPHQWRIRWKHU YHVVHOV5HVWHQRVLVRFFXUUHGLQOHVLRQVRYHUDOO ³/DWHFDWFKXS´LQ restenosis was observed in 20 lesions (0.80%) at second angiographic follow up (median 23.5 months; range of 17.7 to 29.3 months). Clinical presentations of late TLR were silent ischemia (43%) and recurrent angina (57%). Late TLR was performed in 18 patients with 19 lesions. Serial quantitative coronary angiographic DQDO\VLVRIWKHVHOHVLRQVVKRZHGDPLQLPDOOXPHQGLDPHWHURIPP LPPHGLDWHO\DIWHU6(6LPSODQWDWLRQ PPDW PRQWKIROORZXSDQG PPDWVHFRQGIROORZXS S Conclusion: ³/DWH FDWFKXS´ LV DQ LQIUHTXHQW EXW UHDO HQWLW\ $OPRVW DOO FDVHVRI³ODWHFDWFKXS´ H[SUHVVHGDIRFDODQJLRJUDSKLF,65SDWWHUQ Clinical presentations of late TLR was either silent ischemia or recurrent angina, but not acute coronary syndrome. Repeart angiographic follow up could be required for the patients who did not have ISR at 9 month follow up angiography. TCT-365 &RPSDULVRQRI
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Methods: A prospective analysis of 448 patients with LMT stenosis (324 Bifur DQG1%LIXU LQ¿YHKLJKYROXPH$VLDQFHQWHUVDIWHUVXFFHVVIXOVWHQWLQJ in LMT was performed. LMT was treated with 5 strategies (single stenting 195 cases, T-stenting 47 cases, crush stenting 38 cases, Mini-crush stenting 93 FDVHVFXORWWHVWHQWLQJFDVHVNLVVLQJVWHQWLQJFDVHV &RPSOHWHFOLQLFDO follow-up to 4 years is being analyzed for all 448 patients. Results: The baseline clinical characteristics between 2 groups were similar. Angiographic and clinical success were achieved in all patients without any major complication. At 4 years overall cardiac events of N-Bifur (14.5%) ZHUHVLJQL¿FDQWO\ORZHUWKDQ%LIXU S 6HH¿JXUHIRUFOLQLFDO results.
DQGRUPDODSSRVHGVWUXWVDQGVHFWLRQVZLWKFRPSOHWHFRYHUDJH YV S YV S
Conclusion: Number of visualized struts and strut distribution did not show major implications for PES coverage and neointimal growth in this study. TCT-367 Clinical Outcomes with Everolimus-eluting Stents in Unrestricted Contemporary Practice Luca A Ferri1, Azeem Latib1, Cosmo Godino1, Robert Gerber2, Riccardo Colantonio1, Alfonso Ielasi1, Giorgio Bassanelli1, Valeria Magni1, Flavio Airoldi1, Matteo Montorfano1, Mauro Carlino1, Iassen Michev1, Alaide Chieffo1, Antonio Colombo2 1 6DQ5DIIDHOH6FLHQWL¿F,QVWLWXWH0LODQ,WDO\26DQ5DIIDHOH6FLHQWL¿F Institute and EMO Centro Cuore Columbus, Milan, Italy
Conclusion: The use of drug-eluting stent in patients with LMT was safe and feasible with low acute complication and low incidence of restenosis. Drugeluting stent implantation in non-bifurcation lesion of LMT showed lesser incidence of cardiac events (death, myocardial infarction, CABG and PCI) compared with those of bifurcation lesion at 4 years clinical follow-up. TCT-366 Strut Number and Distribution: Implications for Drug-Eluting Stent Coverage and Neointimal Growth. In-vivo Insight from Optical Coherence Tomography Antonio Trivisonno1, Giuseppe Musumeci1, Vasile Sirbu1, Nikoloz Lortkipanidze1, Alexander Matiashvili1, Laurian Mihalcsik1, Giuseppe Biondi-Zoccai2, Nobuaki Suzuki3, John Coletta3, Marco Costa3, Orazio Valsecchi1, Giulio Guagliumi1 1 Ospedali Riuniti di Bergamo, Bergamo, Italy 2University of Turin, S. Giovanni Battista “Molinette” Hospital, Torino, Italy 3Case Western Reserve University, Cleveland, OH Background: Struts spacing and distribution might have implications for drug-eluting stent (DES) coverage and neointimal proliferation (NIH). Optical &RKHUHQFH7RPRJUDSK\ 2&7 SURYLGHVLQYLYRTXDQWL¿FDWLRQRIVWHQWVWUXW tissue response at micron-scale level. Purpose: To assess the importance of DES strut number and distribution on local NIH and coverage. Methods: We performed OCT in 23 consecutive pts with single paclitaxel eluting stent (PES n=30) at 12 months follow-up. Quantitative analysis of NIH, coverage and strut apposition was obtained throughout the entire lenght of the stent at every 1 mm interval by dedicated software with 360 chords. 6WUXWFRYHUDJHZDVJUDGHGDV FRYHUHG !PPWKLFNQHVV DQGXQFRYHUHG struts (< 0.01 mm). To assess stent strut distribution, the number of visualized stent strut and the maximum interstrut angle were measured at every 1 mm FURVVVHFWLRQV7KHQRQXQLIRUPVWUXWVGLVWULEXWLRQLQGH[ 16', ZDVGH¿QHG as the maximun interstrut angle divided by the number of struts Results: 0HDQOHQJKWRIWKHHYDOXDWHGVWHQWVZDVPP:HH[DPLQHG 4662 struts in 486 fully analyzable cross sections. The number of analyzed struts per section was 9.6 (6-12, median,1st-3rd quartile) with mean NIH of -m. No statistical correlation between number of struts and mean NIH per section (r=-0.23; Fig. 1) was observed. The overall rate of uncovered and malapposed struts was 1.6% and 0.9 % respectively. Uncovered and/or malapposed struts were observed in 12 stent. In this group both the maximum interstrut angle and the NSDI were similar between section with uncoverd
The American Journal of Cardiology®
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October 12-17, 2008
Conclusion: In a complex cohort of patients treated in a real world scenario, 6-month clinical outcomes of EES substantially reproduce the data of published randomized trials. However, longer term data are needed to assess the safety of this new platform.
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Background: The randomized Spirit I, II and III trials have evaluated the performance of everolimus- eluting stents (EES), but data regarding daily practice are still missing. The study objective was to evaluate the safety and HI¿FDF\RI((6LQDFRQWHPSRUDU\FRKRUWRIUHDOZRUOGSDWLHQWV Methods: All consecutive patients successfully treated with EES (either 352086%RVWRQ6FLHQWL¿F&RUS1DWLFN0$86$RU;,(1&(9 $EERWW9DVFXODU'HYLFHV5HGZRRG&LW\&$86$ EHWZHHQ2FWREHUDQG November 2007 were analyzed. Endpoints were death, myocardial infarction 0, WDUJHW YHVVHO UHYDVFXODUL]DWLRQ 795 WDUJHW OHVLRQ UHYDVFXODUL]DWLRQ (TLR), stent thrombosis (ST), and major adverse cardiac events (MACE, a composite of death, MI, TLR) at 6 months. Results: :H LGHQWL¿HG SDWLHQWV $JH \UV ZLWK D KLVWRU\ RI diabetes (31%), previous MI (44%), and previous PCI (59%). EES were implanted in 458 lesions, of which 55% included off-label indications such as bifurcations in 30.5%, chronic occlusions in 12.5%, left main in 10.5%, restenotic lesions in 16%, and bypass grafts in 2.5%. Clinical follow-up was FRPSOHWHGLQ $WPRQWKV0$&(RFFXUUHGLQ SDWLHQWV795 in 15 (5.6%), TLR in 11 (4.1%), and MI in 3 (1.2%). Death occurred in 2 (0.8%) SDWLHQWVDQGLQ ZDVRIFDUGLDFRULJLQ'H¿QLWH67SUHVHQWLQJDVDQRQ fatal MI was observed in 2 (0.8%) cases.
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TCT-368 Comparison of Vascular Response to Zotarolimus-Eluting Stent Versus Paclitaxel-Eluting Stent Implantation: IVUS Results From the ENDEAVOR IV Trial Katsuhisa Waseda1, Akiyoshi Miyazawa1, Takao Hasegawa1, Ichizo Tsujino1, Ryota Sakurai1, Junya Ako1, Paul G Yock1, Yasuhiro Honda1, David E Kandzari2, Martin B Leon3, Peter J Fitzgerald1, The ENDEAVOR IV Trial investigators 1 Stanford University, Stanford, CA; 2Duke University, Durham, NC; 3 Columbia University, New York, NY Background: 7KH (1'($925 ,9 WULDO LV D UDQGRPL]HG FRQWUROOHG VWXG\ RI ]RWDUROLPXVHOXWLQJ SKRVSKRU\OFKROLQHFRDWHG '5,9(5 VWHQW IRU WKH treatment of de novo coronary lesions. The aim of this study was to compare the vessel response between zotarolimus-eluting (ZES) and paclitaxel-eluting VWHQWV 3(6 XVLQJ,986 Methods: 7KH(1'($925,9,986FRKRUWFRQVLVWHGRISDWLHQWV =(6 3(6 9ROXPHWULFDQDO\VLVZDVSHUIRUPHGIRUYHVVHOOXPHQSODTXH VWHQW 69 DQGQHRLQWLPD 1,9 1HRLQWLPDIUHHIUDPHUDWLRZDVFDOFXODWHG DVWKHQXPEHURIIUDPHVZLWKRXW,986GHWHFWDEOHQHRLQWLPDGLYLGHGE\WKH total number of frames. Results: While PES showed positive remodeling during follow-up, ZES had QRVLJQL¿FDQWFKDQJHLQSHULVWHQWYHVVHOVWUXFWXUH$WIROORZXS=(6VKRZHG VLJQL¿FDQWO\ JUHDWHU 1,9 1,969 DQG PD[ FURVVVHFWLRQDO QDUURZLQJ (CSN, neointimal area/stent area, %) with smaller minimum lumen area (MLA) FRPSDUHGWR3(6+RZHYHUWKHLQFLGHQFHRIPD[&61!ZDVVLPLODULQWKH JURXSV1HRLQWLPDIUHHIUDPHUDWLRZDVVLJQL¿FDQWO\ORZHULQ=(6VXJJHVWLQJ more evenly distributed neointimal coverage throughout the stent. There were 3 cases of late incomplete stent apposition in PES and 1 in ZES.
E L E C T RO N I C A B S T R AC T S
MLA at baseline (mm2) MLA at follow-up (mm2) Late lumen area loss (mm2) 1,9 Max CSN (%) 6WHQWVZLWKPD[&61! Neointima-free frame ratio (%)
PES (N=86) 10.5
ZES (N=79) 16.5
p <0.05 <0.01 NS <0.01 <0.01 NS <0.01
Conclusion: ZES and PES had different peri-stent and in-stent vessel responses. There was a moderate increase in neointimal hyperplasia in ZES compared with PES. However, due to more evenly distributed neointima, LQFLGHQFHRIVLJQL¿FDQWQDUURZLQJZDVVLPLODUEHWZHHQWKHVWHQWV TCT-369 Very Long-term Risk of Stent Thrombosis After Intracoronary Brachytherapy and Its Relationship with Antiplatelet Regimen: a Lesson from an Old Story Jin-Wook Chung1, Kyung-Woo Park1, Young-Seok Cho2, Tae-Jin Youn2, Woo-Young Chung3, In-Ho Chae2, Hyo-Soo Kim1, Bon-Kwon Koo1 1 SNUH, Seoul, Republic of Korea 2SNUBH, Seongnam, Republic of Korea 3SNU Boramae Medical Center, Seoul, Republic of Korea Background: Delayed or incomplete healing of stent strut plays an essential role in development of late stent thrombosis. In this regard, intracoronary brachytherapy may serve as a possible clinical model for late stent thrombosis after drug-eluting stent implantation. Objectives:7RHYDOXDWHWKHORQJWHUPULVNRIYHU\ODWHVWHQWWKURPERVLV 9/67 after intracoronary brachytherapy and its relationship with antiplatelet regimen. Methods: From the SPARE trial, we retrospectively followed 103 patients for up to 8 years who received new bare-metal stent with (n=51, radiation group) or without (n=52, control group) intracoronary brachytherapy using 188Re'73$¿OOHGEDOORRQV\VWHP Results:/DQGPDUNDQDO\VLVDW\HDULQFOXGHGSDWLHQWVLQWKHUDGLDWLRQ
146i
JURXSDQGSDWLHQWVLQWKHFRQWUROJURXS7KHFXPXODWLYHLQFLGHQFHRI9/67 ZDVVLJQL¿FDQWO\KLJKHULQWKHUDGLDWLRQJURXSWKDQLQWKHFRQWUROJURXS versus 0%, p =0.01). That of cardiac death and myocardial infarction after 1 \HDUZDVDOVRVLJQL¿FDQWO\KLJKHULQWKHUDGLDWLRQJURXS YHUVXVp 2IWKH9/67FDVHVDVVRFLDWHGZLWKLQWUDFRURQDU\EUDFK\WKHUDS\ occurred beyond 4 years, 3 of which presented as fatal myocardial infarction. ,QWKHUDGLDWLRQJURXSWKHUHZHUH9/67FDVHVSHUSHUVRQ\HDUVZLWK regimens containing aspirin but not thienopyridine. However, there were no 9/67FDVHVGXULQJWKHSHUVRQ\HDUVZLWKUHJLPHQVFRQWDLQLQJERWKDVSLULQ and thienopyridine.
Conclusion: Intracoronary brachytherapy was associated with continuously LQFUHDVHGULVNRI9/67$VSLULQSOXVWKLHQRS\ULGLQHFRPELQDWLRQVHHPHGWR EHHIIHFWLYHLQORZHULQJWKLVULVN TCT-370 WITHDRAWN TCT-371 Safety of ENdeavorTM Stent (Zotarolimus-eluting Stent) Associated with Non-cardiac Surgical Procedure and Brief Interruption of Dual Anti-platelet Agents within 12 Months Following Stent Implantation (SENS): a Multicenter Study Jin Won Kim1, Woong Chol Kang2, Ki Seok Kim3, Soo Joong Kim4, Chang-Wook Nam5, Chul-Min Ahn6, Bong-Ki Lee7, Sang Yup Lim8, Hyun Sook Jung9, Jin Ho Choi10, Young Joon Hong11, Dong Joo Oh1 1 Korea University Guro Hospital, Seoul, Republic of Korea 2Gachon University Gil Hospital, Seoul, Republic of Korea 3Cheju National University Hospital, Seoul, Republic of Korea 4Kyung-Hee Univeristy Hospital, Seoul, Republic of Korea 5Keimyung University Hospital, Seoul, Republic of Korea 6Korea University Anam Hospital, Seoul, Republic of Korea 7Kangwon National University Hospital, Seoul, Republic of Korea 8Korea University Ansan Hospital, Seoul, Republic of Korea 9Hong Ik Hospital, Seoul, Republic of Korea 10Sungkyunkwan University Samsung Medical Center, Seoul, Republic of Korea 11 Chonnam National University Hospital, Seoul, Republic of Korea Background: Bare-metal stent is preferable to 1st generation drug-eluting stent (DES) in patients who need non-cardiac surgery within 12 months from FRURQDU\VWHQWLQJGHVSLWHUHVWHQRVLV+RZHYHUGDWDDUHODFNLQJUHJDUGLQJWKH safety of EndeavorTM VWHQWZKLFKKDVEHHQNQRZQWRFDUU\DORZHUULVNRIVWHQW thrombosis due to rapid re-endothelialization. Methods: A total of 3098 consecutive patients treated with EndeavorTM stent (Zotarolimus-eluting stent;ZES) since January 2006 were retrospectively analyzed in Korean 11 teaching hospitals. The primary endpoint was the 30-day major adverse cardiac events (MACE) including death, non-fatal myocardial infarction (MI) and target lesion revascularization. Results: 193 patients (6.2 %, 193/3098) (male 54.9 %, mean age 63.5 years, diabetes 29.7 %) with brief interruption of dual anti-platelet agents (both aspirin and clopidogrel) due to non-cardiac surgical procedure within 12 PRQWKV IROORZLQJ =(6 LPSODQWDWLRQ ZHUH LGHQWL¿HG )RXU SDWLHQWV H[SHULHQFHGD0$&( SDWLHQWV IDWDOSDWLHQWV QRQIDWDO0,ZLWKLGHQWL¿HG thrombus). The incidence of MACE was higher in the early-surgery group (within 3 months following stent implantation) than in the late-surgery group (3 months to 12 months after stent implantation) (p<0.001, Table). There were no differences of clinical, angiographic and procedural characteristics at baseline between two groups (Table).
The American Journal of Cardiology® |
October 12-17, 2008
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2 Year Clinical Outcomes, Study-stent population TAXUS ATLAS TAXUS ATLAS Direct Stent 7$;86 Pre7$;86 Direct Express p Dilation Clinical Outcome /LEHUWp Stent p value Control value Control (N=867) (N=241) (N=978) (N=538) 16.0% 15.6% 19.2% 10.4% MACE (%) 0.82 0.0029 (150/937) (130/833) (99/516) (24/230) ...Cardiac 1.8% 2.5% 1.3% 1.5% (14/937) 0.61 0.41* ...Death (%) (15/833) (13/516) (3/230) 4.8% 4.7% 5.2% 4.8% ...MI (%) 0.91 0.80 (45/937) (39/833) (27/516) (11/230) 795 12.2% 11.4% 14.3% 5.7% 0.62 0.0006 ...Overall (%) (114/937) (95/833) (74/516) (13/230) 6.9% 7.3% 9.1% 3.0% ......TLR (%) 0.75 0.0032 (65/937) (61/833) (47/516) (7/230) 795 5.5% 6.8% 3.5% ......Remote 5.9% (55/937) 0.75 0.07 (46/833) (35/516) (8/230) ......(%) 3URWRFROGH¿QHG6WHQW 1.2% 1.6% 0.4% 1.1% (10/919) 0.79 0.29* Thrombosis (%) (10/816) (8/502) (1/227) $5&GH¿QLWHRU 1.5% 2.0% 0.4% probable Stent 1.3% (12/920) 0.77 0.19* (12/816) (10/502) (1/227) Thrombosis (%) 2.9% 3.5% 2.2% Total Death (%) 3.4% (32/941) 0.53 0.33 (24/835) (18/515) (5/231) Numbers shown are % (count/total) Default p value for comparing two proportions is from the chi-square test. *p values were calculated by Fisher exact test. $EEUHYLDWLRQV 0$&( PDMRUDGYHUVHFDUGLDFHYHQWV FDUGLDFGHDWK0,795 0, P\RFDUGLDOLQIDUFWLRQ 795 WDUJHWYHVVHOUHYDVFXODUL]DWLRQ 7/5 WDUJHWOHVLRQ revascularization; ARC: Academic Research Consortium; CEC: clinical events committee
Early surgery group Late surgery group p-value (n=34) (n=159) Age(yrs)/Male (%)
62.2/63.5
63.1/50.9
Lesion type (B2/C) (%)
73.6
72.8
NS NS
Stent number
1.4
1.5
NS
Mean stent diameter (mm)
NS
Total stent length (mm)
NS
Major surgery (%)
20.5
22.8
NS
Days from stenting to surgery
56.5
233.7
<0.001
DAP withdrawal (days)
13.4
14.8
NS
MACE (%)
8.9 (2 Death, 1 MI)
0.6 (1 MI)
<0.001
16 QRVLJQL¿FDQW'$3 GXDODQWLSODWHOHWDJHQWV
Conclusion: ZES appears to be safe and feasible in patients undergoing non-cardiac surgical procedure after 3 months following stent implantation. 1RQHWKHOHVV FRQVLGHULQJ WKH SRWHQWLDO ULVN RI VWHQW WKURPERVLV FOLQLFLDQV should pay attention to stay on at least aspirin during the perioperative period. TCT-372 TAXUS ATLAS and TAXUS ATLAS DIRECT STENT Trials: Durable Effectiveness of the TAXUS Liberté Stent and Long-term %HQH¿WRI'LUHFW6WHQWLQJ
Conclusion: Clinical outcomes at 2 year post stent implantation were similar for TL and TE stents with proven durable effectiveness in reducing restenosis. 'LUHFWVWHQWLQJRI7$;86/LEHUWpUHGXFHGIXUWKHUFOLQLFDOUHVWHQRVLVDQGKDV DORQJWHUPEHQH¿WLQSWVZLWKFDUHIXOO\VHOHFWHGOHVLRQV
Mark A. Turco1, John A. Ormiston2, Lazar Mandinov3, Tift Mann4, Charles D. O’Shaughnessy5, Thomas F. McGarry6, Louis A. Cannon7, Michael J. Lucca8, Chiung-Jen Wu9, Ehtisham Mahmud10, Keith D. Dawkins3, Donald S. Baim3 1 Washington Adventist Hospital, Takoma Park, MD; 2Mercy Hospital, Auckland, New Zealand 3%RVWRQ6FLHQWL¿F1DWLFN0$ 4Wake Medical Center, Raleigh, NC; 5Elyria Memorial Hospital, Elyria, OH; 6 Oklahoma Heart Hospital, Oklahoma City, OK; 7Northern Michigan Regional Hospital, Petoskey, MI; 8St. Mary’s Duluth Clinic Regional Heart Center, Duluth, MN; 9Chang-Gung Memorial Hospital, NiaoSung Hsiang, Taiwan10UC San Diego Medical Center, San Diego, CA
TCT-373 WITHDRAWN TCT-374 Comparison of the Long-term (2 year) Outcomes of Drug-eluting and Bare-metal Stent Implantation in Saphenous Vein Grafts
The American Journal of Cardiology®
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October 12-17, 2008
Azeem Latib1, Luca A. Ferri1, John Cosgrave2, Cosmo Godino1, Erminio Bonizzoni3, Enrico Romagnoli1, Alfonso Ielasi1, Giorgio Bassanelli1, Flavio Airoldi1, Mauro Carlino1, Matteo Montorfano1, Alaide Chieffo1, Antonio Colombo2 1 6DQ5DIIDHOH6FLHQWL¿F,QVWLWXWH0LODQR,WDO\26DQ5DIIDHOH6FLHQWL¿F Institute and EMO Centro Cuore Columbus, Milan, Italy 3Università degli Studi di Milano, Milan, Italy Background: Concerns about the long-term safety of drug-eluting stents '(6 LQGHJHQHUDWHGVDSKHQRXVYHLQJUDIWV 69* KDVEHFRPHDQDUHDRI controversy after the publication of a small randomized trial. Methods: We compared the outcomes in 127 patients (143 lesions) treated with DES from April 2002 - March 2006 (DES group), to 131 patients (160 lesions) treated with bare-metal stents (BMS) in the preceeding 36 months (BMS group). End-points analyzed were cumulative death, myocardial LQIDUFWLRQ DQG WDUJHW YHVVHO UHYDVFXODUL]DWLRQ 795 DW \HDUV DIWHU VWHQW implantation. Results: 7KH '(6 JURXS ZDV VLJQL¿FDQWO\ S PRUH FRPSOH[ ZLWK D JUHDWHU IUHTXHQF\ RI GLDEHWHV YV ROGHU JUDIWV YV \HDUV UHVWHQRWLFOHVLRQV YV WRWDORFFOXVLRQV YV DQGVPDOOHUJUDIWV YVPP WUHDWHGZLWKORQJHU VWHQWV YVPP At 2 years, there was no statistical difference in death (8.7% v 7.8%), myocardial infarction (3.9% v RU 795 v 24.2%) between DES and BMS UHVSHFWLYHO\$SURSHQVLW\DQDO\VLVWRDGMXVWIRUEDVHOLQHGLIIHUHQFHVFRQ¿UPHG that DES were not associated with death (HR 0.54, [0.19-1.54]; p=0.25) but were DVVRFLDWHGZLWKDUHGXFWLRQLQ795 +5 > @ S
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Background: The 7$;86 /LEHUWp 7/ VWHQW %RVWRQ 6FLHQWL¿F 1DWLFN MA, USA) is designed for improved deliverability and more homogenous GUXJ GLVWULEXWLRQ 7KH 7$;86 $7/$6 7 $7/$6 WULDO SURYHG WKH QRQ LQIHULRULW\ RI 7/ YHUVXV 7$;86 ([SUHVV 7( DW PRQWK IROORZXS 7KH T. ATLAS Direct Stent (DS) study demonstrated reduced clinical and angiographic restenosis with direct implantation of TL as compared to conventional stenting with pre-dilation. Long-term outcomes are being evaluated in the two studies. Methods: T. ATLAS and T. ATLAS DS are multi-center, single-arm studies sharing identical inclusion and exclusion criteria. Both trials are fully monitored, and all MACE are adjudicated by an independent CEC. A total of 871 pts were HQUROOHG LQ 7 $7/$6 DQG OHVLRQPDWFKHG SWV IURP 7$;86 ,9 DQG 9 served as historical controls. A total of 247 pts were enrolled in T. ATLAS DS, and all 543 pts from the angiographic subset in T. ATLAS served as controls. Results: Clinical outcomes at 2 year follow-up were comparable for TL and TE (Table). Assessment of 3 year T. ATLAS clinical outcomes will be SUHVHQWHG'LUHFWVWHQWLPSODQWDWLRQRI7/UHGXFHGVLJQL¿FDQWO\WKHQHHGIRU revascularization in relatively simple lesions.
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TCT-376 Drug-Eluting Stents for the Treatment of Small Coronary Artery with Sirolimus, Paclitaxel, Zotarolimus, EPC Capture and Everolimus-Eluting Stent: Multicenter Registry in Asia
Conclusion: Despite being implanted in patients and lesions more complex WKDQWKH%06JURXS'(6ZHUHQRWDVVRFLDWHGZLWKDQLQFUHDVHGULVNRIGHDWK DW\HDUVDQGPDLQWDLQHGWKHLUHI¿FDF\LQUHGXFLQJUHYDVFXODUL]DWLRQ TCT-375 STEALTH I: Safety and Performance Evaluation of the Biosensors International’s Biolimus A9 Drug Eluting Stent (BioMatrix®). A 4 -year follow-up.
E L E C T RO N I C A B S T R AC T S
Eberhard Grube1, Alexandre Abizaid2, Ralf Mueller1, Karl - Eugen Hauptmann3 1 HELIOS Klinikum Siegburg, Siegburg, Germany 2Institute Dante Pazzane de Cardiologia, São Paulo, Brazil 3Krankenhaus der Barmherzigen Brüder, Trier, Germany Background: Experimental models have shown Biolimus A9® (BA9®) has potent antiproliferative properties. In the BioMatrix® platform the Biolimus A9® is released via a biodegradable polymer. This polymer, polylactic acid (PLA), has been widely used in a variety of medical applications. The Biolimus A9®, the biodegradable polymer (gone in 6-9 month) and the abluminal coating gives unique characteristics to the BioMatrix® platform. Methods: In this, prospective, randomized, double-blinded clinical study 120 patients undergoing angioplasty of stenosis in native coronary arteries with a reference diameter between 2.75 and 4.00 mm received either a single BA9®eluting BioMatrix® stent or bare metal (BMS) S-Stent™. 80 patients were randomized to the BioMatrix®, 40 patients received the BMS stent. Primary HQGSRLQWZDVTXDQWLWDWLYHDQJLRJUDSKLFODWHORVVGH¿QHGDVPLQLPDOOXPHQ diameter (MLD) in the treated segment minus MLD at 6 months. Secondary endpoint was MACE at 30 days, 3 months and 6 months. Results: The mean of 6 months in-stent late loss for BioMatrix® patients ZDV PP PP FRPSDUHGWRWKHPHDQRIPP PP IRU S-Stent™ patients (p<0.001). ,QVHJPHQWODWHORVVZDV YVS MACE at 1 year was 5.1% for BioMatrix® patients and 5.0% for S-Stent™ patients. At 2 years 6.6% vs 7.9% and 3 years 10% vs 8.1% respectively. There was 1 acute stent thrombosis in the BioMatrix® group and no subacute or late stent thrombosis in either group. The 4 years follow up data will be available at time of presentation. Conclusion: The BioMatrix® demonstrated non-inferiority for 6-month insegment late loss compared with the BMS S-Stent™ and demonstrated statistical VXSHULRULW\IRUERWKLQVHJPHQWDQGLQVWHQWODWHORVVDWPRQWKV7KLVEHQH¿W was achieved without an increase in adverse safety outcomes assessed as MACE up to 3 years. These results demonstrate that the BioMatrix® Stent maintains an DGHTXDWHVDIHW\SUR¿OHHTXDOZLWKFRQYHQWLRQDOEDUHPHWDOVWHQWV
Sunao Nakamura1, Hisao Ogawa2, Jang-Ho Bae3, Yeo Hans Cahyadi4, Wasan Udayachalerm5, Damras Tresukosol6, Sudaratana Tansuphaswadikul7 1 New Tokyo Hospital, Chiba, Japan 2Kumamoto University Hospital, Kumamoto, Japan 3Konyang University Hospital, Daejeon, Republic of Korea 4Husada Hospital, Jakarta, Indonesia 5King Chulalongkorn Memorial Hospital, Bangkok, Thailand 6Her Majesty’s Cardiac Center, Siriraj Hospital, Bangkok, Thailand 7Chest Disease Institute, Bangkok, Thailand Aim: 7KH DLP RI WKLV VWXG\ LV WR FRPSDUH WKH VDIHW\ DQG HI¿FDF\ RI Sirolimus (SES), Paclitaxel (PES), Zotarolimus (ZES), EPC capture (ECS) and Everolimus-eluting stent (EES) on the outcome of patients with small coronary artery disease. Methods: A prospective analysis of 1871 patients with small coronary artery VWHQRVLV 6(63(6 =(6(&6 ((6 LQ¿YHKLJKYROXPH Asian centers after successful stenting for small coronary artery stenosis was performed. The study endpoints were major adverse events (MACE) at 30 days, 9 months restenosis rate and target lesion revascularization (TLR) at 9 months. Results: See table for clinical results. SES PES ZES ECS EES Number of patients
808 602 219 153 89
Procedural success (%)
99.8 99.7 100 100 100
Reference diameter (mean: mm)
2.40 2.42 2.37 2.35 2.33
Lesion length (mean: mm)
12.6 11.3 13.7 12.9 18.0
Minimum lumen diameter post procedure (mean: mm)
2.32 2.30 2.28 2.30 2.28
Minimum lumen diameter at 9 months (mean: mm)
2.10 2.01 1.70 1.72 2.10
Restenosis rate at 9 months (%)
7.4* 13.0 20.1 21.6 6.7*
TLR at 9 months (%)
7.4* 11.6 20.1 21.6 4.5*
MACE at 9 months (%)
7.9* 13.0 20.1 21.6 4.5*
Conclusion: The use of drug-eluting stents in patients with small coronary artery stenosis was safe and feasible. Patients treated with SES and EES showed lesser rate of restenosis compared with other drug-eluting stents. *p<0.05 vs ZES, TES TCT-377 The Effect of Drug-Eluting Stents on Clinical and Angiographic Outcomes in Diabetic Patients: Multicenter Registry in Asia Sunao Nakamura1, Hisao Ogawa2, Jang-Ho Bae3, Yeo Hans Cahyadi4, Wasan Udayachalerm5, Damras Tresukosol6, Sudaratana Tansuphaswadikul7 1 New Tokyo Hospital, Chiba, Japan 2Kumamoto University Hospital, Kumamoto, Japan 3Konyang University Hospital, Daejeon, Republic of Korea 4Husada Hospital, Jakarta, Indonesia 5King Chulalongkorn Memorial Hospital, Bangkok, Thailand 6Her Majesty’s Cardiac Center, Siriraj Hospital, Bangkok, Thailand 7Chest Disease Institute, Bangkok, Thailand Aim:7KHDLPRIWKLVVWXG\LVWRFRPSDUHWKHVDIHW\DQGHI¿FDF\RI6LUROLPXV (SES), Paclitaxel (PES), Zotarolimus (ZES) and Everolimus-eluting stent (EES) on the outcome of percutaneous coronary intervention in patients with diabetes mellitus (DM). Methods: A prospective analysis of 1253 patients with DM (508 SES, 420 3(6=(6((6 LQ¿YHKLJKYROXPH$VLDQFHQWHUVDIWHUVXFFHVVIXO stenting was performed. The study endpoints were major adverse cardiac
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The American Journal of Cardiology®
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October 12-17, 2008
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TCT Abstracts/ELECTRONIC
http://www.aievolution.com/tct0801
TCT-380
events (MACE) at 30 days, 9 months and restenosis rate and target lesion revascularization (TLR) at 9 months. Results: See table for clinical results. Number of patients Multivessel disease (%) MACE at 30 days (%) Lesion length (mean: mm) Lesion type: % of B2, C (%) Reference diameter (mean: mm) Minimum lumen diameter post procedure (mean: mm) Minimum lumen diameter at 9 months (mean: mm) Restenosis rate at 9 months (%) TLR at 9 months (%)
SES 508 78.5 0.8 25.8 45.3 2.75 2.72 2.54 7.9* 6.5*
PES 420 72.6 1.2 23.9 47.4 2.69 2.66 2.38 12.6 10.7
ZES 204 76.5 1.0 28.3 52.0 2.73 2.70 2.08 16.2 13.7
Clinical and Angiographic Results of Small Vessel Stenting from the SPIRIT III Randomized Trial: A Comparison of the 2.5 mm Everolimus-Eluting XIENCE and Paclitaxil-Eluting TAXUS Stents
EES 121 81.8 0 24.8 45.5 2.69 2.60 2.52 6.7* 4.1*
James Hermiller1, Todd Fergus1, Wesley Pierson2, Xiaolu Su2, Roseann White2, Poornima Sood2, Krishnankutty Sudhir2, Gregg Stone3 1 Saint Vincent Heart Center of Indiana, Indianapolis, IN; 2Abbott Vascular, Santa Clara, CA; 3Columbia University Medical Center, New York, NY Introduction: Small vessels are less able to accommodate neointimal hyperplasia following stenting, leading to higher rates of restenosis, Consequently, drug-eluting stents with lower late loss may be particularly EHQH¿FLDOLQWKLVOHVLRQVXEVHW7KHDLPRIWKLVVWXG\ZDVWRFRPSDUHWKHFOLQLFDO and angiographic outcomes in patients treated in the SPIRIT III randomized WULDOZKRUHFHLYHGPP;,(1&(9 ; RU7$;86 7 VWHQWV Methods: 7KH63,5,7,,,WULDOZDVDSURVSHFWLYHUDQGRPL]HG ; 7 multicenter, clinical trial that enrolled 1,002 subjects. This report summarizes the subgroup within the randomized trial receiving at least one 2.5 mm stent. 7KHUHZHUHSDWLHQWVLQWKH;JURXSWKDWUHFHLYHGDWOHDVWRQHPPVWHQW DQG LQWKH7JURXS,QWKH;JURXS RIWKHVWHQWVZHUHPPLQ diameter and in the T group 66/67 implanted stents were 2.5 mm in diameter. Larger diameter stents were placed in one patient in each group for bailout of more proximal disease. Results: The baseline patient demographics, including diabetes, were well PDWFKHG3UHSURFHGXUHYHVVHOGLDPHWHUZDVPPDQG PPLQWKH;DQG7JURXSVUHVSHFWLYHO\ S 7KHSUHSURFHGXUHOHVLRQ OHQJWKZDVVLJQL¿FDQWO\VKRUWHULQWKH7JURXS PP YV PPLQWKH;JURXS S ,QKRVSLWDODQGGD\HYHQWUDWHVZHUHORZ LQERWKJURXSVDQGQRGLIIHUHQW(YHQWUDWHVZHUHVLJQL¿FDQWO\ORZHUZLWKWKH ;,(1&(9JURXSWKURXJK PRQWKIROORZXS2EVHUYHG0$&( YV S DQG79) YV S UDWHVZHUHVLJQL¿FDQWO\ ORZHULQWKH;JURXSGULYHQSULPDULO\E\DODUJHUHGXFWLRQLQ7/5 YV 12.5%; p=0.0016). Stent thrombosis rates were low and not different. FollowXSDQJLRJUDSK\GHPRQVWUDWHGDVLJQL¿FDQWGLIIHUHQFHLQLQVHJPHQWODWHORVV // //IRU;ZDVPPDQGIRU7ZDV PP S ,QVHJPHQWELQDU\UHVWHQRVLVIRU;ZDVDQGIRU7ZDV (p=0.02). Conclusion: In this subgroup of small vessel stenting from SPIRIT III, the ;,(1&( 9 PP VWHQW KDG FOLQLFDOO\ DQG DQJLRJUDSKLFDOO\ LPSURYHG RXWFRPHVFRPSDUHGWRWKH7$;86PPVWHQW7KHVHGDWDIXUWKHUVXSSRUW WKHFRQFHSWWKDWORZHUODWHORVVLVEHQH¿FLDOLQVPDOOYHVVHOGLVHDVH
Conclusion: The use of drug-eluting stents in patient with DM was safe with low acute complication. Patients treated with SES and EES showed lesser rate of restenosis compared with other drug-eluting stents. *p<0.05 vs ZES, TES TCT-378 WITHDRAWN TCT-379 Impact of Intensive Antiplatelet Therapy on the Development of Coronary Neo-aneurysm after Drug-eluting Stent Implantation Seung-Woon Rha, Yoshiyasu Minami, Kang-Yin Chen, Yong-Jian Li, Kanhaiya Poddar, Jae Hyoung Park, Jin Oh Na, Cheol Ung Choi, Hong Euy Lim, Jin Won Kim, Eung Ju Kim, Chang Gyu Park, Hong Seog Seo, Dong Joo Oh Korea University Guro Hospital, Seoul, Republic of Korea
The American Journal of Cardiology®
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October 12-17, 2008
TCT-381 Sirolimus- versus Paclitaxel-eluting Stent in the Treatment of Diffuse Coronary Artery Lesion Seung-Woon Rha, Yoshiyasu Minami, Kang-Yin Chen, Yong-Jian Li, Kanhaiya Podder, Jin Oh Na, Jae Hyoung Park, Jin Oh Na, Cheol Ung Choi, Hong Euy Lim, Jin Won Kim, EungJu Kim, Chang Gyu Park, Hong Seog Seo, DongJoo Oh Korea University Guro Hospital, Seoul, Republic of Korea Background: Drug-Eluting Stent (DES) is commonly being used as one of the best treatment choice for the treatment of diffuse coronary lesions but the overall outcomes are still controversial. In this study, we investigated the HI¿FDF\DQGVDIHW\RI'(6LQWKHWUHDWPHQWRIGLIIXVHOHVLRQV PP Methods: From Sept 2004 to Dec 2006, a total 853 patients (pts) underwent percutaneous coronary intervention (PCI) with DES and a total 268 pts with diffuse lesions were treated with either Sirolimus-(Cypher; SES group, n=125 pts) or Paclitaxel-(Taxus; PES group, n=143 pts)-eluting stents. Mid-term angiographic and clinical outcomes of these two groups were compared. Results: Baseline clinical and procedural characteristics were similar EHWZHHQ WKH WZR JURXSV H[FHSW WKH OHVLRQ OHQJWK ZDV ORQJHU PP YV PP S DQG WKHUH ZDV D WUHQG WRZDUG PRUH FKURQLF total occlusion (CTO, 5.4% vs 11.5%, p=0.07) in PES group. At 6 months,
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Background: Previous reports suggested drug-eluting stents (DES) may cause some toxic effects on coronary artery wall such as aneurysm formation, VWHQWWKURPERVLVDQGYHVVHOUXSWXUH+RZHYHUWKHPHFKDQLVPVDQGULVNIDFWRUV RIWKRVHHYHQWVZHUHQRWZHOONQRZQ Methods: A total 510 consecutive patients (pts) treated with DES either Sirolimus- (SES) or Paclitaxel- (PES) eluting stents were enrolled in this study and routine 6 months angiographic followed up was done from Oct 2004 to Sep 2007. We investigated the characteristics of pts who had newly developed coronary aneurysm compared with the pts without neo-aneurysm DQGDQDO\]HGWKHUHODWLRQVKLSEHWZHHQULVNIDFWRUVDQGQHRDQHXU\VPV Results: The incidence of coronary aneurysm was 3.5% (18/510, mean age 61.5 PDOH DQGSWVUHFHLYHG6(6DQGSWV3(6 PHDQGLDPHWHUDQG OHQJWK PPLUUHVSHFWLYHO\ 7KHUHZDVQRVLJQL¿FDQW GLIIHUHQFHLQDJHVH[FRQYHQWLRQDOULVNIDFWRUVDQGVRPHODERUDWRU\¿QGLQJV However most of aneurysm pts were prescribed triple antiplatelet regimen ( aspirin+clopidogrel+cilostazol; 83.3% vs 43.3%, p<0.01) and multivariate analysis indicated cilostazol usage was an independent predictor of neoaneurysm occurrence (OR 6.439, 95% CI 1.84 - 22.53, p<0.01). Conclusion: Prescription of cilostazol or combination of multiple antiplatelet drugs may associated with the development of coronary neo-aneurysm after DES implantation.
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angiographic outcomes including the rate of binary restenosis, minimal lumen diameter (MLD), % diameter stenosis (DS) and late loss were worse in PES group. However, there were no major differences in clinical outcomes (Table). Multivariate logistic analysis showed that the stent type is the independent predictor of restenosis (OR 0.21, 95% CI 0.06-0.76, p=0.017). The lesion length, stented length and the rate of CTO were not independent predictors of restenosis. Table. Angiographic and clinical Outcomes at 6 months 9DULDEOHQ
Cypher group (n=125)
Taxus group (n=143)
P value
Binary restenosis
7 (5.6)
27 (18.9)
<0.01
)ROORZXS0/'6'
<0.01
)ROORZXS'66'
<0.01
/DWH/RVV6'
0.02
Total death
8 (6.4)
7 (4.9)
0.59 -
Q-wave MI
0 (0)
0 (0)
Target Lesion Revascularization
2 (1.6)
1 (0.7)
0.50
7DUJHW9HVVHO5HYDVFXODUL]DWLRQ
2 (1.6)
1 (0.7)
0.50
Total MACE
10 (8.1)
8 (5.8)
0.46
Stent thrombosis
0 (0)
2 (1.3)
0.20
Conclusion: DES is safe and effective in the treatment of diffuse coronary lesion. Although the PES showed higher rate of restenosis compared to SES, this result was not translated into worse clinical outcomes in real world clinical practice. TCT-382 Coronary Stent Fractures - An Under Recognised Problem With Drug Eluting Stents
E L E C T RO N I C A B S T R AC T S
Sanoj Chacko, Sanjiv Petkar, Satheesh Nair, Tahir Hamid, Douglas Fraser, Farzin Fath-Ordoubadi Manchester Heart Centre, Manchester, United Kingdom Background: First introduced in 2002, the use of drug eluting stents (DES) KDVUDSLGO\H[SDQGHGFKLHÀ\GXHWRWKHGUDPDWLFUHGXFWLRQLQUDWHVRIUHVWHQRVLV and need for repeat revascularisation. However, coronary stent fracture (CSF) is an under recognised complication of DES. Aim: 7RUHYLHZWKHSUHVHQWDWLRQRI&6)DQGWRLGHQWLI\ULVNIDFWRUVIRULWV occurrence. Methods: /LWHUDWXUH VHDUFK LQ 3XE0HG XQGHU WKH KHDGLQJ µFRURQDU\ VWHQW IUDFWXUH¶7KHVHDUFKLGHQWL¿HGDWRWDORIVHULHVDQGFDVHUHSRUWVLPDJHV YLJQHWWHVVSDQQLQJWKHODVW\HDUV $OOSDSHUVZLWKSDWLHQWV (8 series: 5 prospective, 3 retrospective) were analysed and the results are given below. Results: Total patients studied: 2395, range: 56-530. Mean incidence of CSF ZDV EXWYDULHGZLGHO\EHWZHHQVHULHV Median incidence: 3.45%. Sirolimus DES was used exclusively in 6/8 (75%) VHULHV0HDQWLPHWRGLDJQRVLV PRQWKV UDQJH &KURQLFVWDEOH angina was most common mode of presentation: 59/120 (49.2%). CSF associated with in-stent restenosis in the majority (68/120, 56.6%) and with VWHQW WKURPERVLV LQ 5HPDLQLQJ > @ LGHQWL¿HG during routine investigations. Most CSF seen in the right coronary artery (RCA): 54.1% (65/120), followed by left anterior descending artery: 29.1% FLUFXPÀH[FRURQDU\DUWHU\ 69*DQGEUDQFKYHVVHOV 3.3% (4/120) each. Most CSF seen in mid or proximal segments. Most patients with CSF had sirolimus DES implanted [114/120 (95%), paclitaxel DES 6/120(5%)]. All CSF occurred in Type B/C lesions. Most common postulated mechanisms (by series): overlapping stents (8/8, 100%), vessel tortuosity (7/8, 87.5%) and long stented segment (7/8, 87.5%). Conclusion: &6)LQ'(6LVDVLJQL¿FDQWEXWXQGHUUHFRJQLVHGSUREOHP,WV incidence approaches the documented rate of restenosis with DES. Most data available is with sirolimus DES. Information on CSF with other DES or bare PHWDOVWHQWVLVODFNLQJDQGXUJHQWO\QHHGHG0RVW&6)ZDVVHHQLQSDWLHQWVZLWK
150i
long overlapping stents for Type B/C lesions, in the mid or proximal portions of the right coronary artery and at the site of maximal vessel tortuousity. TCT-383 A Comparison of Two Drug-Eluting Stents in Diabetes Mellitus William M Wolf1, Helen Vlachos2, Oscar C Marroquin1, Conrad Smith1, John Schindler1, Elizabeth Holper3, Dawn Abbott4, David O Williams4, Kevin E Kip5, Sheryl Kelsey2, Suresh R Mulukutla1 1 University of Pittsburgh Medical Center, Pittsburgh, PA; 2University of Pittsburgh, Pittsburgh, PA; 3University of Texas Southwestern, Dallas, TX; 4Rhode Island Hospital, Providence, RI; 5University of South Florida, Tampa, FL Background: Diabetes is a powerful predictor of adverse events in patients undergoing PCI. Drug-eluting stents (DES) reduce restenosis rates in diabetics versus bare metal stents. Randomized trials have resulted in ongoing FRQWURYHUV\UHJDUGLQJZKLFK'(6PD\SURYLGHJUHDWHUEHQH¿WDPRQJGLDEHWLF SDWLHQWV $FFRUGLQJO\ ZH FRPSDUHG WKH VDIHW\ DQG HI¿FDF\ RI VLUROLPXV eluting stents (SES) versus paclitaxel-eluting stents (PES) among diabetic patients in a contemporary registry. Methods: Using the National Heart, Lung, and Blood Institute Dynamic Registry, we evaluated one-year outcomes of diabetic patients undergoing PCI with SES (n=678) and PES (n=327). Results: 7KHUH ZHUH QR VLJQL¿FDQW GLIIHUHQFHV EHWZHHQ WKH WZR JURXSV LQ baseline clinical and demographic features, except that PES-treated patients had a greater frequency of hypertension and hyperlipidemia. There were no differences in lesion characteristics or procedural success. At one year followXSQRVLJQL¿FDQWGLIIHUHQFHVZHUHREVHUYHG )LJXUH 3(6DQG6(6WUHDWHG patients had similar rates of death (5.8% vs. 4.4%, p=0.42), death and MI (10.1% vs. 9.0%, p=0.60), repeat revascularization (13.4% vs. 11.8%, p=0.42), and stent thrombosis (1.3% vs. 0.9%, p=0.62). These results did not change in the subset of patients in whom 2-year follow-up was available.
Conclusion: 3(6 DQG 6(6 DUH HTXDOO\ HI¿FDFLRXV DQG KDYH VLPLODU VDIHW\ SUR¿OHVLQGLDEHWLFSDWLHQWVXQGHUJRLQJ3&, TCT-384 Mid Term Outcome Results of Patients Presenting with Drug Eluting Stent Failure: Results from a Single Institution Registry Giuseppe Gioia, MariaFrance sca Gioia, Dawn Christensen Christensen, Jackie White, Howard Levite, Sahar Avestimehr, William Matthai Atlanticare Regional Medical Center, Pomona, NJ Background: '(6IDLOXUHLVQRWDVLQIUHTXHQWDVLQLWLDOO\WKRXJKW9HU\OLWWOH LVNQRZQDERXWWKHLQWHUPHGLDWHWHUPRXWFRPHRIWKHVHSDWLHQWV:HORRNHGDW our registry data to assess intermediate term outcome of these patients Methods: Patients previously implanted with any DES who presented to the FDWKODEIURP-DQXDU\WR'HFHPEHUZLWKD'(6IDLOXUH GH¿QHGDVHLWKHU in-stent restenosis or thrombosis) were enrolled and treated. Only patients with at least 3 months follow-up were included for this outcome analysis. 0$&(UDWHZDVGH¿QHGDVFRPELQDWLRQRIFDUGLDFGHDWK0, 67(0,RUQRQ
The American Journal of Cardiology® |
October 12-17, 2008
| TCT Abstracts/ELECTRONIC
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Conclusion: Our results demonstrate that routine use of noncompliant balloons for high-pressure dilatation in patients with paclitaxel eluting stents DQG FRPSOH[ OHVLRQ PRUSKRORJ\ LV DVVRFLDWHG ZLWK VLJQL¿FDQW UHGXFWLRQ LQ the need for TLR. We found excellent 1-year clinical outcomes in real-world patients with off-label use of paclitaxel eluting stents.
67(0, DQG795)XQFWLRQDOFDSDFLW\ZDVDVVHVVHGDWIROORZXS Results: Fifty-six patients were treated for DES failure over one year. The PHDQSDWLHQW¶VDJHZDV\HDUV0HDQWLPHWR'(6IDLOXUHZDV days (range 15-1513 days). Twenty-eight patients (50%) presented with either STEMI (23 patients, 41%) or non-STEMI (5 patients, 9%) and 28 patients (50%) presented with a non-MI syndrome, either unstable angina (17 patients (30%) or stable angina (11 patients (20%). Twenty-nine patients (52%) presented with angiographic documented stent thrombosis and 27 patients with ISR either focal (23 patients, 85%) or diffuse (4 patients, 15%). Thirteen (46%) patients with late ST were on plavix. POBA alone was used in 10 patients (18%), restent with BMS was performed in 33 patients (59%) and restent with a DES in 12 (21%) patients. One patient was treated medically (2%). Complete follow-up ZDVDYDLODEOHIRU SDWLHQWV0HDQIROORZXSZDVGD\V0$&( ZDV7KHUHZHUHFDUGLDFGHDWKV SDWLHQWVXQGHUZHQW795 with CABG (2 patients) or repeat PCI (4 patients). Two patients presented with non-STEMI and one with STEMI (all three revascularized). No differences were seen in MACE according treatment modality or clinical presentation with ISR or thrombosis. Four patients presenting with DES as STEMI died as opposed to 2 patients presenting with ISR (p=0.2). Twenty-two patients (54%) SUHVHQWHGZLWK1<+$IXQFWLRQDOFODVV!WKDQ Conclusion: Despite successful treatment of DES failure with repeat PCI the intermediate event rate appears to be high with a high mortality rate. The functional capacity seems to be impaired in half of the patients.
TCT-387 Endothelial Cell Recovery, Cell Adhesion, and Acute Thrombogenicity Assessments of Fluorinated Copolymer and Phosphorylcholine Polymer Shawn Chin Quee1, Kim-Lien Nguyen1, Steve Hsu1, Julie Tai1, George Abraham1, Stephen Pacetti1, Gaku Nakazawa2, Frank Kolodgie2, Renu Virmani2, Nadine Ding1, Leslie Coleman1 1 Abbott Vascular, Santa Clara, CA; 2CVPath Institute, Inc., Gaithersburg, MD
TCT-385 WITHDRAWN
TCT-386 Real World Experience with Paclitaxel Eluting Stents after Routine High-Pressure Balloon Dilatation with Noncompliant Balloon for Complex Coronary Lesions: Immediate Results and 1-Year Clinical Outcomes Anuj Bhasin, Chih Yuan Fang, Hon Kan Yip, Cheng Hsu Yang, Chiung Jen Wu Chang Gung Memorial Hospital, Kaohsiung, Taiwan Background: 'UXJHOXWLQJVWHQWVKDYHIXO¿OOHGWKHLUSURPLVHRIUHGXFLQJ target lesion revascularization (TLR) and restenosis. However, stent placement alone does not guarantee the best outcome. Postdilatation helps to optimize stent deployment and may lead to better outcomes with reduced TLR and stent thrombosis. We describe our experience of off-label use of paclitaxel-eluting stents after routine high-pressure dilatation with a noncompliant balloon in a complex lesion subset of patients. Methods: Between September 2004 and January 2006, 312 Taxus Express %RVWRQ6FLHQWL¿F1DWLFN0DVVDFKXVHWWV VWHQWVZHUHGHSOR\HGLQSDWLHQWV The primary endpoint was TLR at 12 months. Secondary endpoints were insegment and in-stent restenosis rate at 12 months and major adverse cardiac HYHQWV 0$&( GH¿QHGDVFRPSRVLWHRIGHDWKP\RFDUGLDOLQIDUFWLRQ 0, RU 7/5DWPRQWKV2IIODEHOXVHLQFOXGHGRVWLDOOHIWPDLQORQJ !PP saphenous vein graft, in-stent restenotic, chronic total, and bifurcation lesions, DVZHOODVVPDOORUODUJHYHVVHOV RU!PP PXOWLOHVLRQRUPXOWLYHVVHO percutaneous coronary intervention, and ST-segment elevation MI. Results: 0HDQ SDWLHQW DJH ZDV \HDUV KDG GLDEHWHV ZLWK 8% requiring insulin, 67.3% had hypertension, 26% had a history of prior percutaneous transluminal coronary angioplasty, 30.4% were dyslipidemic, 25% had renal impairment, and 73.7% patients had multivessel disease. The procedural success rate was 94.6% (299/312). Reference vessel diameter ZDV PPDQGPHDQOHVLRQOHQJWKZDV PP0HDQ VWHQWGLDPHWHUZDVPPDQGVWHQWOHQJWKZDVPP Clinical follow-up was available in all patients, and angiographic followup was available in 73.4% (229/312) of patients. The primary endpoint of TLR was 4.2% at 12 months, and MACE rate at 12 months was 5.8%. The angiographic binary in-stent and in-segment restenosis rate were 4.48% and UHVSHFWLYHO\,QVWHQWODWHORVVZDVPP
The American Journal of Cardiology®
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October 12-17, 2008
TCT-388 WITHDRAWN TCT-389 6WHQW6WUXW7KLFNQHVV,QÀXHQFHV7KURPERJHQLFLW\DQG9DVFXODU Injury and Remodeling Steve Hsu1, Kim-Lien Nguyen1, Rajesh Swaminathan2, Shawn Chin Quee1, Kumaran Kolandaivelu2, Leslie Coleman1, Julie Tai1, Virginia Giddings1, James Stanley2, Philip Seifert2, Gee Wong2, Elazer Edelman2 1 Abbott Vascular, Santa Clara, CA; 2Massachusetts Institute of Technology, Cambridge, MA Background: 6WHQWVWUXWWKLFNQHVVPD\LQÀXHQFHWKURPERJHQLFLW\WKURXJK DOWHUDWLRQV LQ ORFDO KHPRG\QDPLF ÀRZ DQG LQGXFWLRQ RI YDVFXODU LQMXU\
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Background: The use of polymers in current drug eluting stents has been DWRSLFRIGLVFXVVLRQDVLWUHODWHVWRDUWHULDOKHDOLQJDQGODWHWKURPERWLFULVN 7ZR SRO\PHUV XVHG LQ $EERWW¶V GUXJ HOXWLQJ VWHQW SURJUDP ÀXRULQDWHG copolymer (FP) and phosphorylcholine polymer (PC), were each coated onto commercially available metallic stents, and comparisons were made using preclinical models. Methods: Iliac arteries of New Zealand White Rabbits were treated by balloon denudation and implanted bilaterally with FP and PC coated stents. Endothelial coverage at 7 and 14 days post-implantation was measured by morphometric analysis of images acquired through en face scanning electron PLFURVFRS\ 6(0 DVZHOODVGXDOÀXRUHVFHQWLPPXQRODEHOLQJIRUSODWHOHW endothelial cell adhesion molecule-1 (PECAM-1) and thrombomodulin (TM). Acute thrombogenicity was also assessed from stents deployed into silicone tubing in the presence of fresh heparinized porcine blood, where thrombus weight and lactate dehydrogenase (LDH) expression were measured. In addition, in vitro cell adhesion assays were performed on glass coupon surfaces spin-coated with FP or PC and seeded with human umbilical vein endothelial FHOOV +89(& KXPDQFRURQDU\DUWHU\HQGRWKHOLDOFHOOV +&$(& KXPDQ coronary artery smooth muscle cells (HCASMCs), or THP-1 monocytes. Results: Near complete endothelial coverage occurred for both FP and 3& FRDWHG VWHQWV ! E\ 6(0 E\ GD\V ZLWK D WUHQG WRZDUG JUHDWHU coverage with FP (p=0.08). Expression of PECAM-1 was equivalent for FP as compared to PC, though both had less than 40% coverage, providing evidence of a transitional healing surface. Acute thrombogenicity showed that )3ZDVVLJQL¿FDQWO\PRUHWKURPERUHVLVWDQWWKDQ3& S &HOODGKHVLRQ KDG VLJQL¿FDQWO\ JUHDWHU QXPEHUV RI +&$(&V +89(&V DQG +&$60&V adhered to FP and control surfaces compared to PC surfaces (p<0.05), with no differences between FP and control surfaces. In regards to THP-1 monocyte adhesion, no differences were observed among all surfaces. Conclusion: Biocompatibility and hemocompatibility of FP and PC were demonstrated in in vitro, ex vivo, and in vivo models with a trend towards LPSURYHGFRPSDWLELOLW\ZLWKÀXRULQDWHGFRSRO\PHUFRDWHGVXUIDFHV
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08/7,/,1. 0/ 9LVLRQ® $EERWW9DVFXODU6DQWD&ODUD&$ DQGWKLFN VWUXW9LVLRQZHUHXVHGWRHYDOXDWHWKURPERJHQLFLW\DQGYDVFXODULQMXU\DQG remodeling in the porcine coronary artery model. Methods: 7KLFN VWUXW 9LVLRQ -m) was developed by isolating the strut KHLJKWRIWKHFRPPHUFLDOO\DYDLODEOH³WKLQQHUVWUXW´0/9,6,21™ (81 -m), while maintaining all other parameters constant. Thrombus adherence following 3d post-stent implantation in the coronary arteries was assessed by histology HYDOXDWLRQRI¿EULQGHSRVLWLRQ9DVFXODULQMXU\DQGUHPRGHOLQJRI0/9LVLRQ™, WKLFNVWUXW9LVLRQDQGQDwYHQRQVWHQWHGDUWHULHVZHUHDVVHVVHGXVLQJEUDQFKHG DNA assay (Panomics, Fremont, CA) to evaluate the gene expression of a panel RIPROHFXODUPDUNHUV6WDWLVWLFDOVLJQL¿FDQFH S ZDVGHWHUPLQHGXVLQJWKH 6WXGHQWWWHVWDQGDQ$129$ZLWK+ROP¶VWWHVWIRUPXOWLSOHFRPSDULVRQV Results: After 3d, thrombus adherence throughout the proximal, mid DQG GLVWDO UHJLRQV ZDV VLJQL¿FDQWO\ ORZHU LQ 0/ 9LVLRQ™ WKDQ WKLFN VWUXW 9LVLRQ YV PP2; p<0.01). Both stent groups after 3d VKRZHGVLPLODUGRZQUHJXODWLRQLQHQGRWKHOLDOFHOOPDUNHUV H126 HQGRJOLQ EXWXSUHJXODWLRQLQSUROLIHUDWLRQ 3&1$ PDWUL[ ¿EURQHFWLQ DQG LQÀDPPDWRU\ ,&$0 9&$0 0&3 PDUNHU H[SUHVVLRQV FRPSDUHG WR WKHFRQWURODUWHULHV S $WGH[SUHVVLRQRI3&1$¿EURQHFWLQDQG LQÀDPPDWRU\PDUNHUVPDLQWDLQHGIROGLQFUHDVHLQWKLFNVWUXW9LVLRQEXW UHWXUQHGWRQHDUO\EDVHOLQHOHYHOLQ0/9LVLRQ™ (p<0.05). eNOS expression IRU0/9LVLRQ™ DWGZDVWLPHVKLJKHUWKDQWKLFNVWUXW9LVLRQ YV S )XUWKHUPRUHWLVVXHIDFWRUZDVXSUHJXODWHGE\IROGLQWKLFNVWUXW 9LVLRQDWG S Conclusion: The use of thin strut stents may minimize thrombogenicity and enhance vascular healing. By isolating the strut height, this study showed that WKLFNVWUXW9LVLRQLQGXFHGJUHDWHUWKURPERJHQLFLW\GHOD\HGYDVFXODUUHPRGHOLQJ DQGLQFUHDVHGYDVFXODULQMXU\FRPSDUHGWRWKHWKLQVWUXW0/9,6,21™. TCT-390 Mid-long Term Results Of Zotarolimus Eluting Stent In Off-label, On -label And Not Approved Indications For Use
E L E C T RO N I C A B S T R AC T S
Dae-Hyun Lee1, Paula Tejedor2, Javier Botas1, Juan M Duran2, Petra Sanz1, Javier Robles2, Lorenzo López-Bescós1, Germán Pérez-Ojeda2 1 Fundacion Hospitalaria Alcorcon, Alcorcon, Spain 2Hospital General Yague, Burgos, Spain Background: Few data are available regarding the performance of the recently approved zotarolimus eluting stent (ZES) in off- label and not approved indications for use (FDA). The purpose of this study was to evaluate WKHPLGORQJWHUPSHUIRUPDQFHRIWKLVGHYLFH PLQLPXPIROORZXS!\HDU in a consecutive and nonselected population comparing the frequency, safety DQGHI¿FDF\RIRQODEHORIIODEHODQGQRWDSSURYHGLQGLFDWLRQVRIXVH Methods: 303 subjects treated with ZES as the only DES were studied. 7KH LQFLGHQFH RI VWHQW WKURPERVLV 67 $5& GH¿QLWLRQV GHYLFH IDLOXUH FDUGLDFGHDWK7DUJHW9HVVHO0,DQG7/5 DQGRWKHU0$&( GHDWK0,DQG UHYDVFXODUL]DWLRQ ZHUHDQDO\]HG6XEMHFWVZHUHFODVVL¿HGLQ JURXSV RQ label, off-label and not approved) according to the indication of use of ZES. Results: 34.3% of the 303 subjects were treated with ZES for an on-label indication; 54.7% for an off-label and 10.8% for a not approved indication. Baseline clinical characteristics and duration of antiplatelet treatment were QRW VWDWLVWLFDOO\ GLIIHUHQW DPRQJ JURXSV 0HDQ IROORZXS ZDV months (range 12-31.4), with only one patient lost. There were not statistically VLJQL¿FDQWGLIIHUHQFHVLQWKHLQFLGHQFHRIHYHQWVDPRQJJURXSV VHHWDEOH Cardiovascular events Events n Alive without events Myocardial infarction 'H¿QLWHDQGSURE67 Possible ST Target lession revasc. Target vessel revasc. Device failure Cardiac death table 1
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% 34.3 98.4 1.9 1 1.11 5.8 6.7 7.7 1
On-label 103 93 2 1 1 6 7 8 1
% 54.7 86.7 0.6 1.2 2.53 4.8 5.5 10.8 3.6
Off-label 166 143 1 2 4 8 9 18 6
% 10.8 90.9 3 3 1 3 3 3 0
Conclusion: In the real world, more than half of ZES are implanted for offlabel indications. Cardiac and non cardiac complications are numerically higher among the more complex off-label population, although the absolute rate of cardiac events remains reasonably low TCT-391 Angiographic and Clinical Outcomes from the XIENCETM V 4.0mm Registry Arm of the SIII Trial Paul C. Gordon1, Steven B. Weinsier1, Xiaolu Su2, Rosann white2, Julie Doostzadeh2, Sherry Cao2, Poornima sood2, Krishna Sudhir2, Gregg W. Stone3 1 Miriam Hospital, Brown University, Providence, RI; 2Abbott vascular, Santa Clara, CA; 3The Cardiovascular Research Foundation and Columbia University Medical Center, New York, NY Background: In the SPIRIT III randomized controlled trial (RCT), an HYHUROLPXVHOXWLQJVWHQW;,(1&(9FRPSDUHGWRDSDFOLWD[HOHOXWLQJVWHQW 7$;86® in 2.5-3.75mm diameter vessels resulted in reduced angiographic ODWHORVVQRQLQIHULRUUDWHVRIWDUJHWYHVVHOIDLOXUH 79) DQGIHZHUPDMRU adverse cardiac events (MACE) during 1 year of follow-up. The safety and HI¿FDF\RIGUXJHOXWLQJVWHQWVLQODUJHUYHVVHOVLVQRWZHOONQRZQ Objective: 7RFRPSDUHWKHVDIHW\DQGHI¿FDF\RI;,(1&(9LQYHVVHOV! DQGPPFRPSDUHGWR7$;86® arm of the RCT. Methods: The SPIRIT III 4.0 registry was a concurrent arm of the SPIRIT III RCT and included non-randomized patients with vessel diameter 3.75 PPZKRUHFHLYHGDPP;,(1&(9VWHQW7KHSULPDU\VWDWLVWLFDO K\SRWKHVLVZDVWRGHPRQVWUDWHQRQLQIHULRULW\WRWKHUDQGRPL]HG7$;86® arm for late loss at 8 months as agreed upon with the FDA. The secondary HQGSRLQWVLQFOXGHG79)0$&(0,7/5DQG795DWRQH\HDUDQGVWHQW thrombosis. Results: 69 patients were enrolled in the 4.0mm arm, 49 had angiographic IROORZXS,QWKH7$;86® arm of the RCT, 333 patients were enrolled and 188 had angiographic follow-up. Baseline demographics were similar between the two groups. Table 1. Angiographic and Clinical Outcomes ;,(1&(9 Outcome mm In-segment Late Loss, mm* 79) 5.9% (4/68) Cardiac Death 1.5% (1/68) MI 4.4% (3/68) TLR 1.5% (1/68) 795 0.0% (0/68) MACE# 5.9% (4/68) Stent Thrombosis Acute (<1 day) 1.4% (1/69) Subacute (1 to 30 days) 0.0 (0/69) /DWH !GD\V 0.0 (0/67)
7$;86 RCT
Difference**
0.0% (0/330) 0.0% (0/330) 0.6% (2/317)
1.45% 0.0 % -0.63%
Non-inferiority P<0.0001 11.3% (36/320) -5.37% 0.9% (3/320) 0.53% 4.1% (13/320) 0.35% 5.6% (18/320) -4.15% 4.4% (14/320) -4.38% 10.3% (33/320) -4.43%
*240 day angiographic follow-up
7KH FRQ¿GHQFH LQWHUYDOV ZHUH QRW FDOFXODWHG GXH WR WKH ORZ REVHUYHG proportions. # Clinical outcome at 393 days Conclusion: 7KHPP;,(1&(9DSSHDUVWREHVDIHDQGHIIHFWLYHLQ treating large diameter native coronary vessels with lower angiographic late ORVVDQGFRPSDUDEOHFOLQLFDORXWFRPHVWR7$;86® in 2.5-3.5mm vessels.
Not approv. 33 30 1 1 1 1 1 1 0
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TCT-392
and yearly up to 6 years (median time: 3.6 years). Results: Baseline data included mean age 63.9 years, 23% female, 29% diabetes, 60% multivessel disease, 49% previous revascularization, and UHQDOLQVXI¿FLHQF\ VHUXPFUHDWLQLQHPJG/ SUHVHQWHGZLWK ACS (including 15% AMI), and LAD was treated in 43%. Most lesions KDG FRPSOH[ SUR¿OH W\SH %& LQFOXGLQJ VLJQL¿FDQW FDOFLXP 69*RVWLDOORFDWLRQ,65DQGELIXUFDWLRQV$WRWDORI DES were implanted in 3,333 lesions, and 40% of pts had multiple stenting SURFHGXUH$QJLRJUDSKLFVXFFHVV ¿QDO7,0, VWHQRVLVE\4&$ ZDV achieved in 98.6%. Clinical outcomes are shown in the Table. Independent SUHGLFWRUVRI0$&(ZHUH 3&,LQ69* +5 &, 3 multivessel disease (HR 1.39; 95%CI 1.03-1.87; P<0.001), residual stenosis by QCA (HR 1.30 per % unit increase; 95%CI 1.10-1.50; P=0.034), diabetes (HR &, 3 DQGUHQDOLQVXI¿FLHQF\ +5 &, 1.34-1.81; P=0.004).
Impact of Lesion Complexity on the Occurence of Stent Thrombosis Following Drug-Eluting Stent Implantation in Unselected Patients from the Real World Clinical Practice Ricardo A Costa, Amanda Sousa, Adriana Moreira, J. Ribamar Costa, Jr, Galo Maldonado, Manuel Cano, Fausto Feres, Rodolfo Staico, Luiz A Mattos, Alexandre Abizaid, Leopoldo Piegas, Daniel França, Mariana T Carballo, Ibraim M Pinto, Otávio Berwanger, J. Eduardo Sousa Hospital do Coração - Associação do Sanatório Sírio, Sao Paulo, Brazil Background: '(6 UHYROXWLRQDOL]HG WKH ¿HOG RI LQWHUYHQWLRQDO FDUGLRORJ\ PDLQO\ E\ PDUNHG UHGXFWLRQV LQ 7/5 FRPSDUHG WR EDUH PHWDO VWHQWV DV demonstrated in several randomized clinical trials. Thus, a widespread use of DES was observed since their introduction, including treatment of highULVNVXEJURXSV+RZHYHUVHYHUDOUHFHQWVWXGLHVLQFOXGLQJSWVIURPWKH³UHDO ZRUOG´KDYHUDLVHGTXHVWLRQVUHJDUGLQJWKHORQJWHUPVDIHW\RI'(6HVSHFLDOO\ in more complex subsets. Methods: Between May/02-Jan/08, 2,365 unselected pts all comers for PCI with DES were prospectively enrolled in this single center study. Lesion criteria LQFOXGHGDWOHDVWOHVLRQVWHQRVLV&OLQLFDOIROORZXS )8 ZDVDVVLJQHG at 1, 6 and 12 months, and yearly up to 6 years (median time: 3.6 years). Stent WKURPERVLV 6) ZDVGH¿QHGDFFRUGLQJWRWKH$FDGHPLF5HVHDUFK&RQVRUWLXP Results: Overall, 29% of pts had diabetes, 60% multivessel disease, 40% presented with ACS (including 15% AMI). LAD was treated in 43%; 67% of lesions had complex morphology (type B2/C), including 29% mod./severe FDOFL¿FDWLRQHFFHQWULFRVWLDOOHVLRQORFDWLRQDQGLQVWHQWUHVWHQRVLV A total of 3.634 DES were implanted, and 40% had multiple stenting procedure. $WODWH)8 RYHUDOO67UDWHZDV 1 RIWKDWZHUHGH¿QLWLYH DQJLRJUDSKLFFRQ¿UPDWLRQ RFFXUUHGEHWZHHQPRQWKV ODWH67 DQGD fatal event was reported in 47%. By multivariate analysis, ST was associated to: FXUUHQWVPRNLQJ +5 &, 3 3&,LQ$0, +5 95%CI 1.31-9.40; P=0.013), multiple steting procedure (HR 1.81; 95%CI 1.093.02; P=0.023), and lesion postdilatation (HR 0.50; 95%CI 0.29-0.90; P=0.020); regarding lesion characteristics, eccentric morphology (HR 1.86; 95%CI 1.033.34; P=0.039), and mod./severe calcium (HR 2.38; 95%CI 1.34-4.23; P=0.003) ZHUH DOVR LQGHSHQGHQW SUHGLFWRUV RI 67 DV ZHOO DV ¿QDO UHVLGXDO VWHQRVLV E\ QCA (HR 1.04 per % unit increase; 95%CI 1.01-1.06; P=0.003). Furthermore, a VLJQL¿FDQWDVVRFLDWLRQEHWZHHQFDOFLXPDQGSRVWGLODWDWLRQIRURFFXUUHQFHRI67 was observed (P=0.007, Mantel-Haenszel). Conclusion: In this study, the cumulative incidence of ST up to 6 years clinical FU was very low (1.6%); however, it was related with a fatal event in half of cases. In this analysis, ST occurred mostly between 1-12 months, and was associated with complex lesion morphology including eccentric and VLJQL¿FDQW FDOFLXP 2WKHU SUHGLFWRUV RI 67 ZHUH FXUUHQW VPRNLQJ 3&, LQ AMI, multiple stenting, postdilatation, and stent underexpansion.
N Cardiac death MI TLR MACE (cardiac death, MI, TLR) 6WHQWWKURPERVLV $5&GH¿QLWLRQ
2,365 0.3% (7) 2.1% (50) 0.1% (1) 2.5% (59) 0% (0)
2,325 2.5% (58) 4.5% (105) 3.6% (84) 10.6% (246) 1.6% (38)
TCT-395 Abnormal Vasomotor Function of Epicardial Resistance Arteries in Pigs after Coronary Artery Implant of Paclitaxel-Eluting Stents
Background: Abnormal endothelium-dependent vasorelaxation of coronary arteries adjacent to drug-eluting stent (DES) implants has been reported and may be associated with late stent thrombosis. However, epicardial resistance vessel vasomotor function in the distal perfusion bed of DES has not been studied. We tested small vessel function 1 mo after coronary artery paclitaxeleluting stent (PES) implant. Methods: Pigs (n=9) received overlapping bare metal stent (BMS) and 3(6 DV ZHOO DV QDwYH YHVVHOV 2QH PRQWK ODWHU P\RFDUGLXP GLVWDO WR WKH VWHQWHGUHJLRQDVZHOODVVLPLODUORFDWLRQLQQRQVWHQWHGYHVVHO Q69 ZDV harvested. Eighteen epicardial resistance arteries (lumen diameter ~ 250-m) were isolated under a dissecting microscope and mounted on a myograph DSSDUDWXV 9DVRFRQVWULFWLRQ .&O 3*)A & ET-1), endothelial-dependent relaxation (EDdR) response to substance P (SP), and endothelial-independent relaxation (EDiR) to sodium nitroprosside (SNP) were measured. Results: Angiographic late lumen loss at 1-mo was less for PES than BMS (p=0.002). Epicardial resistance artery relaxation was attenuated in the perfusion distribution of PES, as maximal EDdR in response to SP was FRPSDUHG WR YHVVHOV LVRODWHG IURP WKH SHUIXVLRQ GLVWULEXWLRQ RI %06 DQGQRQVWHQWHGFRURQDU\VHJPHQWV 3 vs. PES). Maximal EDiR in response to SNP, however, was similar among WKH JURXSV 3(6 %06 Q69 3 16 respectively). Similarly contraction to endothelin-1 was not affected by VWHQWW\SH 3(6 %06 Q69 UDWLRRI
Background: '(6 GHPRQVWUDWHG PDUNHG UHGXFWLRQV LQ 7/5 FRPSDUHG WR EDUHPHWDOVWHQWVLQSUHYLRXVUDQGRPL]HGWULDOV KRZHYHUWKHFOLQLFDOEHQH¿WV of DES in complex patients over the very long-term follow-up (FU) are still XQNQRZQ Methods: Between May/02-Jan/08, 2,365 unselected pts all comers for PCI with DES were prospectively enrolled at 1 institution. Inclusion criteria was OHVLRQZLWK!VWHQRVLV&OLQLFDO)8ZDVDVVLJQHGDWDQGPRQWKV
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Jinsheng Li, Lakshmana K Pendyala, Toshiro Shinke, Jack P. Chen, Nicolas Chronos, Keith Robinson, Dongming Hou Saint Joseph’s Translational Research Institute, Atlanta, GA
Ricardo A Costa, Amanda Sousa, J. Ribamar Costa, Jr, Adriana Moreira, Manuel Cano, Galo Maldonado, Luiz A Mattos, Rodolfo Staico, Fausto Feres, Alexandre Abizaid, Luiz F Tanajura, Ricardo Pavanello, Marco Barbosa, Cantídio Campos, Otávio Berwanger, J. Eduardo Sousa Hospital do Coração - Associação do Sanatório Sírio, Sao Paulo, Brazil
October 12-17, 2008
Late Follow-up (Cumulative events)
TCT-394 WITHDRAWN
6XVWDLQHG6DIHW\DQG&OLQLFDO(I¿FDF\ 8SWR
|
In-Hospital
Conclusion: In this large, prospective study including unselected patients from the real-world clinical practice, DES demonstrated excellent acute performance, and sustained safety and clinical effectiveness up to 6 years clinical FU (<4% TLR). At late FU, the cumulative incidence of ST was very ORZ DQGSUHGLFWRUVRI0$&(ZHUH69*PXOWLYHVVHOGLVHDVHGLDEHWHV DQGUHQDOLQVXI¿FLHQF\
TCT-393
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contraction ET-1/KCl; P=NS respectively). Conclusion: Epicardial resistance artery endothelial-dependent vasomotor dysfunction is present one month after overlapping coronary PES implant in swine. Derangement of microcirculatory vasomotor function may also be present with DES implant in humans and be associated with a spectrum of adverse clinical sequelae. TCT-396 A Comparative Analysis of Major Clinical Outcomes Using DrugEluting Stents vs. Bare Metal Stents in a Large Single Center Israeli Clinical Setting Ran Kornowski, Tamir Bental, Hana Vaknin-Assa, Eli I Lev, David Brosh, Shmuel Fuchs, Abid Assali Rabin Medical Center, Petach Tikva, Israel Background: Concerns have been raised about the long-term safety of drug eluting stents (DES) during routine clinical practice among large population cohorts. Methods:)URPRXUKRVSLWDODQG+021HWZRUN'DWDEDVHZHFRQGXFWHGD large clinical registry of all patients undergoing PCI at our institution. We LGHQWL¿HGDFRQVHFXWLYHFRKRUWRISDWLHQWVZKRZHUHWUHDWHGXVLQJ'(6 (n=1,980) during PCI and compared the total mortality, myocardial infarction 0, DQG UHSHDW WDUJHW YHVVHO UHYDVFXODUL]DWLRQ 795 RXWFRPHV DQG ULVN adjusted event-free survival outcomes to patients treated using bare metal stents (BMS) (n=2770) during PCI between April 1, 2004, and July 1, 2007. Results: Patients receiving DES were somewhat younger (65.8 vs. 66.2 yrs, p<0.0001), had more DM (41.3% vs. 36.9%, p=0.001), sustained less CHF (14.3% vs. 18.6%, p<0.0001), had less acute/recent (i.e. within 24 hrs) STEMI (8.4% vs. 15.2%, p<0.0001), and had more proximal LAD lesions (28.1% vs. 8.4%, p<0.0001). Outcome data for the two groups are presented in the Table. Mean follow up was 2.1 years (range 0.5-3.6 years).
E L E C T RO N I C A B S T R AC T S
Death (%) MI (%) CABG (%) Hosp. d/t ACS (%) 795 Death/MI (%) 'HDWK0,795
All Pts N=4750 7.5 3.1 2.2 6.7 8.4 10.0 16.7
BMS N=2770 9.2 3.8 2.7 7.0 9.6 12.2 19.9
DES N=1980 5.2 2.1 1.4 6.3 6.6 7.0 12.2
P value <0.0001 0.001 0.002 NS <0.0001 <0.0001 <0.0001
Cox regression analysis plots adjusted for age, DM status, presence of CHF, VPRNLQJ SUR[ /$' ORFDWLRQ DQG DFXWHUHFHQW 67(0, VKRZHG VLJQL¿FDQW DGYDQWDJHLQWRWDOGHDWK'HDWK0,DQGGHDWK0,795FRPSRVLWHLQIDYRURI DES utilization (P<0.0001 for all comparisons). Conclusion: According to our comprehensive clinical experiences, DESs LPSURYHWKHORQJWHUPFOLQLFDORXWFRPHV LHRYHUDOOGHDWK0,795 DPRQJ µDOOFRPHUV¶JURXSRISDWLHQWVLQZLGHYDULHW\RIFOLQLFDOVFHQDULRV2XUULVN adjusted event-free survival analysis would indicate a prognostic advantage for DES utilization which sustains to 3 years following PCI. TCT-397 Overlapping Sirolimus- versus Paclitaxel- Eluting Stents in the Treatment of Diffuse Long Coronary Lesions Yong-Jian Li, Kang-Yin Chen, Seung-Woon Rha, Kanhaiya Poddar, Jae Hyoung Park, Jin Oh Na, Cheol Ung Choi, Hong Euy Lim, Jin Won Kim, Eung Ju Kim, Chang Gyu Park, Hong Seog Seo, Dong Joo Oh Korea University Guro Hospital, Seoul, Republic of Korea Background: The clinical and angiographic outcomes after sirolimus- and paclitaxel- eluting stents implantation in patients (pts) with coronary artery GLVHDVHZHUHVLPLODU+RZHYHUOHVVKDVEHHQNQRZQZKHWKHUWKHVHWZRVWHQWV had similar effectiveness in the treatment of diffuse long lesions with same
154i
overlapping stents strategy. Methods: A total of 174 pts who underwent percutaneous coronary intervention (PCI) with overlapping sirolimus- (SES group: Cypher, n=74 pts, 110 lesions) or paclitaxel- eluting stents (PES group: Taxus, n=100 pts, 177 lesions) were enrolled. Angiographic and clinical outcomes at 6 months were evaluated. Results: Both groups had similar baseline clinical and procedural characteristics. At 6 months, the Taxus group showed a trend towards ORZHUIROORZXSPLQLPXPOXPHQGLDPHWHU 0/' YV P=0.078). Except for this, angiographic outcomes including binary restenosis, restenosis percentage, late loss, stent thrombosis, and clinical outcomes including cardiac death, Q-wave myocardial infarction (MI), target lesion UHYDVFXODUL]DWLRQ 7/5 WDUJHW YHVVHO UHYDVFXODUL]DWLRQ 795 DQG PDMRU adverse cardiac events (MACE) were similar between the two groups. Except for 1 case of subacute thrombosis inn the PES group, there was no incidence of acute and late stent thrombosis throughout the follow-up period. Table: Angiographic and clinical outcomes at 6 months 9DULDEOHQ
SES Group PES Group P value (n=74pts, 110 lesions) (n=100pts, 177 lesions)
Binary restenosis Late loss, (mm) Restenosis percentage, (%) Cardiac death Q-wave MI TLR 795 7950$&( Stent thrombosis
7 (6.4) 1 (1.4) 0 (0) 6 (8.1) 6 (8.1) 11 (14.9) 0 (0)
15 (8.5) 4(4.0) 0 (0) 5 (5.0) 8 (8.0) 16(16.0) 1(1.0)
0.513 0.353 0.176 0.396 1.000 0.532 0.979 0.838 1.000
Conclusion: The angiographic and clinical outcomes at 6 month were similar and favorable in pts with diffuse long lesions undergoing PCI by Sirolimusor Paclitaxel- eluting overlapping stenting. Further study with larger study SRSXODWLRQ DQG ORQJHU GXUDWLRQ ZLOO EH ZDUUDQWHG WR JHW ¿QDO ORQJWHUP conclusion. TCT-398 Outcomes Related to Drug-Eluting Stents vs. Bare Metal Stents in Saphenous Vein Graft Intervention: An ACUITY Substudy Ajay J Kirtane1, Roxana Mehran1, Somjot S Brar1, Martin Fahy1, George D Dangas1, Frederick Feit2, Jeffrey W Moses1, Steven Manoukian3, Harvey D White4, Alexandra J Lansky1, Gregg W Stone1 1 Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY; 2New York University School of Medicine, New York, NY; 3Emory University School of Medicine, Atlanta, GA; 4 Auckland City Hospital, Auckland, New Zealand Background:7KHUHODWLYHVDIHW\DQGHI¿FDF\RIGUXJHOXWLQJVWHQWV '(6 IRUVDSKHQRXVYHLQJUDIW 69* LQWHUYHQWLRQLVFRQWURYHUVLDO:HFRPSDUHG outcomes related to the use of DES vs. bare stents (BMS) among 266 pts with acute coronary syndromes (ACS) undergoing percutaneous coronary LQWHUYHQWLRQ 3&, RIDQ69* Methods: ,Q WKH $&8,7< WULDO SWV ZLWK PRGHUDWH DQG KLJK ULVN ACS undergoing an early invasive treatment strategy were randomized to ELYDOLUXGLQ DORQH %,9 %,9JO\FRSURWHLQ ,,E,,,D LQKLELWLRQ *3, RU D heparin+GPI. Among these, 7789 patients underwent PCI, including 266 SWVXQGHUJRLQJ69*LQWHUYHQWLRQ2QH\HDURXWFRPHVZHUHDGMXGLFDWHGE\ an independent clinical events committee. For this analysis, the primary comparison was between pts treated with DES compared to BMS. Results:While the decision to treat with DES vs. BMS was non-randomized (by operator choice), patients treated with DES (n=210) or BMS (n=56) did not differ in baseline clinical characteristics, including the presence of baseline WURSRQLQ HOHYDWLRQ RU 7,0, 5LVN VFRUH RU LQ UDQGRPL]HG WUHDWPHQW JURXS The QCA lesion length and total number of stents were similar (mean length of 16 mm and median of 1 stent); however, the QCA baseline reference vessel GLDPHWHUZDVVLJQL¿FDQWO\ODUJHUDPRQJ%06WUHDWHGSDWLHQWV PPYV
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TCT-400
2.98 mm, p<0.001), and BMS-treated lesions were more often thrombotic. One year outcomes are presented in the table. Death/MI Death MI Stent Thrombosis (ARC) 'H¿QLWH3UREDEOH 'H¿QLWH Probable ,VFKHPLF795 Ischemic TLR Composite ischemia
DES (n=210) 25.3% (50) 8.0% (16) 19.6% (38)
BMS (n=56) 33.0% (18) 9.1% (5) 27.9% (15)
p-value 0.20 0.79 0.15
3.6% (5) 2.1% (4) 1.5% (1) 12.8% (22) 9.6% (16) 35.0% (66)
3.7% (2) 3.7% (2) 0.0% (0) 8.2% (4) 8.2% (4) 36.7% (20)
0.62 0.47 0.62 0.44 0.88 0.52
Early or Late Stent Thrombosis: Is it the Same Prognosis? Gilles Lemesle, Laurent Bonello, Axel de Labriolle, Tina L Pinto Slottow, Probal Roy, Daniel H Steinberg, Rebecca Torguson, Kimberly Kaneshige, Zhenyi Xue, William O Suddath, Lowell F Sattler, Kenneth M Kent, Joseph Lindsay, Augusto D Pichard, Ron Waksman Cardiovascular Research Institute, Washington, DC Aim: Stent thrombosis (ST), a major complication of drug eluting stents, may RFFXUZLWKLQWKH¿UVWGD\VRUODWHU'LIIHUHQFHVLQWKHFOLQLFDOSUHVHQWDWLRQ DQGWKHRXWFRPHKDYHQRWEHHQZHOOGH¿QHG:HFRPSDUHGWKHSUHGLFWRUVDQG the prognosis of patients in these two categories. Methods: Between June 2003 and March 2008, 91 consecutive patients SUHVHQWHG WR RXU FDWKHWHU ODERUDWRU\ ZLWK GH¿QLWH 67 SWV KDG HDUO\ DQG ODWH 67 DV GH¿QHG E\ WKH $5& GH¿QLWLRQ 7KH SULPDU\ HQGSRLQW ZDV D composite criteria Death - Myocardial Infarction (MI) or Recurrent ST at 30 days following the treatment of ST event. Results: Baseline clinical and angiographic characteristics were similar in the 2 groups. However, ST elevation MI as the indication of index PCI was more frequent in the early ST group 43.1% versus 17.5% in the late ST group (p=0.007). The ST presented as an STEMI with equal frequency in both JURXSV YVS EXWWKHUDWHRIFDUGLRJHQLFVKRFNZDVKLJKHU in the early ST group. (39.2% vs. 20%, p=0.04). The treatment strategy in the cath lab was similar between the 2 groups in terms of anticoagulation with aspirin and clopidogrel doses, GpIIb-IIIa inhibitor use, thrombus aspiration device use and new stent implantation rate. The rate of angiographic success after the ST treatment was similar between the 2 groups (82.4% vs. 87.5%, p=0.5). At 30 days, the incidence of the composite primary endpoint Death 0,67ZDVVLJQL¿FDQWO\KLJKHULQWKHHDUO\67JURXSWKDQLQWKHODWH67 group: 47.6% vs. 26.1%, respectively (p=0.02).
Conclusion: 7KH QRQUDQGRPL]HG XVH RI '(6 UDWKHU WKDQ %06 LQ 69* lesions in the ACUITY trial was not associated with discernable differences LQHLWKHUHI¿FDF\RUVDIHW\RXWFRPHVWRRQH\HDU/DUJHUUDQGRPL]HGWULDOV ZLWKORQJHUIROORZXSDUHQHHGHGWRIXUWKHUHVWDEOLVKWKHVDIHW\DQGHI¿FDF\ RI'(6LQ69*OHVLRQV TCT-399 Zotarolimus Drug-Eluting Stent In Patients With S-T Elevation Myocardial Infarction: 12-Month Results From The E-FIVE Registry Chaim Lotan1, Ian T Meredith2, Manuela Negoita3, Martin T Rothman4, For the E-FIVE Registry Investigators 1 Hadassah-Hebrew University Medical Center, Jerusalem, Israel 2 Monash Medical Centre, Southern Health, Melbourne, Victoria, Australia 3Medtronic CardioVascular, Santa Rosa, CA; 4Barts and The London NHS Trust, London, United Kingdom
Conclusion: Patients presenting with an early ST have a worst prognosis when compared to patients presenting with a late ST. This could be explained E\WKHRFFXUUHQFHRIVXFFHVVLYH0,¶VZLWKLQGD\VLQQHDUO\RIWKH patients in the early ST group. TCT-401 The Safety and Effectiveness of Cypher Stent for Bifurcation versus Non-Bifurcation Lesion. Two-Year Follow-Up Analysis From the MATRIX Registry Adriano Caixeta1, Giora Weisz1, Roxana Mehran1, Michael B Collins2, Varinder Singh1, Alexandra J Lansky1, Susheel Kodali1, Theresea Franklin-Bond2, Neil Matharoo2, Roland Wu1, Dorothy Franklin2, Kathy Morgan1, Gregg W Stone1, Jeffrey M Moses1, Martin Fahy1, Martin Leon2, George Dangas1 1 Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY; 2Columbia University Medical Center, New York, NY Background: Percutaneous coronary intervention in coronary bifurcation lesions (BIF) remains challenging in the drug-eluting stent (DES) era. BIF have been associated with higher procedure complication rates and worse short-term clinical outcomes than non-BIF. The long-term clinical outcomes
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Background: Most randomized trials of drug-eluting stents excluded patients presenting with an acute myocardial infarction (AMI) at enrollment due to FRQÀLFWLQJ GDWD DQG SRVVLEOH VDIHW\ FRQFHUQV :H HYDOXDWHG WKH XVH RI WKH (QGHDYRU]RWDUROLPXVHOXWLQJVWHQWLQDVXEJURXSRIKLJKULVN$0,SDWLHQWV IURPDUHDOZRUOGSDWLHQWSRSXODWLRQLQWKH(),9(5HJLVWU\ Methods: 7KH(),9(5HJLVWU\LVDSURVSHFWLYHPXOWLFHQWHUQRQUDQGRPL]HG global registry that enrolled 8314 patients at 188 centers in Europe, South America, Australia, New Zealand and Asia. All patients presenting with symptomatic coronary artery disease amenable to stent implantation were eligible for the study. Patients with documented ST elevation (STE) within 72 hours of the index procedure were considered to have an acute MI. For the last 4000 patients enrolled, we collected more detail as to the time of symptom onset, thus we were able to also evaluated 12 month clinical outcomes based on the time between onset of symptoms and stenting. All MACE events, death, myocardial infarction (MI), and stent thrombosis (ST) events using ARC criteria, were adjudicated by a Clinical Events Committee. Results: ,QWRWDO SDWLHQWVKDGDGRFXPHQWHG$0, DQ\GH¿QLWLRQ ZLWK 12-month rates of TLR, MACE of 2.8% and 7.2%, respectively. The 12-month $5& GH¿QLWH VWHQW WKURPERVLV 67 UDWH ZDV DQG $5& GH¿QLWH probable ST rate was 2.0%. We plan to report detailed outcomes based on time from symptoms to primary PCI in October, 2008. Conclusion: We found that use of the Endeavor zotarolimus-eluting stent in AMI patients, either in the acute phase (within 6 hours of symptom onset) or ZLWKLQWKH¿UVWKRXUVRIV\PSWRPVZDVDVVRFLDWHGZLWKORZ0$&(UDWHV comparable to that seen in more controlled study populations.
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RISWVZLWK'(6VWHQWLQJRI%,)LVQRWZHOONQRZQ Methods:7RWDORIFRQVHFXWLYH³UHDOZRUOG´SWVZLWKFRURQDU\DUWHU\GLVHDVH WUHDWHGZLWKF\SKHUVWHQWZHUHHQUROOHGLQWKH0$75,;UHJLVWU\7KHVKRUWDQG long term outcomes of patients who had stenting of a BIF to patients who had stenting of a non-BIF were compared. Patient were followed for 2 years. Results: Total of 294 pts (18%) had BL and 1291 non-BL. There were no VLJQL¿FDQWGLIIHUHQFHVLQEDVHOLQHDQGGHPRJUDSKLFFKDUDFWHULVWLFVEHWZHHQ groups. The average number of stents used per patient was greater in BL (2.55 vs. 1.98; P<0.0001). There were no between-group differences in in-hospital mortality (0% vs. 0.1%; P=1.00) and myocardial infarction (2.3% in both). The 2-year clinical outcomes are summarized in Table 1. Outcomes @ 2yr
Bifurcation
No Bifurcation
P value
All Death
4.4%
3.9%
0.806 0.570
Cardiac Death
1.4%
1.2%
MI
4.4%
4.0%
0.649
795
11.5%
10.2%
0.546
MACE
19.3%
17.4%
0.410
ARC Def/Prob Stent thrombosis
0.7%
1.0%
0.809
MI: myocardial infarction; MACE: major adverse cardiovascular events (death, MI, 795 795 WDUJHWYHVVHOUHYDVFXODUL]DWLRQ $5& DFDGHPLFUHVHDUFKFRQVRUWLXP
Conclusion: In comparison to non-BIF, treatment of BIF with the sirolimuseluting stent,had similarly low in-hospital as well as 2-year event rates compared with non-BIF groups. TCT-402 Vascular Safety of Sirolimus-Eluting Reservoir-Based Stents in the Porcine Coronary Artery Model
E L E C T RO N I C A B S T R AC T S
G. Sylvester Price1, James R L Stanley2, Andrew Luk1, John Dooley3, Rose Kovalcsik4, Campbell Rogers3 1 Conor Medsystems, Menlo Park, CA; 2CBSET, Inc., Lexington, MA; 3 Cordis Corporation, Warren, NJ; 4MPI Research, Inc., Mattawan, MI Background: The Conor reservoir-based stent platform uses biocompatible bioresorbable polymers for anti-restenosis vascular drug delivery. We incorporated sirolimus into a PLGA polymer matrix similar to that used in previous Conor stent platforms. The sirolimus dose and in vivo release NLQHWLFVRIWKH&RQRUVLUROLPXVHOXWLQJVWHQW 1(92® 0HQOR3DUN&$ ZHUH tailored to be similar to CYPHER® (Cordis Corporation, Warren, NJ). Methods: 6LQJOH 1(92 EDUH PHWDO &RQRU %06 DQG &<3+(5 VWHQWV were implanted in porcine LAD, RCA and/or LCx coronary arteries for 30, 90, or 180 d. QCA, histopathology and histomorphometry were evaluated. In addition, SEM was performed on a subset of arteries. Results:$OOVWHQWVZHUHHQGRWKHOLDOL]HGDWG3HULVWUXWLQÀDPPDWLRQLQ1(92 VWHQWVZDVPLQLPDODQGVLJQL¿FDQWO\OHVVWKDQLQ%06FRQWURO VFRUH YV DWG S 3RO\PHUGHJUDGDWLRQZDVHVVHQWLDOO\FRPSOHWHE\ GZLWKPLQLPDODVVRFLDWHGLQÀDPPDWLRQ 1(92 YV%06 QRWVLJQL¿FDQW ,QÀDPPDWLRQZDVDOVRPLQLPDODWG 1(92 YV%06 QRWVLJQL¿FDQW 3HULVWUXW¿EULQDIWHUGZDVVLJQL¿FDQWO\ JUHDWHULQ1(92WKDQ%06EXWGLGQRWGLIIHUIURP&<3+(5DQGGHFUHDVHG SURJUHVVLYHO\DW DQGG1HRLQWLPDOWKLFNQHVVGLGQRWGLIIHUDPRQJVWHQW W\SHVDWG 1(92 PP&<3+(5 PP%06 PP $VH[SHFWHGLQWKHSRUFLQHPRGHODW G%06QHRLQWLPDOWKLFNQHVV GHFUHDVHGVOLJKWO\ PP ZKHUHDVLQERWKVLUROLPXVHOXWLQJVWHQWW\SHV QHRLQWLPDOWKLFNQHVVZDVVOLJKWO\LQFUHDVHGUHODWLYHWRWKDWDWGD\V 1(92 PP&<3+(5 PP +RZHYHUDWGWKHUHZDVQR GLIIHUHQFHEHWZHHQ1(92DQG%06QHRLQWLPDOWKLFNQHVV 1(92 PP%06 PP Conclusion: Reservoir-based bioresorbable stent-based delivery of sirolimus SURGXFHGOHVVLQÀDPPDWLRQWKDQ%06DWGGUXJWLVVXHHIIHFWVUHPLQLVFHQW of CYPHER, but with no polymer material present after 90 d.
156i
TCT-403 Stent-based Delivery Of Antisense Oligodeoxynucleotides Targeted To The Pdgf A-chain Decreases In-stent Restenosis Of The Coronary Artery Shin-Ichiro Yokoyama, Yuxin Li, Satoshi Saitoh Nihon University School of Medicine, Tokyo, Japan Background: Although the use of drug-eluting stents (DESs) has been shown to limit neointima hyperplasia, currently available DESs may adversely affect reendothelialization, possibly precipitating cardiac events. We evaluated the effect of an antisense oligodeoxynucleotide (ODN) targeted to the platelet-derived growth factor (PDGF) A-chain on in-stent restenosis in pig coronary artery. Methods:$EDUHPHWDOVWHQWFRDWHGZLWKSKRVSKRURWKLRDWHOLQNHGDQWLVHQVH ODN or nonsense ODN, or a bare metal stent without ODN (control), was implanted in the mid segment of the left anterior descending artery (LAD). Twenty-eight days after implantation, angiography and intravascular XOWUDVRXQG ,986 ZHUHSHUIRUPHGWKH/$'ZDVUHPRYHGDQGVWHQRVLVZDV evaluated pathologically. Results:9ROXPHWULFVWHQRVLVUDWLRVZHUH DQG 3.8% in coronary arteries implanted with control, nonsense ODN-coated, and DQWLVHQVH2'1FRDWHGVWHQWVUHVSHFWLYHO\,QDQJLRVFRSLF¿QGLQJVWKHOXPHQ surface was smooth in the stented segments in all groups. Struts of antisense ODN-coated stents were observed embedded in the neointima, whereas embedding was not observed in nonsense ODN-coated stents or control stents, indicating a decrease in hyperplasia in response to antisense ODN WUHDWPHQW3DWKRORJLF¿QGLQJVVKRZHGDQG stenosis in coronary arteries implanted with control stents, nonsense ODNcoated stents, and antisense ODN-coated stents, respectively. A continuous lining of endothelial cells was observed along the lumen of coronary arteries implanted with antisense ODN-coated stents. Conclusion: Stent-based delivery of an antisense ODN targeted to the PDGF A-chain effectively inhibits neointima formation after stent implantation LQ SLJ FRURQDU\ DUWHU\ E\ VXSSUHVVLQJ 960& K\SHUSODVLD DQG SUHVHUYLQJ endothelialization. Antisense-ODNs may provide a therapy for in-stent restenosis of the coronary artery. TCT-404 The Effectiveness and Safety of Zotarolimus Eluting Stent Implantation in Acute Myocardial Infarction: IPS (Infarct Prognosis Study) Registry Won Ho Kim, Jung-Sun Kim, Young-Guk Ko, Donghoon Choi, Jong Won Ha, Yangsoo Jang, Namsik Chung Yonsei University College of Medicine, Yonsei Cardiovascular Center, Seoul, Republic of Korea Background: There is little information on cardiac outcomes in the Zotarolimus Eluting Stent (ZES), compared with the Sirolimus Eluting Stent (SES) and the Paclitaxel Eluting Stent (PES) in acute myocardial infarction. The study was designed to investigate the effectiveness and safety of ZES implantation in acute myocardial infarction Method: )RXU KXQGUHG ¿YH FRQVHFXWLYH SDWLHQWV ZLWK DFXWH P\RFDUGLDO infarction in IPS(Infarct Prognosis Study) Registry [ST elevation myocardial infarction; n=225(55.6%), Non-ST elevation myocardial infarction; n=180(44.4%)], underwent percutaneous coronary intervention at Severance Hospital, were randomly assigned to be implanted SES, PES, or ZES. We assessed the adverse cardiac events [Cardiovascular death, Non-fatal P\RFDUGLDO LQIDUFWLRQ DQG 7DUJHW YHVVHO UHYDVFXODUL]DWLRQ 795 @ DPRQJ three group (SES, n=197, PES, n=114, ZES, n=94). The mean follow-up GXUDWLRQZDVPRQWKV XSWRPRQWKV Results: The baseline characteristics were comparable among the three groups. The cumulative mortality rate was comparable in the three groups: 6.6% in the SES group, 4.4% in the PES group, and 4.3% in the ZES group QRQVLJQL¿FDQWIRUDOO 7KHUDWHRI795ZDVLQWKH=(6JURXSFRPSDUHG
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October 12-17, 2008
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TCT-406
with 2.0% and 4.4% in the SES and PES group, respectively (p=0.008 for ZES vs. SES, 0.133 for ZES vs. PES, 0.252 for SES vs. PES). The cumulative LQFLGHQFHRIFDUGLRYDVFXODUGHDWKQRQIDWDO0,RU795ZDVLQWKH ZES group compared with 10.7% in the SES group, 12.3% in the PES group (p=0.220 for ZES vs. SES, 0.456 for ZES vs. PES, 0.655 for SES vs. PES). 6WHQW WKURPERVLV 67 ZKLFK ZDV GH¿QHG DV GH¿QLWLRQV RI WKH $FDGHPLF Research Consortium(ARC), was investigated during the study period. The rate of ST was 1.1% in the ZES group, 2.5% in the SES group and 0.9% in the PES group (p=0.474). Conclusion: Our data demonstrated that the cumulative of adverse cardiac HYHQW DQG QRQIDWDO 0, ZHUH QRW VLJQL¿FDQWO\ GLIIHUHQW DPRQJ WKH WKUHH JURXSV%XW=(6KDGDKLJKHUUDWHRI795WKDQ6(6RU3(6
The role of diabetes status in the long-term (up to 6 years) results of drug-eluting stents for the treatment of diabetic patients - insights from the Drug Eluting Stents In the REal World(DESIRE) Registry Adriana C Moreira, Amanda Sousa, José Costa Jr, Ricardo Costa, Manuel Cano, Galo Maldonado, Luiz Alberto Mattos, Fausto Feres, Cesar Jardim, Ricardo Pavanello, Marcel Vezzaro, Mariana Carballo, J.Eduardo Sousa Hospital Do Coracao, Sao Paulo, Brazil Background: Diabetic patients are traditionally related to higher rates of major adverse cardiac events (MACE) after percutaneous coronary intervention even in the drug-eluting stent (DES) era. We sought to evaluate the impact of diabetes status in the very long-term clinical outcomes after DES implantation in a complex, non-selected diabetic cohort. Methods and Results: Between May/2002 and May/2007, 2,500 patients treated exclusively with DES were consecutively enrolled in the nonrandomized, single-center DESIRE Registry. Among them, 1,705 elective patients have completed 6 month-follow-up and were divided into 3 groups according to their Diabetes mellitus status. Primary endpoint was longWHUP FRPELQHG 0$&( DQG VWHQW WKURPERVLV UDWH FODVVL¿HG DFFRUGLQJ WR $5&GH¿QLWLRQV&OLQLFDOIROORZXSZDVREWDLQHGDWDQGPRQWKVDQG then annually up to 6 years. Median follow-up time was 3.6 years. Clinical follow-up was achieved in 98% of the eligible cohort. Baseline clinical and procedure characteristics as well as late outcomes are displayed in the table. In the multivariate logistic regression analysis, Diabetes mellitus (OR=1.45; &RQ¿GHQFH LQWHUYDO&, DQG PRGHUDWHVHYHUH FDOFL¿FDWLRQ DW lesion site (OR=3.06;95%CI,1.47-6.34) were independent predictors of MACE .
TCT-405 Incidence Of Stent Thrombosis (st) At 5 Years After Ses Implantation. Results From A Prospective Swiss Registry In The Real World Jean-Jacques Goy1, Urs Kaufmann2, Philip Urban3, Charles Seydoux1, Edoardo de Benedetti3, Alexandre Berger1 1 Clinique Cecil, Lausanne, Switzerland 2Herzzentrum, Bern, Switzerland 3Hôpital la Tour, Genève, Switzerland
Group
Non Diabetics 9DULDEOHV (n =1,211) Mean age ,y 63.4 Female,% 22.5 Hypertension,% 73.7 Obesity,% 23.5 Serum creatinine, mg/dl 1.1 Off-label indications,% 71.2 B2/C lesion Type,% 65.8 Moderate/severe 27.1 FDOFL¿FDWLRQ DES/vessel ratio 1.16 Cumulative MACE(%) 7.0 Cardiac death 1.0 Non-fatal MI 2.7 TLR (PCI/CABG) 2.5 Stent thrombosis rate,% 1.16
Non-insulinrequiring DM (n =385) 64.5 25.7 86.0 37.5 1.2 72.2 68.7
Insulin-requiring DM p-value (n = 109) 65.6 0.049 40.4 <0.001 89.0 <0.001 27.2 <0.001 1.3 0.005 82.6 0.04 69.9 0.43
29.9
40.0
0.001
1.15 9.4 2.9 3.4 3.7 1.8
1.17 11.2 3.7 4.7 3.8 1.8
0.466 0.117 0.35 0.34 0.30 0.35
Conclusion: In the DESIRE registry both insulin and non-insulin requiring diabetics carried poorer long-term outcomes (MACE) when compared to non-diabetic patients. Importantly, there was a tendency for higher stent thrombosis among diabetics. However, the type of diabetes (insulin vs. noninsulin) did not seem to impact the prognosis of PCI with DES. TCT-407 Long-term (up to 6 years) outcomes of diabetic patients with multivessel disease treated with drug-eluting stents in the Drug Eluting Stents In the REal World(DESIRE) Registry Adriana Moreira, Amanda Sousa, José Costa Jr, Ricardo Costa, Manuel Cano, Galo Maldonado, Rodolfo Staico, Luiz Alberto Mattos, Fausto Feres, Felix Ramires, Daniel França, Abrão Cury, Marcos Barbosa, Cantidio Campos, J Eduardo Sousa Hospital Do Coracao, Sao Paulo, Brazil Background: 'UXJHOXWLQJ VWHQWV ZHUH PDUNHWDSSURYHG IRU WUHDWPHQW RI QRQFRPSOH[ OHVLRQV EDVHG RQ WKHLU HI¿FDF\ DQG VDIHW\ SUR¿OH LQ SLYRWDO randomized trials. However, in clinical practice, DES are used in both on-
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Background: The incidence of stent thrombosis and complications following Sirolimus Eluting Stents (SES) implantation is still a matter of debate. Method: We started to implant SES in 2002 at 3 Swiss institutions. In 2007, we conducted a 5 year follow-up, on the day of their 5 year SES implantation anniversary. All patients were included for the follow-up except those who also received another DES or a bare metal stent. After the procedure aspirin 100 mg OD was given long-term and clopidogrel 75 mg OD for 3 to 12 months. 7KHXVHRI6(6LPSODQWDWLRQZDVQRWUHVWULFWHGWR³RQODEHO´LQGLFDWLRQVDQG WDUJHWOHVLRQVLQFOXGHGLQVWHQWUHVWHQRVLV69*ELIXUFDWLRQVDQGORQJOHVLRQV ZHUHWUHDWHG8SWRRIWKHSWVZHUHGH¿QHGDVKLJKULVNRUFRPSOH[OHVLRQ IRUVWHQWLQJ7KH$5&FULWHULDZHUHXVHGIRU67FODVVL¿FDWLRQ Results: 350 patients were treated with SES between April and December 0HDQDJHZDV\HDUVZHUHPDOHSUHVHQWHGZLWK$&6 and 19% were diabetics. Multi-vessel procedures were performed in 11% of patients. The mean stented length was 21+ 5 mm, and the vessel reference GLDPHWHUPP0HDQQXPEHURI6(6SWZDV2QWKHGD\RI WKHLU\HDUIROORZXS67KDGRFFXUUHGLQSWV GH¿QLWH6$7 probable 1 (0.3%) and possible 5 (1.4%). None of the SAT occurred during the ¿UVW\HDURIWUHDWPHQW )LJXUH 6HYHQW\QLQHSHUFHQWRIWKHSRSXODWLRQZDV free of complications. MACE occurred in 21% and were: cardiac death 3%, QRQFDUGLDFGHDWK0,7/5795&$%*,QQRQ 795QRQ7/5UHYDVFXODUL]DWLRQZDVSHUIRUPHG Conclusion:2XUGDWDFRQ¿UPWKHH[FHOOHQWORQJWHUPRXWFRPHRISDWLHQWV treated with SES. The incidence of complications at 5 years in routine clinical practice reproduces the results of the prospective randomized trials, especially for the incidence of SAT. Surprisingly, most of them were very late ST.
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DQGRIIODEHOOHVLRQVDVZHOODVLQKLJKULVNSDWLHQWV'LDEHWLFSDWLHQWVZLWK multivessel disease are traditionally related to higher rates of major adverse cardiac events (MACE) after percutaneous coronary intervention even in the drug-eluting stent (DES) era. We sought to evaluate the very long-term FOLQLFDORXWFRPHDIWHU'(6LPSODQWDWLRQLQWKLVKLJKULVNVXEVHWLQDFRPSOH[ non-selected population. Methods and Results: Between May/2002 and May/2007, 2,500 patients treated exclusively with DES were consecutively enrolled in the nonrandomized, single-center DESIRE Registry. Recent myocardial infarction, saphenous venous graft and patients with < 6months follow-up were excluded. '(6 ZHUH VHOHFWHG DW WKH RSHUDWRU¶V GLVFUHWLRQ $PRQJ WKHP 3 ZLWK multivessel disease were divided into 2 groups: diabetic(137P) and NonGLDEHWLFSDWLHQWV 3 3ULPDU\HQGSRLQWLQFOXGHGORQJWHUP !PRQWKV FRPELQHG0$&(DQGVWHQWWKURPERVLVUDWH6WHQWWKURPERVLVZDVFODVVL¿HG DFFRUGLQJ WR $5& GH¿QLWLRQV &OLQLFDO IROORZXS ZDV REWDLQHG DW DQG 6 months and then annually up to 6 years. Median follow-up time was 3.6 years.Clinical follow-up was achieved in 98% of the eligible cohort. Baseline characteristics and late outcomes are displayed in the table. Non DM (n=300P)
+Diabetes +Diabetes HR (CI) Cypher Taxus (n=184) (n=187)
-Diabetes -Diabetes HR (CI) Cypher Taxus (n=896) (n=860)
MACE
31
40
0.77 (0.49112 1.23)
121
0.88 (0.681.14)
Cardiac death
7
8
0.88 (0.3217 2.44)
14
1.17 (0.582.36)
p
MI
10
12
0.84 (0.3755 1.94)
64
0.82 (0.571.18)
Stent thrombosis
11
9
1.24 (0.5133 2.98)
33
0.96 (0.591.55)
TLR
17
15
1.14 (0.5754 2.27)
67
0.77(0.541.10)
795
21
24
0.88 (0.4972 1.57)
84
0.82 (0.601.12)
251/83.7
103/75.2
0.6
Age (y)
64.1 + 11.6
66.0 + 9.1
0.7
Unstable angina, n/%
74/24.7
51/37.2
0.01
5DWLR9HVVHOV3
2.08
2.16
0.08
Ratio Stents / P
2.38
2.46
0.1
Myocardial infarction,%
4.0
2.2
0.5
Target lesion revascularization, %
3.3
1.4
0.4
Cardiac death,%
1.3
1.4
0.7
Major adverse cardiac events, %
8.6
5.1
0.3
Stent thrombosis (ARC)
2.0
2.2
0.9
Conclusion: In the DESIRE registry, drug-eluting stent for the treatment of patients with multivessel disease was safe and effective and the presence of diabetes mellitus did not seem to negatively impact the outcomes of this cumbersome population. TCT-408
E L E C T RO N I C A B S T R AC T S
Table: Cypher vs. Taxus
DM (n=137P)
Male gender, n/%
Long-term Clinical Outcome After Implantation of Sirolimus-eluting and Paclitaxel-eluting Stents in Diabetic and Nondiabetic Patients in the SORT OUT II Trial Michael Maeng1, Niels Bligaard2, Henning Kelbaek3, Lisette O Jensen4, Rasmussen Klaus5, Jens F Lassen1, Peter R Hansen2, Per Thayssen’4, Leif Thuesen1, Ulrik Abildgaard2, Thomas Engstrøm3, Steen D Kristensen1, Jan S Jensen2, Lars R Krusell1, Søren Galatius2, Hans E Bøtker1, Jan K Madsen2, Evald H Christiansen1, Steen Z Abildstrøm2, Ghita Stephansen2, Anders M Galløe2 1 Aarhus University Hospital, Skejby, Aarhus, Denmark 2Gentofte Hospital, Gentofte, Denmark 3Rigshospitalet, Copenhagen, Denmark 4 Odense University Hospital, Odense, Denmark 5Aarhus University Hospital, Aalborg, Aalborg, Denmark Background: We assessed the impact of diabetes on long-term outcome after SHUFXWDQHRXV FRURQDU\ LQWHUYHQWLRQ 3&, ZLWK WKH ¿UVW WZR FRPPHUFLDOO\ available drug-eluting stents (DES), the sirolimus-eluting Cypher stent &RUGLV-RKQVRQ DQG -RKQVRQ 0LDPL /DNHV )ORULGD DQG WKH SDFOLWD[HO HOXWLQJ7D[XVVWHQW %RVWRQ6FLHQWL¿FFRUS1DWLFN0DVVDFKXVHWWV Methods: After general inclusion in the SORT OUT II trial of 2098 patients, DGGLWLRQDO SDWLHQWV ZLWK GLDEHWHV ZHUH LQFOXGHG WR UHDFK D SUHGH¿QHG number in a diabetic substudy. Together these 2126 patients were randomized to treatment with Cypher (n=1074) or Taxus (n=1045). The patients have so far been followed from 18 to 40 months. The primary endpoint was major DGYHUVH FDUGLDF HYHQWV 0$&( GH¿QHG DV D FRPSRVLWH RI FDUGLDF GHDWK
158i
myocardial infarction (MI), target lesion revascularization (TLR) and target YHVVHOUHYDVFXODUL]DWLRQ 795 Results: 'LDEHWHVZDVDVVRFLDWHGZLWKLQFUHDVHGULVNRIFDUGLDFGHDWK +D]DUG 5DWLR +5 &RQ¿GHQFH,QWHUYDO &, S 0$&( +5&,S DQG795 +5&,S 7KHUHZDVQRVWDWLVWLFDOVLJQL¿FDQWGLIIHUHQFHFRQFHUQLQJ0, +5&, 0.58-1.38, p=0.61), TLR (HR 1.30, CI 0.87-2.02, p=0.19) or the composite of GH¿QLWH DQG SUREDEOH VWHQW WKURPERVLV +5 &, S $V VKRZQLQWKHWDEOHWKHW\SHRI'(6GLGQRWVLJQL¿FDQWO\LQÀXHQFHHQGSRLQWV
'H¿QLWHSUREDEOHVWHQWWKURPERVLV
Conclusion: ,QSDWLHQWVZLWKVLJQL¿FDQWFRURQDU\DUWHU\GLVHDVHWUHDWHGZLWK '(6GLDEHWHVLVDVVRFLDWHGZLWKDLQFUHDVHGULVNRIFDUGLDFGHDWKD LQFUHDVHGULVNRI0$&(DQGDLQFUHDVHGULVNRI795,QWKHGLDEHWLFDQG QRQGLDEHWLFVXESRSXODWLRQVZHIRXQGQRVWDWLVWLFDOO\VLJQL¿FDQWGLIIHUHQFHV EHWZHHQWKH¿UVWWZRFRPPHUFLDOO\DYDLODEOH'(6 TCT-409 In-Stent Restenosis - Benign or Dangerous? Clinical Presentation of Coronary Restenosis in Sweden Elmir Omerovic1, Truls Ramunddal1, Lars Grip1, Jan Boren2, Goran Matejka1, Per Albertsson1 1 Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden2The Wallenberg Laboratory for Cardiovascular Research, Gothenburg, Sweden Background: Restenosis after percutaneous coronary intervention (PCI) was earlier thought to be a benign event clinically manifested as stable exertional angina. The aim of this prospective multicenter registry study was to investigate the incidence of acute coronary syndrome in patients with restenosis in Sweden. Methods: Using data from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR), we analyzed all registered cases of PCI for restenosis (instent, after balloon angioplasty) from 1995 to 2005 in Sweden. Both multivessel and single vessel interventions were included. Restenosis presentations were FODVVL¿HGDV VWDEOHDQJLQD XQVWDEOHDQJLQDQRQ67(0, 67(0, DQG other reasons. As routine angiographic screening was not performed, restenosis HSLVRGHVZHUHGH¿QHGFOLQLFDOO\EDVHGRQV\PSWRPV Results: :HLGHQWL¿HGFDVHVRIUHVWHQRVLVLQ SDWLHQWV LQPHQ 1852 in women). Restenosis presented in 39.7% of cases as stable angina, in 46.0% as unstable angina/non-STEMI, in 11.5% as STEMI and in 2.8% as RWKHUUHDVRQV&DUGLRJHQLFVKRFNZDVUHSRUWHGLQSDWLHQWV:RPHQKDG a higher incidence of unstable angina/non-STEMI compared with men (52.3% v. 43.6%) but a lower incidence of STEMI (9.6% v. 12.2%). The frequency of STEMI was lower with restenosis after balloon angioplasty v. in-stent restenosis (6.9% v. 13.8%), and after drug-eluting stents v. bare metal stents (7.9% v. 18.5%). Mortality rate was 1.7% at 30 days, 3.2% at 6
The American Journal of Cardiology® |
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months and 4.6% at one year in patients with restenosis. These covariates were independent predictors of acute coronary syndrome : gender, age, vessel GLDPHWHU VPRNLQJ VWHQW W\SH QXPEHU RI VWHQWV WUHDWHG YHVVHO SUHYLRXV VWURNHDQGSUHYLRXVLQIDUFWLRQ Conclusion: The majority of patients with coronary restenosis present either with acute MI or unstable angina requiring hospitalization and new LQWHUYHQWLRQV:RPHQPD\KDYHDKLJKHUULVNRIGHYHORSLQJDFXWHFRURQDU\ syndrome due to restenosis. Prevention of restenosis may be an important WDUJHW IRU LPSURYHPHQW RI ³KDUG´ FOLQLFDO RXWFRPHV LQ SDWLHQWV XQGHUJRLQJ coronary revascularization.
DGYDQWDJHVRILQWUDYDVFXODUXOWUDVRXQG ,986 XVDJHSULRUWRDQGRUGXULQJ the procedure are to accurately assess plaque distribution axially and ORQJLWXGLQDOO\+RZHYHUZRUNLQJFULWHULDIRU,986JXLGH6(6LPSODQWDWLRQ have not been established. Methods: We have determined optimal SES landing under the following VWHSZLVH,986FULWHULD 6WHS 6LWHRIQRUPDODSSHDUDQFHZLOOEHVHOHFWHG primarily as reference. Step 2: If step 1 cannot be achieved, a site with %plaque area (PA: plaque area/ external elastic membrane area × 100) of less than 50% should be selected. Step 3: If step 2 cannot be achieved, a site with the least amount of %PA should be selected. To verify these criteria, 1) the achievement rate of step 1 and 2, which were considered as optimal target, and 2) resultant vascular responses, assessed by serial quantitative coronary angiography were investigated. We enrolled initial consecutive 141 lesions of 126 patients for this investigation. Follow-up angiography was available for 106 (76.3%) lesions. Results: 5HVLGXDO 3$ DW SUR[LPDO DQG GLVWDO PDUJLQ ZDV DQG UHVSHFWLYHO\ ZLWKLQ PP RXWVLGH VWHQW 7KH WDUJHW ZDV achieved in 71.2% of proximal and 84.7% of distal margin for the criteria. Overall angiographic restenosis rate was 2.8% of proximal and 0.9% of distal margin. Furthermore, angiographic restenosis rate decreased down to 0.9% at proximal and 0% at distal margin if the cases met step 1 or 2 of the criteria. Conclusion: 2XU SURSRVHG ,986 FULWHULD DUH DWWDLQDEOH DQG IXQFWLRQDO WR maximally reduce margin restenosis after SES implantation in the actual clinical setting.
TCT-410 Long-term Clinical Outcomes Following Successful Coronary DrugEluting Stent Implantation In Patients With Diabetes Mellitus: Comparison Between Sirolimus- and Paclitaxel-Eluting Stent Bo Xu, Kefei Dou, Yuejin Yang, Yongjian Wu, Runlin Gao Fuwai hospital, Beijing, China Backgound:Several clinical studies indicated that diabetes mellitus(DM) increased incidence of cardiovascular events. With the introduction of drug-eluting stents(DES), clinical outcome following successful coronary intervention of the patients with DM improved to some extent. However, the GLIIHUHQFHRIORQJWHUPVDIHW\DQGHI¿FDF\EHWZHHQVLUROLPXVDQGSDFOLWD[HO eluting stent implantation on patients with DM is currently unclear in routine practice. Objectives: To investigate the two-year clinical outcome after successful implantation of SES(cypher or cypher select ) and PES (Taxus or Taxus liberte) on patients with DM in daily practice.. Methods: From April 2004 to December 2006, 627 patients with DM who underwent DES implantation were prospectively registered(SES:400; 3(6 7KH LQFLGHQFH RI GHDWK P\RFDUGLDO LQIDUFWLRQ 7/5 795 DQ\ revascularization(includes re-PCI and CABG), MACE(includes all above), DOO$5&GH¿QLWLRQWKURPERVLVDWPRQWKVZHUHFRPSDUHGEHWZHHQWKHWZR groups. Results:Baseline characteristics were similar in SES and PES groups. Between WKHWZRJURXSVWKHUHZDVQRVLJQL¿FDQWGLIIHUHQFHLQGHDWK YV P\RFDUGLDOLQIDUFWLRQ YV DOO$5&GH¿QLWLRQWKURPERVLV YV 7/5 YV +RZHYHU ZH IRXQG VLJQL¿FDQWO\ KLJKHU LQFLGHQFHRI795 YVS DQ\UHYDVFXODUL]DWLRQ vs 15.04%, p=0.018) and MACE at 24 months(11.28% vs 18.14%,p=0,0184 in PES group. After adjusting baseline difference between the two groups E\ &2; UHJUHVVLRQ DQDO\VLV 3(6 JURXS PRUH LQFOLQHG WR UHODWH WR KLJKHU LQFLGHQFHRI7/5 +5 >&, @S 795 +5 >&, @S DOO$5&GH¿QLWLRQWKURPERVLV +5 >&, 9.324] p=0.0415),any revascularization (HR : 2.228 [CI 1.335-3.718] p=0.002) and MACE(HR : 1.795 [CI 1.176-2.742] p=0.0068). Conclusion: The implantation of SES showed more favorable results UHJDUGLQJ7/5795DQ\UHYDVFXODUL]DWLRQDQG0$&(FRPSDUHGZLWK3(6 implantation. The clinical outcomes showed comparable on the incidence of death, all ARC thrombosis and myocardial infarction.in the two groups
TCT-412 9 Month Outcomes with Drug-eluting Stents versus Bare Metal Stents LQ3DWLHQWVZLWK&KURQLF5HQDO,QVXI¿FLHQF\ $Q$QDO\VLVIURPWKH Strategic Transcatheter Evaluation of New Therapies (STENT) Registry
Background:7KHVDIHW\DQGHI¿FDF\RIGUXJHOXWLQJVWHQWV '(6 LQSDWLHQWV ZLWKFKURQLFUHQDOLQVXI¿FLHQF\ &5, KDVQRWEHHQZHOOVWXGLHG Methods: The STENT Registry is the largest prospective, multicenter registry in the US evaluating DES. Our study population consists of all patients enrolled from 5/2003-6/2006 with CRI (CrCl < 60 ml/min) treated with DES or bare metal stents (BMS) who completed 9 month follow-up (93%). Outcomes were adjusted with propensity score analysis. Results: Patients with CRI vs pts without CRI had higher mortality (8.0% vs 2.1%, p<0.001), more MACE (14.5% vs 9.4%, p<0.001), less target vessel UHYDVFXODUL]DWLRQ 795 YV S DQGVLPLODUUDWHVRIVWHQW thrombosis (0.9% vs 0.9%, p=NS). Pts with CRI treated with DES vs BMS were younger (74 vs 76 yrs, p<0.001), had less prior CABG (22% vs 27%, p=0.003), and less STEMI (11% vs 22%, p<0.001), but had longer lesions (15 vs 12 mm, p<0.001). Pts with CRI treated with DES vs BMS had lower DGMXVWHG UDWHV IRU PRUWDOLW\ 795 DQG 0$&( DQG VLPLODU UDWHV IRU VWHQW thrombosis (Table).
TCT-411 Functional IVUS Criteria to Determine Optimal Landing of Sirolimus-Eluting Stent Seiji Tamiya, Yoshihiro Morino, Yota Kawamura, Naoki Masuda, Takayuki Iida, Daiki Ito, Eri Toda, Toshiharu Fuji, Makiyoshi Shima, Atuhiko Sugimoto, Takashi Matsukage, Nobuhiko Ogata, Teruhisa Tanabe, Yuji Ikari Tokai University School of Medicine, Isehara, Japan Background: Several studies have indicated that clinical outcomes of VLUROLPXVHOXWLQJVWHQWV 6(6 DUHVLJQL¿FDQWO\DVVRFLDWHGZLWKORQJLWXGLQDO positioning of stent relative to underlying plaque distribution. Potential
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Bruce R. Brodie1, Tom Stuckey1, William Downey1, Sherry Laurent2, Angela Humphrey2, Marcy Nussbaum2, Barbara Bradshaw1, Stanley Juk3, Jim Hermiller4, Chris Metzger5, Barry Cheek6, Fred Krainin7, Peter Duffy8, Charles Simonton9 1 LeBauer Cardiovascular Research Foundation and Moses Cone Heart and Vascular Center, Greensboro, NC; 2R. Stuart Dickson Institute for Health Studies, Charlotte, NC; 3Sisters of Charity Providence Hospitals, Columbia, SC; 4Indiana Heart Institute, Indianapolis, IN; 5Holston Valley Medical Center, Kingsport, TN; 6High Point Regional Health System, High Point, NC; 7McLeod Regional Medical Center, Florence, SC; 8Moore Regional Medical Center, Pinehurst, NC; 9Carolinas Medical Center, Charlotte, NC
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TCT-414
Propensity Adjusted BMS
DES
p value
HR
(n=725)
(n=3002)
Death
13.4%
MI Death/MI
95% CI
p value
6.4%
<0.001
0.68 0.51-0.90
5.5%
3.1%
0.001
0.73 0.47-1.14
0.17
17.1%
8.7%
<0.001
0.69 0.52-0.88
0.004
9 Month Outcomes 0.008
795
5.8%
3.5%
0.004
0.45 0.30-0.69
<0.001
MACE
20.8%
11.6%
<0.001
0.64 0.51-0.81
<0.001
Stent Thrombosis
1.5%
0.8%
0.072
0.83 0.36-1.91
0.66
Conclusion:3WVZLWK&5,WUHDWHGZLWK%06KDYHDKLJKHUULVNSUR¿OHWKDQSWV WUHDWHGZLWK'(6$IWHUDGMXVWLQJIRUGLIIHUHQFHVLQEDVHOLQHULVN'(6KDYH EHWWHURXWFRPHVWKDQ%06ZLWKORZHUUDWHVRI795DQG0$&(:KLOHVRPH of these differences in adjusted outcomes may be related to hidden selection bias, the results from the STENT Registry should encourage the use of DES in selected pts with CRI who are compliant with dual anti-platelet therapy. TCT-413 3URVSHFWLYHUDQGRPL]HGFRPSDULVRQRIHI¿FDF\DQGVDIHW\RI different drug eluting stents (Cypher, Taxus and Endeavour)- The ENTACY Study
E L E C T RO N I C A B S T R AC T S
Henrik Schneider1, Huseyin Ince1, Tim C. Rehders1, Thomas Koerber1, Ibrahim Akin1, Stephan Kische1, Ina Korte1, Sabrina Leyh1, Frank Weber2, Christoph A. Nienaber1 1 University of Rostock, Rostock, Germany 2Frankenwaldklinik Kronach, Kronach, Germany Background: The use of drug eluting stent (DES) in the interventional cardiology leads to a considerable reduction of In-Stent-Restenosis (ISR) and 7DUJHW 9HVVHO 5HYDVFXODULVDWLRQ 795 UDWH %XW WKH HI¿FDF\ DQG VDIHW\ RI different DES have not been evaluated in a prospective manner yet. Methods: We performed a prospective, randomised and angiographic controlled all-in-comers-study, to compare 3 DES: Cypher, Taxus and Endeavour. Primary endpoint was the late lumen loss (LLL) after 6 months; secondary endpoint the rate of ISR, Target lesion Revsacularisation (TLR), stentthrombosis (SAT) and MACE after 6 and 12 months. Results:SDWLHQWV \HDUV ZLWK 3&,OHVLRQVZHUDQGRPL]HG in the 3 DES-groups. 76.6% of patients were men, 40.9% of the DESimplantations occurred in acute coronary syndroms, 63.9% in complex lesions (C, B2). The antithrombotic therapy with aspirin and clopidogrel occurred for 6-12 months. An angiographic 6 months-follow up was available for 90% of the patients and a clinical 12 month follow-up for 95%. (Table 1) Results Drug eluting stent patients (n) / PCI-lesions (n) Diabetes mellitus (%) Bifurcation (n,%) In-Stent-Restenosis (n,%) Left main (n,%) 6 month LLL (mm) 6 month TLR (n,%) 6 month MACE (n,%) 12 Month MACE (n,%)
Cypher select plus 112 / 133 40.2 21 (15.8) 11 (8.3) 10 (8.9) 0.19 +/-0.09 8 (6.5) 14 (12.5) 17 (15.2)
Taxus liberte 117 / 136 31.0 15 (11.0) 8 (5.9) 7 (5.9) 0.43 +/-0.12 12 (9.9) 13 (11.1) 16 (13.7)
Endeavour 118 / 126 33.1 18 (14.8) 18 (14.8) 9 (7.6) 0.60 +/-0.15 16 (15.2) 17 (14.6) 21 (17.8)
p
0.02 0.04 0.15 0.10
Conclusion: The Cypher-stent is superior to Taxus- and Endeavour-DES in terms of LLL, ISR and TLR after 6 and 12 month in a randomized all-incomers study. However the Cypher stent was associated with a higher rate of possible late stent thrombosis with an increased cardiac death rate compared with Taxus and Endeavour. The Endeavour Stent is inferior to the other both '(6FRQFHUQLQJ///,65DQG7952QDJJUHJDWHWKH0$&(UDWHDIWHUDQG 12 month for the 3 DES is equal in our prospective study.
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Sirolimus-eluting Versus Paclitaxel-eluting Coronary Stent Implantation in Patients with Diabetes Mellitus Michael Maeng1, Lisette O Jensen2, Anders M Galløe3, Per Thayssen2, Evald H Christiansen1, Henning kelbaek4, Hans E Bøtker1, Jens F Lassen1, Leif Thuesen1 1 Aarhus University Hospital, Skejby, Aarhus N, Denmark 2Odense University Hospital, Odense, Denmark 3Gentofte Hospital, Gentofte, Denmark 4Rigshospitalet, Copenhagen, Denmark Background: We evaluated angiographic late lumen loss after implantation RIVLUROLPXVHOXWLQJ&\SKHU &RUGLV-RKQVRQDQG-RKQVRQ0LDPL/DNHV )ORULGD VWHQWVDQGSDFOLWD[HOHOXWLQJ7D[XV %RVWRQ6FLHQWL¿FFRUS1DWLFN Massachusetts) stents in diabetic patients. Methods: We randomized 153 diabetic patients with coronary artery disease to Cypher (n=76) or Taxus (n=77) stent implantation. The primary endpoint was 8-month angiographic in-stent late lumen loss. Results: The primary endpoint of angiographic in-stent late lumen loss was UHGXFHG LQ WKH &\SKHU JURXS DV FRPSDUHG WR WKH 7D[XV JURXS YHUVXV p=0.025). Angiographic in-segment restenosis at 8-month follow-up, a secondary endpoint, was present in 16 patients (Cypher: n=6, Taxus: n=10; p=0.24). Target lesion revascularization was performed in 5 (6.5%) and 9 (11.8%) in the Cypher and Taxus groups, respectively (p=0.25). 0DMRUDGYHUVHFOLQLFDOHYHQWV FDUGLDFGHDWKP\RFDUGLDOLQIDUFWLRQGH¿QLWH stent thrombosis or target lesion revascularization) were observed in 17 patients (Cypher: n=6, Taxus: n=11; p=0.19). Conclusion: $QJLRJUDSKLF LQVWHQW ODWH OXPHQ ORVV LV VLJQL¿FDQWO\ UHGXFHG in patients with diabetes by use of the sirolimus-eluting Cypher stent as compared to the paclitaxel-eluting Taxus stent. TCT-415 Leaders - A Randomized Comparison Of A Biolimus-A9 Eluting Stent With A Sirolimus-eluting Stent For Percutaneous Coronary Intervention. 12 Months Results Patrick W Serruys1, Stephan Windecker2, Pawel Buszman3, Axel Linke4, Thomas Ischinger5, Volker Klauss6, Franz Eberli7, William Wijns8, Marie-Claude Morice9, Carlo Di Mario10 1 University Medical Center Rotterdam Erasmus, Rotterdam, Netherlands 2Inselspital, Bern, Switzerland 3Medical University of Silesia, Katowice, Poland 4Universität Leipzig, Herzzentrum, Leipzig, Germany 5Städtisches Klinikum, München, Germany 6Klinikum der Universität München, München, Germany 7Stadtspital Triemli, Zürich, Switzerland 8Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium 9L’Institut Cardiovasculaire Paris Sud, Massy, France 10Royal Brompton Hospital, London, United Kingdom Background: Drug-eluting stents (DES) effectively reduce the rate of TLR compared with bare metal stents (BMS). Although rates of death or MI are similar, there is concern of an increased incidence of very late stent thrombosis (ST) associated with 1st generation DES potentially related to the durable polymer. The biolimus-A9 eluting stent platform (BioMatrix Flex; BES) releases biolimus-A9, a sirolimus analogue, from a biodegradable polymer, polylactic acid (PLA), which is degraded into carbondioxide and water during a period of 6-9 months. The purpose of the present study is to FRPSDUHWKHVDIHW\DQGHI¿FDF\RI%(6ZLWKDQHVWDEOLVKHGVWHQWSODWIRUP releasing sirolimus from a durable polymer (Cypher SELECT;SES) in a large scale, non-inferiority trial. Methods: The trial is a prospective, multi-center, randomized, assessor-blind, QRQLQIHULRULW\DOOFRPHUUHDOZRUOG´SDWLHQWSRSXODWLRQWULDOFRQGXFWHGDW European interventional cardiology sites without limitation with respect to lesion length, number of treated lesions or vessels as well as clinical indication (chronic stable angina vs. acute coronary syndromes). The primary endpoint RI WKH WULDO LV D FRPSRVLWH RI FDUGLDF GHDWK 0, RU MXVWL¿HG WDUJHW YHVVHO
The American Journal of Cardiology® |
October 12-17, 2008
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TCT-417
UHYDVFXODUL]DWLRQ 795 ZLWKLQ PRQWKV%DVHGRQDQRQLQIHULRULW\PDUJLQ of 4% between BES and SES and a one-sided type I error of 0.05, a study SRSXODWLRQRISDWLHQWVZLOO\LHOG! SRZHUWRGHWHFWQRQLQIHULRULW\ 7KHSULQFLSDOHQGSRLQWRIWKHSUHVSHFL¿HGDQJLRJUDSKLFVXEJURXSLVLQVWHQW percent diameter stenosis at 9 months. Based on a non-inferiority margin of 5%, an average number of 1.5 lesions per patient and a one-sided type I error of 0.05, a sample of 425 patients will yield greater than 90% power to detect non-inferiority. Secondary endpoints include death, cardiac death, MI, ST DFFRUGLQJWRWKH$5&FULWHULDMXVWL¿HGDQGQRQMXVWL¿HG7/5DQG795$OO patients are followed up to 5 years. Results: A total of 1708 patients underwent PCI of 2782 lesions. The last 12 month follow-up visits were performed in May 2008 and data analysis for the PRQWKDQGPRQWKIROORZXSDUHWDNLQJSODFH Conclusion: The 12 month follow-up data of the study will be presented at the time of the meeting
Impact of Intravascular Ultrasound to Guide Drug Eluting Stent Implantation Decreasing Long Term Clinical Events Costantino O Costantini, Sergio G Tarbine, Marcelo F Santos, Marcos Bubna, Marco A Medeiros, Marcos Barbosa, Edna Duarte, Marco A Denk, Robson Sipraki, Costantino R Costantini Hospital Cardiologico Costantini, Curitiba, Brazil Introduction: ,QWUDYDVFXODU 8OWUDVRXQG ,986 E\ UHDFKLQJ JUHDWHU ¿QDO stent minimal luminal area decrease chances of target lesion revascularization. 7KHLPSRUWDQFHRI,986WRJXLGHGUXJHOXWLQJVWHQWV '(6 LPSODQWDWLRQWR UHGXFHFOLQLFDOHYHQWVLVQRWZHOONQRZQ Methods: A total of 1350 consecutive pts with CAD with PCI indication were treated with DES implantation. Pts with at least 6 months clinical FU were FRPSDUHGDFFRUGLQJWRWKHXVHRI,986WRJXLGH'(6LPSODQWDWLRQ ,986 1 RUQRW 1,9861 -03ZDVXVHGIRUVWDWLVWLFDODQDO\VLV$ SYDOXH ZDVFRQVLGHUHGVLJQL¿FDQWIRUJURXSVFRPSDULVRQV$ORJLVWLF regression analysis was conducted to identify predictors of target vessel failure (TVF)GH¿QHGDVWKHSUHVHQFHRIGHDWKP\RFDUGLDOLQIDUFWLRQVWHQW thrombosis or target vessel revascularization. Results:0HDQDJHZDVIRUERWKJURXSV'LDEHWLFZHUHLQERWK,986 DQG 1,986 JURXSV ,986 SWV ZHUH PRUH FRPSOH[ WKDQ 1,986 09' 46%vs54% p=0.01; Bifurcation treated 51%vs44% p=0.03; #of stents/# of lesions 1,2vs 1,14 p=0.05). Mean follow up was 30 months in both groups. $VVKRZQLQ.0FXUYHV,986SWVKDGORZHU79)UDWHVFRPSDUHGWR 1,986SWVS 7KLVGLIIHUHQFHZDVPDLQO\SURGXFHGE\ORZHU VWHQWWKURPERVLVUDWHVLQ,986YV1,986 YVS /RJLVWLF UHJUHVVLRQ DQDO\VLV VKRZHG 09' S DQG 121 ,986 JXLGDQFH S DVLQGHSHQGHQWSUHGLFWRUVRI79)
TCT-416 Changes in Plasma Composition Common to Diabetes Mellitus are ,QVXI¿FLHQWWR$OWHUP725¶V5ROHLQ9DVFXODU6PRRWK0XVFOH&HOO Proliferation T. Cooper Woods, Daniel Lightell, Jr., Paul McMullan, Stephanie C. Moss Ochsner Clinic Foundation, New Orleans, LA
Conclusion: This retrospective analysis on non selected patients showed WKDW ,986 WR JXLGH '(6 LPSODQWDWLRQ VLJQL¿FDQWO\ GHFUHDVHG WKH FKDQFH RI 79) 7KLV GLIIHUHQFH ZDV PDLQO\ GXH WR UHGXFHG VWHQW WKURPERVLV UDWHV LQ ,986 JXLGHG SDWLHQWV 7KLV EHQH¿W FHUWDLQO\ UHOLHV RQ D PRUH DGHTXDWH stent expansion and strut apposition against vessel wall when guiding DES LPSODQWDWLRQZLWK,986 TCT-418 Pre-clinical Evaluation of the Elixir Myolimus-Eluting Stent System with a Durable Polymer in Porcine Coronary Model Guy Leclerc1, Louis-Georges Guy2, Jean-Martin Lapointe2, Martin /DÀDPPH2, Capucine Lapointe-Corriveau2, Pierre Helie3, Lynn Meredith4, John Yan4,ULQD$VWD¿HYD4, Vinayak Bhat4 1 AccelLab Inc., Boisbriand, QC, Canada 2AccelLab Inc., Montreal, QC, Canada 3University of Montreal, Faculty of Veterinary Medicine, Montreal, QC, Canada 4Elixir Medical Corporation, Sunnyvale, CA
Conclusion: The changes in plasma composition common to diabetics are not VXI¿FLHQWWRDOWHUWKHUROHRIP725LQWKHSUROLIHUDWLRQRI960&VVXJJHVWLQJ cellular aspects of DM such as insulin resistance may play a critical role in the LQFUHDVHGULVNRILQVWHQWUHVWHQRVLVVHHQLQGLDEHWLFV
The American Journal of Cardiology®
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October 12-17, 2008
Background: The Elixir Myolimus Eluting Stent with durable polymer is a novel DES that combines a cobalt chromium alloy stent coated with Myolimus and a thin single-layer methacrylate polymer. Myolimus is macrocyclic lactone mTOR inhibitor similar to rapamycin (sirolimus) with potent antiproliferative properties. The objective of this study was to evaluate safety and HI¿FDF\RIWKH0\ROLPXV(OXWLQJ6WHQWZLWKGXUDEOHSRO\PHU Methods: A dose ranging study with the Myolimus-Eluting Stent with
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Background 'LDEHWHV0HOOLWXV '0 LVDVVRFLDWHGZLWKDQLQFUHDVHGULVN of in-stent restenosis with the rapamycin (sirolimus) eluting stent, which EORFNVYDVFXODUVPRRWKPXVFOHFHOO 960& SUROLIHUDWLRQWKURXJKLQKLELWLRQ of the mammalian target of rapamycin (mTOR). A component of DM is the alteration of the plasma concentrations of multiple factors (e.g. glucose and LQVXOLQ FDSDEOH RI SURPRWLQJ 960& SUROLIHUDWLRQ DQG FRQWULEXWLQJ WR DQ LQFUHDVHGULVNRIUHVWHQRVLV Methods: In order to examine whether the changes in plasma composition FRPPRQ WR GLDEHWLFV DOWHU WKH UROH RI P725 LQ 960& SUROLIHUDWLRQ ZH PHDVXUHG WKH DELOLW\ RI LQKLELWLRQ RI P725 ZLWK UDSDP\FLQ WR EORFN proliferation of human coronary artery smooth muscle cells (CASMC) isolated IURP QRQGLDEHWLFV Q XQGHU FRQGLWLRQV PLPLFNLQJ WKRVH FRPPRQ WR diabetics, including exposure to high glucose and stimulation with insulin. To IXUWKHUWHVWWKHDELOLW\RISODVPDFRPSRQHQWVWRDIIHFWP725¶VUROHLQ960& proliferation, we measured the ability of rapamycin to inhibit the proliferation of CASMCs in response to stimulation with serum collected from diabetics (n = 14) and non-diabetics (n= 16). Results: Inhibition of mTOR with rapamycin was similarly effective in inhibiting serum-stimulated CASMC proliferation in the presence of high (25mM) and low (5.5mM) glucose. Rapamycin was equally effective at inhibiting proliferation of CASMCs stimulated with insulin. Proliferation of CASMCs stimulated by serum from diabetic or non-diabetic donors was equally sensitive to rapamycin (10 nM) treatment (Figure).
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durable polymer was conducted in porcine coronary artery model with the balloon to artery (B/A) ratio of 1.3:1 over a period of 28 days with the drug dose ranging from 40 mcg to 180 mcg. The Cypher® stent was used as a control. Histo-morphometric and histo-pathological analysis were employed WR HYDOXDWH HI¿FDF\ DQG VDIHW\ RI WKH VWHQW V\VWHPV 'UXJ HOXWLRQ SUR¿OHV DQG GUXJ WLVVXH FRQFHQWUDWLRQV ZHUH GHWHUPLQHG E\ SKDUPDFRNLQHWLF 3. analysis . An overlapping stent 28 day safety study and a 90 day safety study were conducted with 120 mcg Myolimus dose. In addition, a high dose safety study using 360 mcg Myolimus was performed. Results:$OOVWHQWVZHUH GHOLYHUHG HI¿FLHQWO\ ZLWKRXW FRPSOLFDWLRQV 7KHUH were no adverse events in the course of the 28 days with any of the treated animals. The dose ranging study with the Myolimus-Eluting Stent with durable polymer demonstrated excellent histomorphometric and histopathological results comparable to the Cypher® stent. Myolimus-eluting stents GHPRQVWUDWHGLQYLYRVWHQWEDVHGHOXWLRQSUR¿OHVVLPLODUWR&\SKHUVWHQWV and the tissue concentration levels correlated with the dose escalation for the study groups. The safety studies demonstrated similar histomorphometric and histopathological results for all evaluated Myolimus-eluting stents at 28 days and 90 days similar to the Cypher® stent comparators. Data from the preclinical studies will be presented at this meeting. Conclusion: The preclinical evaluation of the Myolimus-Eluting Stent System with durable polymer demonstrated safety and similar effectiveness for all tested doses of Myolimus equivalent to Cypher® stents. These studies allowed for the selection of the lowest dose of 40 mcg for the First-in-Man clinical evaluation. TCT-419 Two-Year Clinical Outcome After Abciximab-Coated Stent Implantation in Patients with Coronary Artery Disease
E L E C T RO N I C A B S T R AC T S
Young Joon Hong1, Myung Ho Jeong1, Weon Kim2, Jum Suk Ko1, Min Goo Lee1, Won Yu Kang1, Shin Eun Lee1, Soo Hyun Kim1, Doo Sun Sim1, Keun-Ho Park1, Nam Sik Yoon1, Hyun-Ju Yun1, Kye Hun Kim1, Hyung Wook Park1, Ju Han Kim1, Youngkeun Ahn1, Jeong Gwan Cho1, Jong Chun Park1, Sun Jung Song3, Dong Lyun Cho3, Jung Chaee Kang1 1 Chonnam National University Hospital, Gwangju, Republic of Korea 2 Gwangju Veterans Hospital, Gwangju, Republic of Korea 3Chonnam National University, Gwangju, Republic of Korea Background: Recently we have demonstrated that abciximab (ReoPro®)coated stent has inhibitory effect on coronary restenosis. Objectives: 7KH DLP RI WKLV VWXG\ ZDV WR LQYHVWLJDWH WKH EHQH¿FLDO HIIHFWV RI abciximab-coated stent on two-year clinical outcome after stent implantation. Methods: We performed a prospective, randomized trial to compare the effects of abciximab-coated stent, which was implanted for 95 patients, with those of control stent, which was implanted for 93 patients for de novo coronary lesions. We evaluated the major adverse cardiac events (MACE; cardiac death, non-fatal myocardial infarction, and target vessel revascularization) at two-year follow-up. Results: All abciximab-coated and control stents were deployed successfully. Two-year follow-up was completed in 82 patients (86%) in abciximab-coated stent group and in 82 patients (88%) in control stent group. Although there ZHUHQRVLJQL¿FDQWGLIIHUHQFHVLQWKHLQFLGHQFHVRIFDUGLDFGHDWK YV p=0.3) and target vessel revascularization (16% vs. 21%, p=0.4) between both groups, there was a trend of lower incidences of nonfatal myocardial infarction (0% vs. 2.3%, p=0.16) and total MACE (16% vs. 24%, p=0.19) in abciximabcoated stent group compared with control stent group at two-year follow-up. Moreover, stent thrombosis did not occur in abciximab-coated stent group at two-year follow-up. Intravascular ultrasound analysis showed that larger OXPHQDUHDZDVODUJHU PP2YVPP2, p<0.001) and there ZDVDWUHQGRIVPDOOHUQHRLQWLPDODUHD PP2YVPP2, p=0.2) in abciximab-coated stent group compared with control stent group. Conclusion: Although abciximab-coated stent did not improve target vessel revascularization rate, it tended to inhibit neointimal hyperplasia and lower total MACE without occurrence of cardiac death, myocardial infarction, and stent thrombosis at two-year follow-up after stent implantation.
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TCT-420 Two-Year Clinical Outcome After Carvedilol-Loaded Stent Implantation in Patients with Coronary Artery Disease Young Joon Hong1, Myung Ho Jeong1, Weon Kim2, Jum Suk Ko1, Min Goo Lee1, Won Yu Kang1, Shin Eun Lee1, Soo Hyun Kim1, Doo Sun Sim1, Keun-Ho Park1, Nam Sik Yoon1, Hyun-Ju Yun1, Kye Hun Kim1, Hyung Wook Park1, Ju Han Kim1, Youngkeun Ahn1, Jeong Gwan Cho1, Jong Chun Park1, Jung Chaee Kang1 1 Chonnam National University Hospital, Gwangju, Republic of Korea 2 Gwangju Veterans Hospital, Gwangju, Republic of Korea Background: 7KH ORQJWHUP FOLQLFDO HI¿FDF\ RI LQWUDFRURQDU\ VWHQWLQJ LV limited by restenosis. Carvedilol is an antioxidant that inhibits smooth muscle cell proliferation and migration. Our hypothesis is that delivery of carvedilol by the stent can prevent neointimal hyperplasia and improve long-term clinical outcome. Objectives: 7KHDLPRIWKLVVWXG\ZDVWRLQYHVWLJDWHWKHEHQH¿FLDOHIIHFWVRI carvedilol-loaded stent on two-year clinical outcome after stent implantation. Methods: We performed a prospective, randomized trial to compare the effects of carvedilol stent, which was implanted for 20 patients, with those of control stent, which was implanted for 21 patients for de novo coronary lesions. Carvedilol was loaded onto 3.0×15mm BiodivYsio® drug delivery stents (Biocompatibles Ltd, Farnham, UK) in concentrations of 5mg/ml, which was prepared by dissolving carvedilol powder in methanol. We evaluated the major adverse cardiac events (MACE; cardiac death, non-fatal myocardial infarction, and target vessel revascularization) at two-year follow-up. Results: All carvedilol and control stents were deployed successfully. Twoyear follow-up was completed in 19 patients (95%) in carvedilol-loaded stent JURXSDQGLQSDWLHQWV LQFRQWUROVWHQWJURXS7KHUHZHUHQRVLJQL¿FDQW differences in the incidences of cardiac death (0% in both groups), nonfatal myocardial infarction (0% in both groups), and target vessel revascularization (15.8% vs. 20.0%, p=0.7) between both groups at two-year follow-up after stent implantation. However, intravascular ultrasound analysis showed that WKHUHZDVDWUHQGRIODUJHUOXPHQDUHD PP2YVPP2, S DQG VPDOOHU QHRLQWLPDO DUHD PP2 YV PP2, p=0.18) in carvedilol-loaded stent group compared with control stent group. Stent thrombosis did not occur in both groups at two-year follow-up. Conclusion: Although carvedilol-loaded stent did not improve two-year target vessel revascularization rate, it tended to inhibit neointimal hyperplasia without occurrence of cardiac death, myocardial infarction, and stent thrombosis. TCT-421 Evaluation of a Elixir Novolimus-Eluting Coronary Stent System with Durable and Bioabsorbable Polymer coatings in Porcine Coronary Model Guy Leclerc1, Louis-Georges Guy2, Jean-Martin Lapointe2, Martin /DÀDPPH2, Capucine Lapointe-Corriveau2, Pierre Helie3, Lynn Meredith4, John Yan4,ULQD$VWD¿HYD4, Vinayak Bhat4 1 AccelLab, Boisbriand, QC, Canada 2AccelLab, Montreal, QC, Canada 3 University of Montreal, Faculty of Veterinary Medicine, Montreal, QC, Canada 4Elixir Medical Corporation, Sunnyvale, CA Background: The Elixir Novolimus-Eluting DES (NDES) combines a cobalt chromium alloy stent coated with Novolimus and a thin single-layer durable methacrylate polymer or a bioabsorbable polyester-based polymer. Novolimus is a macrocyclic lactone mTOR inhibitor with antiproliferative properties similar to rapamycin (sirolimus). The total drug dose on the NDES is 85 mcg, as compared to 150 mcg of sirolimus dose on Cypher® stent (Cordis Corp). The objective of this study was to evaluate safety, effectiveness and SKDUPDFRNLQHWLFV 3. RIWKH1'(6ZLWKERWKSRO\PHUFRDWLQJV Methods: NDES with both polymer coatings were implanted in coronary arteries of domestic swine with the balloon to artery (B/A) ratio of 1.3:1 over a period of 28 days. The Cypher® stents were used as a control. Histo-
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morphometric and histo-pathological analysis were employed to evaluate HI¿FDF\DQGVDIHW\RIWKHVWHQWV\VWHPV'UXJHOXWLRQSUR¿OHVDQGGUXJWLVVXH concentrations were determined by PK analysis. Results: $OO VWHQWV ZHUH GHOLYHUHG HI¿FLHQWO\ ZLWKRXW FRPSOLFDWLRQV There were no adverse events in the course of the 28 days with any of the treated animals. NDES with durable and bioabsorbable polymer coatings demonstrated excellent histomorphometric and histo-pathological results comparable to Cypher® and are presented in Table 1 below: Histomorphometric / Histopathologic Analysis
Novolimus-Eluting Stent with Durable Polymer Coating
Novolimus-Eluting Stent Cypher® with Bioabsorbable DES Polymer coating Control
% Area Stenosis
Intimal Area (mm2)
Injury Score
,QÀDPPDWLRQ6FRUH
Endothelialization Score
6(6YV3(6 YVS RUWDUJHWYHVVHOUHYDVFXODUL]DWLRQ 795 (SES vs PES; 4.4 vs 4.6%, p=0.79) at 9 months in the diabetic AMI population. In the non-diabetic AMI population, however, SES was superior to PES in WHUPVRI795 YVS ,QRWKHUZRUGVWKHSUHVHQFHRIGLDEHWHV VLJQL¿FDQWO\LQFUHDVHGWKHULVNRI795RQO\LQWKH6(6JURXS WR p=0.003), but not in the PES group (4.3 to 4.6%, p=0.79). (Figure)
Fibrin Score
Adventitial Fibrosis Score
&DOFL¿FDWLRQ6FRUH
Conclusion:,QGLDEHWLF$0,SDWLHQWVWKHUHZDVQRVLJQL¿FDQWGLIIHUHQFHEHWZHHQ 6(6DQG3(6LQWHUPVRI0$&(DQG795ZKLFKZDVLQFRQWUDVWWRWKHUHVXOWRI QRQGLDEHWLF$0,SDWLHQWVZKRVKRZHGOHVV795ZLWK6(6WKDQ3(6 TCT-424
The PK testing showed that 60% of drug is released for the NDES with durable polymer, and 90% with bioabsorbable polymer at 28 days with residual drug tissue concentrations maintained over the same period. Conclusion: Novolimus-Eluting Stents with durable and bioabsorbable polymer coatings demonstrated safety and effectiveness as compared with Cypher® stent system in preclinical evaluation, and will be further evaluated in clinical setting.
Arterial Responses Following Drug-Eluting Stent Implantation in an Atherosclerotic Rabbit Iliac Model Robert J Melder1, Gaku Kakazawa2, Sean Pruitt1, Frank D Kolodgie2, Renu Virmani2, Josiah N Wilcox1 1 Medtronic Cardiovascular, Santa Rosa, CA; 2CVPath Institute, Inc., Gaithersburg, MD
TCT-422 WITHDRAWN TCT-423 Differrent Outcomes between Sirolimus-Eluting versus PaclitaxelEluting Stents in Patients with Acute Myocardial Infarction According to the Presence of Diabetes Mellitus : Results of KAMIR(Korea Acute Myocardial Infarction Registry) Subgroup Youngjin Cho1, Han-Mo Yang1, Hee-Suk Min1, Woo-Young Chung2, Kyung Woo Park1, Jung-Won Suh3, In-Ho Chae3, Myung-Ho Jeong4, Myeong-Chan Cho5, Young-Jo Kim6, Dong-Ju Choi3, Hyo-Soo Kim1 1 Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea 2Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical center, Seoul, Republic of Korea 3 Cardiovascular Center, Seoul National University Bundang Hospital, Seongnam, Republic of Korea 4The Heart Center of Chonnam National University Hospital, Gwangju, Republic of Korea 5Department of Internal Medicine, Chungbuk National University, Cheongju, Republic of Korea 6Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital, Daegu, Republic of Korea Introduction: Some previous studies have reported favorable outcome of paclitaxle-eluting(PES) over sirolimus-eluting stents(SES) in patients with diabetes. These observations have not studied in patients with acute myocardial infarction (AMI). Methods: In Korea AMI Registry (KAMIR), 40 centers in Korea enrolled 7,100 patients with STEMI from Nov 2005 to Dec 2007. We analyzed the clinical outcomes of 933 diabetic patients in the KAMIR treated with either SES(n=565), or PES(n=368), and compared them with the non-diabetic population. Results: :LWKPHGLDQIROORZXSRIGD\VWKHUHZDVQRVLJQL¿FDQWGLIIHUHQFH between SES and PES in the rate of major adverse cardiac event (MACE)
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E L E C T RO N I C A B S T R AC T S
Background: Drug eluting stents (DES) provide improved therapeutic responses but may also induce delayed arterial healing in man. A relevant animal model for predicting the vascular response to DES in man is needed for understanding '(6VDIHW\DQGHI¿FDF\7RWKLVHQGDK\SHUFKROHVWHUROHPLFUDEELWPRGHOZDV employed to compare DES responses in an atherosclerotic artery. Methods: +\SHUFKROHVWHUROHPLF FKROHVWHURO GLHW IRU ZHHNV IROORZHG E\IRUZHHNVEHIRUHVWHQWLPSODQWDWLRQ 1HZ=HDODQG:KLWHUDEELWV (n=21) received bilateral stents implanted in iliac arteries. Animals were randomized to bare metal stent (Driver; Medtronic, Minneapolis, MN), zotarolimus- (Endeavor; Medtronic), sirolimus- (Cypher; Cordis, Miami /DNHV)/ DQGHYHUROLPXV ;LHQFH9 $EERWW/DERUDWRULHV$EERWW3DUN ,OOLQRLV HOXWLQJVWHQWV6WHQWVZHUHKDUYHVWHGZHHNVDIWHULPSODQWDWLRQDQG morphometric/pathologic analysis performed. Results: %ORRGFKROHVWHUROOHYHOVSHDNHGDWZHHNVRIWKHFKROHVWHUROGLHW which ranged from 1400-2000mg/dL, followed by ideal range of 500 to 800mg/ G/DW ZHHNV VWHQWLPSODQWDWLRQ DQGZHUHVLPLODUDPRQJJURXSV((/DUHD (7.59+1.12, 7.64+0.87, 7.05+0.56, 6.98+0.72 mm2), and stent area (5.68+0.82, 5.88+0.71, 5.58+0.36, 5.58+0.56 mm2 ZHUHFRPSDUDEOHLQDOOJURXSV S! (QGHDYRU'ULYHU&\SKHUDQG;LHQFHUHVSHFWLYHO\ 1HRLQWLPDODUHD PP2) ZDVVXSSUHVVHGLQDOO'(6UHODWLYHWRDEDUHPHWDOVWHQW IRU (QGHDYRU &\SKHU DQG ;LHQFH UHVSHFWLYHO\ IRU 'ULYHU S 1XPEHUV RI DGKHUHQW OXPLQDO LQÀDPPDWRU\ FHOOV ZHUH JUHDWHU LQ ;LHQFH DQG &\SKHU DV FRPSDUHG WR 'ULYHU DQG (QGHDYRU 3 /LNHZLVH )LEULQ GHSRVLWLRQDQGWKHSUHYDOHQFHRIXQFRYHUHGVWUXWVZHUHJUHDWHULQ;LHQFHDQG Cypher as compared to Driver and Endeavor. Conclusion: An atherosclerotic rabbit model mimics neointimal formation in various DES and BMS similar to man with greater number of uncovered stent VWUXWVDQGOXPLQDOLQÀDPPDWLRQVHHQLQ&\SKHUDQG;LHQFHDVFRPSDUHGWR Endeavor and Driver. The atherosclerotic model may be a more appropriate DQGGLIIHUHQWLDWLQJPRGHOIRUWKHDVVHVVPHQWRI'(6HI¿FDF\DQGVDIHW\WKDQ normal artery models.
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TCT-425 WITHDRAWN TCT-426 Long-term (> 20 months) Serial Angiographic and Intravascular Ultrasound Analysis of Sirolimus-eluting Stents: Is There Any Late Catch-up? Daniel Chamié, J. Fábio Almiro Silva, Alexandre Abizaid, Fausto Feres, Andréa S. Abizaid, Ana Cristina Seixas, Luiz Fernando Tanajura, Aurea Chaves, Marinella Centemero, J. Ribamar Costa, Jr., Ricardo Costa, Luiz Alberto P. Mattos, Rodolfo Staico, Amanda G.M.R. Sousa, J. Eduardo Sousa Institute Dante Pazzanese of Cardiology, Sao Paulo, Brazil
E L E C T RO N I C A B S T R AC T S
Background: &RQFHUQV UHJDUGLQJ WKH ORQJWHUP HI¿FDF\ RI GUXJHOXWLQJ stents (DES) have recently been raised, with late intimal hyperplasia (IH) JURZWK ODWH ³FDWFKXS´ SKHQRPHQRQ REVHUYHG LQ UHFHQW VWXGLHV ,I WKLV phenomenon has a class effect and can be attributed to different DES has yet to be demonstrated. Objectives: 7RHYDOXDWHWKHHI¿FDF\RIWKH6LUROLPXVHOXWLQJ&\SKHU® stent, E\PHDQVRIVHULDODQJLRJUDSK\DQGLQWUDYDVFXODUXOWUDVRXQG ,986 RQ,+ VXSSUHVVLRQDWORQJWHUPIROORZXS !PRQWKV Methods: SDWLHQWV SWV LQFOXGHGLQ),0DQG5$9(/VWXGLHVSHUIRUPHG in single center, that had stable coronary syndromes and a single, de novo lesion in a native coronary artery of 2.5 to 3.5 mm in diameter and that could be covered by an 18-mm stent were included in this current analysis. $QJLRJUDSKLFDQG,986GDWDZHUHREWDLQHGLPPHGLDWHO\SRVWSURFHGXUHDQG DWDPHDQWLPHRI PRQWKVDQGPRQWKV7KHSULPDU\ HQGSRLQWRIWKLVDQDO\VLVZDVWKHORQJWHUPHI¿FDF\RIWKH&\SKHU® stent as assessed by in-stent late lumen loss (by QCA) and % of IH obstruction (by ,986 UHVSHFWLYHO\$OODQJLRJUDSK\DQG,986DQDO\VLVZHUHSHUIRUPHGE\ two experienced operators blinded to the time frame each angiography and ,986UXQEHORQJHG Results: 0HDQFRKRUWDJHZDV \HDUVZLWKRIPDOHVDQG RIGLDEHWLFV%DVHOLQHUHIHUHQFHYHVVHOGLDPHWHUZDV PPDQGPHDQ OHVLRQOHQJWKZDVPP$QJLRJUDSKLFLQVWHQWODWHOXPHQORVVDQG ,986RI,+REVWUXFWLRQIRUDOOWLPHIUDPHVDUHSUHVHQWHGLQWKH¿JXUH
Conclusion: This single-center evaluation demonstrated that the Sirolimuseluting Cypher® stent is effective in the IH suppression, with no evidence of ODWH³FDWFKXS´SKHQRPHQRQXSWRPRQWKIROORZXS TCT-427 Predictors of Restenosis of Side-Branch After Implantation of Two Sirolimus-eluting Stents for Bifurcation Lesions. -Importance of Lesion LocationKazushige Kadota, Kazuaki Mitsudo, Tsuyoshi Goto, Satoki Fujii, Hiroyuki Yamamoto, Harumi Kato, Yasushi Fuku, Shingo Hosoki, Hiroyuki Tanaka, Seiji Habara, Daiji Hasegawa, Masao Imai, Suguru Otsuru Kurashiki Central Hospital, Kurashiki, Japan Background: PCI with two stent implantation for bifurcation lesion is necessary in some situations although the restenosis of side branch is still high in drug-eluting stent era. Thus, to clarify the predictors of side-branch restenosis after two stent strategy is important. In this study, we evaluated
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the predictors of side-branch restenosis after two-stent implantation with Sirolimus-eluting stent. Methods: From Nov. 2003 to Nov. 2006, PCI with two stent strategy using Sirolimus-eluting stent (SES) was performed in 140 patients. Of these, 109 patients with 109 lesions underwent follow-up angiography at 6-8 month after stenting. &OLQLFDO DJH VH[ FRURQDU\ ULVN IDFWRUV DQJLRJUDSKLF UHIHUHQFH GLDPHWHU minimal luminal diameter, percent luminal diameter stenosis, bifurcation type, bifurcation site) and procedure characteristics (stenting strategy; Culottes VWHQWLQJSURYLVLRQDO7VWHQWLQJPRGL¿HG7VWHQWLQJ ZHUHHYDOXDWHG Results: Two stent implantation with SES was performed at LMT (28 lesions), /$' OHVLRQV /&; OHVLRQV DQG5&$ OHVLRQV 7RWDOUHVWHQRVLVUDWH of main and side branch were 12.8% and 24.5% respectively. Restenosis rate of VLGHEUDQFKZDV DQGDW/07/$'/&;DQG5&$ ELIXUFDWLRQOHVLRQVUHVSHFWLYHO\7KHUHZDVQRVLJQL¿FDQWGLIIHUHQFHRIPDLQ branch restenosis rate among four bifurcation sites. By multivariate analysis, independent predictors of side branch restenosis was LMT bifurcation (OR &, S WR/$'ELIXUFDWLRQ /&;ELIXUFDWLRQ 25 8.37 95% CI 1.7-41.2 p=0.009 to LAD bifurcation), and post diameter stenosis of side branch (OR 1.08 95% CI 1.08- 1.15 p=0.017),. Conclusion: The lesion location of bifurcation site was an important factor of side-branch restenosis after two stent implantation using SES. Post procedural enough dilatation could be an important factor to obtain good prognosis of the side branch after two stent implantation with SES TCT-428 The e-Select Registry: Final Results of Early (30 days) Followup of 15000 Patients Treated with the Cypher-Select Stent in Contemporary Clinical Practice Philip Urban1, Alex Abizaid2, Adrian Banning3, Antonio Bartorelli4, Viktor Dzavik5, Stephen G Ellis6, Run-Lin Gao7, David Holmes8, M. H. Jeong9, Victor Legrand10, Franz-Josef Neumann11, Christian Spaulding12, Stephen Worthley13, Stephane Carlier14 1 La Tour Hospital, Geneva, Switzerland 2Dante Pazzanese, Sao Paulo, Brazil 3John Radcliffe Hospital, Oxford, United Kingdom 4Centro Cardiologico Monzino University of Milan, Milan, Italy 5University Health Network, Toronto General Hospital, Toronto, ON, Canada 6 Cleveland Clinic, Cleveland, OH; 7Cardiovascular Institute and Fu Wai Hospital, Beijing, China 8Mayo Clinic, Rochester, MN; 9The Heart Center of Chonnam National University Hospital, Gwangju, Republic of Korea 10CHU Sart-Tilman, Liège, Belgium 11Herz Zentrum Bad Krozingen, Bad Krozingen, Germany 12Hopital Cochin, Paris, France 13 Royal Adelaide Hospital, Adelaide, Australia 14Cordis, Waterloo, Belgium Background: Much has changed in the world of drug eluting stents (DES) VLQFH WKH ¿UVW UHVXOWV RI WKH &\SKHU VWHQW ZHUH UHSRUWHG \HDUV DJR LQ WKH 5$9(/WULDO(QVXULQJDSSURSULDWHSDWLHQWVHOHFWLRQDQGEHWWHUFRPSOLDQFH with anti-platelet medication have both been incorporated into clinical practice, but the impact of this more cautious approach has not been TXDQWL¿HG6HYHUDOTXHVWLRQVVWLOOUHPDLQXQDQVZHUHGLQURXWLQHSUDFWLFHVXFK as the current incidence of stent thrombosis (ST) and of bleeding following successful procedures, the impact of co-morbid conditions, and the causes and consequences of unplanned interruption in anti-platelet medication. Methods: Between 2006 and 2008, we prospectively enrolled 15,266 patients from 321 hospitals in 56 countries after implantation of one or several Cypher Select stents. Monitoring of 20% randomly selected enrolled patients is ongoing. All adverse events are adjudicated by an independent CEC. The main outcome measure of the e-Select registry is the incidence of ST at 3 \HDUVIROORZXS+RZHYHUZHZLOOEHUHDG\WRUHSRUWIRUWKH¿UVWWLPHDW7&7 08 the 30 days results for the entire cohort of: 1) The patient demographics, lesion characteristics and procedure parameters, analysed both for on and off-label indications. These will be compared to the data of the previous e-Cypher registry (2002-2004); 2) The incidence of death, myocardial infarction, repeat revascularization, ST
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and bleeding; 3) The incidence of co-morbid conditions, analysed using the Charlson index. The impact of this score on the incidence of adverse events will be evaluated; 4) The compliance with the prescribed anti-platelet regimen and its relationship with bleeding and ST events. Conclusion: The early results from this contemporary registry will shed light on the current use of DES world-wide and will help identify possible changes in practice since the early years and understand their consequences. They will also DOORZIRUWKH¿UVWWLPHWRDQDO\VHWKHLPSDFWRIVHYHUDOHOHPHQWVWKDWDUHVSHFL¿F to routine clinical use, as opposed to those that occur in randomized trials.
from the National Strategic Tracing Service. Results: Patients were followed up until 31st of April 2008. Mean follow up was 26.5 months (6-60 months). The mean stent length was 70.6mm (51135mm) and the average number of stents per vessel was 2.7 (2-5 stents). Acute complications included one case of acute stent thrombosis which was treated successfully, one case of aortic root dissection managed conservatively, and one case of retroperitoneal haemorrhage which required blood transfusion. 7KHUDWHRIQRQ4ZDYHP\RFDUGLDOLQIDUFWLRQ &.0%!WLPHVQRUPDO ZDV 8%. During follow up, the rate of TLR was 6%. Five patients died, 4 of them due to documented chronic non-cardiac conditions. One death was attributed to possible late stent thrombosis at18 months (patient died suddenly 2 days SRVWNHORLGUHSDLU 7ZRSDWLHQWVKDGGH¿QLWHODWHVWHQWWKURPERVLVDWDQG months, and successfully treated.
TCT-429 What Is The Risk Of Cardiac Complications Following Noncardiac Surgery In Patients Having Drug Eluting Stenting More Than Six Month?
Death at Follow-up Death Time from Procedure
Abid Assali, Hana Vaknin Assa, Itsik Ben Dor, Eli Lev, Tamir Ben Tal, Shmuel Fuches, Alexander Battler, Ran Kornowski Rabin Medical Center, Petach Tikva, Israel
Cause of Death
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
9 months
12 months
18 months
18 months
19 months
Acute renal failure and sepsis
Chronic/ aspiration alcoholic liver pneumonia disease
Sudden death, 2 days post /HXNDHPLD surgery
Death at Follow-up
Background and Objectives: Non cardiac perioperative management of patients who recently underwent drug-eluting coronary stents (DESs) may EH FKDOOHQJLQJ GXH WR SRWHQWLDO ULVN RI VWHQW WKURPERVLV 7KHVH VWHQWV PD\ LQKLELWUHHQGRWKHOLDOL]DWLRQRIWKHWUDXPDWL]HGYHVVHOPDNLQJLWYXOQHUDEOH to platelet-mediated thrombosis. Given the anecdotal evidence and case series suggesting that DESs may be less vulnerable to thrombosis after six months, ZHVRXJKWWRTXDQWLI\WKLVULVN Methods:/LQNLQJWKH5DELQ0HGLFDO&HQWHULQWHUYHQWLRQDOFDUGLRORJ\ GDWDEDVHZLWKLWVVXUJLFDOGDWDEDVHZHKDYHLGHQWL¿HG SDWLHQWVZKR underwent DES placement and subsequently [after six months] had noncardiac surgery [33-vascular, 37- abdominal and genitourinary, and 27-others, excluding ophthalmic surgery]. Outcome measures included 30-day rate of postoperative myocardial infarction (MI), DES thrombosis, and cardiac mortality Results: Major adverse cardiac events occurred in 7 (7.2%) patients including 2 cardiac deaths (2.1%), 5 (5.2%) non-fatal myocardial infarctions (MIs) and GH¿QLWHDQG SUREDEOHVWHQWWKURPERVLV$OO0,VDVZHOODV stent thrombosis occurred in the vascular and abdominal surgery. Two of the MIs occurred while the patients were on dual antiplatelet agents]. All death RFFXUUHGLQSDWLHQWVVXEMHFWHGWRVXUJHU\LQWKH³RWKHU´JURXS Conclusion: Noncardiac surgery after six months of DES deployment is DVVRFLDWHGZLWKFRQVLGHUDEOHULVNRIQRQIDWDO0,DQGFDUGLDFGHDWKGHVSLWH continuation of dual antiplatelet therapy. The occurrence of these cardiac complications is of concern.
Conclusion: In our experience, the use of very long and overlapped DES is safe and effective in treating diffuse de novo coronary artery lesions. TCT-431 Interrelationships between Residual Plaque Burden of Peri-Stent Margins and Neointimal Reaction within the In-stent Segments following Sirolimus-eluting Stent Implantation Seiji Tamiya, Naoki Masuda, Yoshihiro Morino, Yota Kawamura, Takayuki Iida, DaikiIto, Eri Toda, Toshiharu Fuji, Makiyoshi Shima, Atuhiko Sugimoto, Takashi Matsukage, Nobuhiko Ogata, Teruhisa Tanabe, Yuji Ikari Tokai University School of Medicine, Isehara, Japan
Background: Data on effectiveness and safety following the implantation of WZRRUPRUHORQJRYHUODSSLQJGUXJHOXWLQJVWHQWVLVODFNLQJ Aim: To describe our experience of consecutive patients undergoing LPSODQWDWLRQRIYHU\ORQJ'(6 !PP LQGHQRYRFRURQDU\OHVLRQV Methods: We evaluated major in-hospital complications, target lesion revascularization (TLR) and long term outcomes in 112 consecutive patients (115 procedures) who underwent a single vessel intervention ZLWK LPSODQWDWLRQ RI !PP RYHUODSSLQJ VWHQWV EHWZHHQ 2FWREHU till October 2007. Patients who were treated for in-stent restenosis (14 patients) and those who received both DES and BMS (10 patients) were excluded. Baseline clinical data, procedural outcomes and completed IROORZXSZHUHFROOHFWHGSURVSHFWLYHO\7KHPRUWDOLW\UDWHZDVFRQ¿UPHG
Conclusion: Peri-stent residual plaque burden impacts on plaque/neointimal proliferation following SES implantation not merely locally at edges but also extensively at the stented segments. The obtained results were quite important
TCT-430 Clinical Outcomes After Percutaneous Coronary Intervention Using Very Long (>50mm) Drug Eluting Stents in de Novo Coronary /HVLRQV 6LQJOH&HQWUH([SHULHQFH
The American Journal of Cardiology®
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October 12-17, 2008
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Mohammed Andron, Khaled Albouaini, Archana Rao, David Ramsdale Cardiothoracic Centre, Liverpool, United Kingdom
Background: In the drug-eluting stent era, peri-stent residual plaque burden is considered as a predominant factor to assess adequateness of stent positioning DVZHOODVWRSUHGLFWHGJHUHVWHQRVLV2QWKHFXUUHQWFRQVHQVXV³LQVWHQW´ODWH RXWFRPHVDUHFRQVLGHUHGFKLHÀ\FRQWUROOHGE\GLPHQVLRQRIVWHQWH[SDQVLRQ hardly affected by adjacent plaque burden of stent edges. Methods: Study population consisted of consecutive 105 patients who XQGHUZHQW LQWUDYDVFXODU ,986 JXLGHG VLUROLPXVHOXWLQJ VWHQW 6(6 implantation and 2) were eligible for follow-up angiography at 8 months. 4XDQWLWDWLYH ,986 DQDO\VLV ZDV SHUIRUPHG DW SHULVWHQW PDUJLQ VHJPHQWV (within 3mm adjacent to edges). Patients were divided into 3 groups based RQSODTXHDUHD 3$ SODTXHDUHDH[WHUQDOHODVWLFPHPEUDQHDUHD; DWSHULVWHQWPDUJLQV 3$DWERWKVWHQWHGJHV JURXS$Q 3$ DWHLWKHURIWKHVWHQWHGJHV JURXS%Q DQG3$ DWERWK edges (group C, n=72). Angiographic late lumen loss of the in-stent segment was compared between the three groups. Results:$VVKRZQLQWKH¿JXUHLQVWHQWODWHORVVZDVVLJQL¿FDQWO\JUHDWHULQ the group A.\
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to weigh the interrelationships between adjacent and in-stent vascular responses. TCT-432 WITHDRAWN TCT-433 Potential Role of Polymer Biocompatibility in Late Stent Thrombosis Josiah N Wilcox, Robert J. Melder, Kishore Udipi, Ayala Hezi-Yamit Medtronic Cardiovascular, Santa Rosa, CA
E L E C T RO N I C A B S T R AC T S
Background 7KH ¿UVWJHQHUDWLRQ VLUROLPXVHOXWLQJ VWHQWV 6(6 DQG paclitaxel-eluting stents (PES) have been associated with a higher incidence RIODWHVWHQWWKURPERVLV /67 WKDQEDUHPHWDOVWHQWV %06 $VLPLODUULVN for LST has not been seen with zotarolimus-eluting stents (ZES). Since these DES all utilize different biostable polymers which remain associated with the metal stent after drug release, we hypothesized that polymer biocompatibility may in part explain differences in rates of LST. Methods: The surface properties of different DES polymers including SIBS, 3%0$ ÀXRURSRO\PHU 3& DQG %LR/LQ[ 0HGWURQLF 0LQQHDSROLV 01 ZHUH evaluated using contact angle measurements to determine relative hydrophobicity or hydrophilicity. Polymer biocompatibility was evaluated by in-vitro assay in which endothelial cells (EC), smooth muscle cells (SMC) and activated monocytes were exposed to polymers coated on 96 well plates. Monocyte DGKHVLRQDQGUHODWLYHJHQHH[SUHVVLRQRILQÀDPPDWRU\DQGSURWKURPERWLFJHQHV was determined. In vivo studies were also conducted with either BMS coated with polymers alone or commercial DES to evaluate vascular responses. Results: We observed a consistent correlation between polymer hydrophobicity DQGLQÀDPPDWRU\UHVSRQVHVERWKLQYLWURDQGLQYLYR WKHPRUHK\GURSKRELF SRO\PHUV 3%0$ 6,%6 DQG ÀXRURSRO\PHU FRQWDFW DQJOH ! LQGXFHG LQFUHDVHGPRQRF\WHELQGLQJH[SUHVVLRQRILQÀDPPDWRU\DQGSURFRDJXODQW JHQHVDQGLQÀDPPDWLRQLQYLYRZKLOHWKHK\GURSKLOLF'(6SRO\PHUV3&DQG BioLinx utilized on the Endeavor and Endeavor Resolute stents respectively FRQWDFW DQJOH VKRZ PLQLPDO LQÀDPPDWRU\ UHVSRQVHV $GGLWLRQDO studies suggested that DES utilizing hydrophobic polymer surfaces may contribute to endothelial dysfunction and are associated with a loss of eNOS and NO production compared to hydrophilic polymer surfaces. Conclusion: Overall, these results lead us to hypothesize that the observed differences in rates of LST among these different DES may be accounted for by differences in the hydrophilic/hydrophobic nature of the polymers utilized on these stents. TCT-434 Comparative In Vitro DES Polymer Biocompatibility Testing: Application for Evaluating Polymer Coatings for Cardiovascular Drug-eluting Stents Ayala Hezi-Yamit, Carol Sullivan, Laura David, Mingfei Chen, David Shumaker, Meena Ramachandran, Stefan Tunev, Josiah N Wilcox Medtronic Cardiovascular, Santa Rosa, CA Background: Synthetic DES polymer coatings have been postulated to HOLFLWDQLQÀDPPDWRU\DQGRUWKURPERWLFUHVSRQVHLQWKHDUWHULDOZDOO7KH responsible mechanisms are comprised of multistep adhesive and signaling events. In this study we assess the potential for differential monocytic and eosonopilic adhesion to various DES polymers and the resulting responses. Methods: Polymers with compositions similar to commercially available DES, were coated onto 96-well plates or metal stents. The polymeric surfaces were incubated with human monocytic (PMA treated U937) or eosinophilic (Clone15+/ FHOOVDQGWKHLUDFWLYDWLRQDQGDGKHVLRQZDVHYDOXDWHGE\JHQHSUR¿OLQJ DQG DGKHVLRQ DVVD\V /LNHZLVH FRPPHUFLDOO\ DYDLODEOH '(6 ZHUH H[DPLQHG in-vitro. We also used neutralizing antibodies targeting adhesion molecules on monocytic and eosinophilic cells and studied the effect on adhesion. Results: A consistent correlation was observed between polymer
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K\GURSKRELFLW\DQGDFWLYDWLRQUHVSRQVHVSHFL¿FDOO\DQLQFUHDVHGPRQRF\WLF adhesion to hydrophobic polymeric surfaces; the more hydrophobic polymers 3%0$ 6,%6 DQG 9)+ ÀXRURSRO\PHU FRQWDFW DQJOH ! LQGXFHG higher monocytic adhesion, at range of 95-129% (p-values <0.005, relative to control surface, 100%), while the hydrophilic DES polymers, BioLinx and PC, (contact angle <95°) show low monocytic adhesion with a range of 1-10% (p-values <0.005, relative to control surface). We have observed an analogous relationship of preferential eosinophilic FHOODGKHVLRQWRK\GURSKRELFSRO\PHUV7KHHRVLQRSKLOLFDGKHVLRQUDQNLQJ ZDV 3%0$ ! 6,%6 !)OXRURSRO\PHU !!3& %LR/LQ[ ZLWK DGKHVLRQ UDQJHV of 1-20% for PC and BioLinx (p-values <0.005, relative to control surface) DQGIRU9)+ÀXRURSRO\PHU6,%6DQG3%0$ SYDOXHV Antibody neutralization experiments demonstrated an integral role for integrin LQYROYHPHQW VSHFL¿FDOO\ &'E DQG /)$ LQ PHGLDWLQJ WKH LQÀDPPDWRU\ adhesion to hydrophobic polymers. Conclusion: 7KHVH¿QGLQJVVXSSRUWWKHYLHZWKDWVSHFL¿FSRO\PHUIRUPXODWLRQV PD\SURPRWHGLIIHUHQWLDOLQÀDPPDWRU\UHVSRQVHVPHGLDWHGLQSDUWE\WKHDELOLW\ of cells to adhere and respond to variations in the hydrophobicity of DES polymeric coatings. Such interactions can trigger differential eosinophilic and monocytic activation resulting in increased potential for restenosis and thrombosis. TCT-435 Impact of Total Drug Eluting Stent Length on Clinical Outcomes in Routine Clinical Practice: Results from the EVENT Registry Ronald Caputo1, michael Pencina2, Neil Kleiman3, john lopez4, Ron Waksman5, P Tolerico6, paul gordon7, R Bach8, David Cohen9 1 SJH Cardiology Associates, Liverpool, NY; 2Boston University, Boston, MA; 3St. Lukes, Houston, TX; 4U Chicago Med Ctr, Chicago, IL; 5Washington Hospital Ctr, Washington, DC; 6Yorktown Hospital, Yorktown, PA; 7Miriam Hospital, Providence, RI; 8Washington University Hospital, St Louis, MO; 9Mid America Heart, Kansas City, MO Background: Greater stent length has been associated with adverse events in drug eluting stent (DES) clinical trials. As these trials often employ routine DQJLRJUDSKLFIROORZXSWKHVSHFL¿FLPSDFWRI'(6OHQJWKLQURXWLQHSUDFWLFH is not well established. Methods: We identifed consecutive unselected patients (n=4232) undergoing DES implantation for non-emergent single vessel PCI between 2004 and 2006 IURPWKH(9(17UHJLVWU\7KHDVVRFLDWLRQEHWZHHQVWHQWOHQJWKDQGFOLQLFDO RXWFRPHVZDVDQDO\]HGLQTXDUWLOHV PP PPPP!PP and as a continuous variable. Results: Mean patient age was 64 years. A higher proportion of women and dialysis patients were in the shorter stent quartiles. Maximum balloon GLDPHWHUZDVJUHDWHULQWKHORQJHVWTXDUWLOH7KHUHZHUHQRRWKHUVLJQL¿FDQW differences in clinical, angiographic or procedural variables between quartiles (diabetes 35%, prior MI 33%, prior CABG 21%, ACS 34%, CHF 10%, LAD lesion 37%). Similar DES types were used between quartiles. In univariate analysis, greater stent length was associated with more frequent MACE, DQG7/5 7DEOH /RQJHUVWHQWOHQJWKZDVDVVRFLDWHGZLWKLQFUHDVHGULVNRI stent thrombosis. Adjusting for baseline characteristics, greater stent length UHPDLQHG DVVRFLDWHG ZLWK DQ LQFUHDVHG ULVN RI 0$&( PP LQFUHDVH stent length) and TLR (1.15/10mm), but not with stent thrombosis. One-Year Outcomes According to total stent length Total Stent Length Quartiles < 15 mm 15-19 mm
20-24 mm
!PP Adjusted HR*
# of pts
1143
1140
833
1211
MACE
6.6%
8.7%
11.0%
14.7%
1.195[1.126-1.267] <0.0001
TLR
2.7%
2.4%
3.9%
4.3%
1.160[1.040-1.292] 0.005
Stent Thrombosis
0.4%
1.4%
0.6%
1.4%
1.230[1.020-1.041] NS
P-value
* Hazard ratio per 10 mm increase in DES length, adjusted for demographic,
The American Journal of Cardiology® |
October 12-17, 2008
| TCT Abstracts/ELECTRONIC
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clinical, angiographic, treatment factors Conclusion: For single vessel disease, increasing DES length appears to be associated with adverse clinical outcomes. This should be considered when selecting strategies for revascularization.
Sahajanand Med, India) uses a stainless steel platform with a bioabsorbable polymer loaded with sirolimus. We sought to determine the safety and clinical effectiveness of this new generation DES in diabetic pts. Methods: The E-SERIES Registry is an open-labeled, non-randomized study with consecutive enrollment (ongoing) of pts all-comers for PCI with SS implantation. All clinical, procedural, and follow-up (FU) information were collected and analyzed by an independent organization, and all adverse events were independently adjudicated. Results: Since July/07, 423 pts were included and completed 6 months FU (170 '0 QRQ'0 &RPSDUHGWRQRQ'0SWVZLWK'0ZHUHROGHU YV \HDUV S KDG PRUH K\SHUWHQVLRQ YV S and chronic renal failure (8.4 vs. 2%, p=0.005). Baseline angiographic characteristics were similar among groups: mean vessel size and lesion length ZHUHPPDQGPPUHVSHFWLYHO\DQGRIOHVLRQVZHUH W\SH %& 3URFHGXUDO VXFFHVV ZDV ! S 16 &OLQLFDO RXWFRPHV DW months are shown in the table.
TCT-436 Development of DES with a Biodegradable Polymer Matrix Ya Guo, Brian Cook, Joe Berglund, Daniel Schulz-Jander, Peiwen Cheng, Eric Yu, Stefan Tunev, Doreen Borkowski, Sean Pruitt, Lesley Crookall Medtronic Cardiovascular, Santa Rosa, CA Background: Drug delivery from drug eluting stents is presently achieved through bio-stable polymeric coatings; these remain in the body following drug release. Development of a polymeric coating that is biodegradable offers the advantage that after polymer degradation is complete, a bare metal stent remains, eliminating concerns about reactions resulting from residual polymer. Methods: Novel biodegradable co-polymers were developed, built around materials with similar chemistry to poly-lactic acid (PLA); PLA is used to good effect in medical implants, such as absorbable sutures. By varying polymer composition (both type of component and component ratio) and polymer molecular weight (MW), we control drug elution and polymer degradation rates. Targeting performance criteria important to a DES product ZH LGHQWL¿HG FDQGLGDWH IRUPXODWLRQV IRU XVH LQ DQLPDO WHVWV 7ZR DQLPDO models were employed: a rat model used to evaluate polymer degradation, and a pig model used to evaluate safety and biocompatibility. Stents coated with four candidate polymers containing 0.8-g/mm2 of Zotarolimus were implanted into porcine coronaries and sampled at 28, 90 and 180 days. The assessment panel included histopathology, polymer degradation and elution. Results: Polymer composition and MW could be adjusted to control drug HOXWLRQ DQG SRO\PHU GHJUDGDWLRQ UDWHV WKLV ZDV FRQ¿UPHG LQYLYR $ W\SLFDOHOXWLRQFXUYHKDVDVKRUWWLPHIUDPH³EXUVW´RIaRIWKHGUXJDQG complete elution by 28 days, but by varying the polymer composition, the burst ranged from 20 - 60% and elution to exhaustion could range from less than 10 days to more than 60 days. Histological performance of the polymers showed comparable performance to bare metal stent controls measured by ORZ LQÀDPPDWLRQ VFRUHV DQG SHUFHQW DUHD RI VWHQRVLV ,Q DGGLWLRQ ZH VDZ SHULVWUXW ¿EULQ DW GD\ LQGLFDWLQJ SUHVHQFH RI DFWLYH GUXJ LQ WLVVXH Invivo degradation correlated with bench top testing. In the rat model, polymer degradation times ranged from 100 days to more than 180 days. Conclusion: These studies have demonstrated that the biodegradable polymers we have developed offer potential as a carrier material for a drug eluting stent.
1,6 % ( 4 )
0,49
MI
2,9 % ( 5 )
4% ( 10 )
0,77
TLR
0,5 % ( 1 )
1,8 % ( 5 )
0,24
6WHQWWKURPERVLVGH¿QWHSUREDEOH
0,6 % ( 1 )
0,4 % ( 1 )
0,99
0,61
TCT-438 Common Site of Stent Fracture after Sirolimus-eluting stent -Unique Distribution at Native Coronary Artery-
Background: Stent fracture after drug-eluting stent has been reported to occur more frequently at RCA than other native coronary arteries. However, further information of common sites of stent fracture remains unclear. In this study, we evaluated the fracture site according to the branches of each coronary vessel after sirolimus-eluting stent (SES). Methods: Between November 2002, and December 2006, a total of 2417 consecutive patients with 3888 lesions underwent stenting with SES. Of these, 2291 patients with 3621 lesions were treated with SES successfully and exclusively. A total of 1979 patients with 3086 lesions which were followed by angiography constituted the study population for evaluation of stent fracture. $QJLRJUDSKLFVWHQWIUDFWXUHZDVGH¿QHGDVDSSDUHQWFRPSOHWHVHSDUDWLRQRI stent segments at any view of angiogram. Fluoroscopy with focusing on stent without contrast medium or inverse image analysis of routine angiography was used in selected cases in which stent fracture was suspected by routine angiography. Stent fracture at ostial or proximal site of RCA was also evaluated XVLQJOHIWREOLTXHYLHZRI/9*LQDGGLWLRQWRURXWLQHFRURQDU\DQJLRJUDP Angiographic stent fractures were observed at 154 lesions (total number of VWHQWIUDFWXUHVZDV 3UHYDOHQFHRIVWHQWIUDFWXUHRI5&$OHIWPDLQWUXQN /07/$'/&;69*DQG,0$ZHUH OHVLRQV lesions), 2.8 % (29/1030 lesions), 3.1 % (21/687 lesions), 25 % (5/20) and 0 % (0/2 lesions) respectively. Prevalence of stent fracture at various branches of native coronary artery was shown in the Figure.
Background:Diabetes mellitus (DM) is a well recognized predictor for adverse HYHQWVIROORZLQJ3&,'HVSLWHWKHXQGHQLDEOHFOLQLFDOHI¿FDF\RIst generation DES with durable polymers, concerns regarding their long-term safety have been raised, especially in more complex subsets. The SupralimusTM stent (SS,
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Kazushige Kadota, Kazuaki Mitsudo, Tsuyoshi Goto, Satoki Fujii, Hiroyuki Yamamoto, Harumi Kato, Yasushi Fuku, Shingo Hosoki, Hiroyuki Tanaka, Seiji Habara, Daiji Hasegawa, Masao Imai, Suguru Otsuru, Masakazu Miyamoto, Masakazu Miyamoto, Naoki Saito, Kentaro Shibayama Kurashiki Central Hospital, Kurashiki, Japan
Dimytri A Siqueira1, Ricardo A. Costa1,2, J. Ribamar Costa Jr.1,2, Andrea S. Abizaid1,2, Alaor Mendes1, J. Airton Arruda3, Fabio S. Brito Jr.4, Mauricio Prudente5, Costantino R. Costantini6, Juliana P. Castro2, Fausto Feres1, Alexandre A. C. Abizaid1,2, Expedito E. Ribeiro7 1 Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil 2 Cardiovascular Research Center, São Paulo, Brazil 3Intercath Meridional, Vitória, ES, Brazil 4Hospital São Camilo, São Paulo, Brazil 5 Centro de Cardiologia e Radiologia, Goiânia-GO, Brazil 6Hospital Cardiologia Costantini, Curitiba- PR, Brazil 7Instituto do Coração FMUSP, São Paulo, Brazil
October 12-17, 2008
2,9% ( 5 )
Conclusions: The novel SupralimusTM DES demonstrated excellent SHUIRUPDQFHDQGVDIHW\SUR¿OHLQXQVHOHFWHGGLDEHWLFSWV$WPRQWKV)8 clinical outcomes were comparable in diabetics vs. non-diabetics, including overall MACE <6% and TLR <2%. Complete 1 year clinical FU will be presented at the meeting.
Supralimus™ Bioabsorbable Sirolimus-Eluting Stent Technology in Diabetic Pts Undergoing Percutaneous Coronary Intervention (PCI): Preliminary Findings from the Prospective, International, Multicenter E-SERIES Registry
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5,9% ( 10 )
Cardiac death
p
MI-myocardial infarction, TLR-target-lesion revascularization
TCT-437
The American Journal of Cardiology®
MACE
Non-diabetics ( n= 253 ) 5,5% ( 14 )
Diabetics( n=170 )
http://www.aievolution.com/tct0801
Conclusion: For coronary artery disease in dialysis patients, SES could not improved the subsequent clinical results. TCT-441 )LUVW5HSRUWRI+XPDQ&OLQLFDO6DIHW\DQG(I¿FDF\RI-$&7$; Drug Application Stent
Conclusion: Although the exact mechanism of unique distribution of common VLWHVRIVWHQWIUDFWXUHDIWHU6(6LPSODQWDWLRQUHPDLQVXQNQRZQE\QRZRXU data could be useful to avoid stent fracture after SES implantation and its related clinical events, such as restenosis. TCT-439 WITHDRAWN TCT-440 Comparison of Therapeutic Strategies for Coronary Artery Disease in Dialysis Patients Between Bare Metal and Drug-eruting Stent Eras
E L E C T RO N I C A B S T R AC T S
Kenya Nasu, Etsuo Tsuchikane, Osamu Katoh, Yoshihisa Kinoshita, Mariko Ehara, Yasushi Asakura, H Matsuo, Tetsuo Matsubara, Mitsuyasu Terashima, Takahiko Suzuki Toyohashi Heart Center, Toyohashi, Japan Background: In most patient subpopulations, sirolimus-eluting stent (SES) SURYLGH VLJQL¿FDQW EHQH¿WV RYHU EDUH PHWDO VWHQWV %06 IRU WDUJHW OHVLRQ revascularization (TLR) and other major adverse cardiac events (MACE). +RZHYHUWKHHIIHFWRI6(6LQGLDO\VLVSDWLHQWVLVXQNQRZQ Methods: From April 2000 to July 2004, a total of 252 lesions in 201dialysis patients were treated (BMS era) and 412 patients with 539 lesions were treated from August 2004 to October 2007 (DES era). Patients were followed for 12 months for TLR and 4 years for MACE. Results: Therapeutic strategies in each era are shown in table. Balloon angioplasty was performed more frequently in BMS era. In DES era, 60% of WKHOHVLRQVZHUHWUDWHGE\6(6ZKLFKZDVVLJQL¿FDQWO\KLJKHUWKDQ%06HUD However, TLR rate at 12 months was not different between BMS and SES. In addition, at 4 years MACE in DES era were not different from those in BMS HUD ¿JXUHS Therapeutic strategies BMS era DES era p
TLR rate in TLR rate in p BMS era DES era
Number of lesion
252
539
18.8%
Balloon angioplasty
101 (40%)
Balloon angioplasty after 35 (14%) rotational atherectomy BMS 81 Stent (32%) Stent after rotational BMS 35 atherectomy (14%)
25.5%
0.12
149 (28) 0.0008 20%
23%
0.75
64 (12%) 0.57
21%
0.71
30%
0.08
32.5%
0.07
20%
SES 243 0.0006 20% (45%) SES 80 0.75 14% (15%)
Eberhardt Grube1, Joachim Schofer2, K Eugen Hauptmann3, Neil J Weissman4, Jeffrey Popma5 1 HELIOS Klinikum Siegburg/ Germany , Siegburg, Germany 2Hamburg University Cardiovascular Center, Hamburg, Germany 3Krankenhaus der Barmherzigen Bruder, Trier, Germany 4MedStar Research Institute, Washington, D.C., DC; 5Brigham and Women’s Hospital Angiographic Core Laboratory, Boston, MA Background: 7KH -$&RDWLQJ ZDV GHVLJQHG IURP ¿UVW SULQFLSOHV DV D unidirectional ablumenal ultra thin bioerodable coating to mitigate the potential long term clinical complications associated with drug eluting stents. The Coating is formulated by combining DLPLA and paclitaxel (1:1 w/w) and is precisely applied as a solution using the Labcoat patented computer controlled system to form a unique discontinuous dot pattern exclusively RQ WKH DEOXPHQDO VWHQW VXUIDFH 7KH -$&7$; 'UXJ $SSOLFDWLRQ VWHQW LV WKH/LEHUWp0RQRUDLO6'6 EDUHPHWDOSUHPRXQWHGVXSSOLHGE\%RVWRQ 6FLHQWL¿F ZLWKWKH-$FRDWLQJDSSOLHGE\/DEFRDW/WG Methods: -$&7$;HQUROOHGDWRWDORISDWLHQWVIURP¿YH FHQWHUVLQ (XURSH7KHSULPDU\HQGSRLQWLV0$&( FDUGLDFGHDWK0,795 HYDOXDWHG DW PRQWKV6HFRQGDU\HQGSRLQWVLQFOXGHDQJLRJUDSKLFDQG,986FULWHULDDW months. All patients have completed one month follow up and approximately 50% of patients have completed a four month clinical follow up. Results: The study enrolled 83 men and 20 women with a mean age of 66 years; 22 pts (21%) presented with diabetes. Eighty-one (79%) patients had one lesion treated; 21 (20%) had a second lesion treated with Taxus® and 1 pt had WKUHHOHVLRQVWUHDWHG PXOWLSOHOHVLRQVZHUHWUHDWHGZLWKQRQ-$&7$;VWHQWV /HVLRQOHQJWKUDQJHGIURPWRPPZLWKDPHDQRIPP %DVHOLQH0/'ZDVPPSUHSURFHGXUH PPSRVWSURFHGXUH 3HUFHQW'LDPHWHU6WHQRVLVUHGXFHGIURP SUHSURFHGXUHWR SRVW SURFHGXUH 'HYLFH WHFKQLFDO VXFFHVV ZDV VWHQWV successfully placed. Lesion success was 99%; 102/103 patients with successful lesions treated and Procedural success was 97%; 100/103 patients with lesion success and no in-hospital MACE. Cumulative MACE through 30 days was 1.9% (2/103) based on two cases of in-hospital non Q-wave MIs. There were no incidences of death or TLR within 30 days. At 4 months, 53 patients have been evaluated with no additional MACE. Conclusion:7KHGD\UHVXOWVRIWKH-$&7$;FOLQLFDOVWXG\GHPRQVWUDWHWKH LQLWLDOVDIHW\DQGDFXWHHI¿FDF\RIWKH-$&7$;VWHQW$QJLRJUDSKLFUHVXOWVDW 9 months post procedure will be reported in October 2008. TCT-442 The Safety of 6-Month versus 12-Month Dual Antiplatelet Therapy in Patients Treated with Zotarolimus-Eluting Stent: A Patient-Level Pooled Analysis of Five ENDEAVOR Randomized Trials Roxana Mehran1, David E Kandzari2, Laura Mauri3, Adriano Caixeta1, George Dangas1, Manuela Negoita4, Martin B Leon5 1 Columbia University Medical Center and Cardiovascular Research Foundation, New York, NY; 2Scripps Clinic, LaJolla, CA; 3Brigham and Women’s Hospital, Harvard Medical School, Boston, MA; 4Medtronic CardioVascular, Santa Rosa, CA; 5Columbia University Medical Center, New York, NY Background: The observation that very late stent thrombosis may occur more frequently with early generation drug eluting stent (DES) [sirolimus and paclitaxel] than with bare metal stents has motivated the guidelines recommendation for at least 12 months of dual antiplatelet therapy (DAPT)
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The American Journal of Cardiology® |
October 12-17, 2008
| TCT Abstracts/ELECTRONIC
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for all patients receiving DES. Given the low rate of late thrombotic events with zotarolimus-eluting stents (ZES, Endeavor), whether clinical outcomes following treatment with ZES differ relative to an abbreviated duration of DAPT compared with extended therapy has not been characterized. Methods: Using multivariable analysis adjusting for baseline clinical and angiographic characteristics, we compared long-term clinical adverse events among ZES patients from the pooled Endeavor clinical trials program (N=1,674). Patients were divided according to duration of DAPT: Group “On 12m” (N=699), patients on DUAPT at both 6 months (m) and 12m; and Group “On 6m/Off 12m” (N=785), patients on DUAPT at 6m but without clopidogrel at 12m. Results: )ROORZLQJ ULVN DGMXVWPHQW DW DQG \HDU IROORZXS WKHUH ZHUH QRVLJQL¿FDQWGLIIHUHQFHVLQWKHFXPXODWLYHLQFLGHQFHRIGHDWKP\RFDUGLDO infarction (MI), stent thrombosis and composite endpoints relative to DUAPT DGKHUHQFHDWPYHUVXVP 7DEOH 7KHUHZHUHQRIXUWKHU9/67HYHQWVLQ either group between 2 and 3 years.
Results:0HDQGXUDWLRQRIIROORZXSLVGD\V7KHUHZHUHVLJQL¿FDQW differences between SES and PES group in rates of family history of coronary artery disease (SES 24.6%, PES 37.0%, p=0.03), diabetes (SES 28.8%, PES 18.5%, p=0.05) and chronic total occlusion (3.4% vs 15.2%, p=0.001). At \HDUVPRUWDOLW\LQ6(6DQG3(6JURXSZDVDQG ORJUDQNS ZKLOH795UDWHZDVDQGUHVSHFWLYHO\ ORJUDQNS The composite endpoint of MACE was found comparable between 2 groups DQG ORJUDQN S &R[ UHJUHVVLRQ DQDO\VLV UHYHDOHG presentation for acute myocardial infarction (hazard ratio [HR] 3.22 [95%CI: 1.59-6.50]), chronic total occlusion (HR 2.23 [95%CI: 1.15-4.31]) and number of stents (HR1.24 [95%CI: 1.05-1.47]) as independent predictors of MACE, while stent type was not. Conclusion: 7KUHH\HDU DIWHU WKH SURFHGXUH WKHUH DUH QR VLJQL¿FDQW differences in MACE rate between SES and PES when used in patients with in-stent restenosis.
Table 1. Long-term Outcomes Relative to On 12m vs. On 6m/Off 12m DUAPT Outcomes at 2 years
On 12m (N=279)
On 6m/Off 12m (N=506)
P value
Death (cardiac) MI
0.0% (0)
1.2% (6)
0.94
3.2% (9)
2.4% (12)
0.57
Death (cardiac) + MI
3.2% (9)
3.6% (18)
0.59
$5&'H¿QLWH3UREDEOH
0.7% (2)
0.4% (2)
0.42
MACE
11.8% (33)
8.9% (45)
0.28
Outcomes at 3 years
(N=275)
(N=497)
Death (cardiac)
0.0% (0)
1.6% (8)
0.95
MI
3.6% (10)
2.6% (13)
0.54 0.50
Death (cardiac) + MI
3.6% (10)
4.2% (21)
$5&'H¿QLWH3UREDEOH
0.7% (2)
0.4% (2)
0.42
MACE
13.8% (38)
11.1% (55)
0.35
TCT-444 United States (US) and Outside US Outcomes of the Off-label use of Bare Metal Stents compared to Drug Eluting Stents: A Meta-Analysis Nirat Beohar Northwestern University Medical School, Chicago, IL Background: Whether US and Outside US (OUS) outcomes of Off-label PCI utilizing bare metal stents (BMS) or drug eluting stents (DES) differ is unclear. Methods: A meta-analytical of was performed of 44,845 patients (149 studies, %06Q '(6Q IRUWKHVDIHW\DQGHI¿FDF\RI86DQG286 outcomes of DES compared to BMS. Off-label use for BMS and DES was GH¿QHGE\LQIRUPDWLRQIRUXVHGH¿QLWLRQVIRU'(65HJLVWU\GDWDEDVHVDQG randomized clinical trials (from May 2000- April 2008) reporting lesion VSHFL¿FRXWFRPHVZLWKDPLQLPXPIROORZXSRIPRQWKVZHUHLQFOXGHG Lesion subtypes were left main, ostial, bifurcation, in-stent restenosis, VDSKHQRXVYHLQJUDIWORQJOHVLRQVVPDOOYHVVHOVWRWDORFFOXVLRQVDQGFDOFL¿HG lesions. Results:
MACE: major adverse cardiovascular events
Conclusion: Following treatment with ZES, late adverse outcomes do not VLJQL¿FDQWO\GLIIHUEHWZHHQSDWLHQWVDGKHUHQWWR'8$37DWPYHUVXVP 7KHVH¿QGLQJVQRWRQO\GHPRQVWUDWHWKHRYHUDOOORQJWHUPVDIHW\ZLWK=(6EXW also suggest favorable long-term safety among ZES patients who discontinue DUAPT prior to 1 year.
1 Year Outcomes of DES vs. BMS in Off-Label Use (mean%, 95% CI) DES
OUS BMS
DES
Death
1.99 (1.2-2.8)
2.9 (2.6-3.2)
2.79 (2.57-3.1)
2.02 (1.8-2.3)
Long-term Outcomes After Treatment Of In-stent Restenosis With Bare-metal Stent And Drug-eluting Stent: Insights From Research And T-search Registry
Death or MI
9 (6.2-11.8)
5.24 (4.7-5.8)
7.35 (6.6-8.1)
3.21 (2.8-3.6)
Yoshinobu Onuma, Neville Kukureja, Joost Daemen, Nieves Gonzalo, Evelyn Regar, Henricus J Duckers, Robert Jan M van Geuns, Martin van der Ent, Peter de Jaegere, Pim J de Feyter, Wim van der Giessen, Ron van Domburg, Patrick W Serruys Thorax center, Rotterdam, Netherlands
Thrombosis
0.93 (0.3-1.5)
0.75 (0.6-0.9)
0.93 (0.4-1.5)
1.42 (0.99-1.8)
TLR
17.79 (16.1-19.5)
4.9 (4.4-5.4)
19.37 (18.3-20.4)
6.31 (5.8-6.8)
Objectives: Drug-eluting stents (DES) have been shown to be superior to conventional brachytherapy, the only FDA-approved treatment for in-stent restenosis for treatment of stenting. Although sirolimus-eluting (SES) and paclitaxel-eluting stents (PES) are commonly used for treatment of in-stent UHVWHQRVLVOLWWOHLVNQRZQUHJDUGLQJORQJWHUPRXWFRPHDIWHUVWHQWLPSODQWDWLRQ DQGUHODWLYHHI¿FDF\RI6(6RU3(6 Methods: Between April 2002 and December 2004, 302 consecutive patients with in-stent restenotic lesion were treated with either SES (n=118; April 2002 to February 2003) or PES (n=184; March 2003 to December 2004). The occurrence of death (obtain from municipal civil registries) and clinical events were collected. Primary endpoint was a composite of major adverse events (MACE: all-cause death, myocardial infarction irrespective of the stented vascular territory or target-vessel revascularization). Survival curves were generated by the Kaplan-Meier method, and survival among groups was FRPSDUHG ZLWK WKH ORJUDQN WHVW &R[ PXOWLYDULDWH UHJUHVVLRQ DQDO\VLV ZDV performed to identify independent predictor of MACE event.
MACE
25.17 (23.3-27.1)
14.26 (13.5-15.05)
18.71 (17.9-19.6)
9.18 (8.7-9.7)
The American Journal of Cardiology®
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October 12-17, 2008
Conclusion: 1. For Off-label use in the US, DES death and thrombosis rate were similar to BMS, however, the death or MI, TLR and MACE rates were lower for DES compared to BMS. 2. For Off-label use OUS, DES thrombosis rates were similar to BMS, however death, death or MI, TLR and MACE rates were higher for DES compared to BMS. 3. Comparing US to OUS for DES, Off-label usage showed higher death, death or MI, and MACE rates, but lower thrombosis and TLR rates. 4. Comparing US to OUS for BMS, Off-label usage showed similar death, death or MI, thrombosis and TLR rates but higher MACE rates. Important geographical differences may exist in Offlabel PCI outcomes and merit further investigation.
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US only BMS
TCT-443
http://www.aievolution.com/tct0801
TCT-445 Comparison of Sirolimus-Eluting Stents With and Without Polymeric Coating: A Serial Angiography and Intravascular Ultrasound Study
E L E C T RO N I C A B S T R AC T S
Daniel Chamié, J. Ribamar Costa, Jr., Alexandre Abizaid, J. Fábio Almiro Silva, Fausto Feres, Andréa S. Abizaid, Luiz Fernando Tanajura, Luiz Alberto P. Mattos, Rodolfo Staico, Ricardo Costa, Amanda G.M.R. Sousa, J. Eduardo Sousa Institute Dante Pazzanese of Cardiology, Sao Paulo, Brazil Background: Recent concerns regarding drug-eluting stents (DES) longterm safety have been raised. Although synthetic polymers in DES may SURYLGH EHWWHU UHOHDVH NLQHWLFV RI WKH GUXJ WKHLU SHUPDQHQW SUHVHQFH KDYH EHHQ DVVRFLDWHG ZLWK DQ LQWHQVH LQÀDPDWRU\ UHVSRQVH DQG H[DFHUEDWHG positive vessel remodeling. Recently, association between exacerbated vessel enlargement and very late DES thrombosis has been demonstrated. In this UHJDUG QHZHU JHQHUDWLRQV RI '(6 KDYH EHHQ GHYHORSHG 7KH 9HVWDV\QF VLUROLPXVHOXWLQJ VWHQW 9(6 FRPELQHV D VWDLQOHVV VWHHO SODWIRUP ZLWK D nanothin-microporous hydroxyapatite surface coating impregnated with a polymer-free sirolimus formulation (55 -g) that elutes the drug for more than GD\V2QFHWKHDEVHQFHRISRO\PHUPD\LQÀXHQFHWKHHI¿FDF\RID'(6 ZHDLPWRFRPSDUHWKHHI¿FDF\RIWKLVQRYHOGHYLFHZLWKWKDWRIWKHSHUPDQHQW polymer sirolimus-eluting Cypher™ stent (SES). Methods: Fifteen patients (pts) with single de novo lesions <14 mm length, in native vessels with 3.0 to 3.5 mm in diameter, were consecutively treated ZLWK9(6GXULQJPD\DQGFRPSDUHGWRDK\VWRULFDOFRKRUWRIDQRWKHU pts treated with SES that matched the same inclusion criteria. Angiographic DQGLQWUDYDVFXODUXOWUDVRXQG ,986 GDWDZHUHREWDLQHGLPPHGLDWHO\SRVW SURFHGXUHDQGVHULDOO\DWPRQWKDQGDWPRQWKIROORZXS3ULPDU\ end-points are the comparison of in-stent late loss (LL) by QCA and % of LQWLPDOK\SHUSODVLD ,+ E\,986$OODQJLRJUDSKLFDQG,986DQDO\VLVZHUH SHUIRUPHG³LQKRXVH´DWRXUFRUHODERUDWRU\E\WZRH[SHULHQFHGRSHUDWRUV blinded to the type of stents and time frame of analysis. Results: Baseline clinical characteristics were similar between groups. The 9(6JURXSKDGYHVVHOVRIVPDOOHUGLDPHWHU PPvs. S $WPRQWKIROORZXSLQVWHQW//ZDV 9(6 YV 6(6 S DQG,986,+REVWUXFWLRQZDV 9(6 YV 6(6 S $WDPHDQIROORZXSRIPRQWKVLQVWHQW// ZDV 9(6 YV 6(6 S DQGWKH,986,+ REVWUXFWLRQZDV 9(6 YV 6(6 S 7KHUHZHUHQR cases of binary restenosis in both groups. Conclusion: 7KH SUHVHQW DQDO\VLV VKRZV WKDW WKH QRYHO 9HVWDV\QF VWHQW LV effective in reducing IH formation up to 10-month follow-up. The absence RISRO\PHUGLGQRWKDYHLPSDFWRQWKHHI¿FDF\RIWKLVWKLUGJHQHUDWLRQ'(6 compared to the Cypher™ stent. Longer-term follow-up with a larger number RISDWLHQWVLVZDUUDQWHGWRFRQ¿UPLWVHI¿FDF\DQGVDIHW\SUR¿OH TCT-446 Vascular Response to Overlapping Everolimus-eluting stents: Comparison with Paclitaxel-eluting Stents Hiromasa Otake1, Junya Ako1, Masao Yamasaki1, Ichizo Tsujino1, Takao Shimohama1, Takao Hasegawa1, Ryota Sakurai1, Katsuhisa Waseda1, Paul G Yock1, Yasuhiro Honda1, Krishnankutty Sudhir2, Gregg W Stone3, Peter J Fitzgerald1 1 Stanford University, Palo Alto, CA; 2Abbott Vascular, Santa Clara, CA; 3 Cardiovascular Rsch Foundation, New York, NY Background: Increased drug dose in the Everolimus-eluting stent (EES) overlap region might be associated with adverse vessel response. We sought to clarify vessel response to overlapping EES versus Paclitaxel-eluting stent (PES) implantation. Methods : )URP WKH 6WDQIRUG 8QLYHUVLW\ ,986 &RUH /DERUDWRU\ database, a total of 74 patients treated with overlapping EES (n=36) and PES (n=38) ZKR XQGHUZHQW PRQWKV IROORZ XS ' ,986 ZHUH HQUROOHG 9ROXPH
170i
LQGH[ YROXPHOHQJWK ZDVFDOFXODWHGIRUQHRLQWLPD 19, VWHQW 69, YHVVHO 99, DQGSHULVWHQWSODTXH 39, 1,9ZDVFDOFXODWHGDV19,[69, 9HVVHO UHVSRQVH ZDV DVVHVVHG DW WKH SUR[LPDO DQG GLVWDO VLQJOH VWHQW VWUXW regions and the overlap region. Results: 2YHUDOO ((6 VKRZHG VLJQL¿FDQWO\ OHVV QHRLQWLPDO K\SHUSODVLD 1,+ WKDQ3(6&RPSDUHGZLWK3(6((6VKRZHGVLJQL¿FDQWVXSSUHVVLRQRI NIH at the proximal and distal single strut regions, and a trend toward lower 1,+DWWKHRYHUODSUHJLRQ 7DEOH 99,DQG39,LQFUHDVHGDWDOOUHJLRQVLQ3(6 whereas no changes were observed LQ((6H[FHSWIRUWKHLQFUHDVHLQ39,DW the distal region. At the overlap region, PES showed greater vessel expansion over time than EES (Table). One late incomplete stent apposition (LISA) case was observed in PES at the distal region, however LISA did not occur at the overlapping of EES and PES. EES
PES
39DOXH
Overall
0.02
Proximal region
0.049
Overlap region
0.09
Distal region
0.02
Proximal region
0.049
Overlap region
0.27
Distal region
0.81
Proximal region
0.09
Overlap region
0.049
Distal region
0.65
1,9
'HOWD3HULVWHQW39,PPPP
'HOWD99,PPPP
Conclusion:'HWDLOHG,986DQDO\VLVFRQ¿UPHGJUHDWHU suppression of NIH in the proximal and distal region with EES, without vessel expansion in the overlapping region, as compared with PES. TCT-447 Long-Term Outcomes of Sirolimus Eluting Stents for the Treatment of Saphenous Vein Graft Disease Robert M Minutello, Smita Aggarwal, Dmitriy N Feldman, Linda J Cuomo, Christopher L Gade, Issam Moussa, Geoffrey Bergman, Shing C Wong Weill Cornell Medical College, New York, NY Background: Data regarding outcomes following the use of sirolimusHOXWLQJVWHQWV 6(6 IRUWKHWUHDWPHQWRIVDSKHQRXVYHLQJUDIW 69* GLVHDVH LV FRQÀLFWLQJ ZLWK UHFHQW VWXGLHV VKRZLQJ QR FOHDU RYHUDOO EHQH¿W RI 6(6 compared to bare metal stents (BMS). Methods: :H FRPSDUHG WKH ORQJWHUP VDIHW\ DQG HI¿FDF\ RI 6(6 LQ 69* lesions in 59 consecutive patients immediately after the approval of SES (March, 2003) to 50 consecutive patients who received BMS in an equivalent time period immediately prior to SES approval. Results:Baseline demographic, clinical, and angiographic variables (including DJH YV \HDUVROG 4&$PHDVXUHG69*FDOLEHU YV PP ODUJHVW VWHQWEDOORRQ GLDPHWHU YV PP /9() YV DQG PCI in setting of an MI (17% vs 24%)) were similar between the two groups DOOS 16 ZLWKWKHH[FHSWLRQRIJUDIWDJHEHLQJVLJQL¿FDQWO\ROGHU YV 9.4 years) and average stent length being longer (26 vs. 21 mm) in the SES vs BMS cohort (both p<0.05), all respectively. Mean time to follow-up was similar in both groups (30 months). At one year, patients who received a SES showed a trend (p=0.1) towards a decrease in MACE (24% vs. 36%) driven by target vessel failure, with no difference in mortality rates (9% vs 10%). +RZHYHUDWIROORZXSDFR[SURSRUWLRQDOKD]DUGVPRGHOGLGQRW¿QG6(6WR EHDVLJQL¿FDQWLQGHSHQGHQWQHJDWLYHSUHGLFWRURI0$&( 25 S
The American Journal of Cardiology® |
October 12-17, 2008
| TCT Abstracts/ELECTRONIC
http://www.aievolution.com/tct0801
TCT-449
Moreover, Kaplan-Meier survival curves show the early MACE-free survival EHQH¿WREVHUYHGLQWKH6(6FRKRUWWRGLPLQLVKRYHUWLPHZLWKFRQYHUJHQFHRI the survival curves at follow-up.
Pharmacokinetic Study of Custom NX 36 and NX 60, Biolimus A9 Drug Eluting Stent Catheter System: The CUSTOM PK Trial Miodrag Ostojic1, Dragan Sagic2, Uwe Christians3 Clinical Center Serbia, Belgrade, Serbia2Institut for Cardiovascular Disease Dedinje, Belgrade, Serbia, Belgrade, Serbia3University of Colorado, Denver, CO 1
Background: 7KH &XVWRP 1; 'UXJ (OXWLQJ 6WHQW &DWKHWHU 6\VWHP¶V &XVWRP1; DOORZVIRUin situ customization of the stent length and multiple stent deployments within single catheter insertion. This prospective, nonrandomized, multi-center trial was conducted to assess the safety and SKDUPDFRNLQHWLFVRI%LROLPXV$ %$ DQGDELRDEVRUEDEOHSRO\PHU3/$ post implantation of the customized stent in patients with de novo lesions in native coronary arteries. The co-primary endpoints of the study were BA9 circulating blood concentration at 28 days and 6 months post implantation of WKH&XVWRP1;6\VWHP Methods: Twenty-eight patients who met the inclusion and exclusion criteria ZHUH HQUROOHG LQ WKH &86720 3. 7ULDO 3DWLHQWV¶ FKDUDFWHULVWLFV LQFOXGHG DYHUDJH DJH RI SUHYLRXV 0,V SULRU 3&,V Diabetes Mellitus, 78.6% hypertension, 60.7% family history of CAD, and KLVWRU\RIVPRNLQJ1LQHWHHQSDWLHQWVKDGVLQJOHOHVLRQVWUHDWHGDQG nine patients had multiple lesions treated. Blood samples were drawn at 15 WLPHSRLQWVWRGHWHUPLQHWKHSKDUPDFRNLQHWLFVRI%LROLPXV$ DQGFOLQLFDO and safety assessments were performed at six of these 15 time points. Results: The lesion lengths ranged from 8mm to 35mm and the stent lengths UDQJHGIURPPPWRPP7KHDYHUDJHOHVLRQOHQJWKZDV PPDQG DYHUDJHVWHQWOHQJWKZDV PP3DWLHQWV¶PRQWKVIROORZXSKDVEHHQ FRPSOHWHGDQGQRPDMRUDGYHUVHFDUGLDFHYHQWV 0$&( RURWKHUVLJQL¿FDQW cardiovascular events have been reported. Clinical examinations and other laboratory assessments were not indicative of any signs of BA9 toxicity. Blood sample measurements showed that maximum BA9 concentration was reached within 1 hour (60 minutes). BA9 peripheral circulating blood concentration OHYHOV ZHUH TXDQWL¿DEOH LQ DOPRVW DOO WKH SDWLHQWV DW GD\V DQG ZHUH QRW TXDQWL¿DEOHLQDQ\RIWKHSDWLHQWVDWPRQWKV Conclusion: 7KHUHVXOWVVRIDUIXUWKHUHVWDEOLVKDVDIHW\SUR¿OHIRUWKH&XVWRP 1;6\VWHPVIRUWKHLQWHQGHGXVHDQGWKHDEVHQFHRIWR[LFLW\FRQVLGHUDWLRQV regarding systemic exposure to Biolimus A9. The 6-month follow-up clinical GDWD DQG ¿QDO 3. UHVXOWV DQDO\VLV DUH SHQGLQJ DQG ZLOO EH DYDLODEOH IRU presentation at TCT in October 2008.
Conclusion:3&,IRUWKHWUHDWPHQWRI69*GLVHDVHLVDVVRFLDWHGZLWKUHODWLYHO\ high long-term MACE and mortality rates. The use of SES in the treatment RI69*GLVHDVHZKLOHUHGXFLQJ0$&(UDWHVZLWKLQWKH¿UVW\HDUGRHVQRW appear to confer a long-term MACE-free survival advantage over BMS. TCT-448 Clinical Outcome Of Patients Treated By A Last Generation Cobaltchromium Stent In The Drug-eluting Stent Era: Results Of The Skice (Skylor In Real World Practice) Registry France sco Burzotta, Carlo Trani, Daniel Todaro, Mario Attilio Mazzari, Italo Porto, Salvatore Brugaletta, Santiago Coroleu, Maria De Vita, Giampaolo Niccoli, Antonio Maria Leone, Rocco Mongiardo, Giovanni Schiavoni, Filippo Crea Policlinico Gemelli, Roma, Italy
The American Journal of Cardiology®
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October 12-17, 2008
TCT-450 Implantation of Drug-Eluting Stents Compared to Bare Metal Stents After Intracoronary Thrombectomy Roland S Wu1, P Boland1, L Higginbotham1, N Dasgupta1, D Fiscela2, K Sfakianakis2, T Franklin-Bond1, K Morgan1, J Stant1, F Esposito1, Piri G1, M Reilly1, S Duru1, L Rabbani2, S Brar1, G Stone2, M Leon2, J W Moses2, G Dangas2, R Mehran2 1 Columbia University Medical Center, New York, NY; 2Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY Background: 7KH HI¿FDF\ DQG VDIHW\ RI GUXJHOXWLQJ VWHQW FRPSDUHG WR bare metal stent implantation in the setting of thrombectomy has not been investigated. We analyzed our clinical and angiographic experience with stent type use in the setting of intracoronary thrombectomy. Methods: From October 2004 to July 2007, 126 consecutive patients underwent coronary thrombectomy on visible thrombus in addition to stent implantation. A total of 87 patients (69%) received a drug-eluting stent (DES) and 39 patients (31%) received a bare metal stent (BMS). Quantitative coronary angiography was performed blinded to the clinical data. Clinical follow-up was obtained through phone contact up to 1 year post-procedure. 0DMRUDGYHUVHFDUGLDFHYHQWV 0$&( ZHUHGH¿QHGDVDOOFDXVHPRUWDOLW\
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Aims: To assess the clinical outcome in unselected patients treated by a new thin-struts cobalt-chromium bare-metal-stent (BMS) in the drug-eluting-stent (DES) era. Methods and Results: SKICE is a single-centre-registry enrolling patients XQGHUJRLQJ SHUFXWDQHRXV FRURQDU\ LQWHUYHQWLRQV 3&, ZLWK 6N\ORU %06 implantation. Clinical and angiographic characteristics were prospectively collected for all patients treated during the study period. Clinical follow-up up to 9-month was obtained for patients enrolled in the registry. Out of 976 consecutive PCI, 458 (47%) were performed using BMS. According to our institution practice, indications for BMS were 1.any clinical condition potentially limiting compliance (CLC) to double antiplatelet therapy, 2.STHOHYDWLRQ P\RFDUGLDO LQIDUFWLRQ 67(0, RU VDSKHQRXV YHLQ JUDIWV 69* interventions, 3.(in the absence of the previously-cited conditions) lesions FRQVLGHUHG DW ORZ UHVWHQRVLV ULVN VKRUW OHVLRQV ODUJH YHVVHOV QR FKURQLF RFFOXVLRQQRELIXUFDWLRQV 2QHKXQGUHG¿IW\SDWLHQWVZHUHWUHDWHGE\6N\ORU on 169 lesions. Base-line characteristics of SKICE patients were similar to patients treated by other BMS during the study and included complex clinical features (25% diabetes, 11% renal failure, 16% STEMI, 15% CLC). At 9-month all-cause death rate was 1.3%, MI rate 2.7% and clinically-driven target vessel revascularization rate 6.7%, resulting in a 8.0% MACE rate. Conclusion: In the DES era, patients with CLC, STEMI, or non-complex angiographic lesions, may have satisfactory clinical outcome when treated by a last-generation cobalt-chromium BMS.
http://www.aievolution.com/tct0801
myocardial infarction, and target vessel revascularization. Results: Baseline characteristics of the two groups were similar. Mean WKURPEXV DUHD DPRQJVW WKH %06 JURXS ZDV VLJQL¿FDQWO\ KLJKHU YV 29mm2; p=0.02). MACE at 30-days and 1-year were similar between the two groups. (Table)
MACE (cumulative) In-Hospital 30 Day 1 year Death In-Hospital 30 Day 1 year
DES (n=87)
BMS (n=39)
p value
7.7% 9.5% 22%
10% 19% 35%
0.73 0.26 0.34
2.2% 3.2% 3.4%
5.1% 9.5% 18%
0.58 0.26 0.07
E L E C T RO N I C A B S T R AC T S
Conclusion: In this study, despite a larger mean thrombus area amongst SDWLHQWVWUHDWHGZLWK%06ZHIRXQGQRVLJQL¿FDQWGLIIHUHQFHLQRYHUDOO0$&( at 1 year when thrombotic lesions were treated with thrombectomy plus either '(6RU%067KHVHUHVXOWVVXJJHVWWKDWVWHQWW\SHLVQRWDVLJQL¿FDQWSUHGLFWRU of outcomes after thrombectomy of highly thrombotic lesions.
172i
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October 12-17, 2008
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E L E C T RO N I C A B S T R AC T S
Alexander Kypta, Clemens Steinwender, Robert Hofmann, Klaus Kerschner, Simon Hönig, Jürgen Kammler, Franz Leisch Cardiovascular Division General and University Teaching Hospital Linz, Linz, Austria Background: Different trials have demonstrated a dramatic reduction in incidence of in-stent restenosis (ISR) following implantation of drug eluting stents (DES) compared with bare metal stents (BMS). The clinical outcome following successful (no re-restenosis after 6 months) implantation of a DES IRU%06,65LVOHVVZHOOGH¿QHG7KHDLPRIWKLVVWXG\ZDVWRDVVHVVWKHVDIHW\ DQGHI¿FDF\RI'(6 VLUROLPXVDQGSDFOLWD[HO LQWKHWUHDWPHQWRISDWLHQWVZLWK BMS ISR which had angiographicaly less than 50% restenosis at 6 month after implantation of DES. Methods and Results: $OOSDWLHQWV PHDQDJHIHPDOH male) who received a DES (120 sirolimus, 84 paclitaxel) for treatment of BMS ISR from May 2002 - December 2004 at a single institution were entered into a prospectively collected database. Six month angiographic follow-up and long term clinical outcomes (36 - 60 months) were collected. At baseline, the most common target vessel was the left anterior descending coronary artery (41%), and 3% of lesions were in the left main (LM). Multivessel disease was present in 82 (40%) of patients. Saphenous vein grafts were excluded. 7KH PHDQ UHIHUHQFH GLDPHWHU ZDV PP DQG WKH PHDQ OHVLRQ OHQJWKZDVPP7KHUHZDVRQHDFXWHOHWDOVWHQWWKURPERVLVWKUHH days after implantation of a sirolimus stent. No additional procedural or inhospital major adverse cardiac events (MACE - cardiac death, myocardial infarction or target lesion revascularisation) occurred. In patients who were V\PSWRPDWLFDWWKHWLPHRIFRQWUROODQJLRJUDSK\ KDGVLJQL¿FDQW ! UHVWHQRVLV,QDOORIWKHVHSDWLHQWVDQHZ'(6ZDVLPSODQWHG$WWKLV point of time, a paclitaxel eluting stent was implanted in pts. previously treated with a sirolimus eluting stent and vice versa. The six months MACE rate was 12.2%. Of the remaining 179 (100%) patients long term clinical follow-up (3660 months) was available in 177 (98.8%) patients. The 36-60 months MACE rate was 17.4%. Late stentthrombosis occurred in 4 (2.3%) of patients. There were 7 (4%) cardiac death and 3 (1.7%) non cardiac deaths. Conclusion: Stenting of restenosis after BMS using a DES evolves as an option with acceptable short-term and mid-term results. Whether a change of stent type (paclitaxel to sirolimus and vice versa) during treatment of reUHVWHQRVLVLVRIIXUWKHUEHQH¿WKDVWREHGH¿QHG TCT-298 Two-Year Follow-up of a New Zotarolimus-Eluting Stent Ian T Meredith1, Stephen Worthley2, Darren Walters3, Robert Whitbourn4, Peter J Fitzgerald5, Manuela Negoita6, Jeffrey J Popma7, On Behalf of the RESOLUTE Investigators 1 MonashHeart, Southern Health, Clayton, Victoria, Australia 2Royal Adelaide Hospital, Adelaide, Australia 3Prince Charles Hospital, Chermside, Queensland, Australia 4St Vincent’s Public Hospital Melbourne, Fitzroy, Victoria, Australia 5Standford University, Standford, CA; 6Medtronic CardioVascular, Santa Rosa, CA; 7St. Elizabeth Medical Center, Boston, MA Background:Year two of follow-up from drug-eluting stent (DES) clinical WULDOVKDVEHFRPHLPSRUWDQWLQDVFULELQJULVNEHQH¿WSUR¿OHV7KH(QGHDYRU Resolute is a zotarolimus-eluting stent (ZES), which incorporates the hydrophilic BioLinx polymer to maximize biocompatibility while minimizing
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LQÀDPPDWLRQ$W\HDUWKH5HVROXWHZDVDVVRFLDWHGZLWKRQO\7/5HYHQW DQG VLJQL¿FDQWO\ ORZ ODWH OXPHQ ORVV ZKHQ FRPSDUHG ZLWK DQ KLVWRULFDO control. Two-year follow-up will be completed in June 2008. Methods:7KLV ¿UVWLQKXPDQ HYDOXDWLRQ RI WKH (QGHDYRU 5HVROXWH =(6 enrolled 130 patients with documented ischemia and single and multi-vessel disease from 12 centers in Australia and New Zealand. Patients were to be treated for only a single de novo OHVLRQPPDQGPPLQOHQJWKLQ FRURQDU\DUWHULHVZLWKDUHIHUHQFHYHVVHOGLDPHWHUEHWZHHQPPDQG PP)RUSDWLHQWV4&$DQG,986ZHUHSHUIRUPHGDWPRQWKVDQG IRUSDWLHQWV4&$DQG,986ZHUHSHUIRUPHGDW PRQWKV7KHSULPDU\ endpoint was in-stent late lumen loss at 9 months post-procedure by QCA. The Endeavor II treatment cohort was used as a control. Key secondary endpoints included, MACE at 30 days, 4 (4-month subset patients only), 6, 9, and 12 months post-procedure; acute device, lesion and procedure success; DQJLRJUDSKLFLQVWHQWDQGLQVHJPHQWSDUDPHWHUV 79)DQG7/5DW PRQWKV DQGQHRLQWLPDOK\SHUSODVWLFYROXPHDQGSHUFHQWYROXPHREVWUXFWLRQLQ,986 subsets. Clinical follow-up is planned through 5 years. Results: Of 131 lesions treated (one patient had 2 lesions treated), mean OHQJWKZDV PP UDQJH ZHUH%&DQG of patients had multivessel disease. Mean late lumen loss at 9 months was PPLQVWHQWDQGPPLQVHJPHQW 1 $W\HDU WKHFXPXODWLYHLQFLGHQFHRI7/579)DQG0$&(ZHUHDQG 8.5%, respectively. Conclusion: The RESOLUTE study enrolled patients with longer and more complex lesions than in previous ZES randomized trials. There were no early RUODWHSURWRFROGH¿QHGVWHQWWKURPERVLVHYHQWV7KH(QGHDYRU5HVROXWH=(6 was shown to be safe and effective for the treatment of obstructive coronary GLVHDVHWKURXJK\HDUIROORZXS:HSODQWRUHSRUWWKHNH\\HDUFOLQLFDO outcomes in October 2008. TCT-299 Long Term Outcome After Des Implantation: Restenosis And Progression Of Atherosclerotic Disease Massimo Fineschi, Tommaso Gori, Giuseppe Sinicropi, Stefano Casini, Alessandro Iadanza, Arcangelo Carrera, Carlo Pierli U.O.Emodinamica Azienda Ospedaliera-Universitaria Senese, Siena, Italy Background: Drug eluting stents (DES) reduce intimal hyperplasia as well as clinical and angiographic restenosis improving event-free survival. However,recurrent angina after percutaneous coronary intervention remains a challenging problem especially in consideration of the increasing complexity of the revascularization procedures being performed in real-world practice. We examined DES outcome in unselected patients in order to identify the relative clinical importance of stented-segment lesion recurrence (in-segment restenosis or thrombosis) compared to the development of arterial lesions in other coronary segments (disease progression). Methods: Between May 2002 and December 2006, 3672 DES (sirolimus and paclitaxel-eluting stents) were implanted in 2626 patients in our tertiary center. Our registry enrolled all patients who had a clinically-driven new percutaneous procedure for restenosis or disease progression. A total of 166 patients (6.3%; 123 males, mean age 65+/-10years) were recruited at a minimum follow-up time of 12 months after the index procedure. Results: Of these patients who underwent a second procedure, 72% were diabetics, 63% were hypertensives, 68% had hypercholesterolemia. Seventy¿YHSDWLHQWV XQGHUZHQWWKHVHFRQGSURFHGXUHIRUGLVHDVHSURJUHVVLRQ the remaining ninety-one (55%) showed in-segment restenosis. Patients showing disease progression returned at a mean of 16+/-11 months. The large majority (61 patients, 81%) of these patients returned with stable angina and/ or a positive stress test. While patients with in-segment restenosis returned at a similar time after the index procedure (mean 15+/-12 months), their presentation was absolutely different, with a predominance of unstable coronary syndromes (70 patients or 77%) over stable angina or inducible ischemia (21 patients, 23%). This difference between groups was statistically VLJQL¿FDQW 3 E\&KLVTXDUH 7KHWLPLQJRIWKHSUHVHQWDWLRQIRUERWK
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with documented OSA (diagnosed by polysomnography) treated with contemporary PCI between 9/2002 and 4/2007 were enrolled and 126 CAD patients without OSA were grouped as controls. All patients were implanted ZLWK'(6VIRURYHUWFRURQDU\VWHQRVLV ! &OLQLFDOSDUDPHWHUVWKHVWHQW type, stent length, and number as well as lesion complexity were collected and all main adverse cardiac events (MACE) including cardiac death, heart failure, recurrent angina pectoris and myocardial infarction from PCI procedure to 1-year follow-up were recorded. Association of OSA with MACE was analyzed by multivariate logistic regression. Results: Plasma levels of triglyceride, white blood cell counts, body mass LQGH[DQGUDWLRRIGLDEHWHVZHUHVLJQL¿FDQWO\KLJKHULQ26$SDWLHQWVWKDQWKDW LQFRQWUROV 3 UHVSHFWLYHO\ 7KHSUHYDOHQFHRIK\SHUWHQVLRQVPRNLQJ family history of CAD, stent types, stent length, and numbers as well as OHVLRQ FRPSOH[LW\ ZHUH QRW VLJQL¿FDQWO\ GLIIHUHQW EHWZHHQ WZR JURXSV DOO S! 0$&(LQ26$DQGFRQWUROVZHUHFDUGLDFGHDWK KHDUWIDLOXUH (6,3), recurrent angina pectoris (14,4) and myocardial infarction (4,2). Patients ZLWK26$DIWHU3&,ZLWK'(6VKDGDVWDWLVWLFDOO\VLJQL¿FDQWLQFUHDVHGQXPEHU of recurrent angina pectoris (C2=5.983, p=0.014) and MACE (C2=8.296, p=0.004) on 1-year follow-up when compared with controls. Multivariate analysis revealed that OSA (OR:2.320, 95%CI 1.198~4.726, p=0.006) was an independent predictor of 1-year prognosis in CAD patients treated with DESs. Conclusion: At 1 year follow-up, CAD patients with OSA suffered from KLJKHU ULVN RI UHFXUUHQW DQJLQD SHFWRULV DQG FRPSOH[ 0$&( HYHQ WUHDWHG with DESs.
JURXSVRISDWLHQWVVKRZHGDELPRGDOSDWWHUQZLWKDSHDNDWPRQWKVDQG DQRWKHUSHDNDURXQGPRQWKVDIWHUWKHLQGH[SURFHGXUH Conclusion: The need for a new percutaneous procedure in patients treated with DES is relatively low (6.3%) in a real-world setting. In-segment restenosis and disease progression account to a similar extent although their clinical SUHVHQWDWLRQ LV VWULNLQJO\ GLIIHUHQW 7KH PRVW FRPPRQ SUHVHQWDWLRQ RI LQ VHJPHQWUHVWHQRVLVLVDQXQVWDEOHV\QGURPHFRQ¿UPLQJWKDWUHVWHQRVLVLQD DES is not a clinically benign entity. TCT-300 Low Incidence of Stent Thrombosis in Asian Races: Multicenter Registry in Asia 3 Years Follow-Up Result Sunao Nakamura1, Hisao Ogawa2, Shotaro Nakamura1, Jang-Ho Bae3, Yeo Hans Cahyadi4, Wasan Udayachalerm5, Damras Tresukosol6, Sudaratana Tansuphaswadikul7 1 New Tokyo Hospital, Chiba, Japan 2Kumamoto University Hospital, Kumamoto, Japan 3Konyang University Hospital, Daejeon, Republic of Korea 4Husada Hospital, Jakarta, Indonesia 5King Chulalongkorn Memorial Hospital, Bangkok, Thailand 6Her Majesty’s Cardiac Center, Siriraj Hospital, Bangkok, Thailand 7Chest Disease Institute, Bangkok, Thailand Background: There are limited data about stent thrombosis which is rare but devastating complication after drug-eluting stent (DES) implantation in unselected patients with a variety of coronary lesions. The aim of this study was to evaluate the frequency, predictors and the clinical outcome of stent thrombosis after DES implantation and bare metal stent (BMS) implantation in Asian races. Method: A total of 14,577 consecutive patients who underwent successful DES implantation (8,809 patients, 62% of the lesion with Sirolimus-eluting stent: SES, 38% of the lesion with paclitaxel-eluting stent: PES) and BMS implantation (5,768 patients) in 5 Asian high volume PCI center during March 2002 to March 2004 were included in this study. We evaluate the frequency, predictor and clinical outcome of stent thrombosis in our multi-center registry of Asian races. Results: $WDPHDQIROORZXSRIPRQWKVLQ'(6DQG PRQWKVLQ%067KHFXPXODWLYHLQFLGHQFHRIVWHQWWKURPERVLVZHUH subacute stent thrombosis (SAT): 0.5% with DES and 0.6% with BMS, late stent thrombosis (LAST): 0.2% with DES and no with BMS, very late stent WKURPERVLV 9/$67 SHU\HDUZLWK'(6DQGQR%06,QGHSHQGHQW predictors of stent thrombosis are bifurcation lesion (OR=1.90, 95% CI: 1.83 to 24.24, p=0.01) and ejection fraction (OR=0.90, 95% CI: 0.86 to 0.94, p=0.03). Only 0.2 % of the patients were died because of the myocardial infarction after stent thrombosis in both groups. Conclusion: The incidence of stent thrombosis in Asian races is relatively low (0.5 % with DES and 0.6% with BMS of SAT, 0.2% increase per year with DES of late stent thrombosis) at mean follow-up more than 3 years. Particular attention will need to be directed to this complication when the patients have bifurcation lesions or low ejection fraction.
TCT-302 Comparison of Stent Delivery Balloon Withdrawal Forces (Bare Metal vs. CYPHER vs. TAXUS Liberte): “Sticky” SIBS Polymer Causes Balloon Withdrawal Issues With TAXUS DES Tim Fischell, Marvee Turk Borgess Heart Institute, Kalamazoo, MI
TCT-301 Obstructive Sleep Apnea Predicts Prognosis in Patients Undergoing Percutaneous Coronary Intervention with Drug-eluting Stents chen zhong1, Genshan Ma1, Fangyi Xie2, Yi Feng1 'HSDUWPHQWRI&DUGLRORJ\WKH$I¿OLDWHG=KRQJ'D+RVSLWDORI Southeast University, Nanjing,Jiangsu, China 2Nanjing Medical University, Nanjing,Jiangsu, China 1
Background: Obstructive sleep apnea (OSA) is associated with an increased ULVN RI DGYHUVH FDUGLDF HYHQWV LQFOXGLQJ FDUGLRYDVFXODU PRUELGLW\ DQG mortality. But the prognostic value of OSA in patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DESs) remains unclear. We are presenting our medium-term following-up results Methods: 126 consecutive coronary artery disease (CAD) patients
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E L E C T RO N I C A B S T R AC T S
Introduction: 7KH 7$;86 /LEHUWp HOXWHV SDFOLWD[HO IURP SRO\ VW\UHQH ELVREXW\OHQHEVW\UHQH 6,%6 7KLV SRO\PHU LV ³WDFN\´ DQG KDV EHHQ DVVRFLDWHGZLWKQXPHURXVUHSRUWVRIFRPSOLFDWLRQVGXHWRGLI¿FXOW\UHPRYLQJ WKHGHÀDWHGVWHQWGHOLYHU\EDOORRQFDWKHWHU )'$0$8'( Objective: The purpose of this study was to determine whether the SIBS polymer ZDV³VWLFN\´DQGDVVRFLDWHGZLWKDQLQFUHDVHGIRUFHUHTXLUHPHQWWRUHPRYHWKH GHÀDWHGVWHQWGHOLYHU\EDOORRQDIWHUVWHQWGHSOR\PHQWFRPSDUHGWRWKH&<3+(5 '(6DQGWREDUHPHWDO/LEHUWpDQG%;9HORFLW\VWHQWVLQDQH[YLYRPRGHO Methods::HDQDO\]HGWKHEDOORRQSRO\PHUVWHQWLQWHUDFWLRQVZLWK7$;86 /LEHUWH /LEHUWH EDUHPHWDO VWHQW QR SRO\PHU FRQWURO &RUGLV¶ &<3+(5 '(6 3(9$ SRO\PHU DQG %; 9HORFLW\ :H PHDVXUHG UHDO WLPH WKHIRUFHUHTXLUHGWRUHPRYHWKHGHÀDWHGVWHQWGHOLYHU\EDOORRQIURP each of these stents in simulated straight (0 degree), curved (30 degree) and sharply curved (75 degree) vessels, in a water bath at 37° C. Results: 70 experiments were performed comparing these 4 stents. The PD[LPXP IRUFH PHDQ UHTXLUHG WR UHPRYH WKH EDOORRQ IURP D 7$;86 /LEHUWp VWHQW D /LEHUWp EDUH PHWDO VWHQW D &<3+(5 '(6 DQG %[ 9HORFLW\VWHQWZHUHOEVOEVOEVDQGOEVUHVSHFWLYHO\ LQ VKDUSO\FXUYHG³VLPXODWHG´YHVVHOV 3YDOXHVZHUHVLJQL¿FDQWIRU7$;86 /LEHUWp KDYLQJ JUHDWHU IRUFHV RI ZLWKGUDZDO LQ FXUYHG DQG YHU\ FXUYHG YHVVHOVFRPSDUHGWRERWKEDUHPHWDODQG&<3+(5'(6 S¶V DQG 0.00001, respectively)
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Conclusion:7KLVVWXG\GHPRQVWUDWHVDKLJKO\VLJQL¿FDQWLQFUHDVHLQIRUFH UHTXLUHGWRUHPRYHWKH7$;86/LEHUWpFRPSDUHGWRWKH/LEHUWpEDUH PHWDO VWHQW RU WKH &\SKHU VWHQW LQ FXUYHG ³YHVVHOV´ 7KHVH REVHUYDWLRQV RI³VWLFNLQHVV´RIWKH6,%6SRO\PHUPD\KHOSWRH[SODLQWKHFRPSOLFDWLRQV UHODWHGWREDOORRQ³ZLWKGUDZDO´LVVXHVREVHUYHGZLWKWKLVGHYLFH TCT-303 Intravascular Ultrasonic, Angioscopic and Histopathological Characterization of Heterogeneous Patterns of Restenosis After Sirolimus-Eluting Stent Implantation -Insights into Potential “Thromborestenosis” PhenomenonYuji Oikawa, Junji Yajima, Shunsuke Matsuno, Tadanori Aizawa The Cardiovascular Institute, Tokyo, Japan Background: Histopathological characterization of DES restenosis remains unclear. Objective To examine restenotic tissue characteristics after sirolimusHOXWLQJVWHQW 6(6 DQGFRPSDUHKLVWRORJLFDODQGFOLQLFDOLPDJH¿QGLQJVZLWK restenosis after bare-metal stent (BMS). Methods: ,986FRURQDU\DQJLRVFRS\ &$6 DQG'&$ZHUHSHUIRUPHGLQ consecutive patients who presented with restenosis after SES (n=13) and BMS (n=8). Histological analyses were performed in the atherectomy samples. Results: Mean time from implantation to restenosis was 10.8 months in the SES YHUVXVPRQWKVLQWKH%067\SLFDOCCEODFNKROH¶¶HFKROXFHQWDSSHDUDQFHE\ ,986ZDVREVHUYHGLQ6(6FDVHDQGFRUUHVSRQGHGWRD¿EULQULFKWLVVXHE\ histology which appeared translucent tissue by CAS (Figure). All restenosis DIWHU%06VKRZHGKRPRJHQRXVORZRULVRHFKRLFDSSHDUDQFHE\,986&$6 did not reveal red thrombus, but showed white thrombus in 6 SES versus 2 BMS (46.2 % vs. 25.0 %, p=0.597). Histology demonstrated various patterns after 6(6LQFOXGLQJWKURPEXV¿EULQLQÀDPPDWRU\LQ¿OWUDWHDQGFROODJHQPDWUL[ rich tissue, while thrombus component was not detected in BMS. Thrombus DQG¿EULQGHSRVLWLRQGHWHFWHGE\HLWKHU&$6RUKLVWRSDWKRORJ\ZHUHREVHUYHG more frequently in SES than in BMS group (92.3 % vs. 37.5 %, p=0.026).
Aim: of our study was to evaluate ST rate on a 5-year clinical follow-up after sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) implantation in daily clinical practice. Methods: We prospectively evaluated 867 patients undergoing DES implantation, 618 patients with SES and 249 with PES, in a single academic center, between april 2002 and April 2004. Results: Multivessel disease was present in 72% of patients, multivessel VWHQWLQJZDVSHUIRUPHGLQORQJ !PP OHVLRQVZHUHWUHDWHGLQ DQGPXOWLSOHVWHQWVSHUOHVLRQZHUHQHHGHGLQ2QDYHUDJHVWHQWV SHUSDWLHQWZHUHLPSODQWHG PHDQVWHQWHGVHJPHQWOHQJWK PPYHVVHO ,,E,,,D LQKLELWRUV ZHUH XVHG LQ ,QWUDYDVFXODU XOWUDVRXQG ,986 guidance was employed in 65% of SES and 50% of PES implantations, and the procedural success rate was 100% in SES and 99% in PES cases. Sixmonth follow-up was performed in all patients, whereas one-year follow-up was completed in 87% patients of the SES group and in 95% of the PES group, DQG¿YH\HDUIROORZXSZDVSHUIRUPHGLQ RI6(6DQG RI3(6SWV We considered that ST occurred when angiographic evidence of thrombus was available, or when patients experienced sudden cardiac death or either STelevation or non-ST-elevation MI through the follow-up period. The overall incidence of ST was 1.3% (0.97% in SES and 2.4% in PES, p=0.05). Of the 12 ST, 2 (16%) were acute, 4 (33%) subacute, 1 (8%) was a late event and 5 YHU\ODWHHYHQWV(OHYHQ67ZHUHFRQ¿UPHGE\DQJLRJUDSK\1R,986 guidance was used in 4/12 (33%) ST patients, while antiplatelet therapy was prematurely discontinued in 4/12 (33%). Among ST patients, mortality and non-fatal myocardial infarction rates were 25% and 42%, respectively. No ST ZDVGLDJQRVHGEHWZHHQVL[DQGWZHOYHPRQWKVZKLOH¿YHWKURPERVLVRFFXUUHG very late (range 390-720 days). Conclusion: The incidence of ST after DES use in daily clinical practice is low and similar to that observed in RCT. Longer lesions and smaller vessels WUHDWHGUHVXOWHGLQDKLJKHUSUHYDOHQFHRI67DPRQJ3(6SWVEXWQRVLJQL¿FDQW differences in cumulative MACE were obtained among SES and PES at 1- and 5-year follow-up. TCT-305
E L E C T RO N I C A B S T R AC T S
Long Term Safety Results From the Endeavor Program: Four-Year Follow-up Laura Mauri1, Donald E Cutlip2, Martin B Leon3, David E Kandzari4, William Wijns5, Jean Fajadet6, Joseph M Massaro7, Wei Guo7, Ian T Meredith8 1 Brigham and Women’s Hospital, Harvard Medical School, Boston, MA; 2 Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; 3 Columbia University Medical Center, New York, NY; 4Scripps Clinic, LaJolla, CA; 5Cardiovascular Centre Aalst, Aalst, Belgium 6Clinique Pasteur, Toulouse, France 7Harvard Clinical Research Institute, Boston, MA; 8MonashHeart, Southern Health, Melbourne, Victoria, Australia Conclusion: Restenosis after SES and BMS have different histological patterns. SES restenosis is heterogeneous and frequently associated with thrombus component. TCT-304 Incidence Of Stent Thrombosis At Five-Year Follow-Up After Sirolimus- And Paclitaxel-Eluting Stent Implantation: A SingleCenter Registry Daniela Trabattoni, Franco Fabbiocchi, Stefano Galli, Piero Montorsi, Luca Grancini, Giovanni Teruzzi, Alessandro Lualdi, Paolo Ravagnani, Cristina Ferrari, Antonio L Bartorelli Centro Cardiologico Monzino, IRCCS, Milan, Italy Background: 7KH VDIHW\ SUR¿OH RI GUXJHOXWLQJ VWHQWV '(6 ZDV predominantly determined in randomized clinical trials (RCT) with narrow inclusion criteria. Concerns about stent thrombosis (ST) have been raised in unselected patients treated with DES.
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Background: Individual randomized controlled trials (RCT) of drug-eluting VWHQWV '(6 KDYHQRWKDGVXI¿FLHQWSRZHUWRFRPSDUHLPSRUWDQWFOLQLFDOHYHQWV beyond 1 year. We analyzed pooled data from 6 trials of the Endeavor DES to compare long term outcomes with the Driver bare metal stent (BMS). Methods: We pooled patient data from 6 trials to compare patients assigned to treatment with the Endeavor DES compared to BMS. Endeavor-treated SDWLHQWV ZHUH SRROHG IURP (1'($925 , Q D ¿UVWLQKXPDQ VWXG\ (1'($925 ,, DQ 5&7 FRPSDULQJ (QGHDYRU Q ZLWK %06 (1'($925,,&RQWLQXHG$FFHVV5HJLVWU\ Q (1'($925,,,DQ RCT comparing Endeavor (n = 323) with a sirolimus-eluting stent (Cypher) DQG(1'($925,9DQ5&7FRPSDULQJ(QGHDYRU Q ZLWKDSDFOLWD[HO HOXWLQJVWHQW 7D[XV DQG(1'($9253. Q IRUDWRWDORISDWLHQWV receiving the Endeavor DES and compared with BMS-treated patients from WKHFRQWURODUPRI(1'($925,, Q 7KHUHFRPPHQGHGPLQLPXP duration of dual antiplatelet therapy (DAPT) in these studies was 3-6 months. Results: The cumulative incidence of each endpoint is reported to 1440 days (4y) (Table). DAPT was extended to 1-2 y in the minority of patients studied in both groups (1 y 29% vs 29%; 2y 11.2 vs 13.5%, DES vs BMS, p=NS).
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$EEUHYLDWLRQV 795 WDUJHWYHVVHOUHLQWHUYHQWLRQ 795UHPRWH 795RXWVLGHWDUJHW OHVLRQ 7/5 7$;86UHODWHGWDUJHWYHVVHOUHLQWHUYHQWLRQ 0, P\RFDUGLDOLQIDUFWLRQ $5&67 $FDGHPLF5HVHDUFK&RQVRUWLXP'H¿QLWH3UREDEOH6WHQW7KURPERVLV Multivariate-adjusted Kaplan-Meier 2-year event rates are shown; unadjusted rates will also be shown at the time of presentation. 1RWHWKDWVLWHPRQLWRULQJLVRQJRLQJ ¿QDOGDWDZLOOEHDYDLODEOHDWWKHWLPHRI presentation. *Treated with oral hypoglycemics or insulin at time of enrollment. Patients with selfreported diabetes not medically treated are included in the non-diabetic cohort.
³+LJKHU5LVN´LQFOXGHVWKHIROORZLQJOHVLRQFKDUDFWHULVWLFVDQGSDWLHQWFRQGLWLRQV ZKLFKDUHH[FOXGHGIURPWKH³/RZHU5LVN´SRSXODWLRQ YHLQJUDIWOHIWPDLQ ELIXUFDWLRQFDUGLRJHQLFVKRFNVHYHUHFDOFL¿FDWLRQGLUHFWVWHQWLQJRIWRWDORFFOXVLRQ WKURPEXVVHYHUHO\WRUWXRXVYHVVHOVWRWDOVWHQWOHQJWK!PP
Table. Cumulative Incidence (%) of Adverse Events Endeavor DES n=2132
Driver BMS n=596
[95% CI]
[95% CI]
Death
4.6
[2.91,6.32]
5.2
[3.20,7.14]
Cardiac Death
1.8
[0.68,2.85]
2.6
[1.16,4.02]
MI
2.7
[1.33,4.01]
4.4
[2.53,6.28]
Cardiac Death/MI
4.3
[2.59,5.92]
7.0
[4.68,9.27]
ST (protocol)
0.5
[0.00, 1.04]
1.2
[0.19,2.16]
ST (ARC Def/Prob)
0.7
[0.01,1.39]
1.5
[0.41,2.64]
Conclusion: 7KLV VWXG\ GHPRQVWUDWHV WKDW WKH 7$;86 3(6 HVVHQWLDOO\ HOLPLQDWHV WKH HIIHFW RI GLDEHWHV RQ UHVWHQRVLV LQGHSHQGHQW RI SDWLHQW ULVN SUR¿OHDQGLVHTXDOO\VDIHDQGHIIHFWLYHLQWUHDWLQJFRURQDU\OHVLRQVLQ'0 and non-DM patients.
Conclusion: In a pooled analysis of over 2132 Endeavor DES-treated patients, 2093 with at least 1 year follow-up and 678 patients with 4 years follow-up, there was no increase in death, cardiac death, MI, or ST compared with BMS. 7KHUHZDVQRLQFUHDVHLQ67ULVNZLWKLQ\HDU YV$5&GHISURE or very late (year 1- 4, 0.1 vs 0.2%), despite low rates of prolonged DAPT in these studies. These analyses will be updated to include 2-year results for 773 additional Endeavor DES patients in October 2008.
TCT-307 Impact Of Stented Segment Length On Long Term Result Of Sirolimus Eluting Stent Implantation: From Two-Year Clinical Outcome Of The j-Cypher Registry
TCT-306
Shinichi Shirai1, Kenji Ando1, Yoshimitsu Soga1, Masahiko Goya1, Hiroyoshi Yokoi1, Masashi Iwabuchi1, Hitoshi Yasumoto1, Hideyuki Nosaka1, Masakiyo Nobuyoshi1, Takeshi Kimura2, Kazuaki Mitsudo3, on behalf of the j-CYPHER Registry investigators 1 Kokura Memorial Hospital, Kitakyusyu, Japan 2Kyoto University Hospital, Kyoto, Japan 3Kurashiki Central Hospital, Kurashiki, Japan
TAXUS Mitigates the Effect of Diabetes on Restenosis Independent RI3DWLHQW5LVN3UR¿OH
DQG ORZHUULVN JURXSV 7ZR\HDU HYHQWV ZHUH DVVHVVHG Multivariate adjustment was performed to correct for baseline differences. Results: Adjusted rates are shown (Table). TLR was similar across groups; in the KLJKHVWULVN'0SDWLHQWV7/5ZDVVLJQL¿FDQWO\lower compared to non-DM. PES yielded comparable MI and ST rates regardless of DM status. Mortality was increased in DM patients in accordance with increased comorbidity. Additional outcomes in subsets of patients with or without prior MI, small vessels, bifurcation lesions, left main and multivessel disease will also be reported. HIGHER-RISK** 795 7955HPRWH --TLR (%) -All Death (%) -MI (%) -ARC ST (%) LOWER-RISK** 795 7955HPRWH --TLR (%) -All Death (%) -MI (%) -ARC ST (%)
Non-Diabetes N=1901 11.3 2.0 8.7 4.6 3.4 2.8 N=3479 7.6 1.8 5.7 3.7 2.1 1.5
Medically-Treated Diabetes* N=702 9.5 1.9 7.3 8.8 4.4 3.3 N=1410 9.9 2.7 7.0 6.4 2.5 1.9
The American Journal of Cardiology®
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P value 0.01 0.53 0.03 <0.001 0.64 0.57 0.10 0.09 0.32 <0.001 0.33 0.15
October 12-17, 2008
Conclusion: Total stented segment length affected the restenosis rates and WKHQHHGIRU7/52QWKHRWKHUKDQGLQFLGHQFHRIVWHQWWKURPERVLVUDWHGLGQ¶W differ according to the total stent length.
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Background: A longer stented segment resulted in a high restenosis rate in Bare Metal Stent (BMS). The advent of Sirolimus Eluting Stent (SES) reduced the rate of restenosis as compared with BMS. In this sub-analysis of the j-Cypher registry, we evaluate the relation between the stent length and the incidence of restenosis and stent thrombosis. Method: Design of the j-Cypher Registry was multi-center prospective enrollment of consecutive patients (pts) receiving SES from 39 centers in Japan. By the end of March, 2008, two-year clinical follow-up data was completed in 11323 pts (14712 lesions) underwent successful implantation of SES. Lesions were devided into four groups according to the implanted VWHQWOHQJWK *URXS6 Q PP7RWDOVWHQW/HQJWK 76/ PP *URXS0 Q PP 76/PP *URXS/ Q PP 76/ PP DQG *URXS9/ Q PP76/ Results:$VFRPSDUHGZLWKWKHSDWLHQWVLQ*URXS6SDWLHQWVLQ*URXS9/ KDGDKLJKHUSUHYDOHQFHRISHULSKHUDODUWHU\GLVHDVHFKURQLFNLGQH\GLVHDVH diabetes and multivessel coronary disease. The restensosis rates through 2 years were 5.19% in Group S, 6.43% in Group M, 11.27% in Group L and LQ*URXS9/7DUJHW/HVLRQ5HYDVFXODUL]DLRQ 7/5 UDWHVDW\HDUV were 3.94% in Group S, 5.23% in Group M, 9.42% in Group L and 12.44% LQ*URXS9/7KHUHZDVQRVLJQL¿FDQWGLIIHUHQFHLQWKHLQFLGHQFHRIVWHQW thrombosis among the four groups (0.54% in Group S, 0.56% in Group M, LQ*URXS/DQG LQ*URXS9/S
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TCT-308 XIENCE™ V, TAXUS®, and ENDEAVOR® Drug Eluting Coronary Stent Systems: Comparison in the Rabbit Iliac Arterial Model Laura E Perkins1, Alexander J Sheehy2, Leslie A Coleman2, Renu Virmani3, Juan F Granada4 1 Abbott Vascular, Mattaponi, VA; 2Abbott Vascular, Santa Clara, CA; 3 CVPath Institute, Inc., Gaithersburg, MD; 4Abbott VascularThe Jack H. Skirball Center for Cardiovascular Research, Orangeburg, NY
E L E C T RO N I C A B S T R AC T S
Background: Commercially available drug eluting stent systems (DES) have GHPRQVWUDWHGSUHFOLQLFDOVDIHW\DQGFOLQLFDOHI¿FDF\+RZHYHUWKHVHGHYLFHV GLIIHUVLJQL¿FDQWO\LQWKHLUEDVHVWHQWDFWLYHGUXJSRO\PHUFDUULHUDQGHOXWLRQ SUR¿OHZKLFKFDQLPSDFWWKHYDVFXODUUHVSRQVHDVVRFLDWHGZLWKHDFKGHYLFH Comparison of these vascular responses in an established preclinical model can further our understanding as to the safety, biocompatibility, and projected HI¿FDF\RIWKHVHDQGQH[WJHQHUDWLRQ'(6 Methods: 6LQJOH [ PP HYHUROLPXV HOXWLQJ ;,(1&(TM 9 $EERWW 9DVFXODU 6DQWD &ODUD &$ ((6 SDFOLWD[HO HOXWLQJ 7$;86 /LEHUWp® %RVWRQ6FLHQWL¿F1DWLFN0$ 3(6 DQG]RWDUROLPXVHOXWLQJ(1'($925® 0HGWURQLF 9DVFXODU 6DQWD 5RVD &$ =(6 FRURQDU\ VWHQW V\VWHPV ZHUH implanted in rabbit iliac arteries at a 1.1:1 balloon:artery ratio. Arteries were explanted at either 28 days or 60 days (n = 2 for each arm at each time point) and evaluated by light microscopy. Results: 1HRLQWLPDOWKLFNQHVVDQGDUHDDQGVWHQRVLVWUHQGHGORZHUIRU((6 PP PP2 DVFRPSDUHGZLWK3(6 PP PP2 DQG=(6 PP PP2 )LEULQGHSRVLWLRQZDVJUHDWHUIRU((6 DQG3(6 DVFRPSDUHGZLWK=(6 DW GD\VDQGZDVODUJHO\UHVROYHGE\GD\V UHVSHFWLYHO\ $WERWKDQGGD\VLQÀDPPDWLRQZDVORZLQUHODWLRQWR ((6 DQG3(6 EXWZDVKLJKHU IRU=(6 GXHWRWKHSUHVHQFHRIPDFURSKDJHVDQG multinucleated giant cells associated with the delamination of PC polymer visible in histological sections. Conclusion: Histological evaluation of rabbit iliac arteries implanted with ;,(1&(TM 9 7$;86® DQG (1'($925® stents reveals noteworthy differences in their associated vascular responses. These differences can EH UHODWHG EDFN WR WKH LQWULQVLF GHVLJQ IHDWXUHV IRU HDFK RI WKHVH GHYLFHV HVSHFLDOO\ ZLWK UHVSHFW WR WKH HOXWLRQ SUR¿OH DQG SRO\PHU FDUULHU 7D[XV /LEHUWp® is neither approved nor available for sale in the U.S. TCT-309 The Unrestricted Use of Sirolimus-eluting Stents: 5-year Results of the RESEARCH Registry Ron T van Domburg1, Neville Kukreja1, Hector Garcia-Garcia2, Joost Daemen1, Yoshinobu Onuma1, Patrick W Serruys1 1 Erasmus Medical Center, Rotterdam, Netherlands 2Cardialysis, Rotterdam, Netherlands Background: Although the safety of drug-eluting stents (DES) has been under scrutiny, limited follow-up data up to 5 years are available, particularly among real-world patients. Therefore, we evaluated the 5-year clinical event rates in patients from the The Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) registry to establish the safety DQG HI¿FDF\ RI VLUROLPXVHOXWLQJ VWHQW 6(6 LQ DQ XQVHOHFWHG DOOFRPHU population. Methods: On April 16, 2002, our institution commenced the use of SES &\SKHU &RUGLV&RUSRUDWLRQ0LDPL/DNHV)ORULGD DVWKHGHIDXOWVWUDWHJ\IRU DOOSHUFXWDQHRXVFRURQDU\LQWHUYHQWLRQVDWRXULQVWLWXWLRQ,QWKH¿UVWPRQWKV of enrollment, 508 patients with de novo lesions were treated exclusively with SES (the SES group) and compared with a group of 450 consecutive patients treated with BMS for de novo lesions in the preceding 6 months (the preSES group), matched for stent diameter. Survival data was acquired from
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municipal civil registries. Questionnaires have been sent to all living patients to obtain data on adverse clinical events. Medical records will be reviewed and family doctors or referring cardiologists contacted as necessary. The primary end-point was composite major adverse events (MACE: all-cause death, P\RFDUGLDOLQIDUFWLRQRUWDUJHWYHVVHOUHYDVFXODUL]DWLRQ>795@ 6HFRQGDU\ HQGSRLQWVLQFOXGHGDOOFDXVHGHDWK795DQGVWHQWWKURPERVLV$SURSHQVLW\ score-adjustment will be performed to compensate for differences in baseline characteristics between the groups. Results: At 5 years follow-up survival status was available for 94% of the patients. The 5-year all-cause mortality rates were 14.0% for SES and 13.4% for BMS S &XPXODWLYH0$&(ZDVIRXQGWREHVLJQL¿FDQWO\ORZHULQWKH6(6JURXS YV DGMXVWHG+5 &,WR DVZHUHWKHUDWHVRI795 (12.2% vs 17.8%, adjusted HR 0.57, 95%CI 0.39 to 0.83). There was no difference in overall stent thrombosis(2.3% vs 2.2%), p=1.0). Conclusion: There is no difference in the 5-year survival rates in the realworld unselected patients treated with SES, compared with BMS. TCT-310 The Unrestricted Use of Everolimus-Eluting Stents for De-novo coronary lesions: The Xience V Stent Evaluated At Rotterdam Cardiology Hospital (X-SEARCH) Registry Ron T van Domburg, Yoshinobu Onuma, Neville Kukreja, Joost Daemen, Nieves Gonazapolez, Nicolo Piazza, Pim de Feijter, Wim van der Giessen, Evelyn Regar, Martin van der Ent, Peter de Jaegere, Patrick W Serruys Erasmus Medical Center, Rotterdam, Netherlands Objective: Everolimus-eluting stents (EES) have been shown to be effective in the context of randomized trials with selected patients. However, the effect of EES implantation in more complex, unselected patients cannot be directly H[WUDSRODWHG IURP WKHVH ¿QGLQJV :H VRXJKW WR HYDOXDWH WKHLPSDFWRIWKLV second generation DES in comparison to bare metal, sirolimus-eluting and paclitaxel-eluting stents (BMS, SES and PES respectively) on the short-term clinical outcomes in a real-life all-comer population. Methods: Since March 2007, our institution commenced the use of EES ;LHQFH9 $EERWW9DVFXODU DVWKHGHIDXOWVWUDWHJ\IRUHYHU\3&,%HWZHHQ 1st March and 31st October 2007, 649 consecutive patients presenting with de novo lesions were treated exclusively with EES. These patients were compared to 3 historical cohorts of consecutive patients; 450 patients treated with bare metal stents (BMS), 508 with sirolimus-eluting stents (SES) and 576 paclitaxel-eluting stents (PES) from the RESEARCH and T-SEARCH registries. Six month survival data is currently acquired from municipal civil registries and questionnaires are currently being sent to all living patients to obtain data on adverse clinical events. Medical records will be reviewed and referring cardiologists will be contacted if necessary. Results: ((6 SDWLHQWV ZHUH VLJQL¿FDQWO\ ROGHU %06 \UV 6(6 \UV PES:62 yrs, EES:64 yrs, p<0.01) and presented more frequently with STHOHYDWLRQ 0, YV YV YV S :LWKLQ WKH ¿UVW month, there were 50/2163 deaths (2.3%); the mortality rates in the BMS, SES, PES and EES groups were 2.0%, 1.6%, 1.6% and 3.8% respectively (p=0.03). Unadjusted analysis revealed that STEMI was a strong predictor of 30 day mortality (HR 10.7, 95%CI 5.4-21.3). Increasing age was also predictive (HR 1.03, 95%CI 1.00-1.08), whilst treatment with EES was associated with with DQRQVLJQL¿FDQWWUHQGWRZDUGVKLJKHUGD\PRUWDOLW\ +5 &, 0.8-6.9). After adjustment for STEMI and age, this trend was less apparent (HR1.3, 95% CI 0.7-2.3). Conclusion:$IWHUGD\VWKHUHZHUHQRVLJQL¿FDQWGLIIHUHQFHVLQPRUWDOLW\ between BMS, SES, PES and EES. Data on 6-month mortality and clinical events are currently being collected and will be presented at the time of the meeting.
The American Journal of Cardiology® |
October 12-17, 2008
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TCT-311
VDIHW\DQGHI¿FDF\RIEDUHPHWDOVWHQWV %06 DQG'(6 Methods: From 2000-2005, 5869 consecutive patients underwent PCI for de novo coronary stenoses. This single-center registry consists of 3 sequential groups of consecutive patients treated with BMS (n=2194; 2000-2002), sirolimus-eluting stents (SES, n=834; 2002-2003) and paclitaxel-eluting stents (PES, n=2841; 20032005). Annual follow-up on the occurrence of death (obtained from municipal civil registries) and clinical events were collected. The values for the 20th, 40th, 60th and 80th age percentiles were 51.8, 58.4, 65.4 and 73.0 years respectively. The patient SRSXODWLRQZDVVXEVHTXHQWO\VWUDWL¿HGLQWRDJHJURXSVXVLQJWKHVHFXWRIIYDOXHV The primary endpoint was all-cause mortality. Secondary endpoints included WDUJHWYHVVHOUHYDVFXODUL]DWLRQ 795 DQGFRPSRVLWHPDMRUDGYHUVHFDUGLDFHYHQWV 0$&(GH¿QHGDVDOOFDXVHGHDWKQRQIDWDOP\RFDUGLDOLQIDUFWLRQRU795 Results: Complete follow-up was available for 98.6%, with a median duration of follow-up of 1366 days (interquartile range [IQR]: 962-1797). The all-cause PRUWDOLW\ZDVVLJQL¿FDQWO\KLJKHULQWKHHOGHVWJURXSV *URXS*URXS *URXS*URXS *URXS 795UDWHVZHUHVLPLODU across all age groups, with similar reductions with DES compared to BMS: Group 1 adjusted HR 0.63 (95%CI 0.40-0.99), Group 2 HR 0.35 (95% CI 0.220.55), Group 3 HR 0.44 (95%CI 0.27-0.71), Group 4 HR 0.59 (95%CI 0.38-0.93) and Group 5 HR 0.64 (0.40-1.02). DES also reduced overall MACE and showed a trend towards reduced mortality in all age groups when compared to BMS. Conclusion: Although all-cause mortality rates are higher in older patients, DES are safe and effective when compared to BMS, irrespective of age.
The Impact Of The Number Of Off-Label Characteristics Per Patient On the MACE Rates In The Sort Out II Trial Anders M Galløe1, Jens F Lassen2, Henning Kelbæk3, Per Thayssen4, Klaus Rasmussen5, Niels Bligaard1, Leif Thuesen2, Ulrik Abildgaard1, Henning R Andersen2, Thomas Engstrøm1, Sten D Kristensen2, Jensen S Jensen1, Lars R Krusell2, Søren Galatius1, Hans E Bøtker2, Jan K Madsen1, Evald H Christiansen2, Sten Z Abildstrøm1, Ghita B Stephansen1, Peter R Hansen1 1 Gentofte University Hospital, Hellerup, Denmark 2Skejby University Hospital, Aarhus, Denmark 3Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark 4Odense University Hospital, Odense, Denmark 5Aalborg University Hospital, Aalborg, Denmark Background::KHQWKH¿UVWWZRGUXJHOXWLQJVWHQWVZHUHUHOHDVHGIRUJHQHUDO use the Food and Drug approval related to the use in certain patients and lesions - the so called on-label characteristics. In everyday clinical practice the stents are used on a much broader spectrum of patients and lesions - the so called off-label characteristics. The present investigation correlates the number of off-label characteristics in each patient to the rate of Major Adverse Cardiac Events (MACE). Methods:7KH SDWLHQWVDQGWKHGH¿QLWLRQRI0$&(LQWKH6RUW2XW,, trial have been extensively described in JAMA 2008; 299: 409-16. Patients had a follow up ranging from 1½ to 3½ years. 18 different off-label characteristics were registered in the trial at inclusion time. Results: Compared to patients with zero off-label characteristics, increasing numbers of off-label indications correlated to stepwise increasing MACE UDWHV ORJUDQN WHVW IRU WUHQG FKL VTXDUH S 7KH 0$&( UDWHV were 25.4% for patients with at least 5 off-label characteristics and 11.9% for SDWLHQWVZLWK]HURRIIODEHOFKDUDFWHULVWLFV ORJUDQNWHVW+D]DUG5DWLR 95% CI 1.30 to 4.00, p<0.04).
TCT-313 Clinical and Angiographic Outcomes of Cardiac Allograft Vasculopathy Treated With Drug-Eluting Stents Versus Bare-Metal Stents Tonga Nfor, Imraan Ansaarie, Mohammad Khalil, Anthony DeFranco, Anjan Gupta, Tanvir Bajwa, Suhail Allaqaband Aurora Sinai/Aurora St. Luke’s Medical Centers, University of Wisconsin School of Medicine and Public Health-Milwaukee Clinical Campus, Milwaukee, WI
Conclusion: With increasing number of off-label characteristics in each patient the MACE rates increased in a stepwise fashion. The number of off ODEHOFKDUDFWHULVWLFVLQHDFKSDWLHQWLVDSURJQRVWLFPDUNHUIRUWKHGHYHORSPHQW of MACE and may be used to determine the need for enhanced clinical follow up or prolonged anti platelet treatment. TCT-312 Contemporary Percutaneous Coronary Intervention in Different Age Groups Neville Kukreja, Yoshinobu Onuma, Hector Garcia-Garcia, Joost Daemen, Ron van Domburg, Patrick Serruys Thoraxcenter, Rotterdam, Netherlands Background: $OWKRXJK WKH EHQH¿W RI SHUFXWDQHRXV FRURQDU\ LQWHUYHQWLRQ 3&, LQWKHHOGHUO\LVZHOOHVWDEOLVKHGGDWDRQWKHVDIHW\DQGHI¿FDF\RIGUXJ eluting stents (DES) in these patients is limited. As the global population ages, this subgroup of patients will form an increasing proportion of patients undergoing PCI. We therefore analysed all patients undergoing PCI for de QRYRVWHQRVHVLQRXWLQVWLWXWLRQVWUDWL¿HGE\DJHWRLQYHVWLJDWHWKHUHODWLYH
The American Journal of Cardiology®
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October 12-17, 2008
Conclusion: This study suggests DES are more effective than BMS in SUHYHQWLQJ,65DIWHU3&,RQ&$9ZKHQYHVVHOGLDPHWHULVPP
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E L E C T RO N I C A B S T R AC T S
Background:&DUGLDFDOORJUDIWYDVFXORSDWK\ &$9 LVWKHOHDGLQJFDXVHRI GHDWK DIWHU WKH ¿UVW \HDU IROORZLQJ KHDUW WUDQVSODQW 'LIIHUHQFH LQ FOLQLFDO and angiographic outcome of drug-eluting stents (DES) vs bare-metal stents %06 LVXQNQRZQ:HFRPSDUHGUHVWHQRVLVWDUJHWYHVVHOUHYDVFXODUL]DWLRQ 795 DQGPRUWDOLW\LQWUDQVSODQWUHFLSLHQWVWUHDWHGZLWK'(6DQG%06 Methods: All patients from our heart transplant registry who had PCI with VWHQWLQJIRU&$9ZHUHLGHQWL¿HG:HWUDFNHGSURFHGXUDODQGEDVHOLQHFOLQLFDO characteristics and follow-up data on yearly coronary angiography, cardiac events and death. Primary outcome was 12-month in-stent restenosis (ISR). Secondary RXWFRPHVZHUHLQVHJPHQWUHVWHQRVLV795DQGDOOFDXVHPRUWDOLW\ Results: Total 40 DES (in 25 pts) were compared with 37 BMS (19 pts). There ZHUH QR VLJQL¿FDQW GLIIHUHQFHV LQ EDVHOLQH FKDUDFWHULVWLFV 7ZHOYHPRQWK incidence of ISR was 0% with DES vs. 12.9% with BMS (p=0.03). On longWHUPIROORZXSWKLVGLIIHUHQFHZDVVLJQL¿FDQWIRUYHVVHOVPPLQGLDPHWHU but ISR was uncommon, irrespective of stent type, in larger vessels. Rates of in-segment restenosis were similar, Cox regression hazard ratio DES vs. BMS +5 &,WR S 795UDWHVZHUHDOVRVLPLODU +5 &,WR S 7KHUHZDVQRVLJQL¿FDQWGLIIHUHQFHLQRYHUDOO mortality: HR 0.75 (95% CI 0.23 to 2.90) p=0.74.
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TCT-314 Differential Healing in Paclitaxel and Sirolimus-Eluting Stents in Combination with Oral PPAR Gamma Agents: The Importance of Drug Interaction in Delayed Healing Aloke V Finn1, Michael C John2, Gaku Nakazawa3, Chitra Raghunathan1, Tucker Ezell1, Scott Lajoie2, Xin Xu3, Qi Cheng3, Frank Kolodgie3, Renu Virmani3, Herman K Gold2 1 Emory University, Atlanta, GA; 2Massachusetts General Hospital, Boston, MA; 3CVPath, Gaithersburg, MD Drug eluting stents (DES) contain different pharmacologic agents, yet the clinical UHOHYDQFHRIWKLVLVXQNQRZQ2YHUODSH[LVWVEHWZHHQWKHPROHFXODUWDUJHWVRI sirolimus (SRL) (i.e. PI3K/mTOR) and many agents used to treat diabetes (DM). %HFDXVHSDFOLWD[HO 3$& ZRUNVWKURXJKRWKHUPHFKDQLVPVLWPLJKWDYRLGWKLV issue. The impact of interactions between eluted drug and commonly used DM PHGVRQKHDOLQJUHPDLQVXQNQRZQ,QUDEELWVUHFHLYLQJEDUH %06 3$&DQG SRL DES, we investigated the effect of oral PPAR gamma agents, rosiglitazone (RSG) and pioglitazone (Pio), on stent endothelialization (ENDO). Methods: Rabbits were randomized to SRL, PAC or BMS and to placebo (PLC) YHUVXV56* PJNJGD\ RU3LR PJNJGD\ $QLPDOVZHUHVDFUL¿FHGDW 28 days and arteries evaluated by scanning electron microscopy (SEM). Cell culture experiments used human aortic endothelial cells (HAEC). Results:56*VLJQL¿FDQWO\UHGXFHG(1'2RIWKHVWHQWE\6(0LQDQLPDOV receiving SRL vs. PLC, but no differences were seen in animals receiving PAC or BMS (table). Similar results were seen in animals randomized to Pio vs. PLC (table). QRT-PCR revealed that SRL inhibited upregulation of heme oxygenase, a PPAR target gene, by RSG and suggests that in addition translational regulation, sirolimus may inhibit PPAR activity.
infarction (STEMI). We compared the mid- to long-term outcomes of DES versus BMS in unselected patients with STEMI in a real-world setting. Methods: We analyzed 684 consecutive patients with STEMI that underwent percutaneous coronary intervention (PCI) at two centers in Korea from January 2003 to December 2006; 540 patients (78.9%) with DES and 144 (21.1%) with BMS. Patients were followed for the occurrence of target vessel IDLOXUH 79) DFRPSRVLWHRIFDUGLDFGHDWKQRQIDWDOP\RFDUGLDOLQIDUFWLRQ 0, DQGWDUJHWYHVVHOUHYDVFXODUL]DWLRQ 795 Results: Among baseline characteristics, dyslipidemia was more common, and implanted stents were smaller in diameter and longer in length in the DES JURXSWKDQLQ%06JURXS$IWHUDPHGLDQIROORZXSRIPRQWKVWKH 79)UDWHZDVVLJQL¿FDQWO\GHFUHDVHGLQWKH'(6JURXSFRPSDUHGZLWKWKH BMS group (16.8% vs. 36.5%; HR, 0.37; 95% CI, 0.24 to 0.60; P<0.001), ZKLFK ZDV PDLQO\ GXH WR D UHGXFWLRQ LQ 795 YV P<0.001). In particular, DES outperformed BMS in those with multivessel disease (18.8% vs. 45.6%, P DQGLQWKRVHZLWKVWHQWGLDPHWHUPP vs. 49.3%, P<0.001). Rigorous adjustment with the use of propensity sore PDWFKLQJFRQFRUGDQWO\LQGLFDWHGDEHQH¿WRI'(6ZLWKUHJDUGWR79) vs. 38.8%; HR, 0.42; 95% CI, 0.25 to 0.71; P=0.001). We also found that the stent thrombosis (ST) rates were comparable between the two groups (4.3% vs. 4.1%, P=0.748), however, 3 cases of very late ST occurred exclusively in the DES group. Furthermore, for STEMI patients receiving DES, interruption of dual antiplatelet therapy (DAT) within 6 months was a strong predictor of a composite of death and MI (HR, 7.19, 95% CI, 2.18 to 23.74; P=0.001). +RZHYHUWKHUHZDVQRVWDWLVWLFDOO\VLJQL¿FDQWEHQH¿WRISURORQJHGGXUDWLRQ of DAT over 12 months (HR, 0.51; 95% CI, 0.22 to1.19; P=0.118). Conclusion: In unselected patients with STEMI, DES compared with BMS, VKRZHGVXSHULRUPLGWRORQJWHUPHI¿FDF\LQZLWKUHJDUGWR79)PDLQO\ GULYHQE\DUHGXFWLRQRI795ZKLOHVKRZLQJFRPSDUDEOHVDIHW\SUR¿OHV TCT-316 ,QÀDPPDWLRQ,QKLELWRU\(IIHFWV3RO\PHUIUHH$QG3RO\PHUFRDWHG Paclitaxel-eluting Stents On Il-1beta Induced Coronary Artery Instent Restenosis In Pigs
E L E C T RO N I C A B S T R AC T S
Xuchen Zhou1,2, Rongchong Huang1, Qigang Guan2, Xizhuo Sun2, Z.L. Miao2, X.Z. He2, F.T. Han2, Y. Cheng2, L. Zhang2, Dingyin Zeng2 1 First Hospital,Dalian Medical University, Dalian, China 2First Hospital, China Medical University, Shenyang, China
Conclusion: 56* 65/ LQKLELWV HQGRWKHOLDOL]DWLRQ EHFDXVH RI VLJQL¿FDQW drug interaction. No effect of PPAR gamma agonists is seen in animals receiving BMS or PAC. Our data suggest that SRL should be avoided in DM receiving PPAR gamma agonists and that investigation of other DM agents in combination with SRL is needed. TCT-315 ‘Real World’ Comparison of Drug-Eluting Stents versus Bare Metal Stents in the Treatment of Unselected Patients with Acute STSegment Elevation Myocardial Infarction: Mid to Long Term Results from a Two Center Registry Kyung Woo Park1, Si-Hyuck Kang1, Hae-Young Lee1, Hyun-Jae Kang1, Tae-Jin Yeon2, Young-Seok Cho2, In-Ho Chae2, Dong-Ju Choi2, Seokyung Hahn3,4, ByungJoo Park3,4, Woo-Young Chung2, Hyo-Soo Kim1 1 Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea 2Department of Internal Medicine and Cardiovascular Center, Seoul National University Bundang Hospital, Seoul, Republic of Korea 3Medical Research Collaborating Center, Seoul, Republic of Korea 4Department of Preventive Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea Background:&RQFHUQVH[LVWUHJDUGLQJWKHORQJWHUPHI¿FDF\DQGVDIHW\RI drug-eluting stents (DES) in patients with ST-segment elevation myocardial
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Objective: Coronary artery in-stent restenosis (ISR) and Late thrombosis still UHSUHVHQWDSUREOHPLQSDWLHQWV7KHLQÀDPPDWLRQUHDFWLRQWRSRO\PHUDQG polymer-free paclitaxel-eluting stents were investigated in a swine stenosis PRGHOLQGXFHGE\LQWHUOHXNLQ Methods: 0LQLSLJV Q PRQWKVROGDQGZHLJKLQJNJ ZHUHVXEMHFWHG to thoracotomy. Segments (10 mm) of the mid left anterior descending coronary DUWHU\ DQG OHIW FLUFXPÀH[ FRURQDU\ DUWHU\ ZHUH XQGHUPLQHG DQG DVHSWLFDOO\ ZUDSSHGZLWKFRWWRQPHVKVRDNHGZLWK,/B (5 -J $IWHUZHHNVWKHDQLPDOV were anesthetized and quantitative coronary arteriography (QCA) was performed. The stenosis sites were randomized into three groups for stent insertion: a polymerfree Paclitaxel -eluting stent group (YINYI™, n=7), a polymer-coated Paclitaxel HOXWLQJVWHQWJURXS 7$;86TM, n=9), and a bare-metal stent (BMS) group (DT1TM, n=8). Three different stents were randomly implanted into stenosis segments. Expression of monocyte chemoattractant protein-1(MCP-1), tumor necrosis factoralpha (TNF-A 3VHOHFWLQDQGYDVFXODUFHOODGKHVLRQPROHFXOH 9&$0 ZDV determined by reverse transcription-PCR (RT-PCR). Results: QCA showed a severe stenosis in IL-1B-treated segments. after 4 ZHHNV )ROORZXS FRPSDUHG ZLWK %06 WKH 4&$ UHVXOWV LQ SRO\PHUIUHH Paclitaxel -eluting stent group and polymer-coated Paclitaxel -eluting stent group showed a lower 1-month angiographic late lumen loss (LLL) within the stent and the lesion (p<0.05). There were no difference between polymerfree and polymerized Paclitaxel stent group in LLL (P=0.16). The RT-PCR results of MPC-1,TNF-A3VHOHFWLQDQG9&$0VKRZHGWKHKLJKHUYDOXH in polymerized Paclitaxel stent group. Conclusion: Both of polymer-free and polymerized Paclitaxel stents were
The American Journal of Cardiology® |
October 12-17, 2008
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TCT Abstracts/ELECTRONIC
http://www.aievolution.com/tct0801
superior in reducing 1-month angiographic ODWHOXPHQORVVLQLQÀDPPDWLRQ lesions in pigs than that of BMSs. Polymer-free Paclitaxel stent showed a UDWKHUOLWWOHLQÀDPPDWLRQUHDFWLRQWKDQWKDWRISRO\PHUL]HG3DFOLWD[HOVWHQWV
following complex pt & lesion types: types B2/C 393 (79.5%), multivessel disease (+ left main stenosis) 183 (60.1%), small vessel < 2.5 mm 154 (51.0%), ORQJOHVLRQ !PP FDOFL¿FDWLRQ GLDEHWHVPHOOLWXV 83 (27.5%), bifurcation lesion 69 (22.8%), chronic total occlusion 29 (9.6%), WKURPEXV OHIWPDLQVWHQRVLV ROGVDSKHQRXVYHLQJUDIW 12 (4%), instent restenosis 10 (3.3%). Procedural and device success was 795ZDVLQDWPRQWKV DWPRQWKVDQG DW yrs. The rates of cardiac deaths, myocardial infarction, stent thrombosis and cumulative MACE were 1 (0.3%), 1 (0.3%), 0 and 1 (0.3%) at 6 months and 3 (1%), 1 (0.3%), 1 (0.3%) and 9 (3%) at 2 yrs. QCA at 6 months (105 patients, 163 lesions and 198 stents) showed in-segment late loss, restenosis of 0.07 mm and 4.3 % respectively; in-stent late loss, restenosis of 0.16 mm and 3.1%, respectively. Conclusion: At follow-up of up to 2 years the low incidence of clinical 0$&(7/5DVZHOODVORZODWHORVVDQGUHVWHQRVLVFRQ¿UPHGWKHVDIHW\DQG HI¿FDF\RIXVLQJ%LRPDWUL[TM stent even in real word patients. Further study in a larger number of pts is underway.
TCT-317 The Risk of Stent Thrombosis in Patients with Acute Coronary Syndromes Treated with Bare Metal and Drug-eluting Stents Neville Kukreja, Yoshinobu Onuma, Hector Garcia-Garcia, Joost Daemen, Ron van Domburg, Patrick Serruys Thoraxcenter, Rotterdam, Netherlands Background: Although dug-eluting stents (DES) reduce the rates of repeat revascularization compared to bare metal stents (BMS), there remain concerns DERXWWKHULVNRIODWHDQGYHU\ODWHVWHQWWKURPERVLV0DQ\IDFWRUVKDYHEHHQ IRXQGWREHDVVRFLDWHGZLWKWKLVULVNLQFOXGLQJDFXWHFRURQDU\V\QGURPH $&6 DWSUHVHQWDWLRQ GH¿QHGDV67HOHYDWLRQ0,QRQ67HOHYDWLRQ0,RUXQVWDEOH DQJLQDDFFRUGLQJWRWKH%UDXQZDOGFODVVL¿FDWLRQ :HDLPHGWRHYDOXDWHWKH ULVNRIGH¿QLWHVWHQWWKURPERVLVZLWKEDUHPHWDODQGGUXJHOXWLQJVWHQWV %06 and DES respectively) in patients treated for acute coronary syndromes. Methods: Between January 2000 and December 2005, 5823 consecutive patients underwent PCI for de novo lesions with a single stent type. These patients consisted of 3 sequential groups of BMS (n=2248), sirolimus-eluting stents (n=822) and paclitaxel-eluting stents (n=2746). Annual follow-up on the occurrence of death (obtained from municipal civil registries) and clinical events were collected. Propensity score-adjustment was performed to compensate for differences in baseline characteristics. Results: In total, 3485 patients presented with an ACS. After a median followXSRI GD\VSDWLHQWVZLWK$&6KDGDGH¿QLWHVWHQWWKURPERVLVUDWHRI 2.5% vs. 1.0% in patients with stable angina (propensity score-adjusted HR 2.80, 95% CI 1.72-4.56). In stable patients, any stent thrombosis resulted in a VLJQL¿FDQWLQFUHDVHLQPRUWDOLW\ DGMXVWHG+5 &, DOWKRXJK this was particularly evident for late or very late stent thrombosis; in contrast RQO\HDUO\VWHQWWKURPERVLVVLJQL¿FDQWO\LQFUHDVHGPRUWDOLW\LQSDWLHQWVZLWK acute coronary syndromes (adjusted HR 2.0, 95% CI 1.0-2.8). The only independent predictor of very late stent thrombosis was the use of bare metal stents (adjusted HR 0.11, 95% CI 0.02-0.54). Conclusion: 3DWLHQWV ZLWK DFXWH FRURQDU\ V\QGURPHV DUH DW KLJKHU ULVN RI early and late stent thrombosis with either BMS or DES, although very late stent thrombosis seems to be uniquely associated with DES. The clinical sequelae of late and very late stent thrombosis are more pronounced in stable patients.
TCT-319 Impact of Sirolimus-Eluting Stent and Paclitaxel-Eluting Stent on the Outcome of Patients with Sirolimus-Eluting Stent Failure: Multicenter Registry in Asia Sunao Nakamura1, Hisao Ogawa2, Jang-Ho Bae3, Yeo Hans Cahyadi4, Wasan Udayachalerm5, Damras Tresukosol6, Sudaratana Tansuphaswadikul7 1 New Tokyo Hospital, Chiba, Japan 2Kumamoto University Hospital, Kumamoto, Japan 3Konyang University Hospital, Daejeon, Republic of Korea 4Husada Hospital, Jakarta, Indonesia 5King Chulalongkorn Memorial Hospital, Bangkok, Thailand 6Her Majesty’s Cardiac Center, Siriraj Hospital, Bangkok, Thailand 7Chest Disease Institute, Bangkok, Thailand
TCT-318 Single Centre Registry Of A Biodegradable Polymer Based Biolimus A9-eluting Stent : Two-year Clinical And Angiographic Follow-up Teguh Santoso , Aaron Wong , Tian-Hai Koh University of Indonesia Medical School, Medistra Hospital, Jakarta, Indonesia 2National Heart Center, Singapore , Singapore 1
2
PES
256/314
264/295
Procedural success (%)
100
100
MACE at 30 days (%)
0.6
1.1 (Stent thrombosis 2 cases)
Proximal reference diameter (mm)
2
1
Background. 5HFHQW GDWD KDYH DWWHVWHG WKH VDIHW\ DQG HI¿FDF\ RI biodegradable polymer based biolimus A9-eluting stent (BiomatrixTM) used in selected patients (pts). The aim of this study was to report the of the clinical outcome following PCI using BiomatrixTM in real world cases being followedup for 2 years (yrs). Methods: Included in this study were 302 all comers who underwent BiomatrixTM stent implantations to treat 638 lesions. Double antiplatelet regimen (aspirin and clopidogrel) was given for 6 months, followed by chronic DVSLULQRQO\7KHSULPDU\HQGSRLQWZDVWDUJHWYHVVHOUHYDVFXODUL]DWLRQ 795 at 6 and 12 months. Secondary End-Points were Major Adverse Cardiac (YHQWV 0$&( GHDWK40, RU795@DQGPRQWKLQVHJPHQWUHVWHQRVLV rate and in-segment late loss. Results: Male:female ratio was 210/92, mean age was 59.5 + 10.0 yrs. Number of stents per patient (pt) 1.95. BiomatrixTM stents were implanted in the
The American Journal of Cardiology®
SES Number of patients/lesions
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October 12-17, 2008
Minimum lumen diameter post procedure (mm) Minimum lumen diameter at 6 months (mm)
Minimum lumen diameter at 12 months (mm)
Restenosis rate (%)
7.0
15.2*
Target lesion revascularization (%)
6.6
15.2*
MACE at 12 months (%)
7.0
17.4*
*p<0.05 vs SES
Conclusion: The use of SES and PES in patients with restenosis after SES implantation was safe with low complications. Patients treated with SES showed lesser rate of restenosis compared with PES.
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Purpose: To evaluate the Sirolimus-eluting stent (SES) and Paclitaxel-eluting stent (PES) on the outcome of patients with SES failure (SES-F). Methods: A total of 520 patients with 609 SES-F lesions (male 74.8%, mean DJH\UV/07/$'/&;5&$69* ZHUHWUHDWHGZLWK6(6 PHDQOHVLRQOHQJWKPPPHDQVWHQWOHQJWK PP DQG 3(6 PHDQOHVLRQOHQJWKPPPHDQVWHQWOHQJWK PP :HHYDOXDWHLPPHGLDWHDQGORQJWHUPFOLQLFDOUHVXOWVE\ and 12 months angiography. Results: The baseline clinical characteristics between 2 groups were similar. See table for clinical results.
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TCT-320 Drug-Eluting Stents for the Treatment of Very Long Coronary Artery Stenosis: A Comparison with Sirolimus, Paclitaxel, Zotarolimus, EPC Capture and Everolimus-Eluting Stent: Multicenter Registry in Asia Sunao Nakamura1, Hisao Ogawa2, Jang-Ho Bae3, Yeo Hans Cahyadi4, Wasan Udayachalerm5, Damras Tresukosol6, Sudaratana Tansuphaswadikul7 1 New Tokyo Hospital, Chiba, Japan 2Kumamoto University Hospital, Kumamoto, Japan 3Konyang University Hospital, Daejeon, Republic of Korea 4Husada Hospital, Jakarta, Indonesia 5King Chulalongkorn Memorial Hospital, Bangkok, Thailand 6Her Majesty’s Cardiac Center, Siriraj Hospital, Bangkok, Thailand 7Chest Disease Institute, Bangkok, Thailand Aim:7KHDLPRIWKLVVWXG\LVWRFRPSDUHWKHVDIHW\DQGHI¿FDF\RI6LUROLPXV (SES), Paclitaxel (PES), Zotarolimus (ZES), EPC capture (ECS) and Everolimus-eluting stent (EES) on the outcome of stenting in patients with YHU\ORQJFRURQDU\OHVLRQ 9// OHVLRQOHQJWKPP Methods:$SURVSHFWLYHDQDO\VLVRI SDWLHQWVZLWK9// 6(6 PES, 151 ZES, 39 ECS, 54 EES) was performed. The study endpoints were major adverse cardiac events (MACE) at 9 months, restenosis rate and target lesion revascularization (TLR) at 9 months. Results: See table for clinical results. SES
PES
ZES
ECS EES
Number of patients/lesions
368/408 288/322 151/164 39/42 54/58
Lesion length (mean: mm)
47.8
46.3
42.8
Stent length (mean: mm)
57.9
59.9
53.9
50.8 53.9
In-hospital MACE (%)
0.8
1.2
0.7
0
0
Subacute thrombosis (%)
0.3
0.7
0.7
0
0
Proximal reference diameter (mean: mm) Minimum lumen diameter post procedure (mean: mm) Minimum lumen diameter at 9 months (mean: mm) Restenosis rate at 9 months (%)
2.88
2.80
2.8
2.89 2.83
2.60
2.52
2.58
2.64 2.54
2.51
2.19
1.89
2.09 2.40
7.6*
9.0
19.2
15.2 5.6*
TLR at 9 months (%)
7.6*
9.0
16.6
10.3 3.7*
43.9 47.8
E L E C T RO N I C A B S T R AC T S
*p<0.05 vs ZES, TES
Conclusion: 7KHXVHRIGUXJHOXWLQJVWHQWVLQSDWLHQWVZLWK9//VHHPVWR be favorable in terms of in-hospital clinical outcome and long-term results. (2) Patients treated with SES and EES showed lesser restenosis rate and TLR compared with other drug-eluting stents. TCT-321 &RPSDULVRQRI
130i
/&;5&$&RPSOHWHFOLQLFDOIROORZXSWR\HDUVLV being analyzed for all patients. Results: The baseline clinical characteristics between 2 groups were similar. At 4 years overall cardiac events of SES (16.3%) were lower than PES (24.0%) (p=0.03). See table for clinical results. Number of patients
SES
PES
p
368
288
-
Age (mean: yrs)
69.6
71.5
NS
MACE at 30 days (%)
1.1
1.7
NS
Proximal reference diameter (mm)
NS
MLD post (mm)
NS
MLD at 12 months (mm)
0.03
Restenosis rate at 12 months (%)
10.1
18.8
0.01
TLR at 12 months (%) 6WHQWWKURPERVLV 6$7/$679/$67
6.6 (0.8 /0.3 /0.5)
14.9 (1.0/ 0.3/ 0.7)
0.01 NS
MACE at 48 months (%)
15.2
24.3
0.03
Conclusion: The use of SES and PES in patients with very long coronary lesion was safe and feasible with low acute complication and low incidence of restenosis. SES showed lesser incidence of cardiac events (death, myocardial infarction, CABG and PCI) at 4 years clinical follow up. SAT (sub acute stent thrombosis), LAST (late stent thrombosis: ~1year), 9/$67 YHU\ODWHVWHQWWKURPERVLV \HDUa\HDUV 0$&( GHDWKP\RFDUGLDO infarction, CABG and PCI). TCT-322 WITHDRAWN TCT-323 WITHDRAWN TCT-324 WITHDRAWN TCT-325 First -in-Man Study of the Endeavor Zotarolimus-Eluting Stent: Final 5-Year Follow-up Ian T Meredith1, John Ormiston2, Robert Whitbourn3, I Patrick Kay4, David Muller5, Manuela Negoita6, Richard E Kuntz7, Peter J Fitzgerald8, On Behalf of the ENDEAVOR I Investigators 1 MonashHeart, Southern Health, Clayton, Victoria, Australia 2Auckland City Hospital, Auckland, Australia 3St Vincent’s Public Hospital Melbourne, Melbourne, Australia 4University of Auckland, Auckland, New Zealand 5Public Hospital Sydney, Sydney, Australia 6Medtronic CardioVascular, Santa Rosa, CA; 7Medtronic, Inc., Minneapolis, MN; 8 Stanford University Medical Center, Stanford, CA Background: (1'($925 , ZDV WKH ¿UVWLQKXPDQ VWXG\ WR HYDOXDWH WKH Endeavor zotarolimus-eluting stent (ZES), which consists of a cobalt-alloy ORZSUR¿OH VWHQW ZLWK D ELRFRPSDWLEOH SKRVSKRU\OFKROLQH SRO\PHU DQG WKH highly lipophilic anti-proliferative rampamycin analog, zotarolimus. Through 4 years follow-up, treatment of symptomatic coronary artery disease (CAD) ZLWKWKH(QGHDYRU=(6LVDVVRFLDWHGZLWKVXVWDLQHGHI¿FDF\7KH¿QDO\HDU follow-up will be completed in June, 2008, which represents the longest available follow-up for this device. Methods: 7KH (1'($925 , WULDO ZDV D SURVSHFWLYH PXOWLFHQWHU nonrandomized, single-arm study that enrolled 100 patients with symptomatic CAD at 8 centers in Australia and New Zealand. Patients were treated for a single de novoOHVLRQZLWKDUHIHUHQFHYHVVHOGLDPHWHU 59' RIWR PPDQGPPLQOHQJWK7KHSULPDU\HQGSRLQWZDV0$&(DWGD\VDQG LQVWHQWODWHOXPHQORVVDWPRQWKV$QJLRJUDSKLFIROORZXSZLWK,986ZDV performed at 4 and 12 months. Clinical follow-up occurred at 30 days, 4, 9, and 12 months, and annually through 5 years.
The American Journal of Cardiology® |
October 12-17, 2008
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Results: Mean age was 59 years, 79% were male, 47% had a previous MI, and 16% had a history of diabetes. Acute lesion, device, procedure, and GHYLFHVSHFL¿FSURFHGXUHVXFFHVVUDWHVZHUHDOO7UHDWHGOHVLRQVZHUH WKH/$' 5&$ DQG/&; ZLWKDPHDQ59'RI PP0/'RIPPDQGPHDQOHQJWKRI PP7KUHH patients have been lost to follow-up (3%) at the 4-year follow-up. At 4-years, WKH FXPXODWLYH 7/5 79) DQG 0$&( UDWHV ZHUH DQG respectively. Freedom from MACE was 92.5% (95% CI; 87.8 % -98.0%), and IUHHGRPIURP79)ZDV &, 2QHSDWLHQWKDGDQRQ Q-wave MI at 10 days, and 4 patients died during the study; all non-cardiac (cancer). One TLR event occurred between year 1 - 4, and 1 stent thrombosis (ST) occurred at 10 days, with no subsequent ST events. Conclusion: With data available for 97% of patients, the Endeavor ZES has been shown to be safe and effective through 4 years of follow-up with ORZ7/5QRFDUGLDFGHDWKVDQGQRODWHWKURPERWLFHYHQWV7KH¿QDO\HDU follow-up results will be reported in October 2008.
LQDOOVWHQWJURXSVDWPRQWKVIROORZXS7KHUHZDVQRGLIIHUHQFHLQ795 rate and stent thrombosis remains a low event occurrence. TCT-327 COMPARE-AMI : Preliminary Results of 6 Months Follow-Up, Comparing the Everolimus - Eluting Stent, XIENCE V, with the Paclitaxel - Eluting Stent, Taxus Liberte’, in Patients with STElevation Myocardial Infarction Elvin Kedhi, Jochem G P Wassing, Carlos A G Van Mieghem, Kayum SheikJoesoef, Eugene P McFadden, Peter C Smits MCRZ, Rotterdam, Netherlands
TCT-326 Comparison of 24-Month Clinical Outcomes of Endothelial Progenitor Cell Capture Stent versus Sirolimus-Eluting Bioabsorbable PolymerCoated Stent versus Bare Metal Stents In Patients Undergoing Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction Eric Chong1, Kian Keong Poh2, Liang Shen3, Chao Yang Soon1, Hean Yee Ong1, Ronald Chi Hang Lee2, Swee Guan Teo2, Adrian Low2, Huay Cheem Tan2 1 Cardiology Department, Alexandra Hospital, Singapore , Singapore 2 Cardiology Department, National University Hospital, Singapore , Singapore 3Biostatistics Department, National University, Singapore , Singapore Background: Endothelial progenitor cell (EPC) capture stent (Genous™, OrbusNeich), is designed to promote rapid endothelization and healing. It is potentially useful in patients undergoing primary percutaneous coronary intervention (PPCI) for acute ST-segment elevation myocardial infarction 67(0, :HFRPSDUHLWVFOLQLFDOHI¿FDF\DQGVDIHW\ZLWKDVLUROLPXVHOXWLQJ (SES) bioabsorbable polymer-coated stent (Cura™, OrbusNeich) and a bare metal stent (BMS) (Liberte™%RVWRQVFLHQWL¿F LQSDWLHQWVZLWK67(0, Methods: All patients presented to our center with STEMI and received PPCI with either EPC, SES or BMS stents from Jan 2004 to June 2006 were enrolled in the cohort study. The study endpoints were stent thrombosis and PDMRU DGYHUVH FDUGLDF HYHQWV 0$&( GH¿QHG DV FRPSRVLWH HQG SRLQWV RI GHDWKP\RFDUGLDOLQIDUFWLRQ 0, DQGWDUJHWYHVVHOUHYDVFXODUL]DWLRQ 795 at 24 months. Results: A total of 366 patients (EPC=95, SES=53, BMS 218) were enrolled. Baseline demographics in terms of age, gender, diabetes, renal impairment, SUHGLVFKDUJH OHIW YHQWULFXODU HMHFWLRQ IUDFWLRQ FDUGLRJHQLF VKRFN ZHUH comparable among the 3 groups. Procedural success rate was high at a mean RI 3RVWSURFHGXUDO 7,0, ÀRZ ZDV DFKLHYHG LQ (3& 6(6 96.2% and BMS 88.5%. The MACE results at 24-months were shown: Events
EPC (n=95)
SES (n=53)
BMS (n=218)
MACE (%)
13 (13.7%)
8 (15.1%) 43 (19.7%)
TCT-328 Unrestricted Use Of Paclitaxel-eluting Stents: Four-year Results Of The T-search Registry
p value
Yoshinobu Onuma, Neville Kukreja, Joost Daemen, Hector M GarciaGarcia, Ron van Domburg, Patrick W J C Serruys Thorax center, Rotterdam, Netherlands
0.383
Death (%)
9 (9.5%)
2 (3.8%)
27 (12.4%) 0.173
Non-fatal MI (%)
1 (1.1%)
2 (3.8%)
9 (4.1%)
0.364
795
4 (4.2%)
5 (9.4%)
13 (6.0%)
0.439
Acute stent thrombosis
1 (1%)
0 (0%)
0 (0%)
0.404
Subacute stent thrombosis (SAT)
0 (0%)
0 (0%)
0 (0%)
1.00
Late stent thrombosis (LST)
0 (0%)
0 (0%)
2 (0.9%)
1.00
9HU\/DWHVWHQWWKURPERVLV 9/67
0
0
0
1.00
Objectives: Although drug-eluting stents (DES) reduce the rate of repeat revascularization compared with bare metal stents (BMS) in carefully selected patients, the long-term safety of DES remains a concern, particularly amongst real-world patients. Furthermore, long-term comparisons between different DES types in a real-world setting are scarce. We therefore evaluated the 4-year clinical event rates in patients from the Taxus Stent Evaluated At Rotterdam Cardiology Hospital (T-SEARCH) registry, to establish the safety DQGHI¿FDF\RIGLIIHUHQW'(6LQDQXQVHOHFWHGDOOFRPHUSRSXODWLRQ Methods: On 16th February 2003, the paclitaxel-eluting stent (PES, Taxus)
Conclusion: The MACE rates in patients who underwent PPCI were similar
The American Journal of Cardiology®
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October 12-17, 2008
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TCT Abstracts/ELECTRONIC
131i
E L E C T RO N I C A B S T R AC T S
Context: Results from the SPIRIT I-III trials showed consistent clinical DQGDQJLRJUDSKLFEHQH¿WVRIWKH(YHUROLPXV(OXWLQJ&RURQDU\6WHQW6\VWHP ;LHQFH96DQWD&ODUD&$86$FRPSDUHGWRWKHZLGHO\XVHG3DFOLWD[HO (OXWLQJ &RURQDU\ 6WHQW 6\VWHP 7D[XV %RVWRQ 6FLHQWL¿F 1DWLFN 0$ USA. However, to date there are no data available for the use of the novel second-generation everolimus-eluting stent system in the setting of the STElevation Myocardial Infarction (STEMI). Objective:7RLQYHVWLJDWHWKHVDIHW\DQGHI¿FLHQF\RI;LHQFH9VWHQWIRUWKH WUHDWPHQWRI67(0,LQ³UHDOZRUOG´SDWLHQWV Methods: COMPARE is a prospective, randomised, single center trial FRPSDULQJWKHFOLQLFDORXWFRPHRIWKH;LHQFH9VWHQW6DQWD&ODUD&$86$ YHUVXVWKH7D[XV/LEHUWH¶VWHQW%RVWRQ6FLHQWL¿F1DWLFN0$86$LQ³UHDO OLIH´SDWLHQWV$OOSDWLHQWVEHWZHHQ\HDUVZLWKQRFRQWUDLQGLFDWLRQVIRU 12-months dual antiplatlet therapy, with lesions judged feasible for treatment with PCI are progressively being randomised on a 1:1 basis for treatment ZLWK7D[XVRU;LHQFH9&RPSOHWHUHYDVFXODULVDWLRQLQPXOWLYHVVHOGLVHDVH is strongly encouraged. The primary end point is a composite of death, non fatal AMI and clinically driven target vessel revascularisation at 1 year. COMPARE AMI is subgroup analysis of patients from the COMPARE database presenting with STEMI. Results: From Feb 2007 to oct 2007, 185 consecutive patients presenting with 67(0, ZHUH UDQGRPLVHG DQG UHVSHFWLYHO\ LQ ;LHQFH 9 DQG 7D[XV /LEHUWH¶ DUPV %DVHOLQH FOLQLFDO DQG DQJLRJUDSKLF FKDUDFWHULVWLFV VKRZHG QR VWDWLVWLFDOO\ VLJQL¿FDQW GLIIHUHQFHV DOWKRXJK WKHUH ZDV D WUHQG IRU PRUH PXOWLYHVVHO GLVHDVH LQ ;LHQFH 9 JURXS $QJLRJUDSKLF VXFFHVV GH¿QHG DV 7,0,,,,ÀRZDQG VWHQRVLVRQYLVXDOHVWLPDWLRQZDVDFKLHYHGLQ DQGLQ LQWKH7D[XVDQG;LHQFH9DUPVUHVSHFWLYHO\ S 7KH SULPDU\HQGSRLQWZDVUHDFKHGLQ LQWKH;LHQFH9DUPDQGLQLQ WKH7D[XVDUP S 1R795DQGQRVSRQWDQHRXV0,RFFXUUHGGXULQJWKH 6-month follow-up, so the end point in both groups was driven by in-hospital mortality en peri-procedural AMI that occurred during non-culprit leasion treatments. Conclusions: 7KH ;LHQFH 9 VWHQW IRU WKH WUHDWPHQW RI 67(0, LV VDIH DQG VKRZHGHTXDOHI¿FLHQF\ZLWKWKH7D[XV/LEHUWH¶VWHQWDWPRQWKIROORZXS
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JDLQHG &RQIRUPLWp (XURSpHQQH DSSURYDO DQG ZDV LPPHGLDWHO\ DGRSWHG DV the default stent for all percutaneous coronary interventions at our institution. 7KH¿UVWSDWLHQWVWUHDWHGH[FOXVLYHO\ZLWK3(6IRUGHQRYROHVLRQVZHUH enrolled in the T-SEARCH registry. These patients were compared with 508 consecutive patients treated with sirolimus-eluting stents (SES, Cypher) from 16th April 2002 onwards from the RESEARCH registry. Annual survival status was acquired from municipal civil registries and questionnaires sent to all living patients to obtain data on adverse clinical events. Medical records will be reviewed and family doctors or referring cardiologists contacted as necessary. The primary endpoint was composite major adverse events (MACE: all-cause death, any myocardial infarction or target vessel revascularization >795@ 6HFRQGDU\ HQGSRLQWV LQFOXGHG DOOFDXVH GHDWK 795 DQG VWHQW thrombosis. Cox proportional hazards regression analysis will be performed to compensate for differences in baseline characteristics between the groups. Results: Four-year follow-up data is currently available for 95% of the patients after 4 years. The 4-year cumulative MACE rates were 30.5% and 30.7% for SES and PES(p=0.9). The 4-year cumulative all-cause mortality rates were 10.9% for SES and 10.1% for PES (p=0.7). Conclusion: Four-year survival and event-free survival rates are similar in real-world all-comer patients treated with SES or PES.
TCT-331 Is It Possible To Predict Stent Thrombsosis with Sirolimus- And Paclitaxel-Eluting Stents After Percutaneous Coronary Intervention? The DERIVATION Score Davide Capodanno, Piera Capranzano, Gianpaolo Ussia, Alfredo R Galassi, Corrado Tamburino Ferrarotto, Catania, Italy
TCT-329 WITHDRAWN TCT-330 Stent Fracture-Associated Restenosis In Bare-Metal Stents Compared With Drug-Eluting Stents Paul S. Pienkos, S. Hinan Ahmed, Imraan Ansaarie, Babak Haddadian, Mubashir Ahmed, Tonga Nfor, Masood Ahmed, Nadeem Najam, Adnan Nazir, Mohamed Rahman, Mohamed Djelmami-Hani, Anthony DeFranco, Neil Oldridge, Masood Akhtar, Anjan Gupta, Suhail Allaqaband, Tanvir Bajwa Aurora Sinai/Aurora St. Luke’s Medical Centers, University of Wisconsin School of Medicine and Public Health-Milwaukee Clinical Campus, Milwaukee, WI
E L E C T RO N I C A B S T R AC T S
Conclusion: &RPSDUHG ZLWK %06 '(6 KDYH VLJQL¿FDQWO\ KLJKHU UDWHV RI stent fracture-associated restenosis. Additionally, closed-cell design stents have VLJQL¿FDQWO\KLJKHUUDWHVRIVWHQWIUDFWXUHFRPSDUHGZLWKRSHQFHOOGHVLJQ
Background 6WHQW IUDFWXUH KDV EHHQ LQFUHDVLQJO\ LGHQWL¿HG LQ SDWLHQWV found to have angiographic in-stent restenosis in drug-eluting stents (DES). However, association between stent fractures and in-stent restenosis in barePHWDOVWHQWV %06 LVXQNQRZQ7RGHWHUPLQHVLJQL¿FDQFHRIVWHQWGHVLJQ type and drug-coating variables in particular, we compared stent fracture rates in BMS and DES. Methods :HLGHQWL¿HGSDWLHQWVZKRXQGHUZHQWUHSHDWFDWKHWHUL]DWLRQ between January 2006 and December 2007 because of acute coronary syndrome or positive functional test. Of these patients, 310 were noted to have HYLGHQFHRIDQJLRJUDSKLFLQVWHQWUHVWHQRVLV7KHVH¿OPVZHUHLQGHSHQGHQWO\ reviewed by two experienced interventional cardiologists and 62 stent IUDFWXUHV ZHUH LGHQWL¿HG )UDFWXUH UDWHV ZHUH FRPSDUHG EHWZHHQ %06 paclitaxel-eluting (PES), and sirolimus-eluting (SES) stents. Results:6L[W\WZRVWHQWIUDFWXUHVZHUHLGHQWL¿HG IUDFWXUHLQFLGHQFHLQ%06 was 11/1,561 (0.7%), PES 16/998 (1.6%), and SES 35/1,208 (2.8%). Fracture UDWH ZDV VLJQL¿FDQWO\ ORZHU LQ %06 WKDQ '(6 >S 25 &, 1.72-6.24)], and also when compared with either SES [p <0.0001, OR 4.11 (CI 2.11-8.03)], or PES [p = 0.046, OR 2.26 (CI 1.07-4.84)]. Fracture rate was VLJQL¿FDQWO\ORZHUZLWKRSHQFHOOGHVLJQ %063(6 FRPSDUHGZLWKFORVH cell design (SES) [p < 0.0001, OR 2.75 (CI 1.66-4.53)]. Additionally, fracture rate trended towards being lower in PES compared with SES [p = 0.063, OR 1.81 (CI 1.00-3.26)].
Aims: Recent studies of drug-eluting stents (DES) use in routine clinical practice have led to concern regarding their long-term safety and to questions about the adequacy of current antiplatelet therapy guidelines. We sought WR GHULYDWH D ULVN VFRUH IRU SUHGLFWLQJ VWHQW WKURPERVLV DIWHU GUXJ HOXWLQJ stenting. Methods and Results: The score was derived from the large single FHQWHU '(6 5HDOZRUOG ,QFUHPHQWDO 9DOXH LQ WKH HU$ RI SHUFXWDQHRXV UHYDVFXODUL]D7,21 '(5,9$7,21 GDWDEDVH FROOHFWLQJ GDWD DERXW patients of any age undergoing PCI with DES as treatment for symptomatic coronary artery disease. Logistic regression and boostrap procedure were used to select correlates of stent thrombosis that were subsequently weighted and integrated into an integer scoring system. Five variables selected from the initial multivariate model were weighted proportionally to their respective odds ratio for stent thrombosis (thienopyridines discontinuation [6 points], baseline left ventricular ejection fraction < 50% [4 points], bifurcation lesion [3 points], angioplasty in the setting of acute coronary syndromes [3 points], OHIWDQWHULRUGHVFHQGLQJDVWDUJHWYHVVHO>SRLQWV@7KUHHVWUDWDRIULVNZHUH GH¿QHG ORZULVNWR LQWHUPHGLDWHULVNWR KLJKULVN ZLWKJRRG prognostic accuracy for early, late and very late thrombosis (c statistic = 0.75, 0.72 and 0.74, respectively) in the derivation set. Conclusion: 7KH '(5,9$7,21 VFRUH PD\ EH XVHG DV D VLPSOH FOLQLFDO WRROIRUWKHLGHQWL¿FDWLRQRIDVL]DEOHFRKRUWLQZKRPFORVHPRQLWRULQJDQG DJJUHVVLYHWKHUDS\PD\EHEHQH¿FLDO TCT-332 5HDO:RUOG6DIHW\$QG(I¿FDF\2I7KH-DQXV7DFUROLPXV(OXWLQJ Stent: Long-Term Clinical Outcome And Angiographic Findings From The Tacrolimus-Eluting Stent (TEST) Registry Corrado Tamburino1, Maria E Di Salvo1, Davide Capodanno1, Piera Capranzano1, Rosario Parisi1, France sca Mirabella1, France sco Scardaci1, Gianpaolo Ussia1, Alfredo R Galassi1, Damiana Fiscella1, Roxana Mehran2, George Dangas2 1 Ferrarotto, Catania, Italy 2Columbia University Medical Center, New York, NY Objectives: We sought to evaluate the safety and performance of the Janus Tacrolimus-Eluting stent (TES) in an unselected population of patients, without application of restrictive clinical or angiographic criteria. Background:&RQWLQXHGDWWHQWLRQWRWKHVDIHW\HI¿FDF\DQGGHOLYHUDELOLW\ RI¿UVWJHQHUDWLRQ'(6KDVOHGWRWKHGHYHORSPHQWRIQHZDQWLSUROLIHUDWLYH
132i
The American Journal of Cardiology® |
October 12-17, 2008
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TCT Abstracts/ELECTRONIC
http://www.aievolution.com/tct0801
agents with alternative stent platforms and different drug carrier vehicles. Methods: The TEST (Tacrolimus Eluting STent) registry is a prospective, nonrandomized single-center registry in which 140 consecutive patients who underwent single- or multi-vessel percutaneous coronary intervention between February 2005 and August 2005 were enrolled. Results: The composite rate of major adverse cardiac events (MACE) at twenty-two months clinical follow-up was 40.9%. The rate of mortality, myocardial infarction and target lesion revascularization (TLR) were 5.5%, 11% and 31.5%, respectively. Angiographic follow-up at 8 months was achieved in 74% of patients; binary restenosis occurred in 39.4% of lesions. Most restenosis lesions (94.6%) had a diffuse pattern, while focal restenosis ZDV REVHUYHG LQ RI FDVHV 'H¿QLWH RU SUREDEOH VWHQW WKURPERVLV ZDV observed in 2.4% of patients. Neither TLR nor MACE statistically varied relative to diabetes, vessel diameter or lesion length. Conclusion: The present prospective, nonrandomized, TEST registry indicated high MACE and restenosis rates, and thereby rather discouraging ORQJWHUPRXWFRPHVZLWKXVHRIWKH-DQXV7(6LQDQXQVHOHFWHG³UHDOZRUOG´ population of patients who underwent single- or multi-vessel percutaneous coronary intervention.
NonDM (N = 5269) 6.4 9.7 (248) (339)
DM (N = 2563) MACE, %(n)
p-value <.001
Death, %(n)
4.1 (104) 1.7 (87) <.001
Cardiac death, %(n)
2.7 (70) 1.2 (65) <.001
MI (all), %(n)*
1.8 (47) 1.5 (81) 0.343
Q-wave MI, %(n)*
0.5 (12) 0.4 (19) 0.565
Non Q-wave MI, 1.4 (35) 1.2 (630 0.518 %(n)* Stent thrombosis (all), 1.6 (41) 0.8 (41) 0.001 %(n) 5.3 TLR, %(n) 4.0 (213) 0.012 (136) TLR (non-TL), %(n) 0.6 (15) 0.7 (37) 0.657 795 Q 79) Q
4.6 5.7 (147) 0.026 (240) 8.7 6.5 (341) <.001 (224)
IDDM (N = 644)
Non-IDDM (N = 1919)
12.6% (81/644) 6.7% (43/644) 4.5% (29/644) 1.7% (11/644) 0.2% (1/644) 1.6% (10/644) 2.3% (15/644) 6.5% (42/644) 0.5% (3/644) 7.0% (45/644) 11.0% (71/644)
8.7% (167/1919) 3.2% (61/1919) 2.1% (41/1919) 1.9% (36/1919) 0.6% (11/1919) 1.3% (25/1919) 1.4% (26/1919) 4.9% (94/1919) 0.6% (12/1919) 5.3% (102/1919) 8.0% (153/1919)
p-value 0.005 <.001 0.003 0.867 0.315 0.695 0.102 0.127 0.774 0.118 0.019
TCT-333
YHUL¿HGE\(&*DQGHQ]\PHV
12 -Month Outcomes In Patients With Diabetes Implanted With A Zotarolimus Drug-Eluting Stent: Results From The E-FIVE Registry
Conclusion: 7KH (),9( 5HJLVWU\ HQUROOHG KLJK ULVN SDWLHQWV WKDW ZRXOG have been excluded from randomized controlled trials. In this diabetic cohort including 36% of patients with unstable angina, 19% with a recent MI, treated with multiple stents, 12-month MACE rates were highly comparable to other reported results. These data represent a real-world report of the use RI WKH (QGHDYRU =(6 LQ KLJKULVN GLDEHWLF SDWLHQWV IURP DQ ³DOOFRPHUV´ population.
Martin T Rothman1, Ian T Meredith2, Minglei Liu3, Chaim Lotan4, For the E-FIVE Registry Investigators 1 Barts and The London National Health Service Trust, London, United Kingdom 2Monash Medical Centre, Southern Health, Melbourne, Victoria, Australia 3Medtronic CardioVascular, Santa Rosa, CA; 4 Hadassah-Hebrew University Medical Center, Jerusalem, Israel Background:'LDEHWLFSDWLHQWVKDYHDQLQFUHDVHGULVNRIUHVWHQRVLVDQGRWKHU major adverse cardiovascular events. The Endeavor zotarolimus-eluting stent (ZES) has been shown to be safe and effective for the treatment of single, de novo lesions, in randomized controlled trials that included patients with diabetes mellitus (DM). We evaluated the effectiveness of the Endeavor ZES LQGLDEHWLFSDWLHQWVLQDUHDOZRUOGSRSXODWLRQLQWKH(),9(5HJLVWU\ Methods:7KH(),9(5HJLVWU\LVDSURVSHFWLYHPXOWLFHQWHUQRQUDQGRPL]HG global registry that enrolled 8314 patients at 188 centers in Europe, South America, Australia, New Zealand and Asia. All patients presenting with symptomatic coronary artery disease amenable to stent implantation were eligible for the study. Event data at 12 months was compared between DM and non-DM patients, and between insulin-dependent (IDDM) and nonIDDM (NIDDM) patients. All MACE events were adjudicated by a Clinical Events Committee. Results:2IWKHSDWLHQWVZLWKPRQWKIROORZXSDVLJQL¿FDQWSURSRUWLRQ ZHUHKLJKULVNZLWKFRPSOH[OHVLRQVLQFOXGLQJZLWK'0RIZKLFK had IDDM. Key baseline characteristics and clinical outcomes are presented in Table. Non-DM (n = 5593 patients/ 6884 lesions)
p-value
30.7 35.6 19.4 78.6 67.7 44.7 60.8 16.0
19.8 33.1 23.0 63.7 60.8 47.5 60.0 16.7
<.001 <.001 0.023 <.001 <.001 <.001 0.007 0.418 0.369
0.319
Long-term Use of Clopidogrel Is Associated with a Reduced Risk for Very Late Stent Thrombosis Following Drug-eluting Stent Implantation in Real-world Registry Jin Won Kim, Jae Hyoung Park, Jin Oh Na, Cheol Ung Choi, Sang-Gi Moon, Byung Won Cheon, Eung Ju Kim, Seung-Woon Rha, Chang Gyu Park, Hong Seog Seo, Dong Joo Oh Cardiovascular Center, Korea University Guro Hospital, Seoul, Republic of Korea Background: There is mounting evidence that delayed endothelialization after drug-eluting stent (DES) implantation may lead to very late stent WKURPERVLV 67 DQGUHODWHGFDWDVWURSKLFHYHQWV+RZHYHUWKHULVNRIYHU\ late ST following cessation of clopidogrel in patients with DES in real-world SUDFWLFHUHPDLQVOHVVGH¿QHG Methods: A total of 1031 consecutive patients (male 66.6 %, mean age 62.2 \HDUVGLDEHWHV WUHDWHGZLWKDWOHDVW'(6 &\SKHUTM 64 %, TaxusTM 16 %, EndeavorTM 13.0 %, combination 7 %) from January 2003 to May 2007, were analyzed in a single academic center. Stent thrombosis was GH¿QHGDFFRUGLQJWR$FDGHPLF5HVHDUFK&RQVRUWLXP $6& GH¿QLWLRQ Results: Clopidogrel was discontinued after 1-year of DES implantation in 24.8 %, 256/1031 of patients. The complex lesions (aorto-ostial, multiple stent, chronic total occlusion, and bifurcation using two stents) were more common LQFORSLGRJUHOVWD\JURXSWKDQLQZLWKGUDZDOJURXS S :HLGHQWL¿HG SDWLHQWV RIWKHWRWDOSDWLHQWVWUHDWHGZLWK'(6 ZLWKGH¿QLWHYHU\ ODWH67 PDOHPHDQDJH\HDUV 7KHLQFLGHQFHRIYHU\ODWH 67ZDVVLJQL¿FDQWO\KLJKHULQSDWLHQWVZKRZLWKGUHZFORSLGRJUHODIWHU\HDU administration compared to those who stayed on clopidogrel (3.13 %, 8/256 vs. 0.26 %, 2/775, p<0.001) (Figure 1). Among the patients with very late ST, the single agent (aspirin 2, cilostazol 3, sarpogrelate 1) were used in 6 patients (6/10, 60 %) (Figure 2).
Clinical Outcomes
The American Journal of Cardiology®
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October 12-17, 2008
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$JHPHDQ6' Female, % Unstable angina, % Recent MI (< 72 hrs), % Hypertension, % Hyperlipidemia, % Target vessel: LAD, % B2/C Lesions Bifurcations, % Number of stents LPSODQWHGPHDQ6'
DM (n = 2721 patients/ 3455 lesions)
TCT-334
http://www.aievolution.com/tct0801
Conclusion: Long-term use of dual anti-platelet regimen of aspirin and clopidogrel beyond 1-year in patients with DES could be associated with a UHGXFHGULVNIRUYHU\ODWH67LQUHDOZRUOGSUDFWLFH TCT-335 &RPSDULVRQRI/RQJ7HUP&OLQLFDO2XWFRPHVLQ3DWLHQWV5HFHLYLQJ 30mm of Drug Eluting Stent(s) versus Bare Metal Stent(s) in a Single Coronary Vessel
E L E C T RO N I C A B S T R AC T S
Hong S Jeong, Anthony J Minisi Virginia Commonwealth University, Glen Allen, VA Objective: Multiple or long stents are often needed to treat multi-focal or diffuse lesions. Purpose of this study was to compare long-term clinical RXWFRPHVLQSDWLHQWVWUHDWHGZLWKPPRIHLWKHUEDUHPHWDOVWHQW V %06 or drug eluting stent(s) (DES) in a single coronary vessel. Methods:$WRWDORIFRQVHFXWLYHSDWLHQWVZKRUHFHLYHGPPRIVWHQW V LQDVLQJOHFRURQDU\YHVVHOZHUHLGHQWL¿HGWKURXJKUHWURVSHFWLYHUHYLHZRI UHFRUGVIURP-DQWR'HFDWD9HWHUDQV$IIDLUPHGLFDOFHQWHU of these patients received BMS and 175 patients received DES. 19 patients who received both BMS and DES were excluded from the study. Average IROORZXSGXUDWLRQIRU%06JURXSZDVPRQWKVDQGDYHUDJHIROORZXS GXUDWLRQIRU'(6JURXSZDVPRQWKV&OLQLFDORXWFRPHV GHDWKDFXWH myocardial infarction, target vessel revascularization, and cardiac admission) post index procedures were recorded for analysis. Results: DES group had higher prevalence of diabetes, hyperlipidemia, and peripheral vascular disease. BMS group had higher frequency of prior myocardial infarction. Cardiac mortality rate for DES group was 3.4% compared to 9.3% for %06JURXS S 7KHUHZDVDVLJQL¿FDQWUHGXFWLRQRIDFXWH0,LQ'(6JURXS (5.1% vs. 14.0%; p=0.009). Target vessel revascularization was also reduced in '(6JURXS YV S '(6JURXSKDGVLJQL¿FDQWOHVVFDUGLDF admission post index procedure (33.1% vs. 61.9%; p<0.0001), as well as, less episodes of recurrent angina (37.7% vs. 51.3%; p=0.02). Conclusion: )RU SDWLHQWV UHFHLYLQJ PP RI VWHQW V IRU WUHDWPHQW RI multi-focal or diffuse lesion in a single coronary vessel, implantation of DES lead to decreased cardiac mortality, myocardial infarction, target vessel revascularization, cardiac admission, and recurrent angina over BMS. TCT-336 (LJKWHHQPRQWK06&7IROORZXSUHVXOWVRID¿UVWLQPDQXVHRID Bioabsorbable Everolimus Eluting Stent Design Nico Bruining, Masato Otsuka, Yoshi Onuma, Evelyn Regar, Annick Weustink, Koen Nieman, Patrick J W C Serruys Erasmus MC, Rotterdam, Netherlands Objective: Bioabsorbable drug-eluting stents (DES) could theoretically overcome problems related to permanent metallic DES (no remodeling, no vasomotion, no dual antiplatelet therapy, fracture, etc.). One of the problems UHODWHG WR PHWDO VWHQWV LV WKH GLI¿FXOW\ WR YLVXDOL]H WKH OXPHQ LQ VWHQWHG segments by non-invasive multi-slice computed tomography (MSCT) imaging. This study explores the feasibility to apply quantitative MSCT in a ¿UVWLQPDQVWXG\RIDQHZJHQHUDWLRQRIELRDEVRUEDEOHVWHQWGHVLJQV %96 $EERWW9DVFXODU6DQWD&ODUD&$86$ Methods and results: ,QSDWLHQWV%96VWHQWVZHUHLPSODQWHGLQVLQJOHOHVLRQV
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(15 * 12mm and 1 * 18 mm length) of which in 10 quantitative MSCT was DYDLODEOH'URSRXWVZHUHFDXVHGE\ FRQWUDVWDOOHUJ\ SRRUNLGQH\IXQFWLRQ (1), motion artifacts on MSCT (1) and not returning for follow-up (FUP) (3). 4XDQWLWDWLYH 06&7 DQDO\VLV ZDV SHUIRUPHG XVLQJ GHGLFDWHG VRIWZDUH 9HVVHO DQDO\VLV &85$' :LMN ELM 'XXUVWHGH 1HWKHUODQGV 6WHQW OHQJWKV PHDVXUHG ZHUHPPDWEDVHOLQH %/ YV PPDW)83S /XPHQ YROXPHVZHUH PP3 %/ YV PP3 (FUP), p=0.11 (-10.33%), UHVSHFWLYHO\0HDQOXPHQDUHDV 0/$ PP2YV PP2, p=0.1 DQGPHDQOXPHQGLDPHWHUV 0/' PPYV PP S 7KHPHDQYHVVHODUHDZDVPP2YV PP2, S DQGWKHPHDQSODTXHDUHD PP2YVPP2, p=0.74 &RPSDUHGWRTXDQWLWDWLYH,986PHDVXUHGDW%/DQGPRQWKV 0 )83 LQWKHVDPHSDWLHQWVQRVLJQL¿FDQWGLIIHUHQFHLQPHDVXUHPHQWVRUDFKDQJHLQ PHDVXUH FRXOG EH GRFXPHQWHG 7KH ,986 PHDVXUHPHQWV DW %/ ZHUH 0/$ PP2 DQG 0/' PP DQG DW 0 0/$ PP2 and 0/'PPUHVSHFWLYHO\ Conclusion: Non-invasive imaging of bioabsorbable stents seems feasible without artifacts as encountered with metallic stent designs. Compared to 0,986DUHODWLYHVLPLODUOXPHQUHGXFWLRQZDVIRXQGGHVSLWHDPRQWK GLIIHUHQFHEHWZHHQWKHPHDVXUHPHQWV$PRQWKV,986)83LVLQSURJUHVV DQGFRXOGFRQ¿UPWKHTXDQWLWDWLYH06&7UHVXOWVDWPRQWKV TCT-337 12-Month Clinical Outcome with the Endeavor™ ABT-578 Eluting Coronary Stent System in Patients Undergoing Primary PCI For ST Elevation Myocardial Infarction (STEMI): THE ENDEAVOR™ PRIMARY PCI STUDY (E-PPCI) Kamal Chitkara, Ravi Singh, Mischa Dorsch, Kathryn Somers, Claire Priestley, Jim Mclenachan, Jonathan Blaxill, Steve Wheatcroft, Dan Blackman, John Greenwood Yorkshire Heart Centre, Leeds, United Kingdom Background: Primary percutaneous coronary intervention (PPCI) is superior to thrombolysis in patients with STEMI. Drug-eluting stents (DES) have been shown to be superior to bare metal stents for reduction of instent-restenosis. 'DWD RQ ODWH VWHQW WKURPERVLV ! GD\V KDV UDLVHG FRQFHUQV UHJDUGLQJ '(6SODFHPHQWLQSDWLHQWVZLWK$&6:HUHSRUWWKH¿UVWPRQWKFOLQLFDO evaluation of the Medtronic Endeavor™ ABT-578 eluting coronary stent system in patients undergoing PPCI. Methods: A prospective, single-centre registry of consecutive patients admitted with STEMI was performed. All underwent PPCI within 12 hours of symptoms; each received one or more Endeavor™ stents in one or more target lesions. All received clopidogrel 600mg and aspirin 300mg pre-procedure followed by 75mg each for 12 months. All patients received abciximab and XQIUDFWLRQDWHGKHSDULQ ,8NJ Results: 102 STEMI patients (76 male) received 162 Endeavor™ stents (mean VWHQWVSDWLHQW $JHUDQJH\UV PHDQ\UV 5LVNIDFWRUSUR¿OH comprised 29% hypertension, 25% hyperlipidaemia and 11% diabetes. Mean call-to-balloon time was 112 (+/-45) minutes. The infarct related artery was the LAD in 49%, LCx in 16% and RCA in 35% of patients. Major Adverse &DUGLRYDVFXODU(YHQWUDWH 0$&( ZDVGH¿QHGDVDFRPSRVLWHHQGSRLQWRI death, recurrent MI and target lesion revascularization (TLR). Thirty-day 0$&(UDWHZDV Q FRPSULVLQJGHDWKV GD\ DQG7/5¶VDV a result of sub-acute stent thrombosis (days 9 & 11). One early stent thrombosis was associated with aspirin and clopidogrel non-compliance. MACE rate at PRQWKVZDV Q 7KHUHZHUHDGGLWLRQDO7/5¶VDWGD\V IRU late stent thrombosis) and 267 (for instent restenosis) respectively. There was 1 death on day 345 related to a non-cardiac cause. Conclusion: 7KLVLVWKH¿UVW\HDUUHSRUWRIWKHXVHRIWKH(QGHDYRU'(6 platform in an unselected, consecutive PPCI population. The low occurrence of MACE (6.9%) at 12-month follow-up is comparable to that of sirolimus (Cypher™; TYPHOON study - 7.3%) and paclitaxel (Taxus™; PASSION study - 8.8%) eluting stents. Longer-term follow-up is necessary to monitor rates of very late stent thrombosis.
The American Journal of Cardiology® |
October 12-17, 2008
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TCT Abstracts/ELECTRONIC
http://www.aievolution.com/tct0801
TCT-338
TCT-339
Acute and 1-year Outcomes of Endeavor TM and Xience VTM Stents in the Real World
A Randomized Comparison of Sirolimus-Eluting Stent and Paclitaxel-Eluting Stent in Diabetic Patients: 2-year Clinical Outcomes of DES-DIABETES Trial
Franco Fabbiocchi, Margherita Pirondini, Stefano De Martini, Giuseppe Calligaris, Daniela Trabattoni, Paolo Ravagnani, Stefano Galli, Alessandro Lualdi, Piero Montorsi, Antonio L Bartorelli Centro Cardiologico Monzino IRCCS, Milan, Italy
Seong-Wook Park1, Seung-Whan Lee1, Young-Hak Kim1, Sung-Cheol Yun1, Duk-Woo Park1, Cheol Whan Lee1, Myeong-Ki Hong1, Kyoung-Suk Rhee2, Jei Keon Chae2, Jae-Ki Ko2, Jae-Hyeong Park3, Jae-Hwan Lee3, Si Wan Choi3, Jin-Ok Jeong3, In-Whan Seong3, Yoon Haeng Cho4, NaeHee Lee4, June Hong Kim5, Kook-Jin Chun5, Hyun-Sook Kim6, SeungJung Park1 1 Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea 2Chonbuk National University Hospital, JeonJoo, Republic of Korea 3Chungnam National University Hospital, DaeJeon, Republic of Korea 4Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea 5Busan National University Hospital, Busan, Republic of Korea 6Hallym University Sacred Heart Hospital, Pyeongchon, Republic of Korea
Background: Second generation DES deliver sirolimus-analogue drugs by PRUHELRFRPSDWLEOHSRO\PHUVDQGÀH[LEOHFREDOWFURPLXPSODWIRUPV,QVSLWH of potential improvement in PCI acute results and safety, few data substantiate VHFRQG JHQHUDWLRQ '(6 HI¿FDF\ LQ WKH UHDO ZRUOG Purpose. To analyze acute and 1-year outcomes of EndeavorTM-zotarolimus-eluting (Medtronic, 0LQQHDSROLV01 ( DQG;LHQFHTM9HYHUROLPXVHOXWLQJ $EERW9DVFXODU 6DQWD&ODUD&$ ; VWHQWLPSODQWDWLRQLQFRPSOH[OHVLRQVSDWLHQWV Methods: Between October 2006 and May 2007, 400 unselected pts. with symptomatic coronary artery disease were enrolled: 200 consecutive pts. KDG ( DQG FRQVHFXWLYH SWV KDG ; VWHQWV 'HPRJUDSKLFV DQG FOLQLFDO presentations were similar in both groups, with no difference in diabetes (YV; PXOWLYHVVHOGLVHDVH (YV; %&OHVLRQV LQ(YVLQ; VWDEOH (YV; DQGXQVWDEOHDQJLQD (YV ; $0, (YV; Results: 7ZR KXQGUHG ¿IW\RQH FRURQDU\ OHVLRQV ZHUH WUHDWHG ZLWK ( VWHQWVDQGOHVLRQVZLWK;VWHQWV VWHQWOHVLRQUDWLRZDV(YV; PHDQVWHQWOHQJWKZDV PPLQ(YV PPLQ;RYHUODSSLQJZDV SHUIRUPHGLQ (YV;OHVLRQV DOOS QV ,QKRVSLWDO0$&(ZHUH QRQ40,LQ(YV LQ; SWZLWKFDUGLRJHQLFVKRFNDWSUHVHQWDWLRQ GLHGLQ;7DEOH,VKRZV\HDUSRVWGLVFKDUJHQHZ0$&( Table I All Death
EndeavorTM stent
;LHQFH709VWHQW
p value
6 (3%)
0 (0%)
0.014
Cardiac Death
3 (1.5%)
0 (0%)
ns
AMI
7 (3.5%)
0 (0%)
0.008
TLR
14 (7%)
4 (2%)
0.016
Re-PCI
12 (6%)
4 (2%)
0.041
CABG
2 (1%)
0 (0%)
ns
LST
1 (0.5%)
1 (0.5%)
ns
Composite MACE
19 (9.5%)
4 (2%)
0.001
One-year post-discharge new MACE
Conclusion:%RWK(DQG;VWHQWVVKDUHVLPLODUH[FHOOHQWDFXWHUHVXOWVLQWKH UHDOZRUOGFRPSOH[OHVLRQVSDWLHQWV$W\HDUIROORZXS;VWHQWLVDVVRFLDWHG ZLWKDVLJQL¿FDQWORZHUUDWHRI$0,7/5DQGFRPSRVLWH0$&(
TCT-340 Comparison of Therapeutic Strategy for the Treatment of SirolimusEluting Stent Restenosis Kiyotake Ishikawa1, Yutaka Aoyama1, Hirayama Haruo1, Katsuhiro Katou2,3, Masayoshi Ajioka3, Akihito Tanaka4, Toshikazu Tanaka4, Mizuho Hiramatsu5, Haruo Kamiya5, Toyoaki Murohara2 1 Nagoya Daini Red Cross Hospital, Nagoya, Japan 2Nagoya University School of Medicine, Nagoya, Japan 3Tousei Hospital, Seto, Japan 4 Okazaki City Hospital, Okazaki, Japan 5Nagoya Daiichi Red Cross Hospital, Nagoya, Japan Background: The optimal treatment for Sirolimus-eluting stents (SES) UHVWHQRVLVLVXQNQRZQ:HVRXJKWWRLQYHVWLJDWHWKHRXWFRPHVRIUHSHDWLQJ revascularization for SES restenosis and the difference between the procedures. Methods: Revascularizations to SES restenosis in 4 cardiovascular centers in $LFKLSUHIHFWXUH-DSDQZHUHLGHQWL¿HGUHWURVSHFWLYHO\ Results: One hundred seventy-seven SES restenosis in 151 patients (mean age 66.4 +/- 9.5, 77% male) was treated by balloon angioplasty (BA), bare
The American Journal of Cardiology®
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TCT Abstracts/ELECTRONIC
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E L E C T RO N I C A B S T R AC T S
Background: 'UXJHOXWLQJ VWHQW LPSODQWDWLRQ VLJQL¿FDQWO\ LPSURYHG WKH angiographic and long-term clinical outcomes compared with bare-metal stent implantation in diabetic patients, mainly driven by reduced target lesion revascularization. However, comparison of long-term clinical outcomes between sirolimus-eluting stent (SES) with paclitaxel-eluting stent (PES) in GLDEHWLFSDWLHQWVKDVQRWEHHQVXI¿FLHQWO\HYDOXDWHG Methods: This prospective, multicenter, randomized study compared SES (n=200) and PES implantation (n=200) for diabetic patients (n=400). We compared the long-term clinical outcomes (death, myocardial infarction, and target lesion revascularization) between two groups. Results: The 2 groups had similar baseline clinical and angiographic characteristics. Six-month angiographic restenosis (4.0% vs. 20.8%, p<0.001), 9-month target lesion revascularization (2.0% vs. 7.5%, p=0.017) and major adverse cardiac events (2.0% vs. 8.0%, p=0.010) including death, myocardial LQIDUFWLRQDQGWDUJHWOHVLRQUHYDVFXODUL]DWLRQZHUHVLJQL¿FDQWO\ORZHULQ6(6 versus PES group. At 2 years, there was no difference in the incidence of death (0% vs. 1.5%, p=0.248) and myocardial infarction (0.5% vs. 1.0%, p=0.999). However, the target lesion revascularization (3.5% vs. 11.0%, p=0.004) and PDMRU DGYHUVH FDUGLDF HYHQWV YV S ZHUH VLJQL¿FDQWO\ lower in SES versus PES group. Two stent thromboses (1 acute, 1 very late) occurred in the SES group during dual antiplatelet therapy and none in the PES group. Conclusion: SES implantation is superior to reducing 2-year target lesion revascularization and improving 2-year clinical outcomes in patients with DM and coronary artery disease compared to PES implantation.
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metal stent implantation (BMS), repeated drug eluting stent implantation (DES) or coronary artery bypass graft (CABG) (55 (31.1%), 3 (1.7%), 101 (57.1%), 17(9.6%); respectively). In total follow up period of 361 +/- 270 days, 28 major advanced cardiovascular events were seen (2 cardiac death, 4 noncardiac death, 2 thrombosis, 20 target lesion revascularization) and follow up coronary angiography was performed in 110 cases (BA 42, BMS 3, DES 59, CABG 13). The proportion of re-restenosis, re-target legion revascularization, and re-target vessel revascularization was lower in CABG group (7.7%, 7.7%, 7.7%, respectively; P=0.007) compared with BA group (45.2%, 26.2%, 26.2%, respectively), or DES group (55.9%, 25.4%, 35.6%, respectively). No VLJQL¿FDQWGLIIHUHQFHUHJDUGLQJEDFNJURXQGVDQGOHVLRQFKDUDFWHULVWLFVZDV seen between patients with and without re-restenosis. Conclusion: SES restenosis presents quite high rate of re-restenosis with percutaneous coronary intervention (PCI) and CABG seems to be the best way to avoid repeat revascularization. Implanting another DES has no advantage to BA when treated with PCI. TCT-341 Prognostic Impact of Preprocedural Levels of C-Reactive Protein on Stent Thrombosis After Coronary Stent Implantation
E L E C T RO N I C A B S T R AC T S
Keiji Inoue, Naoki Makita, Kiyonari Matsuo, Yasutsugu Shiono, Kento Tateishi, Yoshiharu Nishibori, Akiko Matsuo, Tetsuya Tanaka, Hiroshi Fujita, Makoto Kitamura Kyoto Second Red Cross Hospital, Kyoto, Japan Background: Stent thrombosis (ST) is the most concerning adverse outcome of coronary stent placement, frequently presenting as acute myocardial infarction or death. Although the safety concerns regarding ST have EHHQ UDLVHG WKH DFFXUDWH ULVN SUHGLFWLRQ DQG VWUDWL¿FDWLRQ IRU WKHVH HYHQWV after percutaneous coronary intervention (PCI) still remain challenging. ,QÀDPPDWRU\PHFKDQLVPVPD\SOD\DFUXFLDOUROHLQWKHVWHQWWKURPERVLV &UHDFWLYH SURWHLQ &53 D PDUNHU RI V\VWHPLF LQÀDPPDWLRQ KDV EHHQ FRQVLVWHQWO\DVVRFLDWHGZLWKDQLQFUHDVHGULVNRIFDUGLRYDVFXODUHYHQWV:H therefore evaluated whether elevated preinterventional CRP levels were UHODWHGWRDQLQFUHDVHGULVNRI67DIWHUVWHQWLPSODQWDWLRQ Methods::HVWXGLHGFRQVHFXWLYHSDWLHQWV PHDQDJH \UV ZKR XQGHUZHQW VXFFHVVIXO VWHQW LPSODQWDWLRQ %ORRG VDPSOHV ZHUH WDNHQ EHIRUH PCI to evaluate baseline CRP. The subjects were divided into two groups of elevated CRP group (group E) and non-elevated CRP group (group N) according to the median value of baseline CRP for data analysis. The primary HQGSRLQWRIWKHVWXG\ZDVGH¿QLWH677KHVHFRQGDU\HQGSRLQWZDVGH¿QHG as cardiac death due to ST. Results: The median value of baseline CRP was 2.09mg/L in all patients. 'XULQJWKH\HDUIROORZXSGH¿QLWH67ZDVREVHUYHGLQ FDVHV DQG67UHODWHGGHDWKZDVVHHQLQFDVHV 7KHUHZDVQRVLJQL¿FDQW difference of ST rate between bare metal stent cases and drug eluting stent FDVHV3DWLHQWVRIJURXS( Q ZLWKKLJKHUVHUXPOHYHOVRI&53 PJ/ KDGDVLJQL¿FDQWO\KLJKHULQFLGHQFHRIVWHQWWKURPERVLVDVFRPSDUHGWR those of group N (n=1,256) with lower serum levels of CRP (1.83% vs. 0.48%, S $OVRWKHUDWHRIGHDWKDIWHU67RIJURXS(ZDVVLJQL¿FDQWO\KLJKHU than those of group N (0.71% vs. 0.16%, p=0.0349). Conclusion: (OHYDWHG SUHSURFHGXUDO OHYHOV RI &53 ZHUH VLJQL¿FDQWO\ associated with the development of ST and ST related death. Baseline CRP OHYHOV PD\ EH XVHIXO WR SUHGLFW FOLQLFDO ULVN RI 67 LQ SDWLHQWV WUHDWHG ZLWK coronary stents.
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TCT-342 Predictive Value of Preinterventional C-reactive Protein Levels on Long Term Angiographic and Clinical Outcomes after SirolimusEluting Stent Implantation Keiji Inoue, Naoki Makita, Kiyonari Matsuo, Yasutsugu Shiono, Kento Tateishi, Yoshiharu Nishibori, Akiko Matsuo, Tetsuya Tanaka, Hiroshi Fujita, Makoto Kitamura Kyoto Second Red Cross Hospital, Kyoto, Japan Background:$IWHUSHUFXWDQHRXVFRURQDU\LQWHUYHQWLRQ 3&, LQÀDPPDWRU\ mechanisms play a crucial role in the restenosis. However, possible role of LQÀDPPDWLRQLQUHVWHQRVLVDIWHUGUXJHOXWLQJVWHQWVKDVQRWEHHQHVWDEOLVKHG We assessed the association of preprocedural C-reactive protein (CRP) levels with angiographic restenosis and adverse clinical events after Sirolimuseluting stent (SES) implantation. Methods: :H VWXGLHG FRQVHFXWLYH SDWLHQWV PHDQ DJH \UV ZKR XQGHUZHQWVXFFHVVIXO6(6LPSODQWDWLRQ%ORRGVDPSOHVZHUHWDNHQEHIRUH3&, to evaluate CRP and patients were grouped into quartile according to baseline &53YDOXHVIRUGDWDDQDO\VLV7KHSULPDU\HQGSRLQWZDVDPDMRUHYHQWGH¿QHG as cardiac death or Q-wave myocardial infarction. The secondary end point was GH¿QHGDVUHVWHQRVLVUHTXLULQJUHSHDWUHYDVFXODUL]DWLRQDWPRQWKIROORZXS Results: Baseline clinical and angiographic characteristics were similar between the quartile groups. At 1-year follow-up, primary end point occurred in 1 (1.3%) patient of the third quartile and in 5 (6.5%) patients of the highest quartile whereas no major cardiac event occurred in the lowest quartile and second quartile (p<0.005). Restenosis were observed in 38 patients (12.3%) of total subjects at PRQWK IROORZXS %LQDU\ UHVWHQRVLV UDWHV ZHUH UHPDUNDEO\ ORZHU LQ WKH ¿UVW quartile group compared with the second, third and fourth quartile groups (3.8% in quartile I vs. 12.2% in quartile II vs. 16.7% in quartile III vs 16.9% in quartile ,9UHVSHFWLYHO\S ,QVWHQWODWHORVVZHUHORZHULQWKH¿UVWTXDUWLOHDPRQJ JURXSV YV YVYV UHVSHFWLYHO\S The correlation between late loss index and pre-procedure CRP showed positive proportion (y=0.2691x + 0.0103; R=0.202, p<0.001). In multivariate analysis, the higher quartile of CRP levels was an independent predictor of a major cardiac event and subsequent restenosis. Conclusion: 3UHSURFHGXUDO &53 OHYHOV DUH VLJQL¿FDQWO\ DVVRFLDWHG ZLWK cardiac events and angiographic restenosis after SES implantation. Baseline &53OHYHOVPD\EHXVHIXOWRSUHGLFWFOLQLFDOULVNLQSDWLHQWVWUHDWHGZLWK6(6 TCT-343 Biolimus A9 Eluting Self Expandable Designated Bifurcation Stent in a Porcine Coronary Model: Structural Integrity and Biocompatibility in Comparison to Overlapping Cypher Stents Greg L Kaluza1, Gerard B Conditt1, Akira Murata1, Shigenobu Inami1, David Wallace-Bradley1, Kai Xu1, Geng Hua Yi1, Jennifer C McGregor1, Armando Tellez1, Brett Trauthen2, Frank Kolodgie3, Renu Virmani3, Juan F Granada1 1 Cardiovascular Research Foundation, Orangeburg, NY; 2Devax, Inc., Menlo Park, CA; 3CV Path, Gaithersburg, MD Background:7KH$;;(66VWHQW $[%$ LVDQRYHOVHOIH[SDQGDEOHGHYLFH aiming at more anatomically correct reconstruction of the bifurcation than the current techniques using overlapping tubular stents. It features a conical shape covering the entire proximal bifurcation area down to the carina, and can be complemented with conventional stents in the distal parent vessel and in the side branch. It is coated with a bioresorbable (polylactic acid) top coat eluting Biolimus A9 (~22 -g/mm of stent length). Methods: This study evaluated the structural integrity of AxBA9 deployed in a bifurcation and overlapped by Cypher (SES) in a distal parent vessel. Furthermore, it compared the mechanical and biological consequences of stent-stent interaction of 2 different overlapped stents (AxBA9-SES) to 2 identical overlapped (SES) stents. In 11 Yucatan miniswine, overlapping $[%$ 6(6VWHQWVZHUHSODFHGLQELIXUFDWLRQVRI/$'RU/&;ZKLOH
The American Journal of Cardiology®
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October 12-17, 2008
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TCT Abstracts/ELECTRONIC
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TCT-345
other single straight arteries received 2 sequentially overlapped SES. At 90 days, angiography was performed and arteries were harvested for histology. Results: Two stent fractures in the SES-SES combinations were found as RSSRVHGWRQRQHLQWKH$[%$ 6(6FRPELQDWLRQV,QÀDPPDWRU\UHVSRQVH was slightly lower in the AxBA9-SES combination (39% of struts had presence of granulomas) than in the SES-SES combination (61% of struts had presence of granulomas). Granulomas were associated with the presence of SES as the struts with granulomas were found predominantly in the overlap sections, and with similar frequency in both stent combinations. Whereas, WKHUHZHUHVLJQL¿FDQWO\OHVVJUDQXORPDVLQWKHSUR[LPDOVHFWLRQVRIWKH$[[HVV BA9 sections when compared to all the SES-SES stented sections. AxBA96(6FRPELQDWLRQVIHDWXUHGVLPLODUQHRLQWLPDOWKLFNQHVVHVWRWKH6(66(6 combination in the overlapping zone. The remaining sections proximal and distal to the overlap for the AxBA9-SES groups as well as the Cypher-Cypher combination showed similar area measurements. Conclusion: The $;;(66%LROLPXV$ VHOIH[SDQGLQJQLWLQROELIXUFDWLRQ stent overlapped distally with Cypher demonstrated excellent structural integrity (no fractures), while showing at least comparable biocompatibility WRWKHRYHUODSSHGEHQFKPDUN&\SKHUVWHQWVRXWWR GD\V
Pooled Analysis of CUSTOM II and III Trials: Six-Month IVUS Analysis of Very Long Lesions Treated with the Custom NX Biolimus-A9 Eluting Stent Takao Shimohama1, Junya Ako1, Daisaku Nakatani1, Katsuhisa Waseda1, Hyeonsoo Chang1, Paul G. Yock1, Yasuhiro Honda1, Bernard De Bruyne2, Eberhard Grube3, Peter J. Fitzgerald1 1 Stanford University Medical Center, Stanford, CA; 2Cardiovascular Center, OLV Clinic, Aalst, Belgium 3HELIOS Heart Center Siegburg, Siegburg, Germany Background:7KH&XVWRP1;V\VWHPFRQVLVWVRID%LROLPXV$ HOXWLQJVWHQW on a bioabsorbable polymer with interdigitating design which allows operators to customize stent length in 6 mm cobalt-chromium modular units up to 60 mm. The DLPRIWKLV,986VWXG\ZDVWRHYDOXDWHWKHHI¿FDF\RIWKH&XVWRP1; ;7(17 ,QF LQWKHWUHDWPHQWRIYHU\ORQJOHVLRQV OHVLRQOHQJWK!PP Methods: Data were obtained from the CUSTOM II and III trials; prospective, PXOWLFHQWHUVWXGLHVGHVLJQHGWRDVVHVVVDIHW\DQGHI¿FDF\RIWKLVVWHQWV\VWHP 6L[PRQWKVIROORZXSYROXPHWULF,986DQDO\VLVZDVDYDLODEOHLQSDWLHQWV OHVLRQV /HVLRQVZHUHGLYLGHGLQWRJURXSV /RQJ !PPQ DQG 6KRUW PP Q 9ROXPH LQGH[ YROXPHOHQJWK ZDV FDOFXODWHG IRU YHVVHOOXPHQVWHQWDQGQHRLQWLPD 1,9 Results:'HVSLWHYHU\ORQJOHVLRQVDQGVWHQWOHQJWK1,9 1,9VWHQWYROXPH was <10% in the Long group. There was no difference in minimum lumen area at follow-up between the 2 groups. There were 5 cases of stent strut discontinuity (Long: n=1, Short: n=4) between the segments yet no lumen loss was observed at that location in any of the cases. Late-acquired incomplete stent apposition was not observed in either group.
TCT-344 Directional Sirolimus Biodegradable Abluminal Coating and Anti&'6XUIDFH0RGL¿FDWLRQ (DUO\$QLPDO'DWDRQ9DVFXODU+HDOLQJ and Restenosis Juan F Granada1, Carlos L Alviar1, Martin B Leon2, Greg L Kaluza1, Armando Tellez1, David Wallace-Bradley1, Stephen Rowland3, Sherry P Parker3, Frank Kolodgie4, Gaku Nakazawa4, Renu Virmani4 1 Cardiovascular Research Foundation, Orangeburg, NY; 2 Cardiovascular Research Foundation, New York, NY; 3Orbus Neich, Fort Lauderdale, FL; 4CV Path, Gaithersburg, MD
Lesion length, mm
Background: Previous studies with anti-CD34 coating on sirolimus-eluting stents resulted in enhanced endothelialization, but not expression of functional HQGRWKHOLDOPDUNHUV 3(&$0 GXHWRWKHHIIHFWVRIVLUROLPXVRQFDSWXUHG cells. The hypothesis is that separation of the EPC capture effect from drug delivery (i.e. by applying the drug and polymer to the abluminal surface of the stent) would result in both enhanced endothelialization and function (expression of PECAM at endothelial junctions); and still preserve the effect of sirolimus on neointimal proliferation. Methods: A total of 35 stents: 18 R stents with preferential sirolimus ELRGHJUDGDEOH DEOXPLQDO FRDWLQJ DQG DQWL&' VXUIDFH PRGL¿FDWLRQ $E& stent) and 17 R stents with uniform sirolimus biodegradable abluminal coating DQGDQWL&'VXUIDFHPRGL¿FDWLRQ FRQWUROVWHQWV ZHUHGHSOR\HGLQSLJV $QLPDOVZHUHVDFUL¿FHGDW VWHQWV$E&VWHQWVFRQWUROV $E& stents, 6 controls) and 28 (6 AbC stents, 6 controls) days. Stents harvested at 3 and 14 days were used for SEM evaluation and confocal microscopy (with PECAM staining). Stents harvested at 28 days were used for Morphometric evaluation using light microscopy. Results: Stent endothelialization rates evaluated by SEM were comparable at 3 (47% +/-13% AbC stent versus 45%+/-21% control stent) and at 14 (97%+/-2.4% AbC stent versus 96%+/-2.6% control stent) days. However, endothelialization rates evaluated by confocal microscopy (CD31/PECAM-1 positive cells) demonstrated a trend in improved endothelialization in the AbC stent at 3 (AbC 0.6%+/-1.4%, control 0.2%+/-0.4%, p=0.55) and at 14 (AbC FRQWUROS $WGD\VQHRLQWLPDOWKLFNQHVV $E& FRQWURO PHDQ¿EULQVFRUH $E& 16%, control 15%+/-18%) and the intimal score (AbC 0.56+/-0.62, control 0.94%+/-1.14) were similar between both stent groups. Thus, despite almost identical endothelial cell coverage seem by SEM, AbC stents trended toward superior endothelial cell viability at 3 and 14 days. Conclusion: In two similarly designed drug eluting stents using anti-CD34 coating, the preferential abluminal deposition of sirolimus delivery maintained DQ HI¿FDFLRXV FRQWURO RQ QHRLQWLPDO JURZWK EXW VKRZHG D PRUH IDYRUDEOH YDVFXODUKHDOLQJSUR¿OHWKDQWKHFRQYHQWLRQDOO\XQLIRUPFRDWLQJRIVLUROLPXV
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October 12-17, 2008
Short (n=48)
39DOXH
<0.0001
Stent length, mm
<0.0001
Reference diameter, mm
0.81
Baseline MLA, mm2
0.71
Follow up MLA, mm2
0.60
1,9
0.05
Max CSN, %
0.004
Late acquired ISA, %
0
0
-
0/$ PLQLPXPOXPHQDUHD 1,9 SHUFHQWQHRLQWLPDOYROXPH CSN: cross sectional narrowing; ISA: incomplete stent apposition
Conclusion: 7KH &XVWRP 1; GHPRQVWUDWHG H[FHOOHQW VXSSUHVVLRQ RI neointimal hyperplasia in very long lesions at 6 months. Compared to other DES trials, longer average lesion lengths were enrolled and treated successfully. This novel stent system may offer a customized option for treatment of long diffuse lesion molphology. TCT-346 The Impact of Non-Stent Related Progression of Underlying Coronary Artery Disease on Late Clinical Outcomes after PaclitaxelEluting Stents Dominic J. Allocco1, Keith D. Dawkins1, Donald S. Baim1, Martin B. Leon2 %RVWRQ6FLHQWL¿F&RUSRUDWLRQ1DWLFN0$ 2Columbia University Medical Center, New York, NY
1
Background: &OLQLFDOHYHQWVLQWKH¿UVW\HDUDIWHUEDUHPHWDOVWHQW %06 implantation are predominantly stent-related, while clinical events in years 2-5 are more often related to disease activity outside the stented segment. It is QRWNQRZQLIWKHVDPHLVWUXHIRUSDFOLWD[HOHOXWLQJVWHQWV 3(6 Methods::HORRNHGDW7$;8665SDWLHQWVDQG %06SDWLHQWV IURPWKH7$;86,,,,9DQG9WULDOVDQGFDOFXODWHGDQQXDOKD]DUGUDWHV (HR) for major adverse events through a median 4.8 year follow-up. Results: Annualized HR for major adverse events beyond 1 year were relatively
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The American Journal of Cardiology®
Long (n=20)
http://www.aievolution.com/tct0801
constant and similar for PES and BMS (Table). Event rates after 1 year were KLJKHULQSDWLHQWVZLWKPDUNHUVRIDJJUHVVLYHGLVHDVH VXFKDVGLDEHWHVRUORQJ OHVLRQVGDWDQRWVKRZQ :KLOHWDUJHWYHVVHOUHYDVFXODUL]DWLRQ 795 HYHQWV at 1 year consisted mostly of target lesion revascularization (TLR); TLR and QRQ7/5HYHQWVFRQWULEXWHGHTXDOO\WRRYHUDOO795DIWHU\HDU7KHDQQXDO VWHQWWKURPERVLV+5IURPWR\HDUVZDVORZDQGGLGQRWGLIIHUVLJQL¿FDQWO\ between BMS and PES (0.25 and 0.35%/year, respectively). Year 1 Annual Hazard Rate per 100 pt-yrs
Years 2 to 5 Annual Hazard Rate per 100 pt-yrs
BMS n=1397
PES n=1400
P value
BMS n=1349
PES n=1345
P value
795
20.36%
11.21%
<0.0001
3.83%
3.22%
0.16
-TLR
17.57%
7.45%
<0.0001
2.02%
1.61%
0.19
Table
1RQ7/5795 4.45%
4.31%
0.87
2.09%
1.78%
0.32
MI
4.76%
4.24%
0.52
0.68%
0.94%
0.20
-QWMI
0.37%
0.66%
0.28
0.20%
0.23%
0.80
7DUJHW9HVVHO --Non-target 9HVVHO -NQWMI
0.29%
0.44%
0.53
0.07%
0.15%
0.32
0.07%
0.22%
0.32
0.12%
0.07%
0.48
4.37%
3.54%
0.28
0.53%
0.73%
0.25
Death
1.90%
1.97%
0.89
1.94%
1.87%
0.84
Death or MI ARC ST-Def/ Probable ARC ST'H¿QLWH
6.42%
5.99%
0.64
2.59%
2.69%
0.79
0.81%
0.88%
0.83
0.25%
0.35%
0.40
0.66%
0.73%
0.82
0.17%
0.23%
0.61
Conclusion: Given the late stability of the stented segment beyond 1 year for both BMS and PES and evidence of ongoing disease activity outside the stented segment, many of the observed late events with PES (death and MI) may be due to underlying disease activity rather than stent-related events. Analyses of PES outcomes should recognize and attempt to correct for this EDFNJURXQGHYHQWUDWHE\WKHXVHRIVXLWDEOH%06FRQWUROV TCT-347
E L E C T RO N I C A B S T R AC T S
IVUS Analysis in the SPIRIT III Japan Treated with XIENCETM V Everolimus-Eluting Stent Compared to the SPIRIT III US Arm Takao Shimohama1, Hiromasa Otake1, Junya Ako1, Masao Yamasaki1, Ichizo Tsujino1, Katsuhisa Waseda1, Takao Hasegawa1, Ryota Sakurai1, Daisaku Nakatani1, Hyeonsoo Chang1, Paul G. Yock1, Yasuhiro Honda1, Hajime Kusano2, Krishnankutty Sudhir2, Shigeru Saito3, Gregg W. Stone4, Peter J. Fitzgerald1 1 Stanford University Medical Center, Stanford, CA; 2Abbott Vascular, Santa Clara, CA; 3Shonan Kamakura General Hospital, Kamakura, Japan 4Columbia University Medical Center, New York, NY Background: ;,(1&(TM 9 DQ HYHUROLPXVHOXWLQJ FREDOW FKURPLXP VWHQW RQDGXUDEOHÀXRURSRO\PHU ((6 KDVVKRZQSURPLVHLQLPSURYLQJFOLQLFDO and angiographic outcomes in patients with coronary artery disease. The aim RIWKLV,986VWXG\ZDVWRHYDOXDWHYHVVHOUHVSRQVHVWR((6LPSODQWDWLRQLQ SPIRIT III Japan, and compare them with the US arm. Methods: The SPIRIT III Japan is a prospective, multicenter, non-randomized arm using EES in Japan. In this study, we compared SPIRIT III Japan (JAPAN) and SPIRIT III US (EES, PES: paclitaxel-eluting stent). Eight months followXSYROXPHWULF,986GDWDZHUHDYDLODEOHLQ OHVLRQV -$3$1 ((6 3(6 9ROXPH LQGH[ YROXPHOHQJWK ZDV FDOFXODWHG IRU YHVVHO SODTXH QHRLQWLPD 1,9 DQG OXPHQ /9, &URVVVHFWLRQDO QDUURZLQJ &61 ZDV GH¿QHGDVQHRLQWLPDODUHDGLYLGHGE\VWHQWDUHD Results: There was a trend toward larger minimum lumen area (MLA) at baseline and follow-up in JAPAN (Table), although no difference was observed LQYHVVHOVL]HLQWKHUHIHUHQFHVHJPHQWDPRQJWKHDUPV,Q-$3$11,9 1,9VWHQWYROXPH DQGPD[&61ZHUHVLJQL¿FDQWO\ORZHUDWPRQWKVIROORZ XS S E\$129$ 7KHUHZDVDWUHQGWRZDUGORZHUEDVHOLQHLQFRPSOHWH stent apposition (ISA), while there were no differences in tissue prolapse or edge dissection in JAPAN. Late acquired ISA was infrequent in each arm.
138i
JAPAN
EES
PES
39DOXH
/9,LQ3UR[LPDO5HIHUHQFHPPPP
0.78
/9,LQ'LVWDO5HIHUHQFHPPPP
0.66
Baseline MLA, mm2
0.08 0.08
Follow-up MLA, mm2
1,9
<0.0001
Max CSN, %
<0.0001
Baseline ISA, %
19.4
32.9
29.0
0.07
Late acquired ISA, %
1.2
1.7
4.5
0.42
E\$129$
Conclusion:;,(1&(TM9GHPRQVWUDWHGVLJQL¿FDQWVXSSUHVVLRQRIQHRLQWLPDO hyperplasia in the Japanese population up to 8 months as compared with EES and PES in the US arm. TCT-348 Long-Term Outcomes of Drug-Eluting Stents Versus Bare-Metal Stents in Saphenous Vein Graft Disease: Results from the Prairie “Real World” Stent Registry Nilesh J Goswami10DWWKHZ*DI¿JDQ2, Amanda M Pfeiffer3, Anna L. Moore3, Stephen J. Markwell2, Marc E. Shelton1, Gregory J. Mishkel1 1 3UDLULH+HDUW,QVWLWXWHDW6W-RKQ¶V+RVSLWDO6SULQJ¿HOG,/ 2Southern ,OOLQRLV8QLYHUVLW\6FKRRORI0HGLFLQH6SULQJ¿HOG,/ 3Prairie (GXFDWLRQ 5HVHDUFK&RRSHUDWLRQ6SULQJ¿HOG,/ Background: Drug eluting stent (DES) implantation in native coronary arteries has proven to effectively reduce restenosis and even mortality relative WR EDUH PHWDO VWHQWV %06 +RZHYHU WKH HI¿FDF\ RI '(6 LQ VDSKHQRXV YHLQJUDIWV 69* UHPDLQVXQFHUWDLQDQGVRPHVWXGLHVVXJJHVWDQH[FHVVRI PRUWDOLW\LQ'(669*SDWLHQWV:HVRXJKWWRHYDOXDWHORQJWHUPRXWFRPHVRI '(6FRPSDUHGWR%06IRU69*GLVHDVH Methods: Data were obtained on patients undergoing a 1st DES or BMS SODFHPHQWLQD69*IURPWR&OLQLFDOIROORZXSZDVREWDLQHG at regular intervals. We report 3-year major adverse cardiac events (MACE) GH¿QHGDVDFRPSRVLWHRIDOOFDXVHPRUWDOLW\QRQIDWDOP\RFDUGLDOLQIDUFWLRQ (MI), or target segment revascularization (TSR). Propensity scores were generated using pertinent baseline variables. Multivariable Cox regression ZDVXWLOL]HGWRDQDO\]HWKHULVNDVVRFLDWHGZLWK%06YV'(6LPSODQWDWLRQ Results: Our study group included 432 patients (104 BMS; 328 DES) with OHVLRQV&OLQLFDOIROORZXSZDVREWDLQHGRQ RISDWLHQWV PHDQ 449 days). Demographics were similar at baseline except that BMS were used more often in patients with STEMI presentation (12.5% vs 3.0%; p<0.001) DQGLQODUJHUGLDPHWHUYHVVHOV YV S %LYDOLUXGLQZDV used more often in DES procedures (32.9% vs 20.2%; p=0.014). In-hospital outcomes were similar between groups except that death occurred more often in BMS patients (2.9% vs 0.3%; p=0.05). Three-year Kaplan-Meier event rates were similar between cohorts. Cox regression showed similar results between cohorts, even after propensity score adjustment (see table). Unadjusted (BMS vs DES) Hazard Ratio p value &RQ¿GHQFH,QWHUYDO 1.142 Mortality 0.6265 (0.669 - 1.948) 0.373 MI 0.1093 (0.112 - 1.247) 1.029 TSR 0.9270 (0.564 - 1.876) 0.920 Mortality + MI 0.7410 (0.562 - 1.506) 0.948 MACE 0.7890 (0.641 - 1.401)
Adjusted (BMS vs DES) Hazard Ratio p value &RQ¿GHQFH,QWHUYDO 1.604 0.1320 (0.867 - 2.966) 0.323 0.0931 (0.086 - 1.208) 1.336 0.3985 (0.682 - 2.620) 1.045 0.8784 (0.596 - 1.833) 1.150 0.5320 (0.742 - 1.782)
Conclusion: Although our data shows that long-term MACE rates are comparable EHWZHHQ'(6DQG%06LQ69*OHVLRQVZLWKQRH[FHVVPRUWDOLW\ULVNWKHUHGRHV QRWDSSHDUWREHDQ\EHQH¿WLQWKHUHGXFWLRQRIFOLQLFDOUHVWHQRVLV
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TCT-349
loaded with 85-g of Novolimus, as compared to 150-g of Sirolimus loaded on the Cypher stent (Cordis Corp, Miami, Fl, USA) and VLJQL¿FDQWO\ OHVV SRO\PHUWKDQRWKHUPDUNHWDSSURYHG'(6V\VWHPV7KHVDIHW\DQGHI¿FDF\ of this novel device was evaluated in reducing neointimal hyperplasia as DVVHVVHGE\4&$DQG,986 Methods: A consecutive cohort of 15 patients with de novo lesions <14 mm in length, located in native coronary arteries ranging in diameter from 3.0 WRPPZHUHHQUROOHGLQWKLV)LUVW,Q0DQVWXG\$QJLRJUDSK\DQG,986 were completed at baseline and repeated at 4 and 8 months. Dual antiplatelet therapy was maintained for 12 months. The primary endpoint was in-stent late lumen loss at 4-months as assessed by QCA. Secondary endpoints included 0$&(LQVWHQWQHRLQWLPDOREVWUXFWLRQE\,986DQGGHYLFHVXFFHVV Results: A total of 15 patients were enrolled with 67% females and 47% diabetics. Angiographic and procedural success were achieved in all cases. At WKHPRQWKIROORZXSWKHPLQLPXPLQVWHQWODWHOXPHQORVVZDV PPE\DQJLRJUDSK\DQGYROXPHREVWUXFWLRQZDVE\,986$WWKH PRQWKIROORZXSSHULRGWKHLQVWHQWODWHOXPHQORVVZDVPPE\ 4&$DQGWKHYROXPHREVWUXFWLRQZDVE\,9869DVFXODUSRVLWLYH remodeling and late ISA were not present among these patients. There were no 0$&(HYHQWVWKURXJKWKH¿UVW\HDUFOLQLFDOIROORZXSSHULRG Conclusion: ,Q WKLV ¿UVWLQPDQ VWXG\ LPSODQWDWLRQ RI WKH (OL[LU 0HGLFDO Novolimus-Eluting Stent with Durable Polymer was safe and effective exhibiting minimal neointimal proliferation. Additional large clinical trials DUHUHTXLUHGWRFRQ¿UPWKHVHSURPLVLQJUHVXOWV
Treatment of DES In-stent Restenosis with Paclitaxel Eluting Balloon: a Multicenter, Prospective Registry Fabrizio Clementi1, Fina Mauri2, Riccardo Colantonio3, Alessandro Aprile1, Oriol Rodriguez2, Eugenio Martuscelli1, France sco Romeo1, Gennaro Sardella3, Massimo Sangiorgi1 1 University of Rome Tor Vergata, Roma, Italy 2University Hospital Germans Trias i Pujol, Barcelona, Spain 3University of Rome La Sapienza, Roma, Italy Background: DES restenosis, albeit presenting with less aggressive pattern, is more challenging in terms of treatment results both angiographically and clinically. Treatment strategy reported in literature encompass brachitherapy DQG'(6LQ'(6EXWRXWFRPHVDUHQRWVXI¿FLHQWO\HQFRXUDJLQJ PRQWKV MACE ranging from 25% to 40%). Recently the use of paclitaxel eluting balloon (PEB) for BMS restenosis has been reported with encouraging results even when compared with DES treatment. We report here results of a multicenter prospective registry about the use of PEB (DIOR© , EuroCore, Dusseldorf, Germany) for treatment of DES in-stent restenosis. Methods: Between August 2007 and February 2008 we prospectively enrolled 35 patients (38 lesions) with angiographically documented DES inVWHQWUHVWHQRVLV GLDPHWHUVWHQRVLV!ZLWKV\PSWRPVRIRUGRFXPHQWHG cardiac ischemia). Treatment protocol required pre-dilation of the lesion with a non-compliant balloon to reach less than 20% residual stenosis prior to WUHDWPHQWZLWKWKH3(%ZKLFKZDVLQÀDWHGDWOHDVWWRQRPLQDOSUHVVXUH DWP for 60 seconds. After treatment all patients was discharged with 1 months double antiplatelet therapy if not else required. Primary end-point of the study was late-lumen loss at 6 months. Secondary end-points were incidence RI0$&(DQGELQDU\UHVWHQRVLV GLDPHWHUVWHQRVLV! DWPRQWKV'DWD management and QCA analysis was centralized and independent. Results: Restenosis pattern was diffuse in 41,8 % of cases. Diabetic patients ZHUH UHÀHFWLQJWKHKLJKHUULVNRIUHVWHQRVLVLQWKLVSDWLHQWVXEVHW3UH WUHDWPHQWUHIHUHQFHYHVVHOGLDPHWHUZDV PPPHDQ6' OHVLRQ OHQJWKPLQLPDOOXPHQGLDPHWHUZDV DQGSHUFHQWDJH VWHQRVLV ZDV $IWHU SURFHGXUH UHVLGXDO VWHQRVLV ZDV with an acute gain of 1,91 mm. 6 months clinical follow-up is available for 29 patients with an incidence of MACE of 20,6 % (Q-wave MI 3.4%, TLR 17.2%, Death 0%). 1 subacute stent thrombosis was observed in the study interval. Results for angiographic follow-up will be available in late August 2008. Conclusion: Treatment of DES in-stent restenosis with PEB is safe with 6 PRQWKVHI¿FDF\DWOHDVWDVJRRGDVDOWHUQDWLYHVWUDWHJLHVFXUUHQWO\SURSRVHG (DES in DES and brachitherapy). Moreover only 1 month dual antiplatelets therapy is required with low incidence of stent thrombosis.
TCT-351 Six-Month IVUS Analysis of Pimecrolimus and Dual Pimecrolimus/ Paclitaxel Eluting Stents: Results of the GENESIS Trial Takao Shimohama1, Ichizo Tsujino1, Junya Ako1, Takao Hasegawa1, Hyeonsoo Chang1, Paul G. Yock1, Yasuhiro Honda1, Keith D. Dawkins2, Stefan Verheye3, Peter J. Fitzgerald1 1 Stanford University Medical Center, Stanford, CA; 2Southampton University Hospital, Southampton, United Kingdom 3Antwerp Cardiovascular Institute, Antwerp, Belgium
TCT-350 Single Center, First-In-Man Study of the Elixir Novolimus-Eluting Coronary Stent System with Durable Polymer: Twelve Month &OLQLFDO6DIHW\DQG(I¿FDF\5HVXOWV José de Ribamar Costa, Jr.1, Alexandre Abizaid1, Fausto Feres1, Ricardo Costa1, Ana Cristina Seixas1, Rodolfo Staico1, Dimytri Siqueira1, Lynn Meredith2, Vinayak Bhat2, John Yan3, John Ormiston4, Amanda Sousa1, J Eduardo Sousa1, Peter Fitzgerald5 1 Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil 2Elixir Medical, Sunnyvale, CA; 3Elixir Medical, Sunyvale, CA; 4Auckland City Hospital,, Auckland, New Zealand 5Stanford University Medical Center, Stanford, CA
PLES (n=15) PL/PES (n=23) PES (n=16) Baseline 6 Months Baseline 6 Months Baseline 6 Months 9HVVHO9,PPP /XPHQ9,PPP
3ODTXH9,PPP 1,9 Max CSN†, % Late ISA, % 0 0 0
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Background: The Elixir Medical Novolimus-Eluting Stent with Durable Polymer is a novel DES that combines a cobalt chromium alloy stent platform with Novolimus (a unique, antiproliferative macrocyclic lactone similar to sirolimus) and a thin, single-layer methacrylate polymer. The innovative design of this stent system enables drug delivery using a substantially reduced amount of polymer and drug. The Elixir Medical Novolimus Eluting DES is
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Background: Pimecrolimus and dual pimecrolimus/paclitaxel eluting stents KDYHEHHQVKRZQWRGHFUHDVHLQÀDPPDWLRQDQGQHRLQWLPDOSUROLIHUDWLRQLQDQ DQLPDOPRGHO7KHDLPRIWKLV,986VWXG\ZDVWRHYDOXDWHWKHHI¿FDF\RIWKH Conor cobalt-chromium reservoir-based coronary stent system eluting either pimecrolimus (PLES) or a dual drug delivery of pimecrolimus/paclitaxel (PL/ PES) compared with CoStar paclitaxel-eluting stents (PES) in human de novo native coronary lesions. Methods: Data were obtained from the GENESIS Trial, a multicenter, randomized clinical trial comparing PLES or PL/PES coronary stent system WRWKH3(6FRQWURODUP6L[PRQWKVIROORZXSYROXPHWULF,986DQDO\VHVZHUH DYDLODEOHIRUSDWLHQWV 3/(6 3/3(6 3(6 9ROXPHLQGH[ 9, volume/length) was calculated for vessel, lumen, plaque, stent and neointima 1,9 3HUFHQW QHRLQWLPDO YROXPH 1,9 ZDV FDOFXODWHG DV 1,9VWHQW YROXPH ;&URVVVHFWLRQDOQDUURZLQJ &61 ZDVGH¿QHGDVQHRLQWLPDO area divided by stent area. Results:$WPRQWKVIROORZXS1,9DQGPD[&61RI3/(6DQG3/3(6 JURXSVZHUHVLJQL¿FDQWO\KLJKHUWKDQWKRVHRI3(6FRQWUROJURXS S E\ $129$ 9HVVHOYROXPHVLJQL¿FDQWO\LQFUHDVHGLQ3/(6DQG3(6JURXSVGXULQJ 6 months follow up. Peri-stent plaque progression was observed in the PES group. There was no late-acquired incomplete stent apposition (ISA) in each group.
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Conclusion: These results suggest that PLES and PL/PES do not suppress neointimal hyperplasia in humans compared with PES. TCT-352 Paclitaxel-Eluting Stent Induces Endothelial Dysfunction Associated with Local Oxidative Stress in Pig Coronary Model Lakshmana K Pendyala, Jinsheng Li, Toshiro Shinke, Jack P Chen, Nicolas A Chronos, Keith Robinson, Dongming Hou Saint Joseph’s Research Institute, Atlanta, GA
E L E C T RO N I C A B S T R AC T S
Background: Drug-eluting stent (DES) implantation appears to elicit epicardial artery vasomotor dysfunction in human patients and experimental DQLPDOV+RZHYHUWKHPHFKDQLVPLVQRW\HWNQRZQ:HHYDOXDWHGHQGRWKHOLDO function and local superoxide anion production after overlapping paclitaxeleluting stents (PES) implantation in porcine coronary arteries. Methods: Pigs (n=9) received overlapping PES and bare metal stents (BMS). &RURQDU\YDVRPRWRUIXQFWLRQSUR[LPDODQGGLVWDO PP WRWKHVWHQWVZDV measured angiographically in vivo and on harvested tissue in vitro in an organ chamber apparatus 1-month post-implant, and superoxide (O.2 ) production of adjacent segments was estimated by lucigenin chemiluminescence. Results: PES had less late lumen loss than BMS (P=0.01). In vivo, angiographic %diameter change following intracoronary (IC) endothelium-dependent UHOD[DWLRQ ('G5 WRVXEVWDQFH3 V3QJNJ ZDVGLPLQLVKHGLQ3(6 SUR[ GLVW FRPSDUHGWR%06 SUR[GLVW 3 DQGQDwYH SUR[GLVW 3 %XWHQGRWKHOLXPLQGHSHQGHQWUHOD[DWLRQ (EdiR) response to NTG (IC, 200-g) was not different between the two stent types. Similarly, in vitro organ chamber revealed that EDdR response to sP DQG$LQERWKSUR[LPDODQGGLVWDOVHJPHQWVZDVVLJQL¿FDQWO\LPSDLUHGLQ PES versus BMS and naive (p<0.001), but EdiR to SNP was preserved (P=NS). O.2 SURGXFWLRQZDVKLJKHUSUR[LPDODQGGLVWDOWR3(6WKDQ%06DQGQDwYH YVDQG5/8VPJWLVVXH3 DQGYV DQG 5/8VPJWLVVXH3 Conclusion: PES was effective in decreasing neointimal formation. However, a profound adverse effect of PES on endothelium-dependent vasomotor relaxation in conduit vessel segments both proximal and distal to overlapping implants, was observed both in vivo and in vitro, and is associated with local enhancement of oxidative stress. Endothelial dysfunction after implantation of PES may contribute to adverse clinical sequelae through similar pathophysiological mechanisms. TCT-353 Long-term Clinical Outcomes of DES for the Treatment of Complex versus Non-complex Lesions in the DESIRE Registry José de Ribamar Costa, Jr., Amanda Sousa, Adriana Moreira, Ricardo Costa, Manuel Cano, Galo Maldonado, Mariana Carballo, Otavio Berwanger, Luiz Alberto Mattos, Alexandre Abizaid, Edson Romano, J Eduardo Sousa Instituto de Ensino e Pesquisa - Hospital do Coração, São Paulo, Brazil Background: Regardless of the FDA strict indications for DES use, cardiologists have expanded the formal recommendations and treated more complex pts and lesions not previously included in randomized trials. We sought to evaluate the clinical outcomes of DES in the off-label scenario. Methods: Between May 2002 and December 2007 all consecutive pts treated solely with DES were prospectively enrolled in the single center DESIRE UHJLVWU\DQGJURXSHGDFFRUGLQJWRWKHLU³ODEHO´VWDWXV2QODEHOSWVKDGVWDEOH angina or silent ischemia caused by a single, de novo lesion <30mm in length and located in a native coronary artery of 2.5 to 3.5mm in diameter. All UHPDLQLQJSWVZHUHFODVVL¿HGDVRIIODEHO2XUSULPDU\JRDOZDVWRFRPSDUH the incidence of long-term MACE and stent thrombosis (ST) in the 2 groups. Pts were clinically evaluated at 1, 6 and 12 months and then yearly up to 6 years. After conducting bivariate analysis, a model was built to identify subgroup characteristics associated with MACE, TLR and ST, including Cox
140i
Proportional Hazard Regression. Results: Most of the enrolled pts were off-label [1,533 (76%) of 2,014]. During WKH LQKRVSLWDO SKDVH RIIODEHO SWV KDG VLJQL¿FDQW PRUH QRQ4 ZDYH 0, (2.3% vs. 1.2%, p = 0.02) but equivalent ST and combined MACE rates when compared to on-label pts. Long-term FU was obtained in 98.3% of the cases (median 3.6 years). Survival-free of MACE and ST curves are displayed in the chart. Off-label use of DES was an independent predictor of MACE (HR 2.5; 95% IC 1.7 - 4.9) and TLR (HR 3.6; 95% IC 2.8-5.1) but did not impact ST rate in this registry.
Conclusion: In the DESIRE registry, DES in pts with increased complexity SUR¿OH RIIODEHOLQGLFDWLRQ ZDVDVVRFLDWHGZLWKORZUDWHVRI0$&( and ST (<2.0%) up to 6 year of FU; however, the outcomes in this subset are still inferior compared to those with strict indications for DES (on-label). TCT-354 Do Bare-metal And Drug-eluting Stent Restenosis Have Similar Outcomes When Treated With Drug-eluting Stent Implantation?: Insights From The Desire-ISR Registry José de Ribamar Costa, Jr., Amanda Sousa, Adriana Moreira, Ricardo Costa, Galo Maldonado, Manuel Cano, Cantidio Compos, Neto, Mariana Carballo, Enilton Egito, Fausto Feres, Rodolfo Staico, Otavio Berwanger, J Eduardo Sousa Instituto de Ensino e Pesquisa - Hospital do Coração, São Paulo, Brazil Background: Right after their introduction into clinical practice, drugHOXWLQJVWHQWV '(6 EHFDPHWKH¿UVWFKRLFHWRWUHDWEDUHPHWDOVWHQW %06 restenosis, replacing brachterapy and all other available percutaneous DSSURDFKHV $OWKRXJK PDUNHGO\ UHGXFHG '(6 UHVWHQRVLV VWLOO RFFXUV DQG has been frequently treated with another DES deployment, despite a clear GHPRQVWUDWLRQ RI WKH HI¿FDF\ DQG VDIHW\ RI WKLV DSSURDFK :H VRXJKW WR compare the long-term outcomes of pts with BMS and DES restenosis treated with the implantation of DES. Methods: Between May 2002 and Jan 2008, a total of 158 pts with BMS restenosis and 58 pts with DES restenosis were consecutively treated with '(6 DQG HQUROOHG LQWR WKLV VLQJOHFHQWHU UHJLVWU\ 2QO\ SWV ZLWK ¿UVW VWHQW UHVWHQRVLVZHUHLQFOXGHG3DWLHQWVWUHDWHGLQWKHVHWWLQJRI0,DQGZLWK69* lesions were excluded. Primary endpoint included long-term MACE and stent WKURPERVLV 67 UDWH DFFRUGLQJ WR WKH $5& GH¿QLWLRQ &OLQLFDO IROORZXS (FU) was obtained at 1, 6 and 12 months and then annually, up to 6 years. Results: %DVHOLQH FOLQLFDO FKDUDFWHULVWLFV GLG QRW VLJQL¿FDQWO\ GLIIHU EHWZHHQ the 2 groups with a high prevalence of DM in both cohorts (33% in the BMS group and 35% in the DES group, p = 0.7). Unstable angina was the initial clinical presentation in 32.9% of BMS pts and 31.1% of DES pts (p=0.9). LAD was the most frequent treated vessel (36.7% in the BMS group vs. 38% in the DES, S '(6UHVWHQRVLVRFFXUUHGLQYHVVHOVRIVPDOOHUGLDPHWHU PPYV PPS ,QWKH%06FRKRUWUHVWHQRVLVSDWWHUQZDVGLIIXVHLQPRVW cases (51%) while in the DES group, focal restenosis was predominant (82%, S /RQJHU'(6ZHUHXVHGWRWUHDW%06UHVWHQRVLV PPYV PPS 2YHUDOO)8ZDVREWDLQHGLQ RIWKHFDVHV PHGLDQ \HDUV '(6 UHVWHQRVLV JURXS SUHVHQWHG VLJQL¿FDQW PRUH 0$&( YV 7.5%, p<0.001), mainly at the expenses of higher rates of new revascularization
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Conclusion:,QWKLV³UHDOZRUOG´SDWLHQWFRKRUWWKHPRQWK0$&(UDWHZDV 7.5%; 3.8% in the simple group, which were more representative of those enrolled in randomized trials, compared with 7.8% in the complex patient group. With ORZ$5&GH¿QLWHSUREDEOH67UDWHVRI FRPSOH[ DQG VLPSOH WKHVH results support the safe use of the Endeavor ZES in standard practice.
procedure (13.3% vs. 3%, p<0.001). Myocardial infarction ( 1.9% for BMS vs. 0% for DES, p=0.8) and cardiac death (2.8% for BMS vs. 0% for DES, p = 0.4) were very low and equivalent in the two groups. There was a single case of ST in the BMS cohort (0.6%) vs. none in the DES group (p=0.9). Conclusion: With the advent of DES, percutaneous treatment of both BMS RU '(6 UHVWHQRWLF OHVLRQV EHFDPH VLPSOH HI¿FLHQW DQG VDIH ZLWK H[FHOOHQW and sustained long-term results. However, the probability of recurrence of restenosis is considerably higher among pts with prior DES restenosis.
TCT-356 /RQJ7HUP)ROORZ8SRI3DWLHQWVZLWK'UXJ(OXWLQJ6WHQWV '(6 Implications for Contemporary Interventional Practice
TCT-355
Robert T Gerber1,2, Alfonso Ielasi2, Azeem Latib2, Luca Ferri2, Giorgio Bassanelli2, Ricardo Colantonio2, Cosmo Godino2, Flavio Airoldi2, Alaide Chieffo2, Mauro Carlino2, Matteo Montorfano2, Iassen Michev2, Giuseppe Sangiorgi1, Antonio Colombo1,2 1 EMO Centro Cuore Columbus, Milan, Italy 2San Raffaele, Milan, Italy
Twelve-Month Results from the Real-World Use of the Endeavor Zotarolimus -Eluting Stent in the E-FIVE Registry Martin T Rothman1, Chaim Lotan2, Manuela Negoita3, Ian T Meredith4, For the E-FIVE Registry Investigators 1 Barts and The London NHS Trust, London, United Kingdom 2 Hadassah-Hebrew University Medical Center, Jerusalem, Israel 3 Medtronic CardioVascular, Santa Rosa, CA; 4Monash Medical Centre, Southern Health, Melbourne, Victoria, Australia
Introduction: There is limited evidence concerning clinical outcomes for multiple stent insertion in the DES era. Stent thrombosis (ST) and restenosis are always concerns when implanting several stents. We present long-term IROORZXSRISDWLHQWVZKRKDG'(6LPSODQWHG Methods: )URP $SULO DOO SDWLHQWV ZLWK '(6 ZHUH LGHQWL¿HG DQG separated according to whether treatment was for de-novo or restenotic lesions. Results: SDWLHQWV ZHUH LGHQWL¿HG FRPSULVLQJ GHQRYR DQG UHVWHQRWLF '(6 ,QWKHGHQRYRJURXSWKHUHZHUH GH¿QLWHVWHQW thrombosis (ST): 1 acute (0.2%), 3 sub-acute (0.6%), 2 late (0.4%) and 0 very ODWH,QFRQWUDVWWKHUHZHUH GH¿QLWH67LQWKHUHVWHQRWLFJURXS acute (1.9%), 2 sub-acute (1.9%), 3 late (2.9%) and 2 (1.9%) very late.
Background:The Endeavor zotarolimus-eluting stent (ZES) has been shown WREHVDIHDQGHI¿FDFLRXVIRUWUHDWPHQWRIVLQJOHde novo lesions in patients with stable coronary artery disease (CAD). We assessed the effectiveness of WKLV=(6LQDUHDOZRUOGSDWLHQWSRSXODWLRQLQWKH(),9(5HJLVWU\ Methods: (),9( LV D SURVSHFWLYH PXOWLFHQWHU QRQUDQGRPL]HG JOREDO registry designed toevaluate the use of the Endeavor stent in routine treatment RISDWLHQWVLQGLFDWHGIRU3&,DQGWRHYDOXDWHFOLQLFDORXWFRPHVLQKLJKULVN patient groups, e.g. those with diabetes mellitus (DM), longer lesions and small diameter vessels. The study enrolled over 8000 patients at 200 centers in Europe, South America, Australia, New Zealand and Asia. All patients presenting with symptomatic CAD amenable to stent implantation were eligible for the study. All MACE events, death, myocardial infarction (MI), and stent thrombosis (ST) events using ARC criteria, were adjudicated by a Clinical Events Committee. We compared outcomes between patients with simple vs. complex lesions and clinical characteristics. Complex patients included those with at least 1 of the following; AMI (< 24h), unstable angina, '0OHVLRQVPP59'RIPPDQGELIXUFDWLRQOHVLRQV Results: Of 7832 (94.2%) patients with 12-month follow-up, 91.6% had FRPSOH[OHVLRQDQGFOLQLFDOFKDUDFWHULVWLFVDQGZHUHFRQVLGHUHGKLJKULVN Characteristic
Clinical Outcomes MACE, % (n) Death-all % (n) Cardiac, % MI (all), % (n) Q-wave, % (n) Non Q-wave, %(n) Death (cardiac) + MI (all), %(n) Def + Prob ARC ST, %(n) Def ARC ST, %(n) TLR, % (n) TLR (non-TL), %(n) 795 Q 79) Q
TOTAL (3120 Lesions) De Novo (2525 Lesions) Follow-up Median (IQR)
Death (total) [cardiac] 33 (6.5%) [3.4%]
October 12-17, 2008
5 (4.8%) [4.8%] 4 (3.8%)
177 (35%)
65 (61%)
TLR per patient
142 (28%)
60 (57%)
Restenosis per lesion
419/1891 (22%)
191/533 (36%)
795SHUYHVVHO
636/2525 (25%)
295/595 (50%)
TLR per lesion
461/2525 (18%)
231/595 (39%)
MACE 0,7/5795 Cardiac Death)
164 (33%)
63 (60%)
Conclusion: This study demonstrates an acceptable occurrence of MI, death, repeat revascularization and ST in patients with de novo lesions and PXOWLYHVVHOGLVHDVHWUHDWHGZLWK'(6+RZHYHULQSDWLHQWVZLWKUHVWHQRVLV DKLJKFRPSOLFDWLRQUDWHLVH[SHFWHGZKLFKUHÀHFWVWKHFRPSOH[QDWXUHRIWKLV cohort of patients. TCT-357 Anemia Predicts Long-Term Mortality Following PCI with DrugEluting Stents in Real World Clinical Practice Dmitriy N. Feldman, Christopher L. Gade, Linda J. Cuomo, Robert M. Minutello, Issam Moussa, Geoffrey Bergman, S. Chiu Wong New York Presbyterian Hospital - Weill Medical College of Cornell University, New York, NY Background:$QHPLDLVDVVRFLDWHGZLWKLQFUHDVHGULVNRIVKRUWDQGORQJ term mortality after PCI with bare metal stents. Impact of anemia on longterm prognosis in current clinical practice of revascularization with DES is XQNQRZQ Methods: Using the 2004/2005 Cornell Angioplasty Registry, we studied 2,837 consecutive patients undergoing urgent or elective PCI based on the
% = percent of patients unless noted. *Simple includes any patient not meeting FRPSOH[GH¿QLWLRQ
|
Restenotic (595 Lesions) 32 (19-43) months (Clinical 100%; Angiographic 83%)
Myocardial Infarction 18 (3.6%) 795SHUSDWLHQW
(),9($// N = 8314 patients/10339 lesions 76.7 32.2 25.3 32.7 33.9 21.8 46.6 (4817/10339) 42.6 (3336/7832) 43.4 (3402/7832) Simple* Complex p-value N = 655 N = 7177 3.8 (25) 7.8 (562) <0.001 1.1 (7) 2.6 (184) 0.016 0.8 (5) 1.8 (130) 0.057 0.9 (6) 1.7 (122) 0.148 0.0 0.4 (31) 0.107 0.9 (6) 1.3 (92) 0.580 1.5 (10) 3.2 (228) 0.017 0.3 (2) 1.2 (86) 0.032 0.3 (2) 0.7 (47) 0.434 2.3 (15) 4.7 (334) 0.004 0.6 (4) 0.7 (48) 1.000 2.7 (18) 5.1 (369) 0.006 4.0 (26) 7.5 (539) <0.001
The American Journal of Cardiology®
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Male (%) Age (yrs) Previous MI (%) Previous PTCA (%) DM (%) Unstable angina (%) Recent MI [within 72 hrs] (%) LAD (% of lesions) 59'PP /HVLRQOHQJWKPP
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hemoglobin (Hb) value prior to PCI. Patients were divided into 3 groups based RQWKHEDVHOLQH+EOHYHO JO +E VHYHUHDQHPLD +E PLOGDQHPLD +E QRDQHPLD :HH[FOXGHGSDWLHQWVSUHVHQWLQJZLWKDQDFXWH0, KRXUVKHPRG\QDPLFLQVWDELOLW\VKRFNWKURPERO\WLFWKHUDS\GD\VRUUHQDO LQVXI¿FLHQF\0HDQFOLQLFDOIROORZXSZDVGD\V UDQJH GD\V Results: We studied 146 pts (5.1%) with severe anemia, 637 pts (22.5%) with mild anemia, and 2,054 pts (72.4%) without anemia. DES were used in 87% of PCI. The incidence of in-hospital mortality (0% vs. 0.5% vs. 1.4%, p=0.001), non-Q-wave MI (9.3% vs. 10.8% vs. 13.7%, p=0.160), and MACE GHDWKVWURNHHPHUJHQW&$%*3&,0, YVYVS increased incrementally by degree of anemia. By follow-up, there were 40 (1.9%) deaths in pts without anemia, 34 (5.3%) in pts with mild anemia (HR 2.7, 95% CI 1.7-4.3, p<0.001), and 14 (9.6%) in pts with severe anemia (HR 4.6, 95% CI 2.5-8.4, p<0.001) (Figure). After multivariate Cox analysis, severe anemia (HR 2.3, 95%CI 1.1-4.6, p=0.02), and not mild anemia (HR 1.6, 95%CI 1.0-2.5, p=0.08) remained an independent predictor of long-term mortality.
Conclusion: Severe anemia is an independent predictor of long-term mortality after PCI with DES and is associated with higher short-term adverse procedural events. A randomized clinical trial is needed to determine whether RSWLPL]DWLRQRIKHPRJORELQSULRUWR3&,PD\EHRIFOLQLFDOEHQH¿W TCT-358
E L E C T RO N I C A B S T R AC T S
'XUDEOH%HQH¿WRI7$;86/LEHUWpYHUVXV7$;86([SUHVVLQ6PDOO Vessels and Long Lesions in the TAXUS ATLAS SMALL VESSEL and TAXUS ATLAS LONG LESION Trials John A. Ormiston1, Mark A. Turco2, Lazar Mandinov3, Jack J. Hall4, Tift Mann5, Louis A. Cannon6, Mark W. I. Webster7, Gregory J. Mishkel8, Charles D. O’Shaughnessy9, Thomas F. McGarry10, Keith D. Dawkins3, Donald S. Baim3 1 Mercy Hospital, Auckland, New Zealand 2Washington Adventist Hospital, Takoma Park, MD; 3%RVWRQ6FLHQWL¿F1DWLFN0$ 4St. Vincent’s Hospital, Indianapolis, IN; 5Wake Medical Center, Raleigh, NC; 6Northern Michigan Regional Hospital, Petoskey, MI; 7Auckland City Hospital, Auckland, New Zealand 86W-RKQ¶V+RVSLWDO6SULQJ¿HOG,/ 9Elyria Memorial Hospital, Elyria, OH; 10Oklahoma Heart Hospital, Oklahoma City, OK Background: 7KH7$;86/LEHUWp 7/ VWHQW %RVWRQ6FLHQWL¿F1DWLFN0$ 86$ ZDVVSHFL¿FDOO\GHVLJQHGZLWKWKLQQHUVWUXWVDQGXQLIRUPYHVVHOVFDIIROGLQJ to provide more uniform drug distribution. Additionally, the repeating cell design DOORZVIRULQFUHDVHGÀH[LELOLW\DQGFRQIRUPDELOLW\7KH7$;86$7/$66PDOO 9HVVHO 69 DQG/RQJ/HVLRQ // JOREDOVWXGLHVFRPSDUHWKHSHUIRUPDQFHRIWKH 7/PPDQGPPVWHQWVZLWK7$;86([SUHVV 7( DVWJHQHUDWLRQVWHQW ZLWKLGHQWLFDOSRO\PHUFRDWLQJGUXJGRVDJHDQGUHOHDVHNLQHWLFVEXWGLIIHUHQW JHRPHWU\DQGWKLFNHUVWUXWV The primary 9-month non-inferiority endpoint of % diameter stenosis (in-segment) was met in both studies. Long-term outcomes are being evaluated in the two studies. Methods: 7$;86 $7/$6 69 DQG // DUH PXOWLFHQWHU VLQJOH DUP VWXGLHV comparing outcomes of the TL 2.25 mm (N=261) and TL 38 mm (N=150) VWHQWVWROHVLRQPDWFKHG7(KLVWRULFDOFRQWUROVGHULYHGIURP7$;86,9DQG 7$;869%RWKWULDOVDUHIXOO\PRQLWRUHGDQGDOO0$&(DUHDGMXGLFDWHGE\DQ independent CEC. Results: At 1 year, the 69WULDOGHPRQVWUDWHGDPDUNHGGHFUHDVHLQ7/5 for the TL 2.25 mm stent versus TE control, and the LL trial demonstrated
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DVLJQL¿FDQWGHFUHDVHLQ0,UDWHVIRUWKH7/PPORQJVWHQWYHUVXV TE control (Table). Assessment of 2 year clinical outcomes will be available July/August 2008. 1-Year Clinical Outcomes, Per Protocol 7$;86$7/$66PDOO9HVVHO 7$;86$7/$6/RQJ/HVLRQ 7$;86 7$;86 7$;86 7$;86 Express /LEHUWp p Express /LEHUWp Clinical Outcome p value Control 2.25 mm value Control 38 mm (N=73) (N=254) (N=145) (N=150) 26.8 13.4 16.5 10.9 MACE (%) 0.0071 0.16 (19/71) (33/247) (23/139) (16/147) ...Cardiac 4.2 (3/71) 1.2 (3/247) 0.13* 3.6 (5/139) 0.0 (0/147) 0.0261* ...Death (%) ...MI (%) 4.2 (3/71) 2.4 (6/247) 0.42* 6.5 (9/139) 1.4 (2/147) 0.0246 ......Q-Wave 1.4 (1/71) 0.8 (2/247) 0.53* 1.4 (2/139) 0.0 (0/147) 0.24* ......MI (%) ......Non-Q2.8 (2/71) 1.6 (4/247) 0.62* 5.0 (7/139) 1.4 (2/147) 0.10* ......Wave MI (%) 795 22.5 10.5 10.1 10.2 0.0084 0.97 ...Overall (%) (16/71) (26/247) (14/139) (15/147) 7.5 ......TLR (%) 16.9 (12/71) 6.1 (15/247) 0.0039 8.6 (12/139) 0.72 (11/147) 795 8.5 (6/71) 6.9 (17/247) 0.65 1.4 (2/139) 3.4 (5/147) 0.45 ......Remote (%) 3URWRFROGH¿QHG Stent Thrombosis 1.5 (1/67) 0.4 (1/243) 0.39* 0.7 (1/135) 0.0 (0/146) 0.48* (%) $5&GH¿QLWHRU probable Stent 1.5 (1/67) 0.4 (1/243) 0.39* 0.7 (1/135) 0.0 (0/146) 0.48* Thrombosis (%) Total Death (%) 4.3 (3/69) 2.8 (7/249) 0.46* 3.6 (5/139) 0.7 (1/147) 0.11* Numbers shown are % (count/total) Default p value for comparing two proportions is from the chi-square test. *p values were calculated by Fisher exact test. $EEUHYLDWLRQV 0$&( PDMRUDGYHUVHFDUGLDFHYHQWV FDUGLDFGHDWK0,795 0, P\RFDUGLDOLQIDUFWLRQ 795 WDUJHWYHVVHOUHYDVFXODUL]DWLRQ 7/5 WDUJHWOHVLRQ revascularization; ARC: Academic Research Consortium; CEC: clinical events committee
Conclusion: 7$;86 /LEHUWp LPSURYHG RXWFRPHV FRPSDUHG ZLWK 7$;86 ([SUHVV LQ VPDOO YHVVHOV DQG ORQJ OHVLRQV 7KLV PD\ UHODWH WR /LEHUWp¶V improved geometry and thinner strut design. TCT-359 A Randomized Comparison of Triple Antiplatelet Therapy with Dual Antiplatelet Therapy after Drug-Eluting Stent Implantation in Long Coronary Lesions: 2-year Clinical Outcomes of DECLARE-LONG Trial Jae-Hwan Lee1, Seong-Wook Park2, Seung-Whan Lee2, Young-Hak Kim Kim2, Jong-Young Lee2, Jeong-Woo Lee2, Won-Jang Kim2, Sung-Cheol Yun2, Cheol Whan Lee2, Myeong-Ki Hong2, Jae-Ki Ko3, Jae-Hyeong Park1, Si Wan Choi1, Jin-Ok Jeong1, In-Whan Seong1, Yoon Haeng Cho4, Nae-Hee Lee4, June Hong Kim5, Kook-Jin Chun5, Hyun-Sook Kim6, Seung-Jung Park2 1 Chungnam National University Hospital, Daejeon, Republic of Korea 2 Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea 3Chonbuk National University Hospital, Jeonjoo, Republic of Korea 4Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea 5Busan National University Hospital, Busan, Republic of Korea 6Hallym University Sacred Heart Hospital, Pyeongchon, Republic of Korea Background: Although cilostazol reduced angiographic restenosis after baremetal stent or drug-eluting stent (DES) implantation, its long-term clinical impact on the performance of DES has not been evaluated. Methods: This randomized, multicenter, prospective study compared triple antiplatelet therapy (aspirin, clopidogrel and cilostazol, triple group, n=250) and dual antiplatelet therapy (aspirin and clopidogrel, standard group, n=250) for 6 months in patients with long coronary lesions receiving DES. We evaluated long-term clinical outcomes (death, myocardial infarction, and target lesion revascularization) at 2 years. Results: Baseline clinical and angiographic characteristics were comparable between groups. At 2 years, the incidence of death (1.2% vs. 2.0%, p=0.724) and myocardial infarction (0.8% vs. 0.4%, p=0.999) was not statistically different
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TCT-361
EHWZHHQ WKH WZR JURXSV +RZHYHU WULSOH WKHUDS\ VLJQL¿FDQWO\ UHGXFHG WKH 2-year target lesion revascularization compared to standard group (4.0% vs. 8.4%, p=0.041). Major adverse cardiac events including death, myocardial LQIDUFWLRQDQGWDUJHWOHVLRQUHYDVFXODUL]DWLRQZDVDOVRVLJQL¿FDQWO\UHGXFHG in the triple than in the standard group (5.6% vs. 10.4%, p=0.048). During study period, 1 subacute stent thrombosis occurred in the triple therapy and 2 stent thromboses (1 late, 1 very late) in the standard group. Conclusions: Triple antiplatelet therapy after DES implantation is superior WRLQUHGXFLQJ\HDUULVNRIWDUJHWOHVLRQUHYDVFXODUL]DWLRQDQGPDMRUDGYHUVH cardiac events in long coronary lesions compared to dual antiplatelet therapy, which suggests that adding cilostazol on the dual antiplatelet regimen provides WKHLPSURYHGHI¿FDF\RI'(6LQOHVLRQVRUSDWLHQWVDWKLJKULVNRIUHVWHQRVLV
Drug Eluting Stents Do Not Delay Early Endothelialization, But Show Distinct Differences In Endothelial Function Heleen M M van Beusekom1, Yoshinobu Onuma1, Ilona KrabbendamPeters1, Willem J van der Giessen2 1 Erasmus MC, Rotterdam, Netherlands 2Erasmus MC and ICIN-KNAW, Rotterdam, Utrecht, Netherlands Late stent thrombosis and impaired endothelium-dependent vasodilation in Cypher and Taxus are often attributed to delayed re-endothelialization. Data to support this hypothesis is scarce and the functional status of the HQGRWKHOLXP ZLWKLQ WKHVH GUXJ HOXWLQJ VWHQWV LV XQNQRZQ :H FRPSDUHG drug eluting stents (eluting Paclitaxel, Sirolimus (-limus via mTOR) and Tacrolimus (-limus via calcineurin) to bare metal stents in swine coronary arteries with respect to early re-endothelialization at 5 days and endothelial function as assessed by immunocytochemistry for eNOS and vWF expression at 28 days (semiquantitative score). Results:7KHUHZHUHQRVLJQL¿FDQWGLIIHUHQFHVLQUHHQGRWKHOLDOL]DWLRQEHWZHHQ drug eluting stents and bare stents at 5 days (Anova, p=0.7). While vWF expression was similar for all drug eluting stents, paclitaxel did show diminished eNOS expression at 28 days ( † p=0.00002 and ‡ p=0.002 vs PES).
TCT-360 Comparison of Clinical Characteristics and Long-term Outcomes after Sirolimus-eluting stent implantation between Hemodialysis Patients and Non-hemodialysis Patients Insight from Japan Multicenter Post Marketing Surveillance Registry Yoritaka Otsuka1, Sugao Ishiwata2, Tsukasa Inada3, Yasuhiko Hayashi4, Hiroshi Fujita5, Ichiro Michishita6 1 National Cardiovascular Center, Suita, Osaka, Japan 2Toranomon Hospital, Tokyo, Japan 3Osaka Red Cross Hospital, Osaka, Japan 4Tsuchiya General Hospital, Hiroshima, Japan 5Kyoto Second Red Cross Hospital, Kyoto, Japan 6 Yokohama Sakae Kyosai Hospital, Yokohama, Japan Background: 6LUROLPXVHOXWLQJ VWHQW 6(6 KDV PDUNHGO\ UHGXFHG LQVWHQW restenosis compared to bare metal stent in spite of on-label or off-label uses in SDWLHQWVZLWKFRURQDU\DUWHU\GLVHDVH+RZHYHUWKHHI¿FDF\RISHUFXWDQHRXV coronary interventions (PCI) with SES in hemodialysis (HD) patients has remained controversial due to consistent exclusion of these populations from major clinical trials. Methods: We analyzed the data on 2,050 patients who underwent PCI with SES implantation and enrolled in multi-center of Japan. Clinical characteristics, 8-month angiographic results and 2-year clinical outcomes were compared between HD group (n = 106) and non-hemodialysis (NH) group (n = 1,944). Those between HD group and NH group with diabetes mellitus were also compared. Results: Clinical characteristics in HD group revealed higher prevalence of diabetes mellitus and multivessel disease, lower ejection fraction, and lower prevalence of hyperlipidemia and obesity. For PCI, HD group needed more GHEXONLQJ VWUDWHJ\ XVLQJ D URWDEODWRU DWKHUDFWRP\ DQG KLJKHU GHSOR\PHQW SUHVVXUHGXHWRFRPSOH[OHVLRQV$WPRQWKV+'JURXSKDGDVLJQL¿FDQW ODUJHU ODWH ORVV +' PP YV 1+ PP S DQG D VLJQL¿FDQW higher binary restenosis rate (HD: 26.4% vs NH: 8.2%, p<0.001) compared to NH group. At 2-year clinical follow-up period, there were higher mortality and target lesion revascularization (TLR) (HD: 18.2% vs NH: 5.3%, p<0.001) in HD group compared to NH group but no difference in stent thrombosis rate between 2 groups (HD: 2.0% vs NH: 0.6%, p=NS). In diabetic patients, HD JURXSKDGDVLJQL¿FDQWKLJKHULQFLGHQFHRI7/5FRPSDUHGWR1+JURXS +' 21.7% vs NH: 6.4%, p<0.001). Conclusions: 3&,ZLWK6(6LQ+'SDWLHQWVLVVDIHEHFDXVHRIQRVLJQL¿FDQW difference in stent thrombosis rate but not comparable with a higher incidence of repeat revascularization and mortality when compared with NH patients. +LJKPRUWDOLW\LQ+'SDWLHQWVLQÀXHQFHVE\FRQWULEXWLQJFRPRUELGLWLHVDQG more severe conditions such as the low ejection fraction. HD is suggested to be a strong predictor of repeat revascularization after SES implantation not only in the general population but also in the diabetic subset.
SEM and immunocytochemistry eNOS at 28 days
vWF at 28 days
n.d.
n.d.
Tacrolimus (n=7+14
Paclitaxel (n=3+16)
Sirolimus (n=4+15)
Á
eNOS and vWF score between 0 (no EC) 1 (-10%) 2 (10-40%), 3 (40-70%, 4 (70-90%) 5 (90-100%EC).
Conclusion: Drug eluting stents show no differences in re-endothelialization as compared to bare metal stents. Only Paclitaxel induced diminished eNOS expression at 28 days as compared to the other drug eluting stents. TCT-362 ,PSDFWRI/HVLRQ&DOFL¿FDWLRQRQ&OLQLFDODQG$QJLRJUDSKLFRXWFRPH after Sirolimus-Elutimg Stent Implantation in Real-World Patients Ren Kawaguchi, Shigeru Oshima, Takuji Toyama, Hiroshi Hoshizaki Gunma Prefectural Cardiovascular Center, Maebashi, Japan Background: 3UHYLRXV VWXGLHV KDYH GHPRQVWUDWHG VLPLODU HI¿FDF\ RI WKH GUXJHOXWLQJ VWHQW LQ SDWLHQWV ZLWK DQG ZLWKRXW FDOFL¿HG OHVLRQV +RZHYHU PRVW RI WKH UDQGRPL]HG WULDOV KDYH H[FOXGHG SDWLHQWV ZLWK VHYHUH FDOFL¿HG lesions. We aimed to examine the impact of lesion calcium on clinical and angiographic outcome after Sirolimus-Eluting Stent (SES) implantation in real-world patients. Methods: Consecutive 380 patients with 556 lesions treated with SES
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% EC at 5 days Bare stents (n=4)
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were enrolled. Lesions were divided into Calc lesions (moderate or sever FDOFL¿FDWLRQ OHVLRQV DQGQRQ&DOFOHVLRQV QRQHRUPLOGFDOFL¿FDWLRQ lesions) according to the lesion calcium. Quantitative coronary angiography (QCA) parameters, binary restenosis rate (%restenosis), target lesion revascularization (TLR) rate, and major adverse cardiac events (MACE) during follow-up were compared between the two groups. All patients were contacted at 1, 6, and 12 months after the procedure. Results: Lesion success rate was similar in the two groups. %Restenosis YV S DQG7/5 YV S ZHUHVLJQL¿FDQWO\ higher in Calc lesions. Stent thrombosis was observed in 0.7% of overall lesions with no difference between the two groups. The MACE rate in Calc SDWLHQWV ZDV VLJQL¿FDQWO\ KLJKHU WKDQ LQ QRQ&DOF SDWLHQWV By multivariateanalysis, hemodialysis (HD) (OR: 9.84, 95%CI: 2.86 to 36.7, p=0.0003) and requirement of rotational atherectomy (RA) ((OR: 10.14, 95%CI: 2.57 to 41.03, p=0.0008) were predictive factors of TLR in the Calc lesions. Conclusion:&RURQDU\OHVLRQVZLWKFDOFL¿FDWLRQFRPSULVHDKLJKULVNFRKRUW and are associated with a higher TLR and binary restenosis rates in real-world SDWLHQWVWUHDWHGZLWK6(60RUHRYHUSDWLHQWVZLWKFDOFL¿HGOHVLRQVDQGRQ+' are associated with higher MACE rate. TCT-363 /RQJWHUP&OLQLFDO2XWFRPHVLQ3DWLHQWV:LWK5HQDO,QVXI¿FLHQF\ After Sirolimus-eluting Stents Implantation: Two-year Follow-up Results of the j-Cypher Registry
E L E C T RO N I C A B S T R AC T S
Yasushi Fuku, Kazuaki Mitsudo, Kazushige Kadota, Tsuyoshi Goto, Hiroyuki Yamamoto, Shingo Hosogi, Hiroyuki Tanaka, Takeshi Kimura, on behalf of the j-Cypher Registry investigators Kurashiki Central Hospital, Kurashiki City, Japan Background: Previous randomized trials of sirolimus-eluting stents (SES) H[FOXGHGSDWLHQWVZLWKVHYHUHUHQDOLQVXI¿FLHQF\:HVRXJKWWRHYDOXDWHWKH impact of baseline renal function on clinical outcomes in SES recipients in the real-world registry. Methods: The design of the j-Cypher Registry was multicenter prospective enrollment of consecutive patients who underwent SES implantations from 41 centers in Japan. We reviewed 2-year clinical outcomes of 12 809 patients who underwent successful implantation of SES between August DQG'HFHPEHU3DWLHQWVZHUHVWUDWL¿HGLQWRJURXSVDFFRUGLQJ WRWKHLUHVWLPDWHGJORPHUXODU¿OWUDWLRQUDWH H*)5 *URXS,H*)5PO min/1.73m2 QRUPDO IXQFWLRQ RU PLOG LQVXI¿FLHQF\ *URXS ,, H*)5 DQGPOPLQP2 PRGHUDWHLQVXI¿FLHQF\ *URXS,,,H*)5 PO min/1.73m2DQGQRWRQKHPRGLDO\VLV +' VHYHUHLQVXI¿FLHQF\ DQG*URXS ,9UHQDOIDLOXUHWUHDWHGZLWK+' Results: The baseline characteristics and two-year clinical outcomes are shown in the table. The overall mortality rates were 21.0% in Group III and LQ*URXS,9ZKLFKZHUHVLPLODU S %\PXOWLYDULDWHDQDO\VLV *URXS,9DQG*URXS,,, 25 DQG S ZHUHVWURQJSUHGLFWRUV of death.
Conclusion: The target lesion revascularization (TLR) rate of each non-HD JURXS ZDV ORZ DQG VLPLODU UHJDUGOHVV RI WKH GHJUHH RI UHQDO LQVXI¿FLHQF\ However, low rates of TLR were countered by high rates of major adverse cardiac and cerebrovascular events (MACCE) and death among renally LQVXI¿FLHQWSDWLHQWVDW\HDUVDIWHU6(6LPSODQWDWLRQ TCT-364 “Late catch-up” in Restenosis Following Sirolimus-Eluting Stent Implantation Osamu Mastuda, Masashi Kimura, Mitsuyasu Terashima, Kenya Nasu, Yoshihisa Kinoshita, Mariko Ehara, Etsuo Tsuchikane, Hitoshi Matsuo, Tetsuo Matsubara, Keiko Asakura, Yasushi Asakura, Osamu Katoh, Takahiko Suzuki Toyohashi Heart Center, Toyohashi, Japan Background: Despite the suppression of intimal hyperplasia (IH) in coronary arteries with drug eluting stent (DES) compared with bare-metal stents at 6 PRQWKVDIWHUWKHSURFHGXUHWKHUHDSSHDUVWREHD³ODWHFDWFKXS´LQ,+JURZWK among patients treated with DES after 1 year. However, late restenosis after 6(6LPSODQWDWLRQKDVQRWEHHQVXI¿FLHQWO\HYDOXDWHG7KHDLPRIRXUVWXG\ ZDVWRGHWHUPLQHZKHWKHULQVWHQWUHVWHQRVLVRFFXUULQJ!\HDU ³ODWHFDWFK XS´ DIWHUVLUROLPXVHOXWLQJVWHQWLPSODQWDWLRQLVDUHDOFOLQLFDOHQWLW\ Methods: We analyzed data on all sirolimus-eluting stents implanted in our institution ffrom June 2004 to April 2007 and evaluated the incidence, clinical presentation, and angiographic instent restenosis (ISR) pattern after VLUROLPXVHOXWLQJVWHQW 6(6 LPSODQWDWLRQ:HFRQVLGHUHGUHVWHQRVLV³HDUO\´ LILWRFFXUUHGGXULQJWKH¿UVW\HDUDQG³ODWHFDWFKXS´LIDIWHU\HDU³/DWH FDWFKXS´ UHTXLUHG GHPRQVWUDWLRQ RI D SDWHQW VWHQW DW WR PRQWKV ZLWK repeat angiography after 1 year demonstrating restenosis. Results: Of 3420 lesions in 2414 patients treated with SES. Angiographic follow-up was performed in 1763 patients (73.0%) with 2506 lesions (73.3%). Angiography DIWHU\HDUZDVSHUIRUPHGEHFDXVHRISDWLHQWV¶V\PSWRPRUWUHDWPHQWRIRWKHU YHVVHOV5HVWHQRVLVRFFXUUHGLQOHVLRQVRYHUDOO ³/DWHFDWFKXS´LQ restenosis was observed in 20 lesions (0.80%) at second angiographic follow up (median 23.5 months; range of 17.7 to 29.3 months). Clinical presentations of late TLR were silent ischemia (43%) and recurrent angina (57%). Late TLR was performed in 18 patients with 19 lesions. Serial quantitative coronary angiographic DQDO\VLVRIWKHVHOHVLRQVVKRZHGDPLQLPDOOXPHQGLDPHWHURIPP LPPHGLDWHO\DIWHU6(6LPSODQWDWLRQ PPDW PRQWKIROORZXSDQG PPDWVHFRQGIROORZXS S Conclusion: ³/DWH FDWFKXS´ LV DQ LQIUHTXHQW EXW UHDO HQWLW\ $OPRVW DOO FDVHVRI³ODWHFDWFKXS´ H[SUHVVHGDIRFDODQJLRJUDSKLF,65SDWWHUQ Clinical presentations of late TLR was either silent ischemia or recurrent angina, but not acute coronary syndrome. Repeart angiographic follow up could be required for the patients who did not have ISR at 9 month follow up angiography. TCT-365 &RPSDULVRQRI
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Methods: A prospective analysis of 448 patients with LMT stenosis (324 Bifur DQG1%LIXU LQ¿YHKLJKYROXPH$VLDQFHQWHUVDIWHUVXFFHVVIXOVWHQWLQJ in LMT was performed. LMT was treated with 5 strategies (single stenting 195 cases, T-stenting 47 cases, crush stenting 38 cases, Mini-crush stenting 93 FDVHVFXORWWHVWHQWLQJFDVHVNLVVLQJVWHQWLQJFDVHV &RPSOHWHFOLQLFDO follow-up to 4 years is being analyzed for all 448 patients. Results: The baseline clinical characteristics between 2 groups were similar. Angiographic and clinical success were achieved in all patients without any major complication. At 4 years overall cardiac events of N-Bifur (14.5%) ZHUHVLJQL¿FDQWO\ORZHUWKDQ%LIXU S 6HH¿JXUHIRUFOLQLFDO results.
DQGRUPDODSSRVHGVWUXWVDQGVHFWLRQVZLWKFRPSOHWHFRYHUDJH YV S YV S
Conclusion: Number of visualized struts and strut distribution did not show major implications for PES coverage and neointimal growth in this study. TCT-367 Clinical Outcomes with Everolimus-eluting Stents in Unrestricted Contemporary Practice Luca A Ferri1, Azeem Latib1, Cosmo Godino1, Robert Gerber2, Riccardo Colantonio1, Alfonso Ielasi1, Giorgio Bassanelli1, Valeria Magni1, Flavio Airoldi1, Matteo Montorfano1, Mauro Carlino1, Iassen Michev1, Alaide Chieffo1, Antonio Colombo2 1 6DQ5DIIDHOH6FLHQWL¿F,QVWLWXWH0LODQ,WDO\26DQ5DIIDHOH6FLHQWL¿F Institute and EMO Centro Cuore Columbus, Milan, Italy
Conclusion: The use of drug-eluting stent in patients with LMT was safe and feasible with low acute complication and low incidence of restenosis. Drugeluting stent implantation in non-bifurcation lesion of LMT showed lesser incidence of cardiac events (death, myocardial infarction, CABG and PCI) compared with those of bifurcation lesion at 4 years clinical follow-up. TCT-366 Strut Number and Distribution: Implications for Drug-Eluting Stent Coverage and Neointimal Growth. In-vivo Insight from Optical Coherence Tomography Antonio Trivisonno1, Giuseppe Musumeci1, Vasile Sirbu1, Nikoloz Lortkipanidze1, Alexander Matiashvili1, Laurian Mihalcsik1, Giuseppe Biondi-Zoccai2, Nobuaki Suzuki3, John Coletta3, Marco Costa3, Orazio Valsecchi1, Giulio Guagliumi1 1 Ospedali Riuniti di Bergamo, Bergamo, Italy 2University of Turin, S. Giovanni Battista “Molinette” Hospital, Torino, Italy 3Case Western Reserve University, Cleveland, OH Background: Struts spacing and distribution might have implications for drug-eluting stent (DES) coverage and neointimal proliferation (NIH). Optical &RKHUHQFH7RPRJUDSK\ 2&7 SURYLGHVLQYLYRTXDQWL¿FDWLRQRIVWHQWVWUXW tissue response at micron-scale level. Purpose: To assess the importance of DES strut number and distribution on local NIH and coverage. Methods: We performed OCT in 23 consecutive pts with single paclitaxel eluting stent (PES n=30) at 12 months follow-up. Quantitative analysis of NIH, coverage and strut apposition was obtained throughout the entire lenght of the stent at every 1 mm interval by dedicated software with 360 chords. 6WUXWFRYHUDJHZDVJUDGHGDV FRYHUHG !PPWKLFNQHVV DQGXQFRYHUHG struts (< 0.01 mm). To assess stent strut distribution, the number of visualized stent strut and the maximum interstrut angle were measured at every 1 mm FURVVVHFWLRQV7KHQRQXQLIRUPVWUXWVGLVWULEXWLRQLQGH[ 16', ZDVGH¿QHG as the maximun interstrut angle divided by the number of struts Results: 0HDQOHQJKWRIWKHHYDOXDWHGVWHQWVZDVPP:HH[DPLQHG 4662 struts in 486 fully analyzable cross sections. The number of analyzed struts per section was 9.6 (6-12, median,1st-3rd quartile) with mean NIH of -m. No statistical correlation between number of struts and mean NIH per section (r=-0.23; Fig. 1) was observed. The overall rate of uncovered and malapposed struts was 1.6% and 0.9 % respectively. Uncovered and/or malapposed struts were observed in 12 stent. In this group both the maximum interstrut angle and the NSDI were similar between section with uncoverd
The American Journal of Cardiology®
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October 12-17, 2008
Conclusion: In a complex cohort of patients treated in a real world scenario, 6-month clinical outcomes of EES substantially reproduce the data of published randomized trials. However, longer term data are needed to assess the safety of this new platform.
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Background: The randomized Spirit I, II and III trials have evaluated the performance of everolimus- eluting stents (EES), but data regarding daily practice are still missing. The study objective was to evaluate the safety and HI¿FDF\RI((6LQDFRQWHPSRUDU\FRKRUWRIUHDOZRUOGSDWLHQWV Methods: All consecutive patients successfully treated with EES (either 352086%RVWRQ6FLHQWL¿F&RUS1DWLFN0$86$RU;,(1&(9 $EERWW9DVFXODU'HYLFHV5HGZRRG&LW\&$86$ EHWZHHQ2FWREHUDQG November 2007 were analyzed. Endpoints were death, myocardial infarction 0, WDUJHW YHVVHO UHYDVFXODUL]DWLRQ 795 WDUJHW OHVLRQ UHYDVFXODUL]DWLRQ (TLR), stent thrombosis (ST), and major adverse cardiac events (MACE, a composite of death, MI, TLR) at 6 months. Results: :H LGHQWL¿HG SDWLHQWV $JH \UV ZLWK D KLVWRU\ RI diabetes (31%), previous MI (44%), and previous PCI (59%). EES were implanted in 458 lesions, of which 55% included off-label indications such as bifurcations in 30.5%, chronic occlusions in 12.5%, left main in 10.5%, restenotic lesions in 16%, and bypass grafts in 2.5%. Clinical follow-up was FRPSOHWHGLQ $WPRQWKV0$&(RFFXUUHGLQ SDWLHQWV795 in 15 (5.6%), TLR in 11 (4.1%), and MI in 3 (1.2%). Death occurred in 2 (0.8%) SDWLHQWVDQGLQ ZDVRIFDUGLDFRULJLQ'H¿QLWH67SUHVHQWLQJDVDQRQ fatal MI was observed in 2 (0.8%) cases.
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TCT-368 Comparison of Vascular Response to Zotarolimus-Eluting Stent Versus Paclitaxel-Eluting Stent Implantation: IVUS Results From the ENDEAVOR IV Trial Katsuhisa Waseda1, Akiyoshi Miyazawa1, Takao Hasegawa1, Ichizo Tsujino1, Ryota Sakurai1, Junya Ako1, Paul G Yock1, Yasuhiro Honda1, David E Kandzari2, Martin B Leon3, Peter J Fitzgerald1, The ENDEAVOR IV Trial investigators 1 Stanford University, Stanford, CA; 2Duke University, Durham, NC; 3 Columbia University, New York, NY Background: 7KH (1'($925 ,9 WULDO LV D UDQGRPL]HG FRQWUROOHG VWXG\ RI ]RWDUROLPXVHOXWLQJ SKRVSKRU\OFKROLQHFRDWHG '5,9(5 VWHQW IRU WKH treatment of de novo coronary lesions. The aim of this study was to compare the vessel response between zotarolimus-eluting (ZES) and paclitaxel-eluting VWHQWV 3(6 XVLQJ,986 Methods: 7KH(1'($925,9,986FRKRUWFRQVLVWHGRISDWLHQWV =(6 3(6 9ROXPHWULFDQDO\VLVZDVSHUIRUPHGIRUYHVVHOOXPHQSODTXH VWHQW 69 DQGQHRLQWLPD 1,9 1HRLQWLPDIUHHIUDPHUDWLRZDVFDOFXODWHG DVWKHQXPEHURIIUDPHVZLWKRXW,986GHWHFWDEOHQHRLQWLPDGLYLGHGE\WKH total number of frames. Results: While PES showed positive remodeling during follow-up, ZES had QRVLJQL¿FDQWFKDQJHLQSHULVWHQWYHVVHOVWUXFWXUH$WIROORZXS=(6VKRZHG VLJQL¿FDQWO\ JUHDWHU 1,9 1,969 DQG PD[ FURVVVHFWLRQDO QDUURZLQJ (CSN, neointimal area/stent area, %) with smaller minimum lumen area (MLA) FRPSDUHGWR3(6+RZHYHUWKHLQFLGHQFHRIPD[&61!ZDVVLPLODULQWKH JURXSV1HRLQWLPDIUHHIUDPHUDWLRZDVVLJQL¿FDQWO\ORZHULQ=(6VXJJHVWLQJ more evenly distributed neointimal coverage throughout the stent. There were 3 cases of late incomplete stent apposition in PES and 1 in ZES.
E L E C T RO N I C A B S T R AC T S
MLA at baseline (mm2) MLA at follow-up (mm2) Late lumen area loss (mm2) 1,9 Max CSN (%) 6WHQWVZLWKPD[&61! Neointima-free frame ratio (%)
PES (N=86) 10.5
ZES (N=79) 16.5
p <0.05 <0.01 NS <0.01 <0.01 NS <0.01
Conclusion: ZES and PES had different peri-stent and in-stent vessel responses. There was a moderate increase in neointimal hyperplasia in ZES compared with PES. However, due to more evenly distributed neointima, LQFLGHQFHRIVLJQL¿FDQWQDUURZLQJZDVVLPLODUEHWZHHQWKHVWHQWV TCT-369 Very Long-term Risk of Stent Thrombosis After Intracoronary Brachytherapy and Its Relationship with Antiplatelet Regimen: a Lesson from an Old Story Jin-Wook Chung1, Kyung-Woo Park1, Young-Seok Cho2, Tae-Jin Youn2, Woo-Young Chung3, In-Ho Chae2, Hyo-Soo Kim1, Bon-Kwon Koo1 1 SNUH, Seoul, Republic of Korea 2SNUBH, Seongnam, Republic of Korea 3SNU Boramae Medical Center, Seoul, Republic of Korea Background: Delayed or incomplete healing of stent strut plays an essential role in development of late stent thrombosis. In this regard, intracoronary brachytherapy may serve as a possible clinical model for late stent thrombosis after drug-eluting stent implantation. Objectives:7RHYDOXDWHWKHORQJWHUPULVNRIYHU\ODWHVWHQWWKURPERVLV 9/67 after intracoronary brachytherapy and its relationship with antiplatelet regimen. Methods: From the SPARE trial, we retrospectively followed 103 patients for up to 8 years who received new bare-metal stent with (n=51, radiation group) or without (n=52, control group) intracoronary brachytherapy using 188Re'73$¿OOHGEDOORRQV\VWHP Results:/DQGPDUNDQDO\VLVDW\HDULQFOXGHGSDWLHQWVLQWKHUDGLDWLRQ
146i
JURXSDQGSDWLHQWVLQWKHFRQWUROJURXS7KHFXPXODWLYHLQFLGHQFHRI9/67 ZDVVLJQL¿FDQWO\KLJKHULQWKHUDGLDWLRQJURXSWKDQLQWKHFRQWUROJURXS versus 0%, p =0.01). That of cardiac death and myocardial infarction after 1 \HDUZDVDOVRVLJQL¿FDQWO\KLJKHULQWKHUDGLDWLRQJURXS YHUVXVp 2IWKH9/67FDVHVDVVRFLDWHGZLWKLQWUDFRURQDU\EUDFK\WKHUDS\ occurred beyond 4 years, 3 of which presented as fatal myocardial infarction. ,QWKHUDGLDWLRQJURXSWKHUHZHUH9/67FDVHVSHUSHUVRQ\HDUVZLWK regimens containing aspirin but not thienopyridine. However, there were no 9/67FDVHVGXULQJWKHSHUVRQ\HDUVZLWKUHJLPHQVFRQWDLQLQJERWKDVSLULQ and thienopyridine.
Conclusion: Intracoronary brachytherapy was associated with continuously LQFUHDVHGULVNRI9/67$VSLULQSOXVWKLHQRS\ULGLQHFRPELQDWLRQVHHPHGWR EHHIIHFWLYHLQORZHULQJWKLVULVN TCT-370 WITHDRAWN TCT-371 Safety of ENdeavorTM Stent (Zotarolimus-eluting Stent) Associated with Non-cardiac Surgical Procedure and Brief Interruption of Dual Anti-platelet Agents within 12 Months Following Stent Implantation (SENS): a Multicenter Study Jin Won Kim1, Woong Chol Kang2, Ki Seok Kim3, Soo Joong Kim4, Chang-Wook Nam5, Chul-Min Ahn6, Bong-Ki Lee7, Sang Yup Lim8, Hyun Sook Jung9, Jin Ho Choi10, Young Joon Hong11, Dong Joo Oh1 1 Korea University Guro Hospital, Seoul, Republic of Korea 2Gachon University Gil Hospital, Seoul, Republic of Korea 3Cheju National University Hospital, Seoul, Republic of Korea 4Kyung-Hee Univeristy Hospital, Seoul, Republic of Korea 5Keimyung University Hospital, Seoul, Republic of Korea 6Korea University Anam Hospital, Seoul, Republic of Korea 7Kangwon National University Hospital, Seoul, Republic of Korea 8Korea University Ansan Hospital, Seoul, Republic of Korea 9Hong Ik Hospital, Seoul, Republic of Korea 10Sungkyunkwan University Samsung Medical Center, Seoul, Republic of Korea 11 Chonnam National University Hospital, Seoul, Republic of Korea Background: Bare-metal stent is preferable to 1st generation drug-eluting stent (DES) in patients who need non-cardiac surgery within 12 months from FRURQDU\VWHQWLQJGHVSLWHUHVWHQRVLV+RZHYHUGDWDDUHODFNLQJUHJDUGLQJWKH safety of EndeavorTM VWHQWZKLFKKDVEHHQNQRZQWRFDUU\DORZHUULVNRIVWHQW thrombosis due to rapid re-endothelialization. Methods: A total of 3098 consecutive patients treated with EndeavorTM stent (Zotarolimus-eluting stent;ZES) since January 2006 were retrospectively analyzed in Korean 11 teaching hospitals. The primary endpoint was the 30-day major adverse cardiac events (MACE) including death, non-fatal myocardial infarction (MI) and target lesion revascularization. Results: 193 patients (6.2 %, 193/3098) (male 54.9 %, mean age 63.5 years, diabetes 29.7 %) with brief interruption of dual anti-platelet agents (both aspirin and clopidogrel) due to non-cardiac surgical procedure within 12 PRQWKV IROORZLQJ =(6 LPSODQWDWLRQ ZHUH LGHQWL¿HG )RXU SDWLHQWV H[SHULHQFHGD0$&( SDWLHQWV IDWDOSDWLHQWV QRQIDWDO0,ZLWKLGHQWL¿HG thrombus). The incidence of MACE was higher in the early-surgery group (within 3 months following stent implantation) than in the late-surgery group (3 months to 12 months after stent implantation) (p<0.001, Table). There were no differences of clinical, angiographic and procedural characteristics at baseline between two groups (Table).
The American Journal of Cardiology® |
October 12-17, 2008
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2 Year Clinical Outcomes, Study-stent population TAXUS ATLAS TAXUS ATLAS Direct Stent 7$;86 Pre7$;86 Direct Express p Dilation Clinical Outcome /LEHUWp Stent p value Control value Control (N=867) (N=241) (N=978) (N=538) 16.0% 15.6% 19.2% 10.4% MACE (%) 0.82 0.0029 (150/937) (130/833) (99/516) (24/230) ...Cardiac 1.8% 2.5% 1.3% 1.5% (14/937) 0.61 0.41* ...Death (%) (15/833) (13/516) (3/230) 4.8% 4.7% 5.2% 4.8% ...MI (%) 0.91 0.80 (45/937) (39/833) (27/516) (11/230) 795 12.2% 11.4% 14.3% 5.7% 0.62 0.0006 ...Overall (%) (114/937) (95/833) (74/516) (13/230) 6.9% 7.3% 9.1% 3.0% ......TLR (%) 0.75 0.0032 (65/937) (61/833) (47/516) (7/230) 795 5.5% 6.8% 3.5% ......Remote 5.9% (55/937) 0.75 0.07 (46/833) (35/516) (8/230) ......(%) 3URWRFROGH¿QHG6WHQW 1.2% 1.6% 0.4% 1.1% (10/919) 0.79 0.29* Thrombosis (%) (10/816) (8/502) (1/227) $5&GH¿QLWHRU 1.5% 2.0% 0.4% probable Stent 1.3% (12/920) 0.77 0.19* (12/816) (10/502) (1/227) Thrombosis (%) 2.9% 3.5% 2.2% Total Death (%) 3.4% (32/941) 0.53 0.33 (24/835) (18/515) (5/231) Numbers shown are % (count/total) Default p value for comparing two proportions is from the chi-square test. *p values were calculated by Fisher exact test. $EEUHYLDWLRQV 0$&( PDMRUDGYHUVHFDUGLDFHYHQWV FDUGLDFGHDWK0,795 0, P\RFDUGLDOLQIDUFWLRQ 795 WDUJHWYHVVHOUHYDVFXODUL]DWLRQ 7/5 WDUJHWOHVLRQ revascularization; ARC: Academic Research Consortium; CEC: clinical events committee
Early surgery group Late surgery group p-value (n=34) (n=159) Age(yrs)/Male (%)
62.2/63.5
63.1/50.9
Lesion type (B2/C) (%)
73.6
72.8
NS NS
Stent number
1.4
1.5
NS
Mean stent diameter (mm)
NS
Total stent length (mm)
NS
Major surgery (%)
20.5
22.8
NS
Days from stenting to surgery
56.5
233.7
<0.001
DAP withdrawal (days)
13.4
14.8
NS
MACE (%)
8.9 (2 Death, 1 MI)
0.6 (1 MI)
<0.001
16 QRVLJQL¿FDQW'$3 GXDODQWLSODWHOHWDJHQWV
Conclusion: ZES appears to be safe and feasible in patients undergoing non-cardiac surgical procedure after 3 months following stent implantation. 1RQHWKHOHVV FRQVLGHULQJ WKH SRWHQWLDO ULVN RI VWHQW WKURPERVLV FOLQLFLDQV should pay attention to stay on at least aspirin during the perioperative period. TCT-372 TAXUS ATLAS and TAXUS ATLAS DIRECT STENT Trials: Durable Effectiveness of the TAXUS Liberté Stent and Long-term %HQH¿WRI'LUHFW6WHQWLQJ
Conclusion: Clinical outcomes at 2 year post stent implantation were similar for TL and TE stents with proven durable effectiveness in reducing restenosis. 'LUHFWVWHQWLQJRI7$;86/LEHUWpUHGXFHGIXUWKHUFOLQLFDOUHVWHQRVLVDQGKDV DORQJWHUPEHQH¿WLQSWVZLWKFDUHIXOO\VHOHFWHGOHVLRQV
Mark A. Turco1, John A. Ormiston2, Lazar Mandinov3, Tift Mann4, Charles D. O’Shaughnessy5, Thomas F. McGarry6, Louis A. Cannon7, Michael J. Lucca8, Chiung-Jen Wu9, Ehtisham Mahmud10, Keith D. Dawkins3, Donald S. Baim3 1 Washington Adventist Hospital, Takoma Park, MD; 2Mercy Hospital, Auckland, New Zealand 3%RVWRQ6FLHQWL¿F1DWLFN0$ 4Wake Medical Center, Raleigh, NC; 5Elyria Memorial Hospital, Elyria, OH; 6 Oklahoma Heart Hospital, Oklahoma City, OK; 7Northern Michigan Regional Hospital, Petoskey, MI; 8St. Mary’s Duluth Clinic Regional Heart Center, Duluth, MN; 9Chang-Gung Memorial Hospital, NiaoSung Hsiang, Taiwan10UC San Diego Medical Center, San Diego, CA
TCT-373 WITHDRAWN TCT-374 Comparison of the Long-term (2 year) Outcomes of Drug-eluting and Bare-metal Stent Implantation in Saphenous Vein Grafts
The American Journal of Cardiology®
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October 12-17, 2008
Azeem Latib1, Luca A. Ferri1, John Cosgrave2, Cosmo Godino1, Erminio Bonizzoni3, Enrico Romagnoli1, Alfonso Ielasi1, Giorgio Bassanelli1, Flavio Airoldi1, Mauro Carlino1, Matteo Montorfano1, Alaide Chieffo1, Antonio Colombo2 1 6DQ5DIIDHOH6FLHQWL¿F,QVWLWXWH0LODQR,WDO\26DQ5DIIDHOH6FLHQWL¿F Institute and EMO Centro Cuore Columbus, Milan, Italy 3Università degli Studi di Milano, Milan, Italy Background: Concerns about the long-term safety of drug-eluting stents '(6 LQGHJHQHUDWHGVDSKHQRXVYHLQJUDIWV 69* KDVEHFRPHDQDUHDRI controversy after the publication of a small randomized trial. Methods: We compared the outcomes in 127 patients (143 lesions) treated with DES from April 2002 - March 2006 (DES group), to 131 patients (160 lesions) treated with bare-metal stents (BMS) in the preceeding 36 months (BMS group). End-points analyzed were cumulative death, myocardial LQIDUFWLRQ DQG WDUJHW YHVVHO UHYDVFXODUL]DWLRQ 795 DW \HDUV DIWHU VWHQW implantation. Results: 7KH '(6 JURXS ZDV VLJQL¿FDQWO\ S PRUH FRPSOH[ ZLWK D JUHDWHU IUHTXHQF\ RI GLDEHWHV YV ROGHU JUDIWV YV \HDUV UHVWHQRWLFOHVLRQV YV WRWDORFFOXVLRQV YV DQGVPDOOHUJUDIWV YVPP WUHDWHGZLWKORQJHU VWHQWV YVPP At 2 years, there was no statistical difference in death (8.7% v 7.8%), myocardial infarction (3.9% v RU 795 v 24.2%) between DES and BMS UHVSHFWLYHO\$SURSHQVLW\DQDO\VLVWRDGMXVWIRUEDVHOLQHGLIIHUHQFHVFRQ¿UPHG that DES were not associated with death (HR 0.54, [0.19-1.54]; p=0.25) but were DVVRFLDWHGZLWKDUHGXFWLRQLQ795 +5 > @ S
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Background: The 7$;86 /LEHUWp 7/ VWHQW %RVWRQ 6FLHQWL¿F 1DWLFN MA, USA) is designed for improved deliverability and more homogenous GUXJ GLVWULEXWLRQ 7KH 7$;86 $7/$6 7 $7/$6 WULDO SURYHG WKH QRQ LQIHULRULW\ RI 7/ YHUVXV 7$;86 ([SUHVV 7( DW PRQWK IROORZXS 7KH T. ATLAS Direct Stent (DS) study demonstrated reduced clinical and angiographic restenosis with direct implantation of TL as compared to conventional stenting with pre-dilation. Long-term outcomes are being evaluated in the two studies. Methods: T. ATLAS and T. ATLAS DS are multi-center, single-arm studies sharing identical inclusion and exclusion criteria. Both trials are fully monitored, and all MACE are adjudicated by an independent CEC. A total of 871 pts were HQUROOHG LQ 7 $7/$6 DQG OHVLRQPDWFKHG SWV IURP 7$;86 ,9 DQG 9 served as historical controls. A total of 247 pts were enrolled in T. ATLAS DS, and all 543 pts from the angiographic subset in T. ATLAS served as controls. Results: Clinical outcomes at 2 year follow-up were comparable for TL and TE (Table). Assessment of 3 year T. ATLAS clinical outcomes will be SUHVHQWHG'LUHFWVWHQWLPSODQWDWLRQRI7/UHGXFHGVLJQL¿FDQWO\WKHQHHGIRU revascularization in relatively simple lesions.
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TCT-376 Drug-Eluting Stents for the Treatment of Small Coronary Artery with Sirolimus, Paclitaxel, Zotarolimus, EPC Capture and Everolimus-Eluting Stent: Multicenter Registry in Asia
Conclusion: Despite being implanted in patients and lesions more complex WKDQWKH%06JURXS'(6ZHUHQRWDVVRFLDWHGZLWKDQLQFUHDVHGULVNRIGHDWK DW\HDUVDQGPDLQWDLQHGWKHLUHI¿FDF\LQUHGXFLQJUHYDVFXODUL]DWLRQ TCT-375 STEALTH I: Safety and Performance Evaluation of the Biosensors International’s Biolimus A9 Drug Eluting Stent (BioMatrix®). A 4 -year follow-up.
E L E C T RO N I C A B S T R AC T S
Eberhard Grube1, Alexandre Abizaid2, Ralf Mueller1, Karl - Eugen Hauptmann3 1 HELIOS Klinikum Siegburg, Siegburg, Germany 2Institute Dante Pazzane de Cardiologia, São Paulo, Brazil 3Krankenhaus der Barmherzigen Brüder, Trier, Germany Background: Experimental models have shown Biolimus A9® (BA9®) has potent antiproliferative properties. In the BioMatrix® platform the Biolimus A9® is released via a biodegradable polymer. This polymer, polylactic acid (PLA), has been widely used in a variety of medical applications. The Biolimus A9®, the biodegradable polymer (gone in 6-9 month) and the abluminal coating gives unique characteristics to the BioMatrix® platform. Methods: In this, prospective, randomized, double-blinded clinical study 120 patients undergoing angioplasty of stenosis in native coronary arteries with a reference diameter between 2.75 and 4.00 mm received either a single BA9®eluting BioMatrix® stent or bare metal (BMS) S-Stent™. 80 patients were randomized to the BioMatrix®, 40 patients received the BMS stent. Primary HQGSRLQWZDVTXDQWLWDWLYHDQJLRJUDSKLFODWHORVVGH¿QHGDVPLQLPDOOXPHQ diameter (MLD) in the treated segment minus MLD at 6 months. Secondary endpoint was MACE at 30 days, 3 months and 6 months. Results: The mean of 6 months in-stent late loss for BioMatrix® patients ZDV PP PP FRPSDUHGWRWKHPHDQRIPP PP IRU S-Stent™ patients (p<0.001). ,QVHJPHQWODWHORVVZDV YVS MACE at 1 year was 5.1% for BioMatrix® patients and 5.0% for S-Stent™ patients. At 2 years 6.6% vs 7.9% and 3 years 10% vs 8.1% respectively. There was 1 acute stent thrombosis in the BioMatrix® group and no subacute or late stent thrombosis in either group. The 4 years follow up data will be available at time of presentation. Conclusion: The BioMatrix® demonstrated non-inferiority for 6-month insegment late loss compared with the BMS S-Stent™ and demonstrated statistical VXSHULRULW\IRUERWKLQVHJPHQWDQGLQVWHQWODWHORVVDWPRQWKV7KLVEHQH¿W was achieved without an increase in adverse safety outcomes assessed as MACE up to 3 years. These results demonstrate that the BioMatrix® Stent maintains an DGHTXDWHVDIHW\SUR¿OHHTXDOZLWKFRQYHQWLRQDOEDUHPHWDOVWHQWV
Sunao Nakamura1, Hisao Ogawa2, Jang-Ho Bae3, Yeo Hans Cahyadi4, Wasan Udayachalerm5, Damras Tresukosol6, Sudaratana Tansuphaswadikul7 1 New Tokyo Hospital, Chiba, Japan 2Kumamoto University Hospital, Kumamoto, Japan 3Konyang University Hospital, Daejeon, Republic of Korea 4Husada Hospital, Jakarta, Indonesia 5King Chulalongkorn Memorial Hospital, Bangkok, Thailand 6Her Majesty’s Cardiac Center, Siriraj Hospital, Bangkok, Thailand 7Chest Disease Institute, Bangkok, Thailand Aim: 7KH DLP RI WKLV VWXG\ LV WR FRPSDUH WKH VDIHW\ DQG HI¿FDF\ RI Sirolimus (SES), Paclitaxel (PES), Zotarolimus (ZES), EPC capture (ECS) and Everolimus-eluting stent (EES) on the outcome of patients with small coronary artery disease. Methods: A prospective analysis of 1871 patients with small coronary artery VWHQRVLV 6(63(6 =(6(&6 ((6 LQ¿YHKLJKYROXPH Asian centers after successful stenting for small coronary artery stenosis was performed. The study endpoints were major adverse events (MACE) at 30 days, 9 months restenosis rate and target lesion revascularization (TLR) at 9 months. Results: See table for clinical results. SES PES ZES ECS EES Number of patients
808 602 219 153 89
Procedural success (%)
99.8 99.7 100 100 100
Reference diameter (mean: mm)
2.40 2.42 2.37 2.35 2.33
Lesion length (mean: mm)
12.6 11.3 13.7 12.9 18.0
Minimum lumen diameter post procedure (mean: mm)
2.32 2.30 2.28 2.30 2.28
Minimum lumen diameter at 9 months (mean: mm)
2.10 2.01 1.70 1.72 2.10
Restenosis rate at 9 months (%)
7.4* 13.0 20.1 21.6 6.7*
TLR at 9 months (%)
7.4* 11.6 20.1 21.6 4.5*
MACE at 9 months (%)
7.9* 13.0 20.1 21.6 4.5*
Conclusion: The use of drug-eluting stents in patients with small coronary artery stenosis was safe and feasible. Patients treated with SES and EES showed lesser rate of restenosis compared with other drug-eluting stents. *p<0.05 vs ZES, TES TCT-377 The Effect of Drug-Eluting Stents on Clinical and Angiographic Outcomes in Diabetic Patients: Multicenter Registry in Asia Sunao Nakamura1, Hisao Ogawa2, Jang-Ho Bae3, Yeo Hans Cahyadi4, Wasan Udayachalerm5, Damras Tresukosol6, Sudaratana Tansuphaswadikul7 1 New Tokyo Hospital, Chiba, Japan 2Kumamoto University Hospital, Kumamoto, Japan 3Konyang University Hospital, Daejeon, Republic of Korea 4Husada Hospital, Jakarta, Indonesia 5King Chulalongkorn Memorial Hospital, Bangkok, Thailand 6Her Majesty’s Cardiac Center, Siriraj Hospital, Bangkok, Thailand 7Chest Disease Institute, Bangkok, Thailand Aim:7KHDLPRIWKLVVWXG\LVWRFRPSDUHWKHVDIHW\DQGHI¿FDF\RI6LUROLPXV (SES), Paclitaxel (PES), Zotarolimus (ZES) and Everolimus-eluting stent (EES) on the outcome of percutaneous coronary intervention in patients with diabetes mellitus (DM). Methods: A prospective analysis of 1253 patients with DM (508 SES, 420 3(6=(6((6 LQ¿YHKLJKYROXPH$VLDQFHQWHUVDIWHUVXFFHVVIXO stenting was performed. The study endpoints were major adverse cardiac
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The American Journal of Cardiology®
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October 12-17, 2008
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TCT Abstracts/ELECTRONIC
http://www.aievolution.com/tct0801
TCT-380
events (MACE) at 30 days, 9 months and restenosis rate and target lesion revascularization (TLR) at 9 months. Results: See table for clinical results. Number of patients Multivessel disease (%) MACE at 30 days (%) Lesion length (mean: mm) Lesion type: % of B2, C (%) Reference diameter (mean: mm) Minimum lumen diameter post procedure (mean: mm) Minimum lumen diameter at 9 months (mean: mm) Restenosis rate at 9 months (%) TLR at 9 months (%)
SES 508 78.5 0.8 25.8 45.3 2.75 2.72 2.54 7.9* 6.5*
PES 420 72.6 1.2 23.9 47.4 2.69 2.66 2.38 12.6 10.7
ZES 204 76.5 1.0 28.3 52.0 2.73 2.70 2.08 16.2 13.7
Clinical and Angiographic Results of Small Vessel Stenting from the SPIRIT III Randomized Trial: A Comparison of the 2.5 mm Everolimus-Eluting XIENCE and Paclitaxil-Eluting TAXUS Stents
EES 121 81.8 0 24.8 45.5 2.69 2.60 2.52 6.7* 4.1*
James Hermiller1, Todd Fergus1, Wesley Pierson2, Xiaolu Su2, Roseann White2, Poornima Sood2, Krishnankutty Sudhir2, Gregg Stone3 1 Saint Vincent Heart Center of Indiana, Indianapolis, IN; 2Abbott Vascular, Santa Clara, CA; 3Columbia University Medical Center, New York, NY Introduction: Small vessels are less able to accommodate neointimal hyperplasia following stenting, leading to higher rates of restenosis, Consequently, drug-eluting stents with lower late loss may be particularly EHQH¿FLDOLQWKLVOHVLRQVXEVHW7KHDLPRIWKLVVWXG\ZDVWRFRPSDUHWKHFOLQLFDO and angiographic outcomes in patients treated in the SPIRIT III randomized WULDOZKRUHFHLYHGPP;,(1&(9 ; RU7$;86 7 VWHQWV Methods: 7KH63,5,7,,,WULDOZDVDSURVSHFWLYHUDQGRPL]HG ; 7 multicenter, clinical trial that enrolled 1,002 subjects. This report summarizes the subgroup within the randomized trial receiving at least one 2.5 mm stent. 7KHUHZHUHSDWLHQWVLQWKH;JURXSWKDWUHFHLYHGDWOHDVWRQHPPVWHQW DQG LQWKH7JURXS,QWKH;JURXS RIWKHVWHQWVZHUHPPLQ diameter and in the T group 66/67 implanted stents were 2.5 mm in diameter. Larger diameter stents were placed in one patient in each group for bailout of more proximal disease. Results: The baseline patient demographics, including diabetes, were well PDWFKHG3UHSURFHGXUHYHVVHOGLDPHWHUZDVPPDQG PPLQWKH;DQG7JURXSVUHVSHFWLYHO\ S 7KHSUHSURFHGXUHOHVLRQ OHQJWKZDVVLJQL¿FDQWO\VKRUWHULQWKH7JURXS PP YV PPLQWKH;JURXS S ,QKRVSLWDODQGGD\HYHQWUDWHVZHUHORZ LQERWKJURXSVDQGQRGLIIHUHQW(YHQWUDWHVZHUHVLJQL¿FDQWO\ORZHUZLWKWKH ;,(1&(9JURXSWKURXJK PRQWKIROORZXS2EVHUYHG0$&( YV S DQG79) YV S UDWHVZHUHVLJQL¿FDQWO\ ORZHULQWKH;JURXSGULYHQSULPDULO\E\DODUJHUHGXFWLRQLQ7/5 YV 12.5%; p=0.0016). Stent thrombosis rates were low and not different. FollowXSDQJLRJUDSK\GHPRQVWUDWHGDVLJQL¿FDQWGLIIHUHQFHLQLQVHJPHQWODWHORVV // //IRU;ZDVPPDQGIRU7ZDV PP S ,QVHJPHQWELQDU\UHVWHQRVLVIRU;ZDVDQGIRU7ZDV (p=0.02). Conclusion: In this subgroup of small vessel stenting from SPIRIT III, the ;,(1&( 9 PP VWHQW KDG FOLQLFDOO\ DQG DQJLRJUDSKLFDOO\ LPSURYHG RXWFRPHVFRPSDUHGWRWKH7$;86PPVWHQW7KHVHGDWDIXUWKHUVXSSRUW WKHFRQFHSWWKDWORZHUODWHORVVLVEHQH¿FLDOLQVPDOOYHVVHOGLVHDVH
Conclusion: The use of drug-eluting stents in patient with DM was safe with low acute complication. Patients treated with SES and EES showed lesser rate of restenosis compared with other drug-eluting stents. *p<0.05 vs ZES, TES TCT-378 WITHDRAWN TCT-379 Impact of Intensive Antiplatelet Therapy on the Development of Coronary Neo-aneurysm after Drug-eluting Stent Implantation Seung-Woon Rha, Yoshiyasu Minami, Kang-Yin Chen, Yong-Jian Li, Kanhaiya Poddar, Jae Hyoung Park, Jin Oh Na, Cheol Ung Choi, Hong Euy Lim, Jin Won Kim, Eung Ju Kim, Chang Gyu Park, Hong Seog Seo, Dong Joo Oh Korea University Guro Hospital, Seoul, Republic of Korea
The American Journal of Cardiology®
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October 12-17, 2008
TCT-381 Sirolimus- versus Paclitaxel-eluting Stent in the Treatment of Diffuse Coronary Artery Lesion Seung-Woon Rha, Yoshiyasu Minami, Kang-Yin Chen, Yong-Jian Li, Kanhaiya Podder, Jin Oh Na, Jae Hyoung Park, Jin Oh Na, Cheol Ung Choi, Hong Euy Lim, Jin Won Kim, EungJu Kim, Chang Gyu Park, Hong Seog Seo, DongJoo Oh Korea University Guro Hospital, Seoul, Republic of Korea Background: Drug-Eluting Stent (DES) is commonly being used as one of the best treatment choice for the treatment of diffuse coronary lesions but the overall outcomes are still controversial. In this study, we investigated the HI¿FDF\DQGVDIHW\RI'(6LQWKHWUHDWPHQWRIGLIIXVHOHVLRQV PP Methods: From Sept 2004 to Dec 2006, a total 853 patients (pts) underwent percutaneous coronary intervention (PCI) with DES and a total 268 pts with diffuse lesions were treated with either Sirolimus-(Cypher; SES group, n=125 pts) or Paclitaxel-(Taxus; PES group, n=143 pts)-eluting stents. Mid-term angiographic and clinical outcomes of these two groups were compared. Results: Baseline clinical and procedural characteristics were similar EHWZHHQ WKH WZR JURXSV H[FHSW WKH OHVLRQ OHQJWK ZDV ORQJHU PP YV PP S DQG WKHUH ZDV D WUHQG WRZDUG PRUH FKURQLF total occlusion (CTO, 5.4% vs 11.5%, p=0.07) in PES group. At 6 months,
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Background: Previous reports suggested drug-eluting stents (DES) may cause some toxic effects on coronary artery wall such as aneurysm formation, VWHQWWKURPERVLVDQGYHVVHOUXSWXUH+RZHYHUWKHPHFKDQLVPVDQGULVNIDFWRUV RIWKRVHHYHQWVZHUHQRWZHOONQRZQ Methods: A total 510 consecutive patients (pts) treated with DES either Sirolimus- (SES) or Paclitaxel- (PES) eluting stents were enrolled in this study and routine 6 months angiographic followed up was done from Oct 2004 to Sep 2007. We investigated the characteristics of pts who had newly developed coronary aneurysm compared with the pts without neo-aneurysm DQGDQDO\]HGWKHUHODWLRQVKLSEHWZHHQULVNIDFWRUVDQGQHRDQHXU\VPV Results: The incidence of coronary aneurysm was 3.5% (18/510, mean age 61.5 PDOH DQGSWVUHFHLYHG6(6DQGSWV3(6 PHDQGLDPHWHUDQG OHQJWK PPLUUHVSHFWLYHO\ 7KHUHZDVQRVLJQL¿FDQW GLIIHUHQFHLQDJHVH[FRQYHQWLRQDOULVNIDFWRUVDQGVRPHODERUDWRU\¿QGLQJV However most of aneurysm pts were prescribed triple antiplatelet regimen ( aspirin+clopidogrel+cilostazol; 83.3% vs 43.3%, p<0.01) and multivariate analysis indicated cilostazol usage was an independent predictor of neoaneurysm occurrence (OR 6.439, 95% CI 1.84 - 22.53, p<0.01). Conclusion: Prescription of cilostazol or combination of multiple antiplatelet drugs may associated with the development of coronary neo-aneurysm after DES implantation.
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angiographic outcomes including the rate of binary restenosis, minimal lumen diameter (MLD), % diameter stenosis (DS) and late loss were worse in PES group. However, there were no major differences in clinical outcomes (Table). Multivariate logistic analysis showed that the stent type is the independent predictor of restenosis (OR 0.21, 95% CI 0.06-0.76, p=0.017). The lesion length, stented length and the rate of CTO were not independent predictors of restenosis. Table. Angiographic and clinical Outcomes at 6 months 9DULDEOHQ
Cypher group (n=125)
Taxus group (n=143)
P value
Binary restenosis
7 (5.6)
27 (18.9)
<0.01
)ROORZXS0/'6'
<0.01
)ROORZXS'66'
<0.01
/DWH/RVV6'
0.02
Total death
8 (6.4)
7 (4.9)
0.59 -
Q-wave MI
0 (0)
0 (0)
Target Lesion Revascularization
2 (1.6)
1 (0.7)
0.50
7DUJHW9HVVHO5HYDVFXODUL]DWLRQ
2 (1.6)
1 (0.7)
0.50
Total MACE
10 (8.1)
8 (5.8)
0.46
Stent thrombosis
0 (0)
2 (1.3)
0.20
Conclusion: DES is safe and effective in the treatment of diffuse coronary lesion. Although the PES showed higher rate of restenosis compared to SES, this result was not translated into worse clinical outcomes in real world clinical practice. TCT-382 Coronary Stent Fractures - An Under Recognised Problem With Drug Eluting Stents
E L E C T RO N I C A B S T R AC T S
Sanoj Chacko, Sanjiv Petkar, Satheesh Nair, Tahir Hamid, Douglas Fraser, Farzin Fath-Ordoubadi Manchester Heart Centre, Manchester, United Kingdom Background: First introduced in 2002, the use of drug eluting stents (DES) KDVUDSLGO\H[SDQGHGFKLHÀ\GXHWRWKHGUDPDWLFUHGXFWLRQLQUDWHVRIUHVWHQRVLV and need for repeat revascularisation. However, coronary stent fracture (CSF) is an under recognised complication of DES. Aim: 7RUHYLHZWKHSUHVHQWDWLRQRI&6)DQGWRLGHQWLI\ULVNIDFWRUVIRULWV occurrence. Methods: /LWHUDWXUH VHDUFK LQ 3XE0HG XQGHU WKH KHDGLQJ µFRURQDU\ VWHQW IUDFWXUH¶7KHVHDUFKLGHQWL¿HGDWRWDORIVHULHVDQGFDVHUHSRUWVLPDJHV YLJQHWWHVVSDQQLQJWKHODVW\HDUV $OOSDSHUVZLWKSDWLHQWV (8 series: 5 prospective, 3 retrospective) were analysed and the results are given below. Results: Total patients studied: 2395, range: 56-530. Mean incidence of CSF ZDV EXWYDULHGZLGHO\EHWZHHQVHULHV Median incidence: 3.45%. Sirolimus DES was used exclusively in 6/8 (75%) VHULHV0HDQWLPHWRGLDJQRVLV PRQWKV UDQJH &KURQLFVWDEOH angina was most common mode of presentation: 59/120 (49.2%). CSF associated with in-stent restenosis in the majority (68/120, 56.6%) and with VWHQW WKURPERVLV LQ 5HPDLQLQJ > @ LGHQWL¿HG during routine investigations. Most CSF seen in the right coronary artery (RCA): 54.1% (65/120), followed by left anterior descending artery: 29.1% FLUFXPÀH[FRURQDU\DUWHU\ 69*DQGEUDQFKYHVVHOV 3.3% (4/120) each. Most CSF seen in mid or proximal segments. Most patients with CSF had sirolimus DES implanted [114/120 (95%), paclitaxel DES 6/120(5%)]. All CSF occurred in Type B/C lesions. Most common postulated mechanisms (by series): overlapping stents (8/8, 100%), vessel tortuosity (7/8, 87.5%) and long stented segment (7/8, 87.5%). Conclusion: &6)LQ'(6LVDVLJQL¿FDQWEXWXQGHUUHFRJQLVHGSUREOHP,WV incidence approaches the documented rate of restenosis with DES. Most data available is with sirolimus DES. Information on CSF with other DES or bare PHWDOVWHQWVLVODFNLQJDQGXUJHQWO\QHHGHG0RVW&6)ZDVVHHQLQSDWLHQWVZLWK
150i
long overlapping stents for Type B/C lesions, in the mid or proximal portions of the right coronary artery and at the site of maximal vessel tortuousity. TCT-383 A Comparison of Two Drug-Eluting Stents in Diabetes Mellitus William M Wolf1, Helen Vlachos2, Oscar C Marroquin1, Conrad Smith1, John Schindler1, Elizabeth Holper3, Dawn Abbott4, David O Williams4, Kevin E Kip5, Sheryl Kelsey2, Suresh R Mulukutla1 1 University of Pittsburgh Medical Center, Pittsburgh, PA; 2University of Pittsburgh, Pittsburgh, PA; 3University of Texas Southwestern, Dallas, TX; 4Rhode Island Hospital, Providence, RI; 5University of South Florida, Tampa, FL Background: Diabetes is a powerful predictor of adverse events in patients undergoing PCI. Drug-eluting stents (DES) reduce restenosis rates in diabetics versus bare metal stents. Randomized trials have resulted in ongoing FRQWURYHUV\UHJDUGLQJZKLFK'(6PD\SURYLGHJUHDWHUEHQH¿WDPRQJGLDEHWLF SDWLHQWV $FFRUGLQJO\ ZH FRPSDUHG WKH VDIHW\ DQG HI¿FDF\ RI VLUROLPXV eluting stents (SES) versus paclitaxel-eluting stents (PES) among diabetic patients in a contemporary registry. Methods: Using the National Heart, Lung, and Blood Institute Dynamic Registry, we evaluated one-year outcomes of diabetic patients undergoing PCI with SES (n=678) and PES (n=327). Results: 7KHUH ZHUH QR VLJQL¿FDQW GLIIHUHQFHV EHWZHHQ WKH WZR JURXSV LQ baseline clinical and demographic features, except that PES-treated patients had a greater frequency of hypertension and hyperlipidemia. There were no differences in lesion characteristics or procedural success. At one year followXSQRVLJQL¿FDQWGLIIHUHQFHVZHUHREVHUYHG )LJXUH 3(6DQG6(6WUHDWHG patients had similar rates of death (5.8% vs. 4.4%, p=0.42), death and MI (10.1% vs. 9.0%, p=0.60), repeat revascularization (13.4% vs. 11.8%, p=0.42), and stent thrombosis (1.3% vs. 0.9%, p=0.62). These results did not change in the subset of patients in whom 2-year follow-up was available.
Conclusion: 3(6 DQG 6(6 DUH HTXDOO\ HI¿FDFLRXV DQG KDYH VLPLODU VDIHW\ SUR¿OHVLQGLDEHWLFSDWLHQWVXQGHUJRLQJ3&, TCT-384 Mid Term Outcome Results of Patients Presenting with Drug Eluting Stent Failure: Results from a Single Institution Registry Giuseppe Gioia, MariaFrance sca Gioia, Dawn Christensen Christensen, Jackie White, Howard Levite, Sahar Avestimehr, William Matthai Atlanticare Regional Medical Center, Pomona, NJ Background: '(6IDLOXUHLVQRWDVLQIUHTXHQWDVLQLWLDOO\WKRXJKW9HU\OLWWOH LVNQRZQDERXWWKHLQWHUPHGLDWHWHUPRXWFRPHRIWKHVHSDWLHQWV:HORRNHGDW our registry data to assess intermediate term outcome of these patients Methods: Patients previously implanted with any DES who presented to the FDWKODEIURP-DQXDU\WR'HFHPEHUZLWKD'(6IDLOXUH GH¿QHGDVHLWKHU in-stent restenosis or thrombosis) were enrolled and treated. Only patients with at least 3 months follow-up were included for this outcome analysis. 0$&(UDWHZDVGH¿QHGDVFRPELQDWLRQRIFDUGLDFGHDWK0, 67(0,RUQRQ
The American Journal of Cardiology® |
October 12-17, 2008
| TCT Abstracts/ELECTRONIC
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Conclusion: Our results demonstrate that routine use of noncompliant balloons for high-pressure dilatation in patients with paclitaxel eluting stents DQG FRPSOH[ OHVLRQ PRUSKRORJ\ LV DVVRFLDWHG ZLWK VLJQL¿FDQW UHGXFWLRQ LQ the need for TLR. We found excellent 1-year clinical outcomes in real-world patients with off-label use of paclitaxel eluting stents.
67(0, DQG795)XQFWLRQDOFDSDFLW\ZDVDVVHVVHGDWIROORZXS Results: Fifty-six patients were treated for DES failure over one year. The PHDQSDWLHQW¶VDJHZDV\HDUV0HDQWLPHWR'(6IDLOXUHZDV days (range 15-1513 days). Twenty-eight patients (50%) presented with either STEMI (23 patients, 41%) or non-STEMI (5 patients, 9%) and 28 patients (50%) presented with a non-MI syndrome, either unstable angina (17 patients (30%) or stable angina (11 patients (20%). Twenty-nine patients (52%) presented with angiographic documented stent thrombosis and 27 patients with ISR either focal (23 patients, 85%) or diffuse (4 patients, 15%). Thirteen (46%) patients with late ST were on plavix. POBA alone was used in 10 patients (18%), restent with BMS was performed in 33 patients (59%) and restent with a DES in 12 (21%) patients. One patient was treated medically (2%). Complete follow-up ZDVDYDLODEOHIRU SDWLHQWV0HDQIROORZXSZDVGD\V0$&( ZDV7KHUHZHUHFDUGLDFGHDWKV SDWLHQWVXQGHUZHQW795 with CABG (2 patients) or repeat PCI (4 patients). Two patients presented with non-STEMI and one with STEMI (all three revascularized). No differences were seen in MACE according treatment modality or clinical presentation with ISR or thrombosis. Four patients presenting with DES as STEMI died as opposed to 2 patients presenting with ISR (p=0.2). Twenty-two patients (54%) SUHVHQWHGZLWK1<+$IXQFWLRQDOFODVV!WKDQ Conclusion: Despite successful treatment of DES failure with repeat PCI the intermediate event rate appears to be high with a high mortality rate. The functional capacity seems to be impaired in half of the patients.
TCT-387 Endothelial Cell Recovery, Cell Adhesion, and Acute Thrombogenicity Assessments of Fluorinated Copolymer and Phosphorylcholine Polymer Shawn Chin Quee1, Kim-Lien Nguyen1, Steve Hsu1, Julie Tai1, George Abraham1, Stephen Pacetti1, Gaku Nakazawa2, Frank Kolodgie2, Renu Virmani2, Nadine Ding1, Leslie Coleman1 1 Abbott Vascular, Santa Clara, CA; 2CVPath Institute, Inc., Gaithersburg, MD
TCT-385 WITHDRAWN
TCT-386 Real World Experience with Paclitaxel Eluting Stents after Routine High-Pressure Balloon Dilatation with Noncompliant Balloon for Complex Coronary Lesions: Immediate Results and 1-Year Clinical Outcomes Anuj Bhasin, Chih Yuan Fang, Hon Kan Yip, Cheng Hsu Yang, Chiung Jen Wu Chang Gung Memorial Hospital, Kaohsiung, Taiwan Background: 'UXJHOXWLQJVWHQWVKDYHIXO¿OOHGWKHLUSURPLVHRIUHGXFLQJ target lesion revascularization (TLR) and restenosis. However, stent placement alone does not guarantee the best outcome. Postdilatation helps to optimize stent deployment and may lead to better outcomes with reduced TLR and stent thrombosis. We describe our experience of off-label use of paclitaxel-eluting stents after routine high-pressure dilatation with a noncompliant balloon in a complex lesion subset of patients. Methods: Between September 2004 and January 2006, 312 Taxus Express %RVWRQ6FLHQWL¿F1DWLFN0DVVDFKXVHWWV VWHQWVZHUHGHSOR\HGLQSDWLHQWV The primary endpoint was TLR at 12 months. Secondary endpoints were insegment and in-stent restenosis rate at 12 months and major adverse cardiac HYHQWV 0$&( GH¿QHGDVFRPSRVLWHRIGHDWKP\RFDUGLDOLQIDUFWLRQ 0, RU 7/5DWPRQWKV2IIODEHOXVHLQFOXGHGRVWLDOOHIWPDLQORQJ !PP saphenous vein graft, in-stent restenotic, chronic total, and bifurcation lesions, DVZHOODVVPDOORUODUJHYHVVHOV RU!PP PXOWLOHVLRQRUPXOWLYHVVHO percutaneous coronary intervention, and ST-segment elevation MI. Results: 0HDQ SDWLHQW DJH ZDV \HDUV KDG GLDEHWHV ZLWK 8% requiring insulin, 67.3% had hypertension, 26% had a history of prior percutaneous transluminal coronary angioplasty, 30.4% were dyslipidemic, 25% had renal impairment, and 73.7% patients had multivessel disease. The procedural success rate was 94.6% (299/312). Reference vessel diameter ZDV PPDQGPHDQOHVLRQOHQJWKZDV PP0HDQ VWHQWGLDPHWHUZDVPPDQGVWHQWOHQJWKZDVPP Clinical follow-up was available in all patients, and angiographic followup was available in 73.4% (229/312) of patients. The primary endpoint of TLR was 4.2% at 12 months, and MACE rate at 12 months was 5.8%. The angiographic binary in-stent and in-segment restenosis rate were 4.48% and UHVSHFWLYHO\,QVWHQWODWHORVVZDVPP
The American Journal of Cardiology®
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October 12-17, 2008
TCT-388 WITHDRAWN TCT-389 6WHQW6WUXW7KLFNQHVV,QÀXHQFHV7KURPERJHQLFLW\DQG9DVFXODU Injury and Remodeling Steve Hsu1, Kim-Lien Nguyen1, Rajesh Swaminathan2, Shawn Chin Quee1, Kumaran Kolandaivelu2, Leslie Coleman1, Julie Tai1, Virginia Giddings1, James Stanley2, Philip Seifert2, Gee Wong2, Elazer Edelman2 1 Abbott Vascular, Santa Clara, CA; 2Massachusetts Institute of Technology, Cambridge, MA Background: 6WHQWVWUXWWKLFNQHVVPD\LQÀXHQFHWKURPERJHQLFLW\WKURXJK DOWHUDWLRQV LQ ORFDO KHPRG\QDPLF ÀRZ DQG LQGXFWLRQ RI YDVFXODU LQMXU\
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Background: The use of polymers in current drug eluting stents has been DWRSLFRIGLVFXVVLRQDVLWUHODWHVWRDUWHULDOKHDOLQJDQGODWHWKURPERWLFULVN 7ZR SRO\PHUV XVHG LQ $EERWW¶V GUXJ HOXWLQJ VWHQW SURJUDP ÀXRULQDWHG copolymer (FP) and phosphorylcholine polymer (PC), were each coated onto commercially available metallic stents, and comparisons were made using preclinical models. Methods: Iliac arteries of New Zealand White Rabbits were treated by balloon denudation and implanted bilaterally with FP and PC coated stents. Endothelial coverage at 7 and 14 days post-implantation was measured by morphometric analysis of images acquired through en face scanning electron PLFURVFRS\ 6(0 DVZHOODVGXDOÀXRUHVFHQWLPPXQRODEHOLQJIRUSODWHOHW endothelial cell adhesion molecule-1 (PECAM-1) and thrombomodulin (TM). Acute thrombogenicity was also assessed from stents deployed into silicone tubing in the presence of fresh heparinized porcine blood, where thrombus weight and lactate dehydrogenase (LDH) expression were measured. In addition, in vitro cell adhesion assays were performed on glass coupon surfaces spin-coated with FP or PC and seeded with human umbilical vein endothelial FHOOV +89(& KXPDQFRURQDU\DUWHU\HQGRWKHOLDOFHOOV +&$(& KXPDQ coronary artery smooth muscle cells (HCASMCs), or THP-1 monocytes. Results: Near complete endothelial coverage occurred for both FP and 3& FRDWHG VWHQWV ! E\ 6(0 E\ GD\V ZLWK D WUHQG WRZDUG JUHDWHU coverage with FP (p=0.08). Expression of PECAM-1 was equivalent for FP as compared to PC, though both had less than 40% coverage, providing evidence of a transitional healing surface. Acute thrombogenicity showed that )3ZDVVLJQL¿FDQWO\PRUHWKURPERUHVLVWDQWWKDQ3& S &HOODGKHVLRQ KDG VLJQL¿FDQWO\ JUHDWHU QXPEHUV RI +&$(&V +89(&V DQG +&$60&V adhered to FP and control surfaces compared to PC surfaces (p<0.05), with no differences between FP and control surfaces. In regards to THP-1 monocyte adhesion, no differences were observed among all surfaces. Conclusion: Biocompatibility and hemocompatibility of FP and PC were demonstrated in in vitro, ex vivo, and in vivo models with a trend towards LPSURYHGFRPSDWLELOLW\ZLWKÀXRULQDWHGFRSRO\PHUFRDWHGVXUIDFHV
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08/7,/,1. 0/ 9LVLRQ® $EERWW9DVFXODU6DQWD&ODUD&$ DQGWKLFN VWUXW9LVLRQZHUHXVHGWRHYDOXDWHWKURPERJHQLFLW\DQGYDVFXODULQMXU\DQG remodeling in the porcine coronary artery model. Methods: 7KLFN VWUXW 9LVLRQ -m) was developed by isolating the strut KHLJKWRIWKHFRPPHUFLDOO\DYDLODEOH³WKLQQHUVWUXW´0/9,6,21™ (81 -m), while maintaining all other parameters constant. Thrombus adherence following 3d post-stent implantation in the coronary arteries was assessed by histology HYDOXDWLRQRI¿EULQGHSRVLWLRQ9DVFXODULQMXU\DQGUHPRGHOLQJRI0/9LVLRQ™, WKLFNVWUXW9LVLRQDQGQDwYHQRQVWHQWHGDUWHULHVZHUHDVVHVVHGXVLQJEUDQFKHG DNA assay (Panomics, Fremont, CA) to evaluate the gene expression of a panel RIPROHFXODUPDUNHUV6WDWLVWLFDOVLJQL¿FDQFH S ZDVGHWHUPLQHGXVLQJWKH 6WXGHQWWWHVWDQGDQ$129$ZLWK+ROP¶VWWHVWIRUPXOWLSOHFRPSDULVRQV Results: After 3d, thrombus adherence throughout the proximal, mid DQG GLVWDO UHJLRQV ZDV VLJQL¿FDQWO\ ORZHU LQ 0/ 9LVLRQ™ WKDQ WKLFN VWUXW 9LVLRQ YV PP2; p<0.01). Both stent groups after 3d VKRZHGVLPLODUGRZQUHJXODWLRQLQHQGRWKHOLDOFHOOPDUNHUV H126 HQGRJOLQ EXWXSUHJXODWLRQLQSUROLIHUDWLRQ 3&1$ PDWUL[ ¿EURQHFWLQ DQG LQÀDPPDWRU\ ,&$0 9&$0 0&3 PDUNHU H[SUHVVLRQV FRPSDUHG WR WKHFRQWURODUWHULHV S $WGH[SUHVVLRQRI3&1$¿EURQHFWLQDQG LQÀDPPDWRU\PDUNHUVPDLQWDLQHGIROGLQFUHDVHLQWKLFNVWUXW9LVLRQEXW UHWXUQHGWRQHDUO\EDVHOLQHOHYHOLQ0/9LVLRQ™ (p<0.05). eNOS expression IRU0/9LVLRQ™ DWGZDVWLPHVKLJKHUWKDQWKLFNVWUXW9LVLRQ YV S )XUWKHUPRUHWLVVXHIDFWRUZDVXSUHJXODWHGE\IROGLQWKLFNVWUXW 9LVLRQDWG S Conclusion: The use of thin strut stents may minimize thrombogenicity and enhance vascular healing. By isolating the strut height, this study showed that WKLFNVWUXW9LVLRQLQGXFHGJUHDWHUWKURPERJHQLFLW\GHOD\HGYDVFXODUUHPRGHOLQJ DQGLQFUHDVHGYDVFXODULQMXU\FRPSDUHGWRWKHWKLQVWUXW0/9,6,21™. TCT-390 Mid-long Term Results Of Zotarolimus Eluting Stent In Off-label, On -label And Not Approved Indications For Use
E L E C T RO N I C A B S T R AC T S
Dae-Hyun Lee1, Paula Tejedor2, Javier Botas1, Juan M Duran2, Petra Sanz1, Javier Robles2, Lorenzo López-Bescós1, Germán Pérez-Ojeda2 1 Fundacion Hospitalaria Alcorcon, Alcorcon, Spain 2Hospital General Yague, Burgos, Spain Background: Few data are available regarding the performance of the recently approved zotarolimus eluting stent (ZES) in off- label and not approved indications for use (FDA). The purpose of this study was to evaluate WKHPLGORQJWHUPSHUIRUPDQFHRIWKLVGHYLFH PLQLPXPIROORZXS!\HDU in a consecutive and nonselected population comparing the frequency, safety DQGHI¿FDF\RIRQODEHORIIODEHODQGQRWDSSURYHGLQGLFDWLRQVRIXVH Methods: 303 subjects treated with ZES as the only DES were studied. 7KH LQFLGHQFH RI VWHQW WKURPERVLV 67 $5& GH¿QLWLRQV GHYLFH IDLOXUH FDUGLDFGHDWK7DUJHW9HVVHO0,DQG7/5 DQGRWKHU0$&( GHDWK0,DQG UHYDVFXODUL]DWLRQ ZHUHDQDO\]HG6XEMHFWVZHUHFODVVL¿HGLQ JURXSV RQ label, off-label and not approved) according to the indication of use of ZES. Results: 34.3% of the 303 subjects were treated with ZES for an on-label indication; 54.7% for an off-label and 10.8% for a not approved indication. Baseline clinical characteristics and duration of antiplatelet treatment were QRW VWDWLVWLFDOO\ GLIIHUHQW DPRQJ JURXSV 0HDQ IROORZXS ZDV months (range 12-31.4), with only one patient lost. There were not statistically VLJQL¿FDQWGLIIHUHQFHVLQWKHLQFLGHQFHRIHYHQWVDPRQJJURXSV VHHWDEOH Cardiovascular events Events n Alive without events Myocardial infarction 'H¿QLWHDQGSURE67 Possible ST Target lession revasc. Target vessel revasc. Device failure Cardiac death table 1
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% 34.3 98.4 1.9 1 1.11 5.8 6.7 7.7 1
On-label 103 93 2 1 1 6 7 8 1
% 54.7 86.7 0.6 1.2 2.53 4.8 5.5 10.8 3.6
Off-label 166 143 1 2 4 8 9 18 6
% 10.8 90.9 3 3 1 3 3 3 0
Conclusion: In the real world, more than half of ZES are implanted for offlabel indications. Cardiac and non cardiac complications are numerically higher among the more complex off-label population, although the absolute rate of cardiac events remains reasonably low TCT-391 Angiographic and Clinical Outcomes from the XIENCETM V 4.0mm Registry Arm of the SIII Trial Paul C. Gordon1, Steven B. Weinsier1, Xiaolu Su2, Rosann white2, Julie Doostzadeh2, Sherry Cao2, Poornima sood2, Krishna Sudhir2, Gregg W. Stone3 1 Miriam Hospital, Brown University, Providence, RI; 2Abbott vascular, Santa Clara, CA; 3The Cardiovascular Research Foundation and Columbia University Medical Center, New York, NY Background: In the SPIRIT III randomized controlled trial (RCT), an HYHUROLPXVHOXWLQJVWHQW;,(1&(9FRPSDUHGWRDSDFOLWD[HOHOXWLQJVWHQW 7$;86® in 2.5-3.75mm diameter vessels resulted in reduced angiographic ODWHORVVQRQLQIHULRUUDWHVRIWDUJHWYHVVHOIDLOXUH 79) DQGIHZHUPDMRU adverse cardiac events (MACE) during 1 year of follow-up. The safety and HI¿FDF\RIGUXJHOXWLQJVWHQWVLQODUJHUYHVVHOVLVQRWZHOONQRZQ Objective: 7RFRPSDUHWKHVDIHW\DQGHI¿FDF\RI;,(1&(9LQYHVVHOV! DQGPPFRPSDUHGWR7$;86® arm of the RCT. Methods: The SPIRIT III 4.0 registry was a concurrent arm of the SPIRIT III RCT and included non-randomized patients with vessel diameter 3.75 PPZKRUHFHLYHGDPP;,(1&(9VWHQW7KHSULPDU\VWDWLVWLFDO K\SRWKHVLVZDVWRGHPRQVWUDWHQRQLQIHULRULW\WRWKHUDQGRPL]HG7$;86® arm for late loss at 8 months as agreed upon with the FDA. The secondary HQGSRLQWVLQFOXGHG79)0$&(0,7/5DQG795DWRQH\HDUDQGVWHQW thrombosis. Results: 69 patients were enrolled in the 4.0mm arm, 49 had angiographic IROORZXS,QWKH7$;86® arm of the RCT, 333 patients were enrolled and 188 had angiographic follow-up. Baseline demographics were similar between the two groups. Table 1. Angiographic and Clinical Outcomes ;,(1&(9 Outcome mm In-segment Late Loss, mm* 79) 5.9% (4/68) Cardiac Death 1.5% (1/68) MI 4.4% (3/68) TLR 1.5% (1/68) 795 0.0% (0/68) MACE# 5.9% (4/68) Stent Thrombosis Acute (<1 day) 1.4% (1/69) Subacute (1 to 30 days) 0.0 (0/69) /DWH !GD\V 0.0 (0/67)
7$;86 RCT
Difference**
0.0% (0/330) 0.0% (0/330) 0.6% (2/317)
1.45% 0.0 % -0.63%
Non-inferiority P<0.0001 11.3% (36/320) -5.37% 0.9% (3/320) 0.53% 4.1% (13/320) 0.35% 5.6% (18/320) -4.15% 4.4% (14/320) -4.38% 10.3% (33/320) -4.43%
*240 day angiographic follow-up
7KH FRQ¿GHQFH LQWHUYDOV ZHUH QRW FDOFXODWHG GXH WR WKH ORZ REVHUYHG proportions. # Clinical outcome at 393 days Conclusion: 7KHPP;,(1&(9DSSHDUVWREHVDIHDQGHIIHFWLYHLQ treating large diameter native coronary vessels with lower angiographic late ORVVDQGFRPSDUDEOHFOLQLFDORXWFRPHVWR7$;86® in 2.5-3.5mm vessels.
Not approv. 33 30 1 1 1 1 1 1 0
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TCT-392
and yearly up to 6 years (median time: 3.6 years). Results: Baseline data included mean age 63.9 years, 23% female, 29% diabetes, 60% multivessel disease, 49% previous revascularization, and UHQDOLQVXI¿FLHQF\ VHUXPFUHDWLQLQHPJG/ SUHVHQWHGZLWK ACS (including 15% AMI), and LAD was treated in 43%. Most lesions KDG FRPSOH[ SUR¿OH W\SH %& LQFOXGLQJ VLJQL¿FDQW FDOFLXP 69*RVWLDOORFDWLRQ,65DQGELIXUFDWLRQV$WRWDORI DES were implanted in 3,333 lesions, and 40% of pts had multiple stenting SURFHGXUH$QJLRJUDSKLFVXFFHVV ¿QDO7,0, VWHQRVLVE\4&$ ZDV achieved in 98.6%. Clinical outcomes are shown in the Table. Independent SUHGLFWRUVRI0$&(ZHUH 3&,LQ69* +5 &, 3 multivessel disease (HR 1.39; 95%CI 1.03-1.87; P<0.001), residual stenosis by QCA (HR 1.30 per % unit increase; 95%CI 1.10-1.50; P=0.034), diabetes (HR &, 3 DQGUHQDOLQVXI¿FLHQF\ +5 &, 1.34-1.81; P=0.004).
Impact of Lesion Complexity on the Occurence of Stent Thrombosis Following Drug-Eluting Stent Implantation in Unselected Patients from the Real World Clinical Practice Ricardo A Costa, Amanda Sousa, Adriana Moreira, J. Ribamar Costa, Jr, Galo Maldonado, Manuel Cano, Fausto Feres, Rodolfo Staico, Luiz A Mattos, Alexandre Abizaid, Leopoldo Piegas, Daniel França, Mariana T Carballo, Ibraim M Pinto, Otávio Berwanger, J. Eduardo Sousa Hospital do Coração - Associação do Sanatório Sírio, Sao Paulo, Brazil Background: '(6 UHYROXWLRQDOL]HG WKH ¿HOG RI LQWHUYHQWLRQDO FDUGLRORJ\ PDLQO\ E\ PDUNHG UHGXFWLRQV LQ 7/5 FRPSDUHG WR EDUH PHWDO VWHQWV DV demonstrated in several randomized clinical trials. Thus, a widespread use of DES was observed since their introduction, including treatment of highULVNVXEJURXSV+RZHYHUVHYHUDOUHFHQWVWXGLHVLQFOXGLQJSWVIURPWKH³UHDO ZRUOG´KDYHUDLVHGTXHVWLRQVUHJDUGLQJWKHORQJWHUPVDIHW\RI'(6HVSHFLDOO\ in more complex subsets. Methods: Between May/02-Jan/08, 2,365 unselected pts all comers for PCI with DES were prospectively enrolled in this single center study. Lesion criteria LQFOXGHGDWOHDVWOHVLRQVWHQRVLV&OLQLFDOIROORZXS )8 ZDVDVVLJQHG at 1, 6 and 12 months, and yearly up to 6 years (median time: 3.6 years). Stent WKURPERVLV 6) ZDVGH¿QHGDFFRUGLQJWRWKH$FDGHPLF5HVHDUFK&RQVRUWLXP Results: Overall, 29% of pts had diabetes, 60% multivessel disease, 40% presented with ACS (including 15% AMI). LAD was treated in 43%; 67% of lesions had complex morphology (type B2/C), including 29% mod./severe FDOFL¿FDWLRQHFFHQWULFRVWLDOOHVLRQORFDWLRQDQGLQVWHQWUHVWHQRVLV A total of 3.634 DES were implanted, and 40% had multiple stenting procedure. $WODWH)8 RYHUDOO67UDWHZDV 1 RIWKDWZHUHGH¿QLWLYH DQJLRJUDSKLFFRQ¿UPDWLRQ RFFXUUHGEHWZHHQPRQWKV ODWH67 DQGD fatal event was reported in 47%. By multivariate analysis, ST was associated to: FXUUHQWVPRNLQJ +5 &, 3 3&,LQ$0, +5 95%CI 1.31-9.40; P=0.013), multiple steting procedure (HR 1.81; 95%CI 1.093.02; P=0.023), and lesion postdilatation (HR 0.50; 95%CI 0.29-0.90; P=0.020); regarding lesion characteristics, eccentric morphology (HR 1.86; 95%CI 1.033.34; P=0.039), and mod./severe calcium (HR 2.38; 95%CI 1.34-4.23; P=0.003) ZHUH DOVR LQGHSHQGHQW SUHGLFWRUV RI 67 DV ZHOO DV ¿QDO UHVLGXDO VWHQRVLV E\ QCA (HR 1.04 per % unit increase; 95%CI 1.01-1.06; P=0.003). Furthermore, a VLJQL¿FDQWDVVRFLDWLRQEHWZHHQFDOFLXPDQGSRVWGLODWDWLRQIRURFFXUUHQFHRI67 was observed (P=0.007, Mantel-Haenszel). Conclusion: In this study, the cumulative incidence of ST up to 6 years clinical FU was very low (1.6%); however, it was related with a fatal event in half of cases. In this analysis, ST occurred mostly between 1-12 months, and was associated with complex lesion morphology including eccentric and VLJQL¿FDQW FDOFLXP 2WKHU SUHGLFWRUV RI 67 ZHUH FXUUHQW VPRNLQJ 3&, LQ AMI, multiple stenting, postdilatation, and stent underexpansion.
N Cardiac death MI TLR MACE (cardiac death, MI, TLR) 6WHQWWKURPERVLV $5&GH¿QLWLRQ
2,365 0.3% (7) 2.1% (50) 0.1% (1) 2.5% (59) 0% (0)
2,325 2.5% (58) 4.5% (105) 3.6% (84) 10.6% (246) 1.6% (38)
TCT-395 Abnormal Vasomotor Function of Epicardial Resistance Arteries in Pigs after Coronary Artery Implant of Paclitaxel-Eluting Stents
Background: Abnormal endothelium-dependent vasorelaxation of coronary arteries adjacent to drug-eluting stent (DES) implants has been reported and may be associated with late stent thrombosis. However, epicardial resistance vessel vasomotor function in the distal perfusion bed of DES has not been studied. We tested small vessel function 1 mo after coronary artery paclitaxeleluting stent (PES) implant. Methods: Pigs (n=9) received overlapping bare metal stent (BMS) and 3(6 DV ZHOO DV QDwYH YHVVHOV 2QH PRQWK ODWHU P\RFDUGLXP GLVWDO WR WKH VWHQWHGUHJLRQDVZHOODVVLPLODUORFDWLRQLQQRQVWHQWHGYHVVHO Q69 ZDV harvested. Eighteen epicardial resistance arteries (lumen diameter ~ 250-m) were isolated under a dissecting microscope and mounted on a myograph DSSDUDWXV 9DVRFRQVWULFWLRQ .&O 3*)A & ET-1), endothelial-dependent relaxation (EDdR) response to substance P (SP), and endothelial-independent relaxation (EDiR) to sodium nitroprosside (SNP) were measured. Results: Angiographic late lumen loss at 1-mo was less for PES than BMS (p=0.002). Epicardial resistance artery relaxation was attenuated in the perfusion distribution of PES, as maximal EDdR in response to SP was FRPSDUHG WR YHVVHOV LVRODWHG IURP WKH SHUIXVLRQ GLVWULEXWLRQ RI %06 DQGQRQVWHQWHGFRURQDU\VHJPHQWV 3 vs. PES). Maximal EDiR in response to SNP, however, was similar among WKH JURXSV 3(6 %06 Q69 3 16 respectively). Similarly contraction to endothelin-1 was not affected by VWHQWW\SH 3(6 %06 Q69 UDWLRRI
Background: '(6 GHPRQVWUDWHG PDUNHG UHGXFWLRQV LQ 7/5 FRPSDUHG WR EDUHPHWDOVWHQWVLQSUHYLRXVUDQGRPL]HGWULDOV KRZHYHUWKHFOLQLFDOEHQH¿WV of DES in complex patients over the very long-term follow-up (FU) are still XQNQRZQ Methods: Between May/02-Jan/08, 2,365 unselected pts all comers for PCI with DES were prospectively enrolled at 1 institution. Inclusion criteria was OHVLRQZLWK!VWHQRVLV&OLQLFDO)8ZDVDVVLJQHGDWDQGPRQWKV
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Jinsheng Li, Lakshmana K Pendyala, Toshiro Shinke, Jack P. Chen, Nicolas Chronos, Keith Robinson, Dongming Hou Saint Joseph’s Translational Research Institute, Atlanta, GA
Ricardo A Costa, Amanda Sousa, J. Ribamar Costa, Jr, Adriana Moreira, Manuel Cano, Galo Maldonado, Luiz A Mattos, Rodolfo Staico, Fausto Feres, Alexandre Abizaid, Luiz F Tanajura, Ricardo Pavanello, Marco Barbosa, Cantídio Campos, Otávio Berwanger, J. Eduardo Sousa Hospital do Coração - Associação do Sanatório Sírio, Sao Paulo, Brazil
October 12-17, 2008
Late Follow-up (Cumulative events)
TCT-394 WITHDRAWN
6XVWDLQHG6DIHW\DQG&OLQLFDO(I¿FDF\ 8SWR
|
In-Hospital
Conclusion: In this large, prospective study including unselected patients from the real-world clinical practice, DES demonstrated excellent acute performance, and sustained safety and clinical effectiveness up to 6 years clinical FU (<4% TLR). At late FU, the cumulative incidence of ST was very ORZ DQGSUHGLFWRUVRI0$&(ZHUH69*PXOWLYHVVHOGLVHDVHGLDEHWHV DQGUHQDOLQVXI¿FLHQF\
TCT-393
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contraction ET-1/KCl; P=NS respectively). Conclusion: Epicardial resistance artery endothelial-dependent vasomotor dysfunction is present one month after overlapping coronary PES implant in swine. Derangement of microcirculatory vasomotor function may also be present with DES implant in humans and be associated with a spectrum of adverse clinical sequelae. TCT-396 A Comparative Analysis of Major Clinical Outcomes Using DrugEluting Stents vs. Bare Metal Stents in a Large Single Center Israeli Clinical Setting Ran Kornowski, Tamir Bental, Hana Vaknin-Assa, Eli I Lev, David Brosh, Shmuel Fuchs, Abid Assali Rabin Medical Center, Petach Tikva, Israel Background: Concerns have been raised about the long-term safety of drug eluting stents (DES) during routine clinical practice among large population cohorts. Methods:)URPRXUKRVSLWDODQG+021HWZRUN'DWDEDVHZHFRQGXFWHGD large clinical registry of all patients undergoing PCI at our institution. We LGHQWL¿HGDFRQVHFXWLYHFRKRUWRISDWLHQWVZKRZHUHWUHDWHGXVLQJ'(6 (n=1,980) during PCI and compared the total mortality, myocardial infarction 0, DQG UHSHDW WDUJHW YHVVHO UHYDVFXODUL]DWLRQ 795 RXWFRPHV DQG ULVN adjusted event-free survival outcomes to patients treated using bare metal stents (BMS) (n=2770) during PCI between April 1, 2004, and July 1, 2007. Results: Patients receiving DES were somewhat younger (65.8 vs. 66.2 yrs, p<0.0001), had more DM (41.3% vs. 36.9%, p=0.001), sustained less CHF (14.3% vs. 18.6%, p<0.0001), had less acute/recent (i.e. within 24 hrs) STEMI (8.4% vs. 15.2%, p<0.0001), and had more proximal LAD lesions (28.1% vs. 8.4%, p<0.0001). Outcome data for the two groups are presented in the Table. Mean follow up was 2.1 years (range 0.5-3.6 years).
E L E C T RO N I C A B S T R AC T S
Death (%) MI (%) CABG (%) Hosp. d/t ACS (%) 795 Death/MI (%) 'HDWK0,795
All Pts N=4750 7.5 3.1 2.2 6.7 8.4 10.0 16.7
BMS N=2770 9.2 3.8 2.7 7.0 9.6 12.2 19.9
DES N=1980 5.2 2.1 1.4 6.3 6.6 7.0 12.2
P value <0.0001 0.001 0.002 NS <0.0001 <0.0001 <0.0001
Cox regression analysis plots adjusted for age, DM status, presence of CHF, VPRNLQJ SUR[ /$' ORFDWLRQ DQG DFXWHUHFHQW 67(0, VKRZHG VLJQL¿FDQW DGYDQWDJHLQWRWDOGHDWK'HDWK0,DQGGHDWK0,795FRPSRVLWHLQIDYRURI DES utilization (P<0.0001 for all comparisons). Conclusion: According to our comprehensive clinical experiences, DESs LPSURYHWKHORQJWHUPFOLQLFDORXWFRPHV LHRYHUDOOGHDWK0,795 DPRQJ µDOOFRPHUV¶JURXSRISDWLHQWVLQZLGHYDULHW\RIFOLQLFDOVFHQDULRV2XUULVN adjusted event-free survival analysis would indicate a prognostic advantage for DES utilization which sustains to 3 years following PCI. TCT-397 Overlapping Sirolimus- versus Paclitaxel- Eluting Stents in the Treatment of Diffuse Long Coronary Lesions Yong-Jian Li, Kang-Yin Chen, Seung-Woon Rha, Kanhaiya Poddar, Jae Hyoung Park, Jin Oh Na, Cheol Ung Choi, Hong Euy Lim, Jin Won Kim, Eung Ju Kim, Chang Gyu Park, Hong Seog Seo, Dong Joo Oh Korea University Guro Hospital, Seoul, Republic of Korea Background: The clinical and angiographic outcomes after sirolimus- and paclitaxel- eluting stents implantation in patients (pts) with coronary artery GLVHDVHZHUHVLPLODU+RZHYHUOHVVKDVEHHQNQRZQZKHWKHUWKHVHWZRVWHQWV had similar effectiveness in the treatment of diffuse long lesions with same
154i
overlapping stents strategy. Methods: A total of 174 pts who underwent percutaneous coronary intervention (PCI) with overlapping sirolimus- (SES group: Cypher, n=74 pts, 110 lesions) or paclitaxel- eluting stents (PES group: Taxus, n=100 pts, 177 lesions) were enrolled. Angiographic and clinical outcomes at 6 months were evaluated. Results: Both groups had similar baseline clinical and procedural characteristics. At 6 months, the Taxus group showed a trend towards ORZHUIROORZXSPLQLPXPOXPHQGLDPHWHU 0/' YV P=0.078). Except for this, angiographic outcomes including binary restenosis, restenosis percentage, late loss, stent thrombosis, and clinical outcomes including cardiac death, Q-wave myocardial infarction (MI), target lesion UHYDVFXODUL]DWLRQ 7/5 WDUJHW YHVVHO UHYDVFXODUL]DWLRQ 795 DQG PDMRU adverse cardiac events (MACE) were similar between the two groups. Except for 1 case of subacute thrombosis inn the PES group, there was no incidence of acute and late stent thrombosis throughout the follow-up period. Table: Angiographic and clinical outcomes at 6 months 9DULDEOHQ
SES Group PES Group P value (n=74pts, 110 lesions) (n=100pts, 177 lesions)
Binary restenosis Late loss, (mm) Restenosis percentage, (%) Cardiac death Q-wave MI TLR 795 7950$&( Stent thrombosis
7 (6.4) 1 (1.4) 0 (0) 6 (8.1) 6 (8.1) 11 (14.9) 0 (0)
15 (8.5) 4(4.0) 0 (0) 5 (5.0) 8 (8.0) 16(16.0) 1(1.0)
0.513 0.353 0.176 0.396 1.000 0.532 0.979 0.838 1.000
Conclusion: The angiographic and clinical outcomes at 6 month were similar and favorable in pts with diffuse long lesions undergoing PCI by Sirolimusor Paclitaxel- eluting overlapping stenting. Further study with larger study SRSXODWLRQ DQG ORQJHU GXUDWLRQ ZLOO EH ZDUUDQWHG WR JHW ¿QDO ORQJWHUP conclusion. TCT-398 Outcomes Related to Drug-Eluting Stents vs. Bare Metal Stents in Saphenous Vein Graft Intervention: An ACUITY Substudy Ajay J Kirtane1, Roxana Mehran1, Somjot S Brar1, Martin Fahy1, George D Dangas1, Frederick Feit2, Jeffrey W Moses1, Steven Manoukian3, Harvey D White4, Alexandra J Lansky1, Gregg W Stone1 1 Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY; 2New York University School of Medicine, New York, NY; 3Emory University School of Medicine, Atlanta, GA; 4 Auckland City Hospital, Auckland, New Zealand Background:7KHUHODWLYHVDIHW\DQGHI¿FDF\RIGUXJHOXWLQJVWHQWV '(6 IRUVDSKHQRXVYHLQJUDIW 69* LQWHUYHQWLRQLVFRQWURYHUVLDO:HFRPSDUHG outcomes related to the use of DES vs. bare stents (BMS) among 266 pts with acute coronary syndromes (ACS) undergoing percutaneous coronary LQWHUYHQWLRQ 3&, RIDQ69* Methods: ,Q WKH $&8,7< WULDO SWV ZLWK PRGHUDWH DQG KLJK ULVN ACS undergoing an early invasive treatment strategy were randomized to ELYDOLUXGLQ DORQH %,9 %,9JO\FRSURWHLQ ,,E,,,D LQKLELWLRQ *3, RU D heparin+GPI. Among these, 7789 patients underwent PCI, including 266 SWVXQGHUJRLQJ69*LQWHUYHQWLRQ2QH\HDURXWFRPHVZHUHDGMXGLFDWHGE\ an independent clinical events committee. For this analysis, the primary comparison was between pts treated with DES compared to BMS. Results:While the decision to treat with DES vs. BMS was non-randomized (by operator choice), patients treated with DES (n=210) or BMS (n=56) did not differ in baseline clinical characteristics, including the presence of baseline WURSRQLQ HOHYDWLRQ RU 7,0, 5LVN VFRUH RU LQ UDQGRPL]HG WUHDWPHQW JURXS The QCA lesion length and total number of stents were similar (mean length of 16 mm and median of 1 stent); however, the QCA baseline reference vessel GLDPHWHUZDVVLJQL¿FDQWO\ODUJHUDPRQJ%06WUHDWHGSDWLHQWV PPYV
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TCT-400
2.98 mm, p<0.001), and BMS-treated lesions were more often thrombotic. One year outcomes are presented in the table. Death/MI Death MI Stent Thrombosis (ARC) 'H¿QLWH3UREDEOH 'H¿QLWH Probable ,VFKHPLF795 Ischemic TLR Composite ischemia
DES (n=210) 25.3% (50) 8.0% (16) 19.6% (38)
BMS (n=56) 33.0% (18) 9.1% (5) 27.9% (15)
p-value 0.20 0.79 0.15
3.6% (5) 2.1% (4) 1.5% (1) 12.8% (22) 9.6% (16) 35.0% (66)
3.7% (2) 3.7% (2) 0.0% (0) 8.2% (4) 8.2% (4) 36.7% (20)
0.62 0.47 0.62 0.44 0.88 0.52
Early or Late Stent Thrombosis: Is it the Same Prognosis? Gilles Lemesle, Laurent Bonello, Axel de Labriolle, Tina L Pinto Slottow, Probal Roy, Daniel H Steinberg, Rebecca Torguson, Kimberly Kaneshige, Zhenyi Xue, William O Suddath, Lowell F Sattler, Kenneth M Kent, Joseph Lindsay, Augusto D Pichard, Ron Waksman Cardiovascular Research Institute, Washington, DC Aim: Stent thrombosis (ST), a major complication of drug eluting stents, may RFFXUZLWKLQWKH¿UVWGD\VRUODWHU'LIIHUHQFHVLQWKHFOLQLFDOSUHVHQWDWLRQ DQGWKHRXWFRPHKDYHQRWEHHQZHOOGH¿QHG:HFRPSDUHGWKHSUHGLFWRUVDQG the prognosis of patients in these two categories. Methods: Between June 2003 and March 2008, 91 consecutive patients SUHVHQWHG WR RXU FDWKHWHU ODERUDWRU\ ZLWK GH¿QLWH 67 SWV KDG HDUO\ DQG ODWH 67 DV GH¿QHG E\ WKH $5& GH¿QLWLRQ 7KH SULPDU\ HQGSRLQW ZDV D composite criteria Death - Myocardial Infarction (MI) or Recurrent ST at 30 days following the treatment of ST event. Results: Baseline clinical and angiographic characteristics were similar in the 2 groups. However, ST elevation MI as the indication of index PCI was more frequent in the early ST group 43.1% versus 17.5% in the late ST group (p=0.007). The ST presented as an STEMI with equal frequency in both JURXSV YVS EXWWKHUDWHRIFDUGLRJHQLFVKRFNZDVKLJKHU in the early ST group. (39.2% vs. 20%, p=0.04). The treatment strategy in the cath lab was similar between the 2 groups in terms of anticoagulation with aspirin and clopidogrel doses, GpIIb-IIIa inhibitor use, thrombus aspiration device use and new stent implantation rate. The rate of angiographic success after the ST treatment was similar between the 2 groups (82.4% vs. 87.5%, p=0.5). At 30 days, the incidence of the composite primary endpoint Death 0,67ZDVVLJQL¿FDQWO\KLJKHULQWKHHDUO\67JURXSWKDQLQWKHODWH67 group: 47.6% vs. 26.1%, respectively (p=0.02).
Conclusion: 7KH QRQUDQGRPL]HG XVH RI '(6 UDWKHU WKDQ %06 LQ 69* lesions in the ACUITY trial was not associated with discernable differences LQHLWKHUHI¿FDF\RUVDIHW\RXWFRPHVWRRQH\HDU/DUJHUUDQGRPL]HGWULDOV ZLWKORQJHUIROORZXSDUHQHHGHGWRIXUWKHUHVWDEOLVKWKHVDIHW\DQGHI¿FDF\ RI'(6LQ69*OHVLRQV TCT-399 Zotarolimus Drug-Eluting Stent In Patients With S-T Elevation Myocardial Infarction: 12-Month Results From The E-FIVE Registry Chaim Lotan1, Ian T Meredith2, Manuela Negoita3, Martin T Rothman4, For the E-FIVE Registry Investigators 1 Hadassah-Hebrew University Medical Center, Jerusalem, Israel 2 Monash Medical Centre, Southern Health, Melbourne, Victoria, Australia 3Medtronic CardioVascular, Santa Rosa, CA; 4Barts and The London NHS Trust, London, United Kingdom
Conclusion: Patients presenting with an early ST have a worst prognosis when compared to patients presenting with a late ST. This could be explained E\WKHRFFXUUHQFHRIVXFFHVVLYH0,¶VZLWKLQGD\VLQQHDUO\RIWKH patients in the early ST group. TCT-401 The Safety and Effectiveness of Cypher Stent for Bifurcation versus Non-Bifurcation Lesion. Two-Year Follow-Up Analysis From the MATRIX Registry Adriano Caixeta1, Giora Weisz1, Roxana Mehran1, Michael B Collins2, Varinder Singh1, Alexandra J Lansky1, Susheel Kodali1, Theresea Franklin-Bond2, Neil Matharoo2, Roland Wu1, Dorothy Franklin2, Kathy Morgan1, Gregg W Stone1, Jeffrey M Moses1, Martin Fahy1, Martin Leon2, George Dangas1 1 Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY; 2Columbia University Medical Center, New York, NY Background: Percutaneous coronary intervention in coronary bifurcation lesions (BIF) remains challenging in the drug-eluting stent (DES) era. BIF have been associated with higher procedure complication rates and worse short-term clinical outcomes than non-BIF. The long-term clinical outcomes
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Background: Most randomized trials of drug-eluting stents excluded patients presenting with an acute myocardial infarction (AMI) at enrollment due to FRQÀLFWLQJ GDWD DQG SRVVLEOH VDIHW\ FRQFHUQV :H HYDOXDWHG WKH XVH RI WKH (QGHDYRU]RWDUROLPXVHOXWLQJVWHQWLQDVXEJURXSRIKLJKULVN$0,SDWLHQWV IURPDUHDOZRUOGSDWLHQWSRSXODWLRQLQWKH(),9(5HJLVWU\ Methods: 7KH(),9(5HJLVWU\LVDSURVSHFWLYHPXOWLFHQWHUQRQUDQGRPL]HG global registry that enrolled 8314 patients at 188 centers in Europe, South America, Australia, New Zealand and Asia. All patients presenting with symptomatic coronary artery disease amenable to stent implantation were eligible for the study. Patients with documented ST elevation (STE) within 72 hours of the index procedure were considered to have an acute MI. For the last 4000 patients enrolled, we collected more detail as to the time of symptom onset, thus we were able to also evaluated 12 month clinical outcomes based on the time between onset of symptoms and stenting. All MACE events, death, myocardial infarction (MI), and stent thrombosis (ST) events using ARC criteria, were adjudicated by a Clinical Events Committee. Results: ,QWRWDO SDWLHQWVKDGDGRFXPHQWHG$0, DQ\GH¿QLWLRQ ZLWK 12-month rates of TLR, MACE of 2.8% and 7.2%, respectively. The 12-month $5& GH¿QLWH VWHQW WKURPERVLV 67 UDWH ZDV DQG $5& GH¿QLWH probable ST rate was 2.0%. We plan to report detailed outcomes based on time from symptoms to primary PCI in October, 2008. Conclusion: We found that use of the Endeavor zotarolimus-eluting stent in AMI patients, either in the acute phase (within 6 hours of symptom onset) or ZLWKLQWKH¿UVWKRXUVRIV\PSWRPVZDVDVVRFLDWHGZLWKORZ0$&(UDWHV comparable to that seen in more controlled study populations.
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RISWVZLWK'(6VWHQWLQJRI%,)LVQRWZHOONQRZQ Methods:7RWDORIFRQVHFXWLYH³UHDOZRUOG´SWVZLWKFRURQDU\DUWHU\GLVHDVH WUHDWHGZLWKF\SKHUVWHQWZHUHHQUROOHGLQWKH0$75,;UHJLVWU\7KHVKRUWDQG long term outcomes of patients who had stenting of a BIF to patients who had stenting of a non-BIF were compared. Patient were followed for 2 years. Results: Total of 294 pts (18%) had BL and 1291 non-BL. There were no VLJQL¿FDQWGLIIHUHQFHVLQEDVHOLQHDQGGHPRJUDSKLFFKDUDFWHULVWLFVEHWZHHQ groups. The average number of stents used per patient was greater in BL (2.55 vs. 1.98; P<0.0001). There were no between-group differences in in-hospital mortality (0% vs. 0.1%; P=1.00) and myocardial infarction (2.3% in both). The 2-year clinical outcomes are summarized in Table 1. Outcomes @ 2yr
Bifurcation
No Bifurcation
P value
All Death
4.4%
3.9%
0.806 0.570
Cardiac Death
1.4%
1.2%
MI
4.4%
4.0%
0.649
795
11.5%
10.2%
0.546
MACE
19.3%
17.4%
0.410
ARC Def/Prob Stent thrombosis
0.7%
1.0%
0.809
MI: myocardial infarction; MACE: major adverse cardiovascular events (death, MI, 795 795 WDUJHWYHVVHOUHYDVFXODUL]DWLRQ $5& DFDGHPLFUHVHDUFKFRQVRUWLXP
Conclusion: In comparison to non-BIF, treatment of BIF with the sirolimuseluting stent,had similarly low in-hospital as well as 2-year event rates compared with non-BIF groups. TCT-402 Vascular Safety of Sirolimus-Eluting Reservoir-Based Stents in the Porcine Coronary Artery Model
E L E C T RO N I C A B S T R AC T S
G. Sylvester Price1, James R L Stanley2, Andrew Luk1, John Dooley3, Rose Kovalcsik4, Campbell Rogers3 1 Conor Medsystems, Menlo Park, CA; 2CBSET, Inc., Lexington, MA; 3 Cordis Corporation, Warren, NJ; 4MPI Research, Inc., Mattawan, MI Background: The Conor reservoir-based stent platform uses biocompatible bioresorbable polymers for anti-restenosis vascular drug delivery. We incorporated sirolimus into a PLGA polymer matrix similar to that used in previous Conor stent platforms. The sirolimus dose and in vivo release NLQHWLFVRIWKH&RQRUVLUROLPXVHOXWLQJVWHQW 1(92® 0HQOR3DUN&$ ZHUH tailored to be similar to CYPHER® (Cordis Corporation, Warren, NJ). Methods: 6LQJOH 1(92 EDUH PHWDO &RQRU %06 DQG &<3+(5 VWHQWV were implanted in porcine LAD, RCA and/or LCx coronary arteries for 30, 90, or 180 d. QCA, histopathology and histomorphometry were evaluated. In addition, SEM was performed on a subset of arteries. Results:$OOVWHQWVZHUHHQGRWKHOLDOL]HGDWG3HULVWUXWLQÀDPPDWLRQLQ1(92 VWHQWVZDVPLQLPDODQGVLJQL¿FDQWO\OHVVWKDQLQ%06FRQWURO VFRUH YV DWG S 3RO\PHUGHJUDGDWLRQZDVHVVHQWLDOO\FRPSOHWHE\ GZLWKPLQLPDODVVRFLDWHGLQÀDPPDWLRQ 1(92 YV%06 QRWVLJQL¿FDQW ,QÀDPPDWLRQZDVDOVRPLQLPDODWG 1(92 YV%06 QRWVLJQL¿FDQW 3HULVWUXW¿EULQDIWHUGZDVVLJQL¿FDQWO\ JUHDWHULQ1(92WKDQ%06EXWGLGQRWGLIIHUIURP&<3+(5DQGGHFUHDVHG SURJUHVVLYHO\DW DQGG1HRLQWLPDOWKLFNQHVVGLGQRWGLIIHUDPRQJVWHQW W\SHVDWG 1(92 PP&<3+(5 PP%06 PP $VH[SHFWHGLQWKHSRUFLQHPRGHODW G%06QHRLQWLPDOWKLFNQHVV GHFUHDVHGVOLJKWO\ PP ZKHUHDVLQERWKVLUROLPXVHOXWLQJVWHQWW\SHV QHRLQWLPDOWKLFNQHVVZDVVOLJKWO\LQFUHDVHGUHODWLYHWRWKDWDWGD\V 1(92 PP&<3+(5 PP +RZHYHUDWGWKHUHZDVQR GLIIHUHQFHEHWZHHQ1(92DQG%06QHRLQWLPDOWKLFNQHVV 1(92 PP%06 PP Conclusion: Reservoir-based bioresorbable stent-based delivery of sirolimus SURGXFHGOHVVLQÀDPPDWLRQWKDQ%06DWGGUXJWLVVXHHIIHFWVUHPLQLVFHQW of CYPHER, but with no polymer material present after 90 d.
156i
TCT-403 Stent-based Delivery Of Antisense Oligodeoxynucleotides Targeted To The Pdgf A-chain Decreases In-stent Restenosis Of The Coronary Artery Shin-Ichiro Yokoyama, Yuxin Li, Satoshi Saitoh Nihon University School of Medicine, Tokyo, Japan Background: Although the use of drug-eluting stents (DESs) has been shown to limit neointima hyperplasia, currently available DESs may adversely affect reendothelialization, possibly precipitating cardiac events. We evaluated the effect of an antisense oligodeoxynucleotide (ODN) targeted to the platelet-derived growth factor (PDGF) A-chain on in-stent restenosis in pig coronary artery. Methods:$EDUHPHWDOVWHQWFRDWHGZLWKSKRVSKRURWKLRDWHOLQNHGDQWLVHQVH ODN or nonsense ODN, or a bare metal stent without ODN (control), was implanted in the mid segment of the left anterior descending artery (LAD). Twenty-eight days after implantation, angiography and intravascular XOWUDVRXQG ,986 ZHUHSHUIRUPHGWKH/$'ZDVUHPRYHGDQGVWHQRVLVZDV evaluated pathologically. Results:9ROXPHWULFVWHQRVLVUDWLRVZHUH DQG 3.8% in coronary arteries implanted with control, nonsense ODN-coated, and DQWLVHQVH2'1FRDWHGVWHQWVUHVSHFWLYHO\,QDQJLRVFRSLF¿QGLQJVWKHOXPHQ surface was smooth in the stented segments in all groups. Struts of antisense ODN-coated stents were observed embedded in the neointima, whereas embedding was not observed in nonsense ODN-coated stents or control stents, indicating a decrease in hyperplasia in response to antisense ODN WUHDWPHQW3DWKRORJLF¿QGLQJVVKRZHGDQG stenosis in coronary arteries implanted with control stents, nonsense ODNcoated stents, and antisense ODN-coated stents, respectively. A continuous lining of endothelial cells was observed along the lumen of coronary arteries implanted with antisense ODN-coated stents. Conclusion: Stent-based delivery of an antisense ODN targeted to the PDGF A-chain effectively inhibits neointima formation after stent implantation LQ SLJ FRURQDU\ DUWHU\ E\ VXSSUHVVLQJ 960& K\SHUSODVLD DQG SUHVHUYLQJ endothelialization. Antisense-ODNs may provide a therapy for in-stent restenosis of the coronary artery. TCT-404 The Effectiveness and Safety of Zotarolimus Eluting Stent Implantation in Acute Myocardial Infarction: IPS (Infarct Prognosis Study) Registry Won Ho Kim, Jung-Sun Kim, Young-Guk Ko, Donghoon Choi, Jong Won Ha, Yangsoo Jang, Namsik Chung Yonsei University College of Medicine, Yonsei Cardiovascular Center, Seoul, Republic of Korea Background: There is little information on cardiac outcomes in the Zotarolimus Eluting Stent (ZES), compared with the Sirolimus Eluting Stent (SES) and the Paclitaxel Eluting Stent (PES) in acute myocardial infarction. The study was designed to investigate the effectiveness and safety of ZES implantation in acute myocardial infarction Method: )RXU KXQGUHG ¿YH FRQVHFXWLYH SDWLHQWV ZLWK DFXWH P\RFDUGLDO infarction in IPS(Infarct Prognosis Study) Registry [ST elevation myocardial infarction; n=225(55.6%), Non-ST elevation myocardial infarction; n=180(44.4%)], underwent percutaneous coronary intervention at Severance Hospital, were randomly assigned to be implanted SES, PES, or ZES. We assessed the adverse cardiac events [Cardiovascular death, Non-fatal P\RFDUGLDO LQIDUFWLRQ DQG 7DUJHW YHVVHO UHYDVFXODUL]DWLRQ 795 @ DPRQJ three group (SES, n=197, PES, n=114, ZES, n=94). The mean follow-up GXUDWLRQZDVPRQWKV XSWRPRQWKV Results: The baseline characteristics were comparable among the three groups. The cumulative mortality rate was comparable in the three groups: 6.6% in the SES group, 4.4% in the PES group, and 4.3% in the ZES group QRQVLJQL¿FDQWIRUDOO 7KHUDWHRI795ZDVLQWKH=(6JURXSFRPSDUHG
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October 12-17, 2008
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TCT-406
with 2.0% and 4.4% in the SES and PES group, respectively (p=0.008 for ZES vs. SES, 0.133 for ZES vs. PES, 0.252 for SES vs. PES). The cumulative LQFLGHQFHRIFDUGLRYDVFXODUGHDWKQRQIDWDO0,RU795ZDVLQWKH ZES group compared with 10.7% in the SES group, 12.3% in the PES group (p=0.220 for ZES vs. SES, 0.456 for ZES vs. PES, 0.655 for SES vs. PES). 6WHQW WKURPERVLV 67 ZKLFK ZDV GH¿QHG DV GH¿QLWLRQV RI WKH $FDGHPLF Research Consortium(ARC), was investigated during the study period. The rate of ST was 1.1% in the ZES group, 2.5% in the SES group and 0.9% in the PES group (p=0.474). Conclusion: Our data demonstrated that the cumulative of adverse cardiac HYHQW DQG QRQIDWDO 0, ZHUH QRW VLJQL¿FDQWO\ GLIIHUHQW DPRQJ WKH WKUHH JURXSV%XW=(6KDGDKLJKHUUDWHRI795WKDQ6(6RU3(6
The role of diabetes status in the long-term (up to 6 years) results of drug-eluting stents for the treatment of diabetic patients - insights from the Drug Eluting Stents In the REal World(DESIRE) Registry Adriana C Moreira, Amanda Sousa, José Costa Jr, Ricardo Costa, Manuel Cano, Galo Maldonado, Luiz Alberto Mattos, Fausto Feres, Cesar Jardim, Ricardo Pavanello, Marcel Vezzaro, Mariana Carballo, J.Eduardo Sousa Hospital Do Coracao, Sao Paulo, Brazil Background: Diabetic patients are traditionally related to higher rates of major adverse cardiac events (MACE) after percutaneous coronary intervention even in the drug-eluting stent (DES) era. We sought to evaluate the impact of diabetes status in the very long-term clinical outcomes after DES implantation in a complex, non-selected diabetic cohort. Methods and Results: Between May/2002 and May/2007, 2,500 patients treated exclusively with DES were consecutively enrolled in the nonrandomized, single-center DESIRE Registry. Among them, 1,705 elective patients have completed 6 month-follow-up and were divided into 3 groups according to their Diabetes mellitus status. Primary endpoint was longWHUP FRPELQHG 0$&( DQG VWHQW WKURPERVLV UDWH FODVVL¿HG DFFRUGLQJ WR $5&GH¿QLWLRQV&OLQLFDOIROORZXSZDVREWDLQHGDWDQGPRQWKVDQG then annually up to 6 years. Median follow-up time was 3.6 years. Clinical follow-up was achieved in 98% of the eligible cohort. Baseline clinical and procedure characteristics as well as late outcomes are displayed in the table. In the multivariate logistic regression analysis, Diabetes mellitus (OR=1.45; &RQ¿GHQFH LQWHUYDO&, DQG PRGHUDWHVHYHUH FDOFL¿FDWLRQ DW lesion site (OR=3.06;95%CI,1.47-6.34) were independent predictors of MACE .
TCT-405 Incidence Of Stent Thrombosis (st) At 5 Years After Ses Implantation. Results From A Prospective Swiss Registry In The Real World Jean-Jacques Goy1, Urs Kaufmann2, Philip Urban3, Charles Seydoux1, Edoardo de Benedetti3, Alexandre Berger1 1 Clinique Cecil, Lausanne, Switzerland 2Herzzentrum, Bern, Switzerland 3Hôpital la Tour, Genève, Switzerland
Group
Non Diabetics 9DULDEOHV (n =1,211) Mean age ,y 63.4 Female,% 22.5 Hypertension,% 73.7 Obesity,% 23.5 Serum creatinine, mg/dl 1.1 Off-label indications,% 71.2 B2/C lesion Type,% 65.8 Moderate/severe 27.1 FDOFL¿FDWLRQ DES/vessel ratio 1.16 Cumulative MACE(%) 7.0 Cardiac death 1.0 Non-fatal MI 2.7 TLR (PCI/CABG) 2.5 Stent thrombosis rate,% 1.16
Non-insulinrequiring DM (n =385) 64.5 25.7 86.0 37.5 1.2 72.2 68.7
Insulin-requiring DM p-value (n = 109) 65.6 0.049 40.4 <0.001 89.0 <0.001 27.2 <0.001 1.3 0.005 82.6 0.04 69.9 0.43
29.9
40.0
0.001
1.15 9.4 2.9 3.4 3.7 1.8
1.17 11.2 3.7 4.7 3.8 1.8
0.466 0.117 0.35 0.34 0.30 0.35
Conclusion: In the DESIRE registry both insulin and non-insulin requiring diabetics carried poorer long-term outcomes (MACE) when compared to non-diabetic patients. Importantly, there was a tendency for higher stent thrombosis among diabetics. However, the type of diabetes (insulin vs. noninsulin) did not seem to impact the prognosis of PCI with DES. TCT-407 Long-term (up to 6 years) outcomes of diabetic patients with multivessel disease treated with drug-eluting stents in the Drug Eluting Stents In the REal World(DESIRE) Registry Adriana Moreira, Amanda Sousa, José Costa Jr, Ricardo Costa, Manuel Cano, Galo Maldonado, Rodolfo Staico, Luiz Alberto Mattos, Fausto Feres, Felix Ramires, Daniel França, Abrão Cury, Marcos Barbosa, Cantidio Campos, J Eduardo Sousa Hospital Do Coracao, Sao Paulo, Brazil Background: 'UXJHOXWLQJ VWHQWV ZHUH PDUNHWDSSURYHG IRU WUHDWPHQW RI QRQFRPSOH[ OHVLRQV EDVHG RQ WKHLU HI¿FDF\ DQG VDIHW\ SUR¿OH LQ SLYRWDO randomized trials. However, in clinical practice, DES are used in both on-
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Background: The incidence of stent thrombosis and complications following Sirolimus Eluting Stents (SES) implantation is still a matter of debate. Method: We started to implant SES in 2002 at 3 Swiss institutions. In 2007, we conducted a 5 year follow-up, on the day of their 5 year SES implantation anniversary. All patients were included for the follow-up except those who also received another DES or a bare metal stent. After the procedure aspirin 100 mg OD was given long-term and clopidogrel 75 mg OD for 3 to 12 months. 7KHXVHRI6(6LPSODQWDWLRQZDVQRWUHVWULFWHGWR³RQODEHO´LQGLFDWLRQVDQG WDUJHWOHVLRQVLQFOXGHGLQVWHQWUHVWHQRVLV69*ELIXUFDWLRQVDQGORQJOHVLRQV ZHUHWUHDWHG8SWRRIWKHSWVZHUHGH¿QHGDVKLJKULVNRUFRPSOH[OHVLRQ IRUVWHQWLQJ7KH$5&FULWHULDZHUHXVHGIRU67FODVVL¿FDWLRQ Results: 350 patients were treated with SES between April and December 0HDQDJHZDV\HDUVZHUHPDOHSUHVHQWHGZLWK$&6 and 19% were diabetics. Multi-vessel procedures were performed in 11% of patients. The mean stented length was 21+ 5 mm, and the vessel reference GLDPHWHUPP0HDQQXPEHURI6(6SWZDV2QWKHGD\RI WKHLU\HDUIROORZXS67KDGRFFXUUHGLQSWV GH¿QLWH6$7 probable 1 (0.3%) and possible 5 (1.4%). None of the SAT occurred during the ¿UVW\HDURIWUHDWPHQW )LJXUH 6HYHQW\QLQHSHUFHQWRIWKHSRSXODWLRQZDV free of complications. MACE occurred in 21% and were: cardiac death 3%, QRQFDUGLDFGHDWK0,7/5795&$%*,QQRQ 795QRQ7/5UHYDVFXODUL]DWLRQZDVSHUIRUPHG Conclusion:2XUGDWDFRQ¿UPWKHH[FHOOHQWORQJWHUPRXWFRPHRISDWLHQWV treated with SES. The incidence of complications at 5 years in routine clinical practice reproduces the results of the prospective randomized trials, especially for the incidence of SAT. Surprisingly, most of them were very late ST.
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DQGRIIODEHOOHVLRQVDVZHOODVLQKLJKULVNSDWLHQWV'LDEHWLFSDWLHQWVZLWK multivessel disease are traditionally related to higher rates of major adverse cardiac events (MACE) after percutaneous coronary intervention even in the drug-eluting stent (DES) era. We sought to evaluate the very long-term FOLQLFDORXWFRPHDIWHU'(6LPSODQWDWLRQLQWKLVKLJKULVNVXEVHWLQDFRPSOH[ non-selected population. Methods and Results: Between May/2002 and May/2007, 2,500 patients treated exclusively with DES were consecutively enrolled in the nonrandomized, single-center DESIRE Registry. Recent myocardial infarction, saphenous venous graft and patients with < 6months follow-up were excluded. '(6 ZHUH VHOHFWHG DW WKH RSHUDWRU¶V GLVFUHWLRQ $PRQJ WKHP 3 ZLWK multivessel disease were divided into 2 groups: diabetic(137P) and NonGLDEHWLFSDWLHQWV 3 3ULPDU\HQGSRLQWLQFOXGHGORQJWHUP !PRQWKV FRPELQHG0$&(DQGVWHQWWKURPERVLVUDWH6WHQWWKURPERVLVZDVFODVVL¿HG DFFRUGLQJ WR $5& GH¿QLWLRQV &OLQLFDO IROORZXS ZDV REWDLQHG DW DQG 6 months and then annually up to 6 years. Median follow-up time was 3.6 years.Clinical follow-up was achieved in 98% of the eligible cohort. Baseline characteristics and late outcomes are displayed in the table. Non DM (n=300P)
+Diabetes +Diabetes HR (CI) Cypher Taxus (n=184) (n=187)
-Diabetes -Diabetes HR (CI) Cypher Taxus (n=896) (n=860)
MACE
31
40
0.77 (0.49112 1.23)
121
0.88 (0.681.14)
Cardiac death
7
8
0.88 (0.3217 2.44)
14
1.17 (0.582.36)
p
MI
10
12
0.84 (0.3755 1.94)
64
0.82 (0.571.18)
Stent thrombosis
11
9
1.24 (0.5133 2.98)
33
0.96 (0.591.55)
TLR
17
15
1.14 (0.5754 2.27)
67
0.77(0.541.10)
795
21
24
0.88 (0.4972 1.57)
84
0.82 (0.601.12)
251/83.7
103/75.2
0.6
Age (y)
64.1 + 11.6
66.0 + 9.1
0.7
Unstable angina, n/%
74/24.7
51/37.2
0.01
5DWLR9HVVHOV3
2.08
2.16
0.08
Ratio Stents / P
2.38
2.46
0.1
Myocardial infarction,%
4.0
2.2
0.5
Target lesion revascularization, %
3.3
1.4
0.4
Cardiac death,%
1.3
1.4
0.7
Major adverse cardiac events, %
8.6
5.1
0.3
Stent thrombosis (ARC)
2.0
2.2
0.9
Conclusion: In the DESIRE registry, drug-eluting stent for the treatment of patients with multivessel disease was safe and effective and the presence of diabetes mellitus did not seem to negatively impact the outcomes of this cumbersome population. TCT-408
E L E C T RO N I C A B S T R AC T S
Table: Cypher vs. Taxus
DM (n=137P)
Male gender, n/%
Long-term Clinical Outcome After Implantation of Sirolimus-eluting and Paclitaxel-eluting Stents in Diabetic and Nondiabetic Patients in the SORT OUT II Trial Michael Maeng1, Niels Bligaard2, Henning Kelbaek3, Lisette O Jensen4, Rasmussen Klaus5, Jens F Lassen1, Peter R Hansen2, Per Thayssen’4, Leif Thuesen1, Ulrik Abildgaard2, Thomas Engstrøm3, Steen D Kristensen1, Jan S Jensen2, Lars R Krusell1, Søren Galatius2, Hans E Bøtker1, Jan K Madsen2, Evald H Christiansen1, Steen Z Abildstrøm2, Ghita Stephansen2, Anders M Galløe2 1 Aarhus University Hospital, Skejby, Aarhus, Denmark 2Gentofte Hospital, Gentofte, Denmark 3Rigshospitalet, Copenhagen, Denmark 4 Odense University Hospital, Odense, Denmark 5Aarhus University Hospital, Aalborg, Aalborg, Denmark Background: We assessed the impact of diabetes on long-term outcome after SHUFXWDQHRXV FRURQDU\ LQWHUYHQWLRQ 3&, ZLWK WKH ¿UVW WZR FRPPHUFLDOO\ available drug-eluting stents (DES), the sirolimus-eluting Cypher stent &RUGLV-RKQVRQ DQG -RKQVRQ 0LDPL /DNHV )ORULGD DQG WKH SDFOLWD[HO HOXWLQJ7D[XVVWHQW %RVWRQ6FLHQWL¿FFRUS1DWLFN0DVVDFKXVHWWV Methods: After general inclusion in the SORT OUT II trial of 2098 patients, DGGLWLRQDO SDWLHQWV ZLWK GLDEHWHV ZHUH LQFOXGHG WR UHDFK D SUHGH¿QHG number in a diabetic substudy. Together these 2126 patients were randomized to treatment with Cypher (n=1074) or Taxus (n=1045). The patients have so far been followed from 18 to 40 months. The primary endpoint was major DGYHUVH FDUGLDF HYHQWV 0$&( GH¿QHG DV D FRPSRVLWH RI FDUGLDF GHDWK
158i
myocardial infarction (MI), target lesion revascularization (TLR) and target YHVVHOUHYDVFXODUL]DWLRQ 795 Results: 'LDEHWHVZDVDVVRFLDWHGZLWKLQFUHDVHGULVNRIFDUGLDFGHDWK +D]DUG 5DWLR +5 &RQ¿GHQFH,QWHUYDO &, S 0$&( +5&,S DQG795 +5&,S 7KHUHZDVQRVWDWLVWLFDOVLJQL¿FDQWGLIIHUHQFHFRQFHUQLQJ0, +5&, 0.58-1.38, p=0.61), TLR (HR 1.30, CI 0.87-2.02, p=0.19) or the composite of GH¿QLWH DQG SUREDEOH VWHQW WKURPERVLV +5 &, S $V VKRZQLQWKHWDEOHWKHW\SHRI'(6GLGQRWVLJQL¿FDQWO\LQÀXHQFHHQGSRLQWV
'H¿QLWHSUREDEOHVWHQWWKURPERVLV
Conclusion: ,QSDWLHQWVZLWKVLJQL¿FDQWFRURQDU\DUWHU\GLVHDVHWUHDWHGZLWK '(6GLDEHWHVLVDVVRFLDWHGZLWKDLQFUHDVHGULVNRIFDUGLDFGHDWKD LQFUHDVHGULVNRI0$&(DQGDLQFUHDVHGULVNRI795,QWKHGLDEHWLFDQG QRQGLDEHWLFVXESRSXODWLRQVZHIRXQGQRVWDWLVWLFDOO\VLJQL¿FDQWGLIIHUHQFHV EHWZHHQWKH¿UVWWZRFRPPHUFLDOO\DYDLODEOH'(6 TCT-409 In-Stent Restenosis - Benign or Dangerous? Clinical Presentation of Coronary Restenosis in Sweden Elmir Omerovic1, Truls Ramunddal1, Lars Grip1, Jan Boren2, Goran Matejka1, Per Albertsson1 1 Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden2The Wallenberg Laboratory for Cardiovascular Research, Gothenburg, Sweden Background: Restenosis after percutaneous coronary intervention (PCI) was earlier thought to be a benign event clinically manifested as stable exertional angina. The aim of this prospective multicenter registry study was to investigate the incidence of acute coronary syndrome in patients with restenosis in Sweden. Methods: Using data from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR), we analyzed all registered cases of PCI for restenosis (instent, after balloon angioplasty) from 1995 to 2005 in Sweden. Both multivessel and single vessel interventions were included. Restenosis presentations were FODVVL¿HGDV VWDEOHDQJLQD XQVWDEOHDQJLQDQRQ67(0, 67(0, DQG other reasons. As routine angiographic screening was not performed, restenosis HSLVRGHVZHUHGH¿QHGFOLQLFDOO\EDVHGRQV\PSWRPV Results: :HLGHQWL¿HGFDVHVRIUHVWHQRVLVLQ SDWLHQWV LQPHQ 1852 in women). Restenosis presented in 39.7% of cases as stable angina, in 46.0% as unstable angina/non-STEMI, in 11.5% as STEMI and in 2.8% as RWKHUUHDVRQV&DUGLRJHQLFVKRFNZDVUHSRUWHGLQSDWLHQWV:RPHQKDG a higher incidence of unstable angina/non-STEMI compared with men (52.3% v. 43.6%) but a lower incidence of STEMI (9.6% v. 12.2%). The frequency of STEMI was lower with restenosis after balloon angioplasty v. in-stent restenosis (6.9% v. 13.8%), and after drug-eluting stents v. bare metal stents (7.9% v. 18.5%). Mortality rate was 1.7% at 30 days, 3.2% at 6
The American Journal of Cardiology® |
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months and 4.6% at one year in patients with restenosis. These covariates were independent predictors of acute coronary syndrome : gender, age, vessel GLDPHWHU VPRNLQJ VWHQW W\SH QXPEHU RI VWHQWV WUHDWHG YHVVHO SUHYLRXV VWURNHDQGSUHYLRXVLQIDUFWLRQ Conclusion: The majority of patients with coronary restenosis present either with acute MI or unstable angina requiring hospitalization and new LQWHUYHQWLRQV:RPHQPD\KDYHDKLJKHUULVNRIGHYHORSLQJDFXWHFRURQDU\ syndrome due to restenosis. Prevention of restenosis may be an important WDUJHW IRU LPSURYHPHQW RI ³KDUG´ FOLQLFDO RXWFRPHV LQ SDWLHQWV XQGHUJRLQJ coronary revascularization.
DGYDQWDJHVRILQWUDYDVFXODUXOWUDVRXQG ,986 XVDJHSULRUWRDQGRUGXULQJ the procedure are to accurately assess plaque distribution axially and ORQJLWXGLQDOO\+RZHYHUZRUNLQJFULWHULDIRU,986JXLGH6(6LPSODQWDWLRQ have not been established. Methods: We have determined optimal SES landing under the following VWHSZLVH,986FULWHULD 6WHS 6LWHRIQRUPDODSSHDUDQFHZLOOEHVHOHFWHG primarily as reference. Step 2: If step 1 cannot be achieved, a site with %plaque area (PA: plaque area/ external elastic membrane area × 100) of less than 50% should be selected. Step 3: If step 2 cannot be achieved, a site with the least amount of %PA should be selected. To verify these criteria, 1) the achievement rate of step 1 and 2, which were considered as optimal target, and 2) resultant vascular responses, assessed by serial quantitative coronary angiography were investigated. We enrolled initial consecutive 141 lesions of 126 patients for this investigation. Follow-up angiography was available for 106 (76.3%) lesions. Results: 5HVLGXDO 3$ DW SUR[LPDO DQG GLVWDO PDUJLQ ZDV DQG UHVSHFWLYHO\ ZLWKLQ PP RXWVLGH VWHQW 7KH WDUJHW ZDV achieved in 71.2% of proximal and 84.7% of distal margin for the criteria. Overall angiographic restenosis rate was 2.8% of proximal and 0.9% of distal margin. Furthermore, angiographic restenosis rate decreased down to 0.9% at proximal and 0% at distal margin if the cases met step 1 or 2 of the criteria. Conclusion: 2XU SURSRVHG ,986 FULWHULD DUH DWWDLQDEOH DQG IXQFWLRQDO WR maximally reduce margin restenosis after SES implantation in the actual clinical setting.
TCT-410 Long-term Clinical Outcomes Following Successful Coronary DrugEluting Stent Implantation In Patients With Diabetes Mellitus: Comparison Between Sirolimus- and Paclitaxel-Eluting Stent Bo Xu, Kefei Dou, Yuejin Yang, Yongjian Wu, Runlin Gao Fuwai hospital, Beijing, China Backgound:Several clinical studies indicated that diabetes mellitus(DM) increased incidence of cardiovascular events. With the introduction of drug-eluting stents(DES), clinical outcome following successful coronary intervention of the patients with DM improved to some extent. However, the GLIIHUHQFHRIORQJWHUPVDIHW\DQGHI¿FDF\EHWZHHQVLUROLPXVDQGSDFOLWD[HO eluting stent implantation on patients with DM is currently unclear in routine practice. Objectives: To investigate the two-year clinical outcome after successful implantation of SES(cypher or cypher select ) and PES (Taxus or Taxus liberte) on patients with DM in daily practice.. Methods: From April 2004 to December 2006, 627 patients with DM who underwent DES implantation were prospectively registered(SES:400; 3(6 7KH LQFLGHQFH RI GHDWK P\RFDUGLDO LQIDUFWLRQ 7/5 795 DQ\ revascularization(includes re-PCI and CABG), MACE(includes all above), DOO$5&GH¿QLWLRQWKURPERVLVDWPRQWKVZHUHFRPSDUHGEHWZHHQWKHWZR groups. Results:Baseline characteristics were similar in SES and PES groups. Between WKHWZRJURXSVWKHUHZDVQRVLJQL¿FDQWGLIIHUHQFHLQGHDWK YV P\RFDUGLDOLQIDUFWLRQ YV DOO$5&GH¿QLWLRQWKURPERVLV YV 7/5 YV +RZHYHU ZH IRXQG VLJQL¿FDQWO\ KLJKHU LQFLGHQFHRI795 YVS DQ\UHYDVFXODUL]DWLRQ vs 15.04%, p=0.018) and MACE at 24 months(11.28% vs 18.14%,p=0,0184 in PES group. After adjusting baseline difference between the two groups E\ &2; UHJUHVVLRQ DQDO\VLV 3(6 JURXS PRUH LQFOLQHG WR UHODWH WR KLJKHU LQFLGHQFHRI7/5 +5 >&, @S 795 +5 >&, @S DOO$5&GH¿QLWLRQWKURPERVLV +5 >&, 9.324] p=0.0415),any revascularization (HR : 2.228 [CI 1.335-3.718] p=0.002) and MACE(HR : 1.795 [CI 1.176-2.742] p=0.0068). Conclusion: The implantation of SES showed more favorable results UHJDUGLQJ7/5795DQ\UHYDVFXODUL]DWLRQDQG0$&(FRPSDUHGZLWK3(6 implantation. The clinical outcomes showed comparable on the incidence of death, all ARC thrombosis and myocardial infarction.in the two groups
TCT-412 9 Month Outcomes with Drug-eluting Stents versus Bare Metal Stents LQ3DWLHQWVZLWK&KURQLF5HQDO,QVXI¿FLHQF\ $Q$QDO\VLVIURPWKH Strategic Transcatheter Evaluation of New Therapies (STENT) Registry
Background:7KHVDIHW\DQGHI¿FDF\RIGUXJHOXWLQJVWHQWV '(6 LQSDWLHQWV ZLWKFKURQLFUHQDOLQVXI¿FLHQF\ &5, KDVQRWEHHQZHOOVWXGLHG Methods: The STENT Registry is the largest prospective, multicenter registry in the US evaluating DES. Our study population consists of all patients enrolled from 5/2003-6/2006 with CRI (CrCl < 60 ml/min) treated with DES or bare metal stents (BMS) who completed 9 month follow-up (93%). Outcomes were adjusted with propensity score analysis. Results: Patients with CRI vs pts without CRI had higher mortality (8.0% vs 2.1%, p<0.001), more MACE (14.5% vs 9.4%, p<0.001), less target vessel UHYDVFXODUL]DWLRQ 795 YV S DQGVLPLODUUDWHVRIVWHQW thrombosis (0.9% vs 0.9%, p=NS). Pts with CRI treated with DES vs BMS were younger (74 vs 76 yrs, p<0.001), had less prior CABG (22% vs 27%, p=0.003), and less STEMI (11% vs 22%, p<0.001), but had longer lesions (15 vs 12 mm, p<0.001). Pts with CRI treated with DES vs BMS had lower DGMXVWHG UDWHV IRU PRUWDOLW\ 795 DQG 0$&( DQG VLPLODU UDWHV IRU VWHQW thrombosis (Table).
TCT-411 Functional IVUS Criteria to Determine Optimal Landing of Sirolimus-Eluting Stent Seiji Tamiya, Yoshihiro Morino, Yota Kawamura, Naoki Masuda, Takayuki Iida, Daiki Ito, Eri Toda, Toshiharu Fuji, Makiyoshi Shima, Atuhiko Sugimoto, Takashi Matsukage, Nobuhiko Ogata, Teruhisa Tanabe, Yuji Ikari Tokai University School of Medicine, Isehara, Japan Background: Several studies have indicated that clinical outcomes of VLUROLPXVHOXWLQJVWHQWV 6(6 DUHVLJQL¿FDQWO\DVVRFLDWHGZLWKORQJLWXGLQDO positioning of stent relative to underlying plaque distribution. Potential
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Bruce R. Brodie1, Tom Stuckey1, William Downey1, Sherry Laurent2, Angela Humphrey2, Marcy Nussbaum2, Barbara Bradshaw1, Stanley Juk3, Jim Hermiller4, Chris Metzger5, Barry Cheek6, Fred Krainin7, Peter Duffy8, Charles Simonton9 1 LeBauer Cardiovascular Research Foundation and Moses Cone Heart and Vascular Center, Greensboro, NC; 2R. Stuart Dickson Institute for Health Studies, Charlotte, NC; 3Sisters of Charity Providence Hospitals, Columbia, SC; 4Indiana Heart Institute, Indianapolis, IN; 5Holston Valley Medical Center, Kingsport, TN; 6High Point Regional Health System, High Point, NC; 7McLeod Regional Medical Center, Florence, SC; 8Moore Regional Medical Center, Pinehurst, NC; 9Carolinas Medical Center, Charlotte, NC
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TCT-414
Propensity Adjusted BMS
DES
p value
HR
(n=725)
(n=3002)
Death
13.4%
MI Death/MI
95% CI
p value
6.4%
<0.001
0.68 0.51-0.90
5.5%
3.1%
0.001
0.73 0.47-1.14
0.17
17.1%
8.7%
<0.001
0.69 0.52-0.88
0.004
9 Month Outcomes 0.008
795
5.8%
3.5%
0.004
0.45 0.30-0.69
<0.001
MACE
20.8%
11.6%
<0.001
0.64 0.51-0.81
<0.001
Stent Thrombosis
1.5%
0.8%
0.072
0.83 0.36-1.91
0.66
Conclusion:3WVZLWK&5,WUHDWHGZLWK%06KDYHDKLJKHUULVNSUR¿OHWKDQSWV WUHDWHGZLWK'(6$IWHUDGMXVWLQJIRUGLIIHUHQFHVLQEDVHOLQHULVN'(6KDYH EHWWHURXWFRPHVWKDQ%06ZLWKORZHUUDWHVRI795DQG0$&(:KLOHVRPH of these differences in adjusted outcomes may be related to hidden selection bias, the results from the STENT Registry should encourage the use of DES in selected pts with CRI who are compliant with dual anti-platelet therapy. TCT-413 3URVSHFWLYHUDQGRPL]HGFRPSDULVRQRIHI¿FDF\DQGVDIHW\RI different drug eluting stents (Cypher, Taxus and Endeavour)- The ENTACY Study
E L E C T RO N I C A B S T R AC T S
Henrik Schneider1, Huseyin Ince1, Tim C. Rehders1, Thomas Koerber1, Ibrahim Akin1, Stephan Kische1, Ina Korte1, Sabrina Leyh1, Frank Weber2, Christoph A. Nienaber1 1 University of Rostock, Rostock, Germany 2Frankenwaldklinik Kronach, Kronach, Germany Background: The use of drug eluting stent (DES) in the interventional cardiology leads to a considerable reduction of In-Stent-Restenosis (ISR) and 7DUJHW 9HVVHO 5HYDVFXODULVDWLRQ 795 UDWH %XW WKH HI¿FDF\ DQG VDIHW\ RI different DES have not been evaluated in a prospective manner yet. Methods: We performed a prospective, randomised and angiographic controlled all-in-comers-study, to compare 3 DES: Cypher, Taxus and Endeavour. Primary endpoint was the late lumen loss (LLL) after 6 months; secondary endpoint the rate of ISR, Target lesion Revsacularisation (TLR), stentthrombosis (SAT) and MACE after 6 and 12 months. Results:SDWLHQWV \HDUV ZLWK 3&,OHVLRQVZHUDQGRPL]HG in the 3 DES-groups. 76.6% of patients were men, 40.9% of the DESimplantations occurred in acute coronary syndroms, 63.9% in complex lesions (C, B2). The antithrombotic therapy with aspirin and clopidogrel occurred for 6-12 months. An angiographic 6 months-follow up was available for 90% of the patients and a clinical 12 month follow-up for 95%. (Table 1) Results Drug eluting stent patients (n) / PCI-lesions (n) Diabetes mellitus (%) Bifurcation (n,%) In-Stent-Restenosis (n,%) Left main (n,%) 6 month LLL (mm) 6 month TLR (n,%) 6 month MACE (n,%) 12 Month MACE (n,%)
Cypher select plus 112 / 133 40.2 21 (15.8) 11 (8.3) 10 (8.9) 0.19 +/-0.09 8 (6.5) 14 (12.5) 17 (15.2)
Taxus liberte 117 / 136 31.0 15 (11.0) 8 (5.9) 7 (5.9) 0.43 +/-0.12 12 (9.9) 13 (11.1) 16 (13.7)
Endeavour 118 / 126 33.1 18 (14.8) 18 (14.8) 9 (7.6) 0.60 +/-0.15 16 (15.2) 17 (14.6) 21 (17.8)
p
0.02 0.04 0.15 0.10
Conclusion: The Cypher-stent is superior to Taxus- and Endeavour-DES in terms of LLL, ISR and TLR after 6 and 12 month in a randomized all-incomers study. However the Cypher stent was associated with a higher rate of possible late stent thrombosis with an increased cardiac death rate compared with Taxus and Endeavour. The Endeavour Stent is inferior to the other both '(6FRQFHUQLQJ///,65DQG7952QDJJUHJDWHWKH0$&(UDWHDIWHUDQG 12 month for the 3 DES is equal in our prospective study.
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Sirolimus-eluting Versus Paclitaxel-eluting Coronary Stent Implantation in Patients with Diabetes Mellitus Michael Maeng1, Lisette O Jensen2, Anders M Galløe3, Per Thayssen2, Evald H Christiansen1, Henning kelbaek4, Hans E Bøtker1, Jens F Lassen1, Leif Thuesen1 1 Aarhus University Hospital, Skejby, Aarhus N, Denmark 2Odense University Hospital, Odense, Denmark 3Gentofte Hospital, Gentofte, Denmark 4Rigshospitalet, Copenhagen, Denmark Background: We evaluated angiographic late lumen loss after implantation RIVLUROLPXVHOXWLQJ&\SKHU &RUGLV-RKQVRQDQG-RKQVRQ0LDPL/DNHV )ORULGD VWHQWVDQGSDFOLWD[HOHOXWLQJ7D[XV %RVWRQ6FLHQWL¿FFRUS1DWLFN Massachusetts) stents in diabetic patients. Methods: We randomized 153 diabetic patients with coronary artery disease to Cypher (n=76) or Taxus (n=77) stent implantation. The primary endpoint was 8-month angiographic in-stent late lumen loss. Results: The primary endpoint of angiographic in-stent late lumen loss was UHGXFHG LQ WKH &\SKHU JURXS DV FRPSDUHG WR WKH 7D[XV JURXS YHUVXV p=0.025). Angiographic in-segment restenosis at 8-month follow-up, a secondary endpoint, was present in 16 patients (Cypher: n=6, Taxus: n=10; p=0.24). Target lesion revascularization was performed in 5 (6.5%) and 9 (11.8%) in the Cypher and Taxus groups, respectively (p=0.25). 0DMRUDGYHUVHFOLQLFDOHYHQWV FDUGLDFGHDWKP\RFDUGLDOLQIDUFWLRQGH¿QLWH stent thrombosis or target lesion revascularization) were observed in 17 patients (Cypher: n=6, Taxus: n=11; p=0.19). Conclusion: $QJLRJUDSKLF LQVWHQW ODWH OXPHQ ORVV LV VLJQL¿FDQWO\ UHGXFHG in patients with diabetes by use of the sirolimus-eluting Cypher stent as compared to the paclitaxel-eluting Taxus stent. TCT-415 Leaders - A Randomized Comparison Of A Biolimus-A9 Eluting Stent With A Sirolimus-eluting Stent For Percutaneous Coronary Intervention. 12 Months Results Patrick W Serruys1, Stephan Windecker2, Pawel Buszman3, Axel Linke4, Thomas Ischinger5, Volker Klauss6, Franz Eberli7, William Wijns8, Marie-Claude Morice9, Carlo Di Mario10 1 University Medical Center Rotterdam Erasmus, Rotterdam, Netherlands 2Inselspital, Bern, Switzerland 3Medical University of Silesia, Katowice, Poland 4Universität Leipzig, Herzzentrum, Leipzig, Germany 5Städtisches Klinikum, München, Germany 6Klinikum der Universität München, München, Germany 7Stadtspital Triemli, Zürich, Switzerland 8Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium 9L’Institut Cardiovasculaire Paris Sud, Massy, France 10Royal Brompton Hospital, London, United Kingdom Background: Drug-eluting stents (DES) effectively reduce the rate of TLR compared with bare metal stents (BMS). Although rates of death or MI are similar, there is concern of an increased incidence of very late stent thrombosis (ST) associated with 1st generation DES potentially related to the durable polymer. The biolimus-A9 eluting stent platform (BioMatrix Flex; BES) releases biolimus-A9, a sirolimus analogue, from a biodegradable polymer, polylactic acid (PLA), which is degraded into carbondioxide and water during a period of 6-9 months. The purpose of the present study is to FRPSDUHWKHVDIHW\DQGHI¿FDF\RI%(6ZLWKDQHVWDEOLVKHGVWHQWSODWIRUP releasing sirolimus from a durable polymer (Cypher SELECT;SES) in a large scale, non-inferiority trial. Methods: The trial is a prospective, multi-center, randomized, assessor-blind, QRQLQIHULRULW\DOOFRPHUUHDOZRUOG´SDWLHQWSRSXODWLRQWULDOFRQGXFWHGDW European interventional cardiology sites without limitation with respect to lesion length, number of treated lesions or vessels as well as clinical indication (chronic stable angina vs. acute coronary syndromes). The primary endpoint RI WKH WULDO LV D FRPSRVLWH RI FDUGLDF GHDWK 0, RU MXVWL¿HG WDUJHW YHVVHO
The American Journal of Cardiology® |
October 12-17, 2008
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TCT-417
UHYDVFXODUL]DWLRQ 795 ZLWKLQ PRQWKV%DVHGRQDQRQLQIHULRULW\PDUJLQ of 4% between BES and SES and a one-sided type I error of 0.05, a study SRSXODWLRQRISDWLHQWVZLOO\LHOG! SRZHUWRGHWHFWQRQLQIHULRULW\ 7KHSULQFLSDOHQGSRLQWRIWKHSUHVSHFL¿HGDQJLRJUDSKLFVXEJURXSLVLQVWHQW percent diameter stenosis at 9 months. Based on a non-inferiority margin of 5%, an average number of 1.5 lesions per patient and a one-sided type I error of 0.05, a sample of 425 patients will yield greater than 90% power to detect non-inferiority. Secondary endpoints include death, cardiac death, MI, ST DFFRUGLQJWRWKH$5&FULWHULDMXVWL¿HGDQGQRQMXVWL¿HG7/5DQG795$OO patients are followed up to 5 years. Results: A total of 1708 patients underwent PCI of 2782 lesions. The last 12 month follow-up visits were performed in May 2008 and data analysis for the PRQWKDQGPRQWKIROORZXSDUHWDNLQJSODFH Conclusion: The 12 month follow-up data of the study will be presented at the time of the meeting
Impact of Intravascular Ultrasound to Guide Drug Eluting Stent Implantation Decreasing Long Term Clinical Events Costantino O Costantini, Sergio G Tarbine, Marcelo F Santos, Marcos Bubna, Marco A Medeiros, Marcos Barbosa, Edna Duarte, Marco A Denk, Robson Sipraki, Costantino R Costantini Hospital Cardiologico Costantini, Curitiba, Brazil Introduction: ,QWUDYDVFXODU 8OWUDVRXQG ,986 E\ UHDFKLQJ JUHDWHU ¿QDO stent minimal luminal area decrease chances of target lesion revascularization. 7KHLPSRUWDQFHRI,986WRJXLGHGUXJHOXWLQJVWHQWV '(6 LPSODQWDWLRQWR UHGXFHFOLQLFDOHYHQWVLVQRWZHOONQRZQ Methods: A total of 1350 consecutive pts with CAD with PCI indication were treated with DES implantation. Pts with at least 6 months clinical FU were FRPSDUHGDFFRUGLQJWRWKHXVHRI,986WRJXLGH'(6LPSODQWDWLRQ ,986 1 RUQRW 1,9861 -03ZDVXVHGIRUVWDWLVWLFDODQDO\VLV$ SYDOXH ZDVFRQVLGHUHGVLJQL¿FDQWIRUJURXSVFRPSDULVRQV$ORJLVWLF regression analysis was conducted to identify predictors of target vessel failure (TVF)GH¿QHGDVWKHSUHVHQFHRIGHDWKP\RFDUGLDOLQIDUFWLRQVWHQW thrombosis or target vessel revascularization. Results:0HDQDJHZDVIRUERWKJURXSV'LDEHWLFZHUHLQERWK,986 DQG 1,986 JURXSV ,986 SWV ZHUH PRUH FRPSOH[ WKDQ 1,986 09' 46%vs54% p=0.01; Bifurcation treated 51%vs44% p=0.03; #of stents/# of lesions 1,2vs 1,14 p=0.05). Mean follow up was 30 months in both groups. $VVKRZQLQ.0FXUYHV,986SWVKDGORZHU79)UDWHVFRPSDUHGWR 1,986SWVS 7KLVGLIIHUHQFHZDVPDLQO\SURGXFHGE\ORZHU VWHQWWKURPERVLVUDWHVLQ,986YV1,986 YVS /RJLVWLF UHJUHVVLRQ DQDO\VLV VKRZHG 09' S DQG 121 ,986 JXLGDQFH S DVLQGHSHQGHQWSUHGLFWRUVRI79)
TCT-416 Changes in Plasma Composition Common to Diabetes Mellitus are ,QVXI¿FLHQWWR$OWHUP725¶V5ROHLQ9DVFXODU6PRRWK0XVFOH&HOO Proliferation T. Cooper Woods, Daniel Lightell, Jr., Paul McMullan, Stephanie C. Moss Ochsner Clinic Foundation, New Orleans, LA
Conclusion: This retrospective analysis on non selected patients showed WKDW ,986 WR JXLGH '(6 LPSODQWDWLRQ VLJQL¿FDQWO\ GHFUHDVHG WKH FKDQFH RI 79) 7KLV GLIIHUHQFH ZDV PDLQO\ GXH WR UHGXFHG VWHQW WKURPERVLV UDWHV LQ ,986 JXLGHG SDWLHQWV 7KLV EHQH¿W FHUWDLQO\ UHOLHV RQ D PRUH DGHTXDWH stent expansion and strut apposition against vessel wall when guiding DES LPSODQWDWLRQZLWK,986 TCT-418 Pre-clinical Evaluation of the Elixir Myolimus-Eluting Stent System with a Durable Polymer in Porcine Coronary Model Guy Leclerc1, Louis-Georges Guy2, Jean-Martin Lapointe2, Martin /DÀDPPH2, Capucine Lapointe-Corriveau2, Pierre Helie3, Lynn Meredith4, John Yan4,ULQD$VWD¿HYD4, Vinayak Bhat4 1 AccelLab Inc., Boisbriand, QC, Canada 2AccelLab Inc., Montreal, QC, Canada 3University of Montreal, Faculty of Veterinary Medicine, Montreal, QC, Canada 4Elixir Medical Corporation, Sunnyvale, CA
Conclusion: The changes in plasma composition common to diabetics are not VXI¿FLHQWWRDOWHUWKHUROHRIP725LQWKHSUROLIHUDWLRQRI960&VVXJJHVWLQJ cellular aspects of DM such as insulin resistance may play a critical role in the LQFUHDVHGULVNRILQVWHQWUHVWHQRVLVVHHQLQGLDEHWLFV
The American Journal of Cardiology®
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October 12-17, 2008
Background: The Elixir Myolimus Eluting Stent with durable polymer is a novel DES that combines a cobalt chromium alloy stent coated with Myolimus and a thin single-layer methacrylate polymer. Myolimus is macrocyclic lactone mTOR inhibitor similar to rapamycin (sirolimus) with potent antiproliferative properties. The objective of this study was to evaluate safety and HI¿FDF\RIWKH0\ROLPXV(OXWLQJ6WHQWZLWKGXUDEOHSRO\PHU Methods: A dose ranging study with the Myolimus-Eluting Stent with
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Background 'LDEHWHV0HOOLWXV '0 LVDVVRFLDWHGZLWKDQLQFUHDVHGULVN of in-stent restenosis with the rapamycin (sirolimus) eluting stent, which EORFNVYDVFXODUVPRRWKPXVFOHFHOO 960& SUROLIHUDWLRQWKURXJKLQKLELWLRQ of the mammalian target of rapamycin (mTOR). A component of DM is the alteration of the plasma concentrations of multiple factors (e.g. glucose and LQVXOLQ FDSDEOH RI SURPRWLQJ 960& SUROLIHUDWLRQ DQG FRQWULEXWLQJ WR DQ LQFUHDVHGULVNRIUHVWHQRVLV Methods: In order to examine whether the changes in plasma composition FRPPRQ WR GLDEHWLFV DOWHU WKH UROH RI P725 LQ 960& SUROLIHUDWLRQ ZH PHDVXUHG WKH DELOLW\ RI LQKLELWLRQ RI P725 ZLWK UDSDP\FLQ WR EORFN proliferation of human coronary artery smooth muscle cells (CASMC) isolated IURP QRQGLDEHWLFV Q XQGHU FRQGLWLRQV PLPLFNLQJ WKRVH FRPPRQ WR diabetics, including exposure to high glucose and stimulation with insulin. To IXUWKHUWHVWWKHDELOLW\RISODVPDFRPSRQHQWVWRDIIHFWP725¶VUROHLQ960& proliferation, we measured the ability of rapamycin to inhibit the proliferation of CASMCs in response to stimulation with serum collected from diabetics (n = 14) and non-diabetics (n= 16). Results: Inhibition of mTOR with rapamycin was similarly effective in inhibiting serum-stimulated CASMC proliferation in the presence of high (25mM) and low (5.5mM) glucose. Rapamycin was equally effective at inhibiting proliferation of CASMCs stimulated with insulin. Proliferation of CASMCs stimulated by serum from diabetic or non-diabetic donors was equally sensitive to rapamycin (10 nM) treatment (Figure).
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durable polymer was conducted in porcine coronary artery model with the balloon to artery (B/A) ratio of 1.3:1 over a period of 28 days with the drug dose ranging from 40 mcg to 180 mcg. The Cypher® stent was used as a control. Histo-morphometric and histo-pathological analysis were employed WR HYDOXDWH HI¿FDF\ DQG VDIHW\ RI WKH VWHQW V\VWHPV 'UXJ HOXWLRQ SUR¿OHV DQG GUXJ WLVVXH FRQFHQWUDWLRQV ZHUH GHWHUPLQHG E\ SKDUPDFRNLQHWLF 3. analysis . An overlapping stent 28 day safety study and a 90 day safety study were conducted with 120 mcg Myolimus dose. In addition, a high dose safety study using 360 mcg Myolimus was performed. Results:$OOVWHQWVZHUH GHOLYHUHG HI¿FLHQWO\ ZLWKRXW FRPSOLFDWLRQV 7KHUH were no adverse events in the course of the 28 days with any of the treated animals. The dose ranging study with the Myolimus-Eluting Stent with durable polymer demonstrated excellent histomorphometric and histopathological results comparable to the Cypher® stent. Myolimus-eluting stents GHPRQVWUDWHGLQYLYRVWHQWEDVHGHOXWLRQSUR¿OHVVLPLODUWR&\SKHUVWHQWV and the tissue concentration levels correlated with the dose escalation for the study groups. The safety studies demonstrated similar histomorphometric and histopathological results for all evaluated Myolimus-eluting stents at 28 days and 90 days similar to the Cypher® stent comparators. Data from the preclinical studies will be presented at this meeting. Conclusion: The preclinical evaluation of the Myolimus-Eluting Stent System with durable polymer demonstrated safety and similar effectiveness for all tested doses of Myolimus equivalent to Cypher® stents. These studies allowed for the selection of the lowest dose of 40 mcg for the First-in-Man clinical evaluation. TCT-419 Two-Year Clinical Outcome After Abciximab-Coated Stent Implantation in Patients with Coronary Artery Disease
E L E C T RO N I C A B S T R AC T S
Young Joon Hong1, Myung Ho Jeong1, Weon Kim2, Jum Suk Ko1, Min Goo Lee1, Won Yu Kang1, Shin Eun Lee1, Soo Hyun Kim1, Doo Sun Sim1, Keun-Ho Park1, Nam Sik Yoon1, Hyun-Ju Yun1, Kye Hun Kim1, Hyung Wook Park1, Ju Han Kim1, Youngkeun Ahn1, Jeong Gwan Cho1, Jong Chun Park1, Sun Jung Song3, Dong Lyun Cho3, Jung Chaee Kang1 1 Chonnam National University Hospital, Gwangju, Republic of Korea 2 Gwangju Veterans Hospital, Gwangju, Republic of Korea 3Chonnam National University, Gwangju, Republic of Korea Background: Recently we have demonstrated that abciximab (ReoPro®)coated stent has inhibitory effect on coronary restenosis. Objectives: 7KH DLP RI WKLV VWXG\ ZDV WR LQYHVWLJDWH WKH EHQH¿FLDO HIIHFWV RI abciximab-coated stent on two-year clinical outcome after stent implantation. Methods: We performed a prospective, randomized trial to compare the effects of abciximab-coated stent, which was implanted for 95 patients, with those of control stent, which was implanted for 93 patients for de novo coronary lesions. We evaluated the major adverse cardiac events (MACE; cardiac death, non-fatal myocardial infarction, and target vessel revascularization) at two-year follow-up. Results: All abciximab-coated and control stents were deployed successfully. Two-year follow-up was completed in 82 patients (86%) in abciximab-coated stent group and in 82 patients (88%) in control stent group. Although there ZHUHQRVLJQL¿FDQWGLIIHUHQFHVLQWKHLQFLGHQFHVRIFDUGLDFGHDWK YV p=0.3) and target vessel revascularization (16% vs. 21%, p=0.4) between both groups, there was a trend of lower incidences of nonfatal myocardial infarction (0% vs. 2.3%, p=0.16) and total MACE (16% vs. 24%, p=0.19) in abciximabcoated stent group compared with control stent group at two-year follow-up. Moreover, stent thrombosis did not occur in abciximab-coated stent group at two-year follow-up. Intravascular ultrasound analysis showed that larger OXPHQDUHDZDVODUJHU PP2YVPP2, p<0.001) and there ZDVDWUHQGRIVPDOOHUQHRLQWLPDODUHD PP2YVPP2, p=0.2) in abciximab-coated stent group compared with control stent group. Conclusion: Although abciximab-coated stent did not improve target vessel revascularization rate, it tended to inhibit neointimal hyperplasia and lower total MACE without occurrence of cardiac death, myocardial infarction, and stent thrombosis at two-year follow-up after stent implantation.
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TCT-420 Two-Year Clinical Outcome After Carvedilol-Loaded Stent Implantation in Patients with Coronary Artery Disease Young Joon Hong1, Myung Ho Jeong1, Weon Kim2, Jum Suk Ko1, Min Goo Lee1, Won Yu Kang1, Shin Eun Lee1, Soo Hyun Kim1, Doo Sun Sim1, Keun-Ho Park1, Nam Sik Yoon1, Hyun-Ju Yun1, Kye Hun Kim1, Hyung Wook Park1, Ju Han Kim1, Youngkeun Ahn1, Jeong Gwan Cho1, Jong Chun Park1, Jung Chaee Kang1 1 Chonnam National University Hospital, Gwangju, Republic of Korea 2 Gwangju Veterans Hospital, Gwangju, Republic of Korea Background: 7KH ORQJWHUP FOLQLFDO HI¿FDF\ RI LQWUDFRURQDU\ VWHQWLQJ LV limited by restenosis. Carvedilol is an antioxidant that inhibits smooth muscle cell proliferation and migration. Our hypothesis is that delivery of carvedilol by the stent can prevent neointimal hyperplasia and improve long-term clinical outcome. Objectives: 7KHDLPRIWKLVVWXG\ZDVWRLQYHVWLJDWHWKHEHQH¿FLDOHIIHFWVRI carvedilol-loaded stent on two-year clinical outcome after stent implantation. Methods: We performed a prospective, randomized trial to compare the effects of carvedilol stent, which was implanted for 20 patients, with those of control stent, which was implanted for 21 patients for de novo coronary lesions. Carvedilol was loaded onto 3.0×15mm BiodivYsio® drug delivery stents (Biocompatibles Ltd, Farnham, UK) in concentrations of 5mg/ml, which was prepared by dissolving carvedilol powder in methanol. We evaluated the major adverse cardiac events (MACE; cardiac death, non-fatal myocardial infarction, and target vessel revascularization) at two-year follow-up. Results: All carvedilol and control stents were deployed successfully. Twoyear follow-up was completed in 19 patients (95%) in carvedilol-loaded stent JURXSDQGLQSDWLHQWV LQFRQWUROVWHQWJURXS7KHUHZHUHQRVLJQL¿FDQW differences in the incidences of cardiac death (0% in both groups), nonfatal myocardial infarction (0% in both groups), and target vessel revascularization (15.8% vs. 20.0%, p=0.7) between both groups at two-year follow-up after stent implantation. However, intravascular ultrasound analysis showed that WKHUHZDVDWUHQGRIODUJHUOXPHQDUHD PP2YVPP2, S DQG VPDOOHU QHRLQWLPDO DUHD PP2 YV PP2, p=0.18) in carvedilol-loaded stent group compared with control stent group. Stent thrombosis did not occur in both groups at two-year follow-up. Conclusion: Although carvedilol-loaded stent did not improve two-year target vessel revascularization rate, it tended to inhibit neointimal hyperplasia without occurrence of cardiac death, myocardial infarction, and stent thrombosis. TCT-421 Evaluation of a Elixir Novolimus-Eluting Coronary Stent System with Durable and Bioabsorbable Polymer coatings in Porcine Coronary Model Guy Leclerc1, Louis-Georges Guy2, Jean-Martin Lapointe2, Martin /DÀDPPH2, Capucine Lapointe-Corriveau2, Pierre Helie3, Lynn Meredith4, John Yan4,ULQD$VWD¿HYD4, Vinayak Bhat4 1 AccelLab, Boisbriand, QC, Canada 2AccelLab, Montreal, QC, Canada 3 University of Montreal, Faculty of Veterinary Medicine, Montreal, QC, Canada 4Elixir Medical Corporation, Sunnyvale, CA Background: The Elixir Novolimus-Eluting DES (NDES) combines a cobalt chromium alloy stent coated with Novolimus and a thin single-layer durable methacrylate polymer or a bioabsorbable polyester-based polymer. Novolimus is a macrocyclic lactone mTOR inhibitor with antiproliferative properties similar to rapamycin (sirolimus). The total drug dose on the NDES is 85 mcg, as compared to 150 mcg of sirolimus dose on Cypher® stent (Cordis Corp). The objective of this study was to evaluate safety, effectiveness and SKDUPDFRNLQHWLFV 3. RIWKH1'(6ZLWKERWKSRO\PHUFRDWLQJV Methods: NDES with both polymer coatings were implanted in coronary arteries of domestic swine with the balloon to artery (B/A) ratio of 1.3:1 over a period of 28 days. The Cypher® stents were used as a control. Histo-
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morphometric and histo-pathological analysis were employed to evaluate HI¿FDF\DQGVDIHW\RIWKHVWHQWV\VWHPV'UXJHOXWLRQSUR¿OHVDQGGUXJWLVVXH concentrations were determined by PK analysis. Results: $OO VWHQWV ZHUH GHOLYHUHG HI¿FLHQWO\ ZLWKRXW FRPSOLFDWLRQV There were no adverse events in the course of the 28 days with any of the treated animals. NDES with durable and bioabsorbable polymer coatings demonstrated excellent histomorphometric and histo-pathological results comparable to Cypher® and are presented in Table 1 below: Histomorphometric / Histopathologic Analysis
Novolimus-Eluting Stent with Durable Polymer Coating
Novolimus-Eluting Stent Cypher® with Bioabsorbable DES Polymer coating Control
% Area Stenosis
Intimal Area (mm2)
Injury Score
,QÀDPPDWLRQ6FRUH
Endothelialization Score
6(6YV3(6 YVS RUWDUJHWYHVVHOUHYDVFXODUL]DWLRQ 795 (SES vs PES; 4.4 vs 4.6%, p=0.79) at 9 months in the diabetic AMI population. In the non-diabetic AMI population, however, SES was superior to PES in WHUPVRI795 YVS ,QRWKHUZRUGVWKHSUHVHQFHRIGLDEHWHV VLJQL¿FDQWO\LQFUHDVHGWKHULVNRI795RQO\LQWKH6(6JURXS WR p=0.003), but not in the PES group (4.3 to 4.6%, p=0.79). (Figure)
Fibrin Score
Adventitial Fibrosis Score
&DOFL¿FDWLRQ6FRUH
Conclusion:,QGLDEHWLF$0,SDWLHQWVWKHUHZDVQRVLJQL¿FDQWGLIIHUHQFHEHWZHHQ 6(6DQG3(6LQWHUPVRI0$&(DQG795ZKLFKZDVLQFRQWUDVWWRWKHUHVXOWRI QRQGLDEHWLF$0,SDWLHQWVZKRVKRZHGOHVV795ZLWK6(6WKDQ3(6 TCT-424
The PK testing showed that 60% of drug is released for the NDES with durable polymer, and 90% with bioabsorbable polymer at 28 days with residual drug tissue concentrations maintained over the same period. Conclusion: Novolimus-Eluting Stents with durable and bioabsorbable polymer coatings demonstrated safety and effectiveness as compared with Cypher® stent system in preclinical evaluation, and will be further evaluated in clinical setting.
Arterial Responses Following Drug-Eluting Stent Implantation in an Atherosclerotic Rabbit Iliac Model Robert J Melder1, Gaku Kakazawa2, Sean Pruitt1, Frank D Kolodgie2, Renu Virmani2, Josiah N Wilcox1 1 Medtronic Cardiovascular, Santa Rosa, CA; 2CVPath Institute, Inc., Gaithersburg, MD
TCT-422 WITHDRAWN TCT-423 Differrent Outcomes between Sirolimus-Eluting versus PaclitaxelEluting Stents in Patients with Acute Myocardial Infarction According to the Presence of Diabetes Mellitus : Results of KAMIR(Korea Acute Myocardial Infarction Registry) Subgroup Youngjin Cho1, Han-Mo Yang1, Hee-Suk Min1, Woo-Young Chung2, Kyung Woo Park1, Jung-Won Suh3, In-Ho Chae3, Myung-Ho Jeong4, Myeong-Chan Cho5, Young-Jo Kim6, Dong-Ju Choi3, Hyo-Soo Kim1 1 Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea 2Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical center, Seoul, Republic of Korea 3 Cardiovascular Center, Seoul National University Bundang Hospital, Seongnam, Republic of Korea 4The Heart Center of Chonnam National University Hospital, Gwangju, Republic of Korea 5Department of Internal Medicine, Chungbuk National University, Cheongju, Republic of Korea 6Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital, Daegu, Republic of Korea Introduction: Some previous studies have reported favorable outcome of paclitaxle-eluting(PES) over sirolimus-eluting stents(SES) in patients with diabetes. These observations have not studied in patients with acute myocardial infarction (AMI). Methods: In Korea AMI Registry (KAMIR), 40 centers in Korea enrolled 7,100 patients with STEMI from Nov 2005 to Dec 2007. We analyzed the clinical outcomes of 933 diabetic patients in the KAMIR treated with either SES(n=565), or PES(n=368), and compared them with the non-diabetic population. Results: :LWKPHGLDQIROORZXSRIGD\VWKHUHZDVQRVLJQL¿FDQWGLIIHUHQFH between SES and PES in the rate of major adverse cardiac event (MACE)
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E L E C T RO N I C A B S T R AC T S
Background: Drug eluting stents (DES) provide improved therapeutic responses but may also induce delayed arterial healing in man. A relevant animal model for predicting the vascular response to DES in man is needed for understanding '(6VDIHW\DQGHI¿FDF\7RWKLVHQGDK\SHUFKROHVWHUROHPLFUDEELWPRGHOZDV employed to compare DES responses in an atherosclerotic artery. Methods: +\SHUFKROHVWHUROHPLF FKROHVWHURO GLHW IRU ZHHNV IROORZHG E\IRUZHHNVEHIRUHVWHQWLPSODQWDWLRQ 1HZ=HDODQG:KLWHUDEELWV (n=21) received bilateral stents implanted in iliac arteries. Animals were randomized to bare metal stent (Driver; Medtronic, Minneapolis, MN), zotarolimus- (Endeavor; Medtronic), sirolimus- (Cypher; Cordis, Miami /DNHV)/ DQGHYHUROLPXV ;LHQFH9 $EERWW/DERUDWRULHV$EERWW3DUN ,OOLQRLV HOXWLQJVWHQWV6WHQWVZHUHKDUYHVWHGZHHNVDIWHULPSODQWDWLRQDQG morphometric/pathologic analysis performed. Results: %ORRGFKROHVWHUROOHYHOVSHDNHGDWZHHNVRIWKHFKROHVWHUROGLHW which ranged from 1400-2000mg/dL, followed by ideal range of 500 to 800mg/ G/DW ZHHNV VWHQWLPSODQWDWLRQ DQGZHUHVLPLODUDPRQJJURXSV((/DUHD (7.59+1.12, 7.64+0.87, 7.05+0.56, 6.98+0.72 mm2), and stent area (5.68+0.82, 5.88+0.71, 5.58+0.36, 5.58+0.56 mm2 ZHUHFRPSDUDEOHLQDOOJURXSV S! (QGHDYRU'ULYHU&\SKHUDQG;LHQFHUHVSHFWLYHO\ 1HRLQWLPDODUHD PP2) ZDVVXSSUHVVHGLQDOO'(6UHODWLYHWRDEDUHPHWDOVWHQW IRU (QGHDYRU &\SKHU DQG ;LHQFH UHVSHFWLYHO\ IRU 'ULYHU S 1XPEHUV RI DGKHUHQW OXPLQDO LQÀDPPDWRU\ FHOOV ZHUH JUHDWHU LQ ;LHQFH DQG &\SKHU DV FRPSDUHG WR 'ULYHU DQG (QGHDYRU 3 /LNHZLVH )LEULQ GHSRVLWLRQDQGWKHSUHYDOHQFHRIXQFRYHUHGVWUXWVZHUHJUHDWHULQ;LHQFHDQG Cypher as compared to Driver and Endeavor. Conclusion: An atherosclerotic rabbit model mimics neointimal formation in various DES and BMS similar to man with greater number of uncovered stent VWUXWVDQGOXPLQDOLQÀDPPDWLRQVHHQLQ&\SKHUDQG;LHQFHDVFRPSDUHGWR Endeavor and Driver. The atherosclerotic model may be a more appropriate DQGGLIIHUHQWLDWLQJPRGHOIRUWKHDVVHVVPHQWRI'(6HI¿FDF\DQGVDIHW\WKDQ normal artery models.
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TCT-425 WITHDRAWN TCT-426 Long-term (> 20 months) Serial Angiographic and Intravascular Ultrasound Analysis of Sirolimus-eluting Stents: Is There Any Late Catch-up? Daniel Chamié, J. Fábio Almiro Silva, Alexandre Abizaid, Fausto Feres, Andréa S. Abizaid, Ana Cristina Seixas, Luiz Fernando Tanajura, Aurea Chaves, Marinella Centemero, J. Ribamar Costa, Jr., Ricardo Costa, Luiz Alberto P. Mattos, Rodolfo Staico, Amanda G.M.R. Sousa, J. Eduardo Sousa Institute Dante Pazzanese of Cardiology, Sao Paulo, Brazil
E L E C T RO N I C A B S T R AC T S
Background: &RQFHUQV UHJDUGLQJ WKH ORQJWHUP HI¿FDF\ RI GUXJHOXWLQJ stents (DES) have recently been raised, with late intimal hyperplasia (IH) JURZWK ODWH ³FDWFKXS´ SKHQRPHQRQ REVHUYHG LQ UHFHQW VWXGLHV ,I WKLV phenomenon has a class effect and can be attributed to different DES has yet to be demonstrated. Objectives: 7RHYDOXDWHWKHHI¿FDF\RIWKH6LUROLPXVHOXWLQJ&\SKHU® stent, E\PHDQVRIVHULDODQJLRJUDSK\DQGLQWUDYDVFXODUXOWUDVRXQG ,986 RQ,+ VXSSUHVVLRQDWORQJWHUPIROORZXS !PRQWKV Methods: SDWLHQWV SWV LQFOXGHGLQ),0DQG5$9(/VWXGLHVSHUIRUPHG in single center, that had stable coronary syndromes and a single, de novo lesion in a native coronary artery of 2.5 to 3.5 mm in diameter and that could be covered by an 18-mm stent were included in this current analysis. $QJLRJUDSKLFDQG,986GDWDZHUHREWDLQHGLPPHGLDWHO\SRVWSURFHGXUHDQG DWDPHDQWLPHRI PRQWKVDQGPRQWKV7KHSULPDU\ HQGSRLQWRIWKLVDQDO\VLVZDVWKHORQJWHUPHI¿FDF\RIWKH&\SKHU® stent as assessed by in-stent late lumen loss (by QCA) and % of IH obstruction (by ,986 UHVSHFWLYHO\$OODQJLRJUDSK\DQG,986DQDO\VLVZHUHSHUIRUPHGE\ two experienced operators blinded to the time frame each angiography and ,986UXQEHORQJHG Results: 0HDQFRKRUWDJHZDV \HDUVZLWKRIPDOHVDQG RIGLDEHWLFV%DVHOLQHUHIHUHQFHYHVVHOGLDPHWHUZDV PPDQGPHDQ OHVLRQOHQJWKZDVPP$QJLRJUDSKLFLQVWHQWODWHOXPHQORVVDQG ,986RI,+REVWUXFWLRQIRUDOOWLPHIUDPHVDUHSUHVHQWHGLQWKH¿JXUH
Conclusion: This single-center evaluation demonstrated that the Sirolimuseluting Cypher® stent is effective in the IH suppression, with no evidence of ODWH³FDWFKXS´SKHQRPHQRQXSWRPRQWKIROORZXS TCT-427 Predictors of Restenosis of Side-Branch After Implantation of Two Sirolimus-eluting Stents for Bifurcation Lesions. -Importance of Lesion LocationKazushige Kadota, Kazuaki Mitsudo, Tsuyoshi Goto, Satoki Fujii, Hiroyuki Yamamoto, Harumi Kato, Yasushi Fuku, Shingo Hosoki, Hiroyuki Tanaka, Seiji Habara, Daiji Hasegawa, Masao Imai, Suguru Otsuru Kurashiki Central Hospital, Kurashiki, Japan Background: PCI with two stent implantation for bifurcation lesion is necessary in some situations although the restenosis of side branch is still high in drug-eluting stent era. Thus, to clarify the predictors of side-branch restenosis after two stent strategy is important. In this study, we evaluated
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the predictors of side-branch restenosis after two-stent implantation with Sirolimus-eluting stent. Methods: From Nov. 2003 to Nov. 2006, PCI with two stent strategy using Sirolimus-eluting stent (SES) was performed in 140 patients. Of these, 109 patients with 109 lesions underwent follow-up angiography at 6-8 month after stenting. &OLQLFDO DJH VH[ FRURQDU\ ULVN IDFWRUV DQJLRJUDSKLF UHIHUHQFH GLDPHWHU minimal luminal diameter, percent luminal diameter stenosis, bifurcation type, bifurcation site) and procedure characteristics (stenting strategy; Culottes VWHQWLQJSURYLVLRQDO7VWHQWLQJPRGL¿HG7VWHQWLQJ ZHUHHYDOXDWHG Results: Two stent implantation with SES was performed at LMT (28 lesions), /$' OHVLRQV /&; OHVLRQV DQG5&$ OHVLRQV 7RWDOUHVWHQRVLVUDWH of main and side branch were 12.8% and 24.5% respectively. Restenosis rate of VLGHEUDQFKZDV DQGDW/07/$'/&;DQG5&$ ELIXUFDWLRQOHVLRQVUHVSHFWLYHO\7KHUHZDVQRVLJQL¿FDQWGLIIHUHQFHRIPDLQ branch restenosis rate among four bifurcation sites. By multivariate analysis, independent predictors of side branch restenosis was LMT bifurcation (OR &, S WR/$'ELIXUFDWLRQ /&;ELIXUFDWLRQ 25 8.37 95% CI 1.7-41.2 p=0.009 to LAD bifurcation), and post diameter stenosis of side branch (OR 1.08 95% CI 1.08- 1.15 p=0.017),. Conclusion: The lesion location of bifurcation site was an important factor of side-branch restenosis after two stent implantation using SES. Post procedural enough dilatation could be an important factor to obtain good prognosis of the side branch after two stent implantation with SES TCT-428 The e-Select Registry: Final Results of Early (30 days) Followup of 15000 Patients Treated with the Cypher-Select Stent in Contemporary Clinical Practice Philip Urban1, Alex Abizaid2, Adrian Banning3, Antonio Bartorelli4, Viktor Dzavik5, Stephen G Ellis6, Run-Lin Gao7, David Holmes8, M. H. Jeong9, Victor Legrand10, Franz-Josef Neumann11, Christian Spaulding12, Stephen Worthley13, Stephane Carlier14 1 La Tour Hospital, Geneva, Switzerland 2Dante Pazzanese, Sao Paulo, Brazil 3John Radcliffe Hospital, Oxford, United Kingdom 4Centro Cardiologico Monzino University of Milan, Milan, Italy 5University Health Network, Toronto General Hospital, Toronto, ON, Canada 6 Cleveland Clinic, Cleveland, OH; 7Cardiovascular Institute and Fu Wai Hospital, Beijing, China 8Mayo Clinic, Rochester, MN; 9The Heart Center of Chonnam National University Hospital, Gwangju, Republic of Korea 10CHU Sart-Tilman, Liège, Belgium 11Herz Zentrum Bad Krozingen, Bad Krozingen, Germany 12Hopital Cochin, Paris, France 13 Royal Adelaide Hospital, Adelaide, Australia 14Cordis, Waterloo, Belgium Background: Much has changed in the world of drug eluting stents (DES) VLQFH WKH ¿UVW UHVXOWV RI WKH &\SKHU VWHQW ZHUH UHSRUWHG \HDUV DJR LQ WKH 5$9(/WULDO(QVXULQJDSSURSULDWHSDWLHQWVHOHFWLRQDQGEHWWHUFRPSOLDQFH with anti-platelet medication have both been incorporated into clinical practice, but the impact of this more cautious approach has not been TXDQWL¿HG6HYHUDOTXHVWLRQVVWLOOUHPDLQXQDQVZHUHGLQURXWLQHSUDFWLFHVXFK as the current incidence of stent thrombosis (ST) and of bleeding following successful procedures, the impact of co-morbid conditions, and the causes and consequences of unplanned interruption in anti-platelet medication. Methods: Between 2006 and 2008, we prospectively enrolled 15,266 patients from 321 hospitals in 56 countries after implantation of one or several Cypher Select stents. Monitoring of 20% randomly selected enrolled patients is ongoing. All adverse events are adjudicated by an independent CEC. The main outcome measure of the e-Select registry is the incidence of ST at 3 \HDUVIROORZXS+RZHYHUZHZLOOEHUHDG\WRUHSRUWIRUWKH¿UVWWLPHDW7&7 08 the 30 days results for the entire cohort of: 1) The patient demographics, lesion characteristics and procedure parameters, analysed both for on and off-label indications. These will be compared to the data of the previous e-Cypher registry (2002-2004); 2) The incidence of death, myocardial infarction, repeat revascularization, ST
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and bleeding; 3) The incidence of co-morbid conditions, analysed using the Charlson index. The impact of this score on the incidence of adverse events will be evaluated; 4) The compliance with the prescribed anti-platelet regimen and its relationship with bleeding and ST events. Conclusion: The early results from this contemporary registry will shed light on the current use of DES world-wide and will help identify possible changes in practice since the early years and understand their consequences. They will also DOORZIRUWKH¿UVWWLPHWRDQDO\VHWKHLPSDFWRIVHYHUDOHOHPHQWVWKDWDUHVSHFL¿F to routine clinical use, as opposed to those that occur in randomized trials.
from the National Strategic Tracing Service. Results: Patients were followed up until 31st of April 2008. Mean follow up was 26.5 months (6-60 months). The mean stent length was 70.6mm (51135mm) and the average number of stents per vessel was 2.7 (2-5 stents). Acute complications included one case of acute stent thrombosis which was treated successfully, one case of aortic root dissection managed conservatively, and one case of retroperitoneal haemorrhage which required blood transfusion. 7KHUDWHRIQRQ4ZDYHP\RFDUGLDOLQIDUFWLRQ &.0%!WLPHVQRUPDO ZDV 8%. During follow up, the rate of TLR was 6%. Five patients died, 4 of them due to documented chronic non-cardiac conditions. One death was attributed to possible late stent thrombosis at18 months (patient died suddenly 2 days SRVWNHORLGUHSDLU 7ZRSDWLHQWVKDGGH¿QLWHODWHVWHQWWKURPERVLVDWDQG months, and successfully treated.
TCT-429 What Is The Risk Of Cardiac Complications Following Noncardiac Surgery In Patients Having Drug Eluting Stenting More Than Six Month?
Death at Follow-up Death Time from Procedure
Abid Assali, Hana Vaknin Assa, Itsik Ben Dor, Eli Lev, Tamir Ben Tal, Shmuel Fuches, Alexander Battler, Ran Kornowski Rabin Medical Center, Petach Tikva, Israel
Cause of Death
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
9 months
12 months
18 months
18 months
19 months
Acute renal failure and sepsis
Chronic/ aspiration alcoholic liver pneumonia disease
Sudden death, 2 days post /HXNDHPLD surgery
Death at Follow-up
Background and Objectives: Non cardiac perioperative management of patients who recently underwent drug-eluting coronary stents (DESs) may EH FKDOOHQJLQJ GXH WR SRWHQWLDO ULVN RI VWHQW WKURPERVLV 7KHVH VWHQWV PD\ LQKLELWUHHQGRWKHOLDOL]DWLRQRIWKHWUDXPDWL]HGYHVVHOPDNLQJLWYXOQHUDEOH to platelet-mediated thrombosis. Given the anecdotal evidence and case series suggesting that DESs may be less vulnerable to thrombosis after six months, ZHVRXJKWWRTXDQWLI\WKLVULVN Methods:/LQNLQJWKH5DELQ0HGLFDO&HQWHULQWHUYHQWLRQDOFDUGLRORJ\ GDWDEDVHZLWKLWVVXUJLFDOGDWDEDVHZHKDYHLGHQWL¿HG SDWLHQWVZKR underwent DES placement and subsequently [after six months] had noncardiac surgery [33-vascular, 37- abdominal and genitourinary, and 27-others, excluding ophthalmic surgery]. Outcome measures included 30-day rate of postoperative myocardial infarction (MI), DES thrombosis, and cardiac mortality Results: Major adverse cardiac events occurred in 7 (7.2%) patients including 2 cardiac deaths (2.1%), 5 (5.2%) non-fatal myocardial infarctions (MIs) and GH¿QLWHDQG SUREDEOHVWHQWWKURPERVLV$OO0,VDVZHOODV stent thrombosis occurred in the vascular and abdominal surgery. Two of the MIs occurred while the patients were on dual antiplatelet agents]. All death RFFXUUHGLQSDWLHQWVVXEMHFWHGWRVXUJHU\LQWKH³RWKHU´JURXS Conclusion: Noncardiac surgery after six months of DES deployment is DVVRFLDWHGZLWKFRQVLGHUDEOHULVNRIQRQIDWDO0,DQGFDUGLDFGHDWKGHVSLWH continuation of dual antiplatelet therapy. The occurrence of these cardiac complications is of concern.
Conclusion: In our experience, the use of very long and overlapped DES is safe and effective in treating diffuse de novo coronary artery lesions. TCT-431 Interrelationships between Residual Plaque Burden of Peri-Stent Margins and Neointimal Reaction within the In-stent Segments following Sirolimus-eluting Stent Implantation Seiji Tamiya, Naoki Masuda, Yoshihiro Morino, Yota Kawamura, Takayuki Iida, DaikiIto, Eri Toda, Toshiharu Fuji, Makiyoshi Shima, Atuhiko Sugimoto, Takashi Matsukage, Nobuhiko Ogata, Teruhisa Tanabe, Yuji Ikari Tokai University School of Medicine, Isehara, Japan
Background: Data on effectiveness and safety following the implantation of WZRRUPRUHORQJRYHUODSSLQJGUXJHOXWLQJVWHQWVLVODFNLQJ Aim: To describe our experience of consecutive patients undergoing LPSODQWDWLRQRIYHU\ORQJ'(6 !PP LQGHQRYRFRURQDU\OHVLRQV Methods: We evaluated major in-hospital complications, target lesion revascularization (TLR) and long term outcomes in 112 consecutive patients (115 procedures) who underwent a single vessel intervention ZLWK LPSODQWDWLRQ RI !PP RYHUODSSLQJ VWHQWV EHWZHHQ 2FWREHU till October 2007. Patients who were treated for in-stent restenosis (14 patients) and those who received both DES and BMS (10 patients) were excluded. Baseline clinical data, procedural outcomes and completed IROORZXSZHUHFROOHFWHGSURVSHFWLYHO\7KHPRUWDOLW\UDWHZDVFRQ¿UPHG
Conclusion: Peri-stent residual plaque burden impacts on plaque/neointimal proliferation following SES implantation not merely locally at edges but also extensively at the stented segments. The obtained results were quite important
TCT-430 Clinical Outcomes After Percutaneous Coronary Intervention Using Very Long (>50mm) Drug Eluting Stents in de Novo Coronary /HVLRQV 6LQJOH&HQWUH([SHULHQFH
The American Journal of Cardiology®
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October 12-17, 2008
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Mohammed Andron, Khaled Albouaini, Archana Rao, David Ramsdale Cardiothoracic Centre, Liverpool, United Kingdom
Background: In the drug-eluting stent era, peri-stent residual plaque burden is considered as a predominant factor to assess adequateness of stent positioning DVZHOODVWRSUHGLFWHGJHUHVWHQRVLV2QWKHFXUUHQWFRQVHQVXV³LQVWHQW´ODWH RXWFRPHVDUHFRQVLGHUHGFKLHÀ\FRQWUROOHGE\GLPHQVLRQRIVWHQWH[SDQVLRQ hardly affected by adjacent plaque burden of stent edges. Methods: Study population consisted of consecutive 105 patients who XQGHUZHQW LQWUDYDVFXODU ,986 JXLGHG VLUROLPXVHOXWLQJ VWHQW 6(6 implantation and 2) were eligible for follow-up angiography at 8 months. 4XDQWLWDWLYH ,986 DQDO\VLV ZDV SHUIRUPHG DW SHULVWHQW PDUJLQ VHJPHQWV (within 3mm adjacent to edges). Patients were divided into 3 groups based RQSODTXHDUHD 3$ SODTXHDUHDH[WHUQDOHODVWLFPHPEUDQHDUHD; DWSHULVWHQWPDUJLQV 3$DWERWKVWHQWHGJHV JURXS$Q 3$ DWHLWKHURIWKHVWHQWHGJHV JURXS%Q DQG3$ DWERWK edges (group C, n=72). Angiographic late lumen loss of the in-stent segment was compared between the three groups. Results:$VVKRZQLQWKH¿JXUHLQVWHQWODWHORVVZDVVLJQL¿FDQWO\JUHDWHULQ the group A.\
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to weigh the interrelationships between adjacent and in-stent vascular responses. TCT-432 WITHDRAWN TCT-433 Potential Role of Polymer Biocompatibility in Late Stent Thrombosis Josiah N Wilcox, Robert J. Melder, Kishore Udipi, Ayala Hezi-Yamit Medtronic Cardiovascular, Santa Rosa, CA
E L E C T RO N I C A B S T R AC T S
Background 7KH ¿UVWJHQHUDWLRQ VLUROLPXVHOXWLQJ VWHQWV 6(6 DQG paclitaxel-eluting stents (PES) have been associated with a higher incidence RIODWHVWHQWWKURPERVLV /67 WKDQEDUHPHWDOVWHQWV %06 $VLPLODUULVN for LST has not been seen with zotarolimus-eluting stents (ZES). Since these DES all utilize different biostable polymers which remain associated with the metal stent after drug release, we hypothesized that polymer biocompatibility may in part explain differences in rates of LST. Methods: The surface properties of different DES polymers including SIBS, 3%0$ ÀXRURSRO\PHU 3& DQG %LR/LQ[ 0HGWURQLF 0LQQHDSROLV 01 ZHUH evaluated using contact angle measurements to determine relative hydrophobicity or hydrophilicity. Polymer biocompatibility was evaluated by in-vitro assay in which endothelial cells (EC), smooth muscle cells (SMC) and activated monocytes were exposed to polymers coated on 96 well plates. Monocyte DGKHVLRQDQGUHODWLYHJHQHH[SUHVVLRQRILQÀDPPDWRU\DQGSURWKURPERWLFJHQHV was determined. In vivo studies were also conducted with either BMS coated with polymers alone or commercial DES to evaluate vascular responses. Results: We observed a consistent correlation between polymer hydrophobicity DQGLQÀDPPDWRU\UHVSRQVHVERWKLQYLWURDQGLQYLYR WKHPRUHK\GURSKRELF SRO\PHUV 3%0$ 6,%6 DQG ÀXRURSRO\PHU FRQWDFW DQJOH ! LQGXFHG LQFUHDVHGPRQRF\WHELQGLQJH[SUHVVLRQRILQÀDPPDWRU\DQGSURFRDJXODQW JHQHVDQGLQÀDPPDWLRQLQYLYRZKLOHWKHK\GURSKLOLF'(6SRO\PHUV3&DQG BioLinx utilized on the Endeavor and Endeavor Resolute stents respectively FRQWDFW DQJOH VKRZ PLQLPDO LQÀDPPDWRU\ UHVSRQVHV $GGLWLRQDO studies suggested that DES utilizing hydrophobic polymer surfaces may contribute to endothelial dysfunction and are associated with a loss of eNOS and NO production compared to hydrophilic polymer surfaces. Conclusion: Overall, these results lead us to hypothesize that the observed differences in rates of LST among these different DES may be accounted for by differences in the hydrophilic/hydrophobic nature of the polymers utilized on these stents. TCT-434 Comparative In Vitro DES Polymer Biocompatibility Testing: Application for Evaluating Polymer Coatings for Cardiovascular Drug-eluting Stents Ayala Hezi-Yamit, Carol Sullivan, Laura David, Mingfei Chen, David Shumaker, Meena Ramachandran, Stefan Tunev, Josiah N Wilcox Medtronic Cardiovascular, Santa Rosa, CA Background: Synthetic DES polymer coatings have been postulated to HOLFLWDQLQÀDPPDWRU\DQGRUWKURPERWLFUHVSRQVHLQWKHDUWHULDOZDOO7KH responsible mechanisms are comprised of multistep adhesive and signaling events. In this study we assess the potential for differential monocytic and eosonopilic adhesion to various DES polymers and the resulting responses. Methods: Polymers with compositions similar to commercially available DES, were coated onto 96-well plates or metal stents. The polymeric surfaces were incubated with human monocytic (PMA treated U937) or eosinophilic (Clone15+/ FHOOVDQGWKHLUDFWLYDWLRQDQGDGKHVLRQZDVHYDOXDWHGE\JHQHSUR¿OLQJ DQG DGKHVLRQ DVVD\V /LNHZLVH FRPPHUFLDOO\ DYDLODEOH '(6 ZHUH H[DPLQHG in-vitro. We also used neutralizing antibodies targeting adhesion molecules on monocytic and eosinophilic cells and studied the effect on adhesion. Results: A consistent correlation was observed between polymer
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K\GURSKRELFLW\DQGDFWLYDWLRQUHVSRQVHVSHFL¿FDOO\DQLQFUHDVHGPRQRF\WLF adhesion to hydrophobic polymeric surfaces; the more hydrophobic polymers 3%0$ 6,%6 DQG 9)+ ÀXRURSRO\PHU FRQWDFW DQJOH ! LQGXFHG higher monocytic adhesion, at range of 95-129% (p-values <0.005, relative to control surface, 100%), while the hydrophilic DES polymers, BioLinx and PC, (contact angle <95°) show low monocytic adhesion with a range of 1-10% (p-values <0.005, relative to control surface). We have observed an analogous relationship of preferential eosinophilic FHOODGKHVLRQWRK\GURSKRELFSRO\PHUV7KHHRVLQRSKLOLFDGKHVLRQUDQNLQJ ZDV 3%0$ ! 6,%6 !)OXRURSRO\PHU !!3& %LR/LQ[ ZLWK DGKHVLRQ UDQJHV of 1-20% for PC and BioLinx (p-values <0.005, relative to control surface) DQGIRU9)+ÀXRURSRO\PHU6,%6DQG3%0$ SYDOXHV Antibody neutralization experiments demonstrated an integral role for integrin LQYROYHPHQW VSHFL¿FDOO\ &'E DQG /)$ LQ PHGLDWLQJ WKH LQÀDPPDWRU\ adhesion to hydrophobic polymers. Conclusion: 7KHVH¿QGLQJVVXSSRUWWKHYLHZWKDWVSHFL¿FSRO\PHUIRUPXODWLRQV PD\SURPRWHGLIIHUHQWLDOLQÀDPPDWRU\UHVSRQVHVPHGLDWHGLQSDUWE\WKHDELOLW\ of cells to adhere and respond to variations in the hydrophobicity of DES polymeric coatings. Such interactions can trigger differential eosinophilic and monocytic activation resulting in increased potential for restenosis and thrombosis. TCT-435 Impact of Total Drug Eluting Stent Length on Clinical Outcomes in Routine Clinical Practice: Results from the EVENT Registry Ronald Caputo1, michael Pencina2, Neil Kleiman3, john lopez4, Ron Waksman5, P Tolerico6, paul gordon7, R Bach8, David Cohen9 1 SJH Cardiology Associates, Liverpool, NY; 2Boston University, Boston, MA; 3St. Lukes, Houston, TX; 4U Chicago Med Ctr, Chicago, IL; 5Washington Hospital Ctr, Washington, DC; 6Yorktown Hospital, Yorktown, PA; 7Miriam Hospital, Providence, RI; 8Washington University Hospital, St Louis, MO; 9Mid America Heart, Kansas City, MO Background: Greater stent length has been associated with adverse events in drug eluting stent (DES) clinical trials. As these trials often employ routine DQJLRJUDSKLFIROORZXSWKHVSHFL¿FLPSDFWRI'(6OHQJWKLQURXWLQHSUDFWLFH is not well established. Methods: We identifed consecutive unselected patients (n=4232) undergoing DES implantation for non-emergent single vessel PCI between 2004 and 2006 IURPWKH(9(17UHJLVWU\7KHDVVRFLDWLRQEHWZHHQVWHQWOHQJWKDQGFOLQLFDO RXWFRPHVZDVDQDO\]HGLQTXDUWLOHV PP PPPP!PP and as a continuous variable. Results: Mean patient age was 64 years. A higher proportion of women and dialysis patients were in the shorter stent quartiles. Maximum balloon GLDPHWHUZDVJUHDWHULQWKHORQJHVWTXDUWLOH7KHUHZHUHQRRWKHUVLJQL¿FDQW differences in clinical, angiographic or procedural variables between quartiles (diabetes 35%, prior MI 33%, prior CABG 21%, ACS 34%, CHF 10%, LAD lesion 37%). Similar DES types were used between quartiles. In univariate analysis, greater stent length was associated with more frequent MACE, DQG7/5 7DEOH /RQJHUVWHQWOHQJWKZDVDVVRFLDWHGZLWKLQFUHDVHGULVNRI stent thrombosis. Adjusting for baseline characteristics, greater stent length UHPDLQHG DVVRFLDWHG ZLWK DQ LQFUHDVHG ULVN RI 0$&( PP LQFUHDVH stent length) and TLR (1.15/10mm), but not with stent thrombosis. One-Year Outcomes According to total stent length Total Stent Length Quartiles < 15 mm 15-19 mm
20-24 mm
!PP Adjusted HR*
# of pts
1143
1140
833
1211
MACE
6.6%
8.7%
11.0%
14.7%
1.195[1.126-1.267] <0.0001
TLR
2.7%
2.4%
3.9%
4.3%
1.160[1.040-1.292] 0.005
Stent Thrombosis
0.4%
1.4%
0.6%
1.4%
1.230[1.020-1.041] NS
P-value
* Hazard ratio per 10 mm increase in DES length, adjusted for demographic,
The American Journal of Cardiology® |
October 12-17, 2008
| TCT Abstracts/ELECTRONIC
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clinical, angiographic, treatment factors Conclusion: For single vessel disease, increasing DES length appears to be associated with adverse clinical outcomes. This should be considered when selecting strategies for revascularization.
Sahajanand Med, India) uses a stainless steel platform with a bioabsorbable polymer loaded with sirolimus. We sought to determine the safety and clinical effectiveness of this new generation DES in diabetic pts. Methods: The E-SERIES Registry is an open-labeled, non-randomized study with consecutive enrollment (ongoing) of pts all-comers for PCI with SS implantation. All clinical, procedural, and follow-up (FU) information were collected and analyzed by an independent organization, and all adverse events were independently adjudicated. Results: Since July/07, 423 pts were included and completed 6 months FU (170 '0 QRQ'0 &RPSDUHGWRQRQ'0SWVZLWK'0ZHUHROGHU YV \HDUV S KDG PRUH K\SHUWHQVLRQ YV S and chronic renal failure (8.4 vs. 2%, p=0.005). Baseline angiographic characteristics were similar among groups: mean vessel size and lesion length ZHUHPPDQGPPUHVSHFWLYHO\DQGRIOHVLRQVZHUH W\SH %& 3URFHGXUDO VXFFHVV ZDV ! S 16 &OLQLFDO RXWFRPHV DW months are shown in the table.
TCT-436 Development of DES with a Biodegradable Polymer Matrix Ya Guo, Brian Cook, Joe Berglund, Daniel Schulz-Jander, Peiwen Cheng, Eric Yu, Stefan Tunev, Doreen Borkowski, Sean Pruitt, Lesley Crookall Medtronic Cardiovascular, Santa Rosa, CA Background: Drug delivery from drug eluting stents is presently achieved through bio-stable polymeric coatings; these remain in the body following drug release. Development of a polymeric coating that is biodegradable offers the advantage that after polymer degradation is complete, a bare metal stent remains, eliminating concerns about reactions resulting from residual polymer. Methods: Novel biodegradable co-polymers were developed, built around materials with similar chemistry to poly-lactic acid (PLA); PLA is used to good effect in medical implants, such as absorbable sutures. By varying polymer composition (both type of component and component ratio) and polymer molecular weight (MW), we control drug elution and polymer degradation rates. Targeting performance criteria important to a DES product ZH LGHQWL¿HG FDQGLGDWH IRUPXODWLRQV IRU XVH LQ DQLPDO WHVWV 7ZR DQLPDO models were employed: a rat model used to evaluate polymer degradation, and a pig model used to evaluate safety and biocompatibility. Stents coated with four candidate polymers containing 0.8-g/mm2 of Zotarolimus were implanted into porcine coronaries and sampled at 28, 90 and 180 days. The assessment panel included histopathology, polymer degradation and elution. Results: Polymer composition and MW could be adjusted to control drug HOXWLRQ DQG SRO\PHU GHJUDGDWLRQ UDWHV WKLV ZDV FRQ¿UPHG LQYLYR $ W\SLFDOHOXWLRQFXUYHKDVDVKRUWWLPHIUDPH³EXUVW´RIaRIWKHGUXJDQG complete elution by 28 days, but by varying the polymer composition, the burst ranged from 20 - 60% and elution to exhaustion could range from less than 10 days to more than 60 days. Histological performance of the polymers showed comparable performance to bare metal stent controls measured by ORZ LQÀDPPDWLRQ VFRUHV DQG SHUFHQW DUHD RI VWHQRVLV ,Q DGGLWLRQ ZH VDZ SHULVWUXW ¿EULQ DW GD\ LQGLFDWLQJ SUHVHQFH RI DFWLYH GUXJ LQ WLVVXH Invivo degradation correlated with bench top testing. In the rat model, polymer degradation times ranged from 100 days to more than 180 days. Conclusion: These studies have demonstrated that the biodegradable polymers we have developed offer potential as a carrier material for a drug eluting stent.
1,6 % ( 4 )
0,49
MI
2,9 % ( 5 )
4% ( 10 )
0,77
TLR
0,5 % ( 1 )
1,8 % ( 5 )
0,24
6WHQWWKURPERVLVGH¿QWHSUREDEOH
0,6 % ( 1 )
0,4 % ( 1 )
0,99
0,61
TCT-438 Common Site of Stent Fracture after Sirolimus-eluting stent -Unique Distribution at Native Coronary Artery-
Background: Stent fracture after drug-eluting stent has been reported to occur more frequently at RCA than other native coronary arteries. However, further information of common sites of stent fracture remains unclear. In this study, we evaluated the fracture site according to the branches of each coronary vessel after sirolimus-eluting stent (SES). Methods: Between November 2002, and December 2006, a total of 2417 consecutive patients with 3888 lesions underwent stenting with SES. Of these, 2291 patients with 3621 lesions were treated with SES successfully and exclusively. A total of 1979 patients with 3086 lesions which were followed by angiography constituted the study population for evaluation of stent fracture. $QJLRJUDSKLFVWHQWIUDFWXUHZDVGH¿QHGDVDSSDUHQWFRPSOHWHVHSDUDWLRQRI stent segments at any view of angiogram. Fluoroscopy with focusing on stent without contrast medium or inverse image analysis of routine angiography was used in selected cases in which stent fracture was suspected by routine angiography. Stent fracture at ostial or proximal site of RCA was also evaluated XVLQJOHIWREOLTXHYLHZRI/9*LQDGGLWLRQWRURXWLQHFRURQDU\DQJLRJUDP Angiographic stent fractures were observed at 154 lesions (total number of VWHQWIUDFWXUHVZDV 3UHYDOHQFHRIVWHQWIUDFWXUHRI5&$OHIWPDLQWUXQN /07/$'/&;69*DQG,0$ZHUH OHVLRQV lesions), 2.8 % (29/1030 lesions), 3.1 % (21/687 lesions), 25 % (5/20) and 0 % (0/2 lesions) respectively. Prevalence of stent fracture at various branches of native coronary artery was shown in the Figure.
Background:Diabetes mellitus (DM) is a well recognized predictor for adverse HYHQWVIROORZLQJ3&,'HVSLWHWKHXQGHQLDEOHFOLQLFDOHI¿FDF\RIst generation DES with durable polymers, concerns regarding their long-term safety have been raised, especially in more complex subsets. The SupralimusTM stent (SS,
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Kazushige Kadota, Kazuaki Mitsudo, Tsuyoshi Goto, Satoki Fujii, Hiroyuki Yamamoto, Harumi Kato, Yasushi Fuku, Shingo Hosoki, Hiroyuki Tanaka, Seiji Habara, Daiji Hasegawa, Masao Imai, Suguru Otsuru, Masakazu Miyamoto, Masakazu Miyamoto, Naoki Saito, Kentaro Shibayama Kurashiki Central Hospital, Kurashiki, Japan
Dimytri A Siqueira1, Ricardo A. Costa1,2, J. Ribamar Costa Jr.1,2, Andrea S. Abizaid1,2, Alaor Mendes1, J. Airton Arruda3, Fabio S. Brito Jr.4, Mauricio Prudente5, Costantino R. Costantini6, Juliana P. Castro2, Fausto Feres1, Alexandre A. C. Abizaid1,2, Expedito E. Ribeiro7 1 Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil 2 Cardiovascular Research Center, São Paulo, Brazil 3Intercath Meridional, Vitória, ES, Brazil 4Hospital São Camilo, São Paulo, Brazil 5 Centro de Cardiologia e Radiologia, Goiânia-GO, Brazil 6Hospital Cardiologia Costantini, Curitiba- PR, Brazil 7Instituto do Coração FMUSP, São Paulo, Brazil
October 12-17, 2008
2,9% ( 5 )
Conclusions: The novel SupralimusTM DES demonstrated excellent SHUIRUPDQFHDQGVDIHW\SUR¿OHLQXQVHOHFWHGGLDEHWLFSWV$WPRQWKV)8 clinical outcomes were comparable in diabetics vs. non-diabetics, including overall MACE <6% and TLR <2%. Complete 1 year clinical FU will be presented at the meeting.
Supralimus™ Bioabsorbable Sirolimus-Eluting Stent Technology in Diabetic Pts Undergoing Percutaneous Coronary Intervention (PCI): Preliminary Findings from the Prospective, International, Multicenter E-SERIES Registry
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5,9% ( 10 )
Cardiac death
p
MI-myocardial infarction, TLR-target-lesion revascularization
TCT-437
The American Journal of Cardiology®
MACE
Non-diabetics ( n= 253 ) 5,5% ( 14 )
Diabetics( n=170 )
http://www.aievolution.com/tct0801
Conclusion: For coronary artery disease in dialysis patients, SES could not improved the subsequent clinical results. TCT-441 )LUVW5HSRUWRI+XPDQ&OLQLFDO6DIHW\DQG(I¿FDF\RI-$&7$; Drug Application Stent
Conclusion: Although the exact mechanism of unique distribution of common VLWHVRIVWHQWIUDFWXUHDIWHU6(6LPSODQWDWLRQUHPDLQVXQNQRZQE\QRZRXU data could be useful to avoid stent fracture after SES implantation and its related clinical events, such as restenosis. TCT-439 WITHDRAWN TCT-440 Comparison of Therapeutic Strategies for Coronary Artery Disease in Dialysis Patients Between Bare Metal and Drug-eruting Stent Eras
E L E C T RO N I C A B S T R AC T S
Kenya Nasu, Etsuo Tsuchikane, Osamu Katoh, Yoshihisa Kinoshita, Mariko Ehara, Yasushi Asakura, H Matsuo, Tetsuo Matsubara, Mitsuyasu Terashima, Takahiko Suzuki Toyohashi Heart Center, Toyohashi, Japan Background: In most patient subpopulations, sirolimus-eluting stent (SES) SURYLGH VLJQL¿FDQW EHQH¿WV RYHU EDUH PHWDO VWHQWV %06 IRU WDUJHW OHVLRQ revascularization (TLR) and other major adverse cardiac events (MACE). +RZHYHUWKHHIIHFWRI6(6LQGLDO\VLVSDWLHQWVLVXQNQRZQ Methods: From April 2000 to July 2004, a total of 252 lesions in 201dialysis patients were treated (BMS era) and 412 patients with 539 lesions were treated from August 2004 to October 2007 (DES era). Patients were followed for 12 months for TLR and 4 years for MACE. Results: Therapeutic strategies in each era are shown in table. Balloon angioplasty was performed more frequently in BMS era. In DES era, 60% of WKHOHVLRQVZHUHWUDWHGE\6(6ZKLFKZDVVLJQL¿FDQWO\KLJKHUWKDQ%06HUD However, TLR rate at 12 months was not different between BMS and SES. In addition, at 4 years MACE in DES era were not different from those in BMS HUD ¿JXUHS Therapeutic strategies BMS era DES era p
TLR rate in TLR rate in p BMS era DES era
Number of lesion
252
539
18.8%
Balloon angioplasty
101 (40%)
Balloon angioplasty after 35 (14%) rotational atherectomy BMS 81 Stent (32%) Stent after rotational BMS 35 atherectomy (14%)
25.5%
0.12
149 (28) 0.0008 20%
23%
0.75
64 (12%) 0.57
21%
0.71
30%
0.08
32.5%
0.07
20%
SES 243 0.0006 20% (45%) SES 80 0.75 14% (15%)
Eberhardt Grube1, Joachim Schofer2, K Eugen Hauptmann3, Neil J Weissman4, Jeffrey Popma5 1 HELIOS Klinikum Siegburg/ Germany , Siegburg, Germany 2Hamburg University Cardiovascular Center, Hamburg, Germany 3Krankenhaus der Barmherzigen Bruder, Trier, Germany 4MedStar Research Institute, Washington, D.C., DC; 5Brigham and Women’s Hospital Angiographic Core Laboratory, Boston, MA Background: 7KH -$&RDWLQJ ZDV GHVLJQHG IURP ¿UVW SULQFLSOHV DV D unidirectional ablumenal ultra thin bioerodable coating to mitigate the potential long term clinical complications associated with drug eluting stents. The Coating is formulated by combining DLPLA and paclitaxel (1:1 w/w) and is precisely applied as a solution using the Labcoat patented computer controlled system to form a unique discontinuous dot pattern exclusively RQ WKH DEOXPHQDO VWHQW VXUIDFH 7KH -$&7$; 'UXJ $SSOLFDWLRQ VWHQW LV WKH/LEHUWp0RQRUDLO6'6 EDUHPHWDOSUHPRXQWHGVXSSOLHGE\%RVWRQ 6FLHQWL¿F ZLWKWKH-$FRDWLQJDSSOLHGE\/DEFRDW/WG Methods: -$&7$;HQUROOHGDWRWDORISDWLHQWVIURP¿YH FHQWHUVLQ (XURSH7KHSULPDU\HQGSRLQWLV0$&( FDUGLDFGHDWK0,795 HYDOXDWHG DW PRQWKV6HFRQGDU\HQGSRLQWVLQFOXGHDQJLRJUDSKLFDQG,986FULWHULDDW months. All patients have completed one month follow up and approximately 50% of patients have completed a four month clinical follow up. Results: The study enrolled 83 men and 20 women with a mean age of 66 years; 22 pts (21%) presented with diabetes. Eighty-one (79%) patients had one lesion treated; 21 (20%) had a second lesion treated with Taxus® and 1 pt had WKUHHOHVLRQVWUHDWHG PXOWLSOHOHVLRQVZHUHWUHDWHGZLWKQRQ-$&7$;VWHQWV /HVLRQOHQJWKUDQJHGIURPWRPPZLWKDPHDQRIPP %DVHOLQH0/'ZDVPPSUHSURFHGXUH PPSRVWSURFHGXUH 3HUFHQW'LDPHWHU6WHQRVLVUHGXFHGIURP SUHSURFHGXUHWR SRVW SURFHGXUH 'HYLFH WHFKQLFDO VXFFHVV ZDV VWHQWV successfully placed. Lesion success was 99%; 102/103 patients with successful lesions treated and Procedural success was 97%; 100/103 patients with lesion success and no in-hospital MACE. Cumulative MACE through 30 days was 1.9% (2/103) based on two cases of in-hospital non Q-wave MIs. There were no incidences of death or TLR within 30 days. At 4 months, 53 patients have been evaluated with no additional MACE. Conclusion:7KHGD\UHVXOWVRIWKH-$&7$;FOLQLFDOVWXG\GHPRQVWUDWHWKH LQLWLDOVDIHW\DQGDFXWHHI¿FDF\RIWKH-$&7$;VWHQW$QJLRJUDSKLFUHVXOWVDW 9 months post procedure will be reported in October 2008. TCT-442 The Safety of 6-Month versus 12-Month Dual Antiplatelet Therapy in Patients Treated with Zotarolimus-Eluting Stent: A Patient-Level Pooled Analysis of Five ENDEAVOR Randomized Trials Roxana Mehran1, David E Kandzari2, Laura Mauri3, Adriano Caixeta1, George Dangas1, Manuela Negoita4, Martin B Leon5 1 Columbia University Medical Center and Cardiovascular Research Foundation, New York, NY; 2Scripps Clinic, LaJolla, CA; 3Brigham and Women’s Hospital, Harvard Medical School, Boston, MA; 4Medtronic CardioVascular, Santa Rosa, CA; 5Columbia University Medical Center, New York, NY Background: The observation that very late stent thrombosis may occur more frequently with early generation drug eluting stent (DES) [sirolimus and paclitaxel] than with bare metal stents has motivated the guidelines recommendation for at least 12 months of dual antiplatelet therapy (DAPT)
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The American Journal of Cardiology® |
October 12-17, 2008
| TCT Abstracts/ELECTRONIC
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for all patients receiving DES. Given the low rate of late thrombotic events with zotarolimus-eluting stents (ZES, Endeavor), whether clinical outcomes following treatment with ZES differ relative to an abbreviated duration of DAPT compared with extended therapy has not been characterized. Methods: Using multivariable analysis adjusting for baseline clinical and angiographic characteristics, we compared long-term clinical adverse events among ZES patients from the pooled Endeavor clinical trials program (N=1,674). Patients were divided according to duration of DAPT: Group “On 12m” (N=699), patients on DUAPT at both 6 months (m) and 12m; and Group “On 6m/Off 12m” (N=785), patients on DUAPT at 6m but without clopidogrel at 12m. Results: )ROORZLQJ ULVN DGMXVWPHQW DW DQG \HDU IROORZXS WKHUH ZHUH QRVLJQL¿FDQWGLIIHUHQFHVLQWKHFXPXODWLYHLQFLGHQFHRIGHDWKP\RFDUGLDO infarction (MI), stent thrombosis and composite endpoints relative to DUAPT DGKHUHQFHDWPYHUVXVP 7DEOH 7KHUHZHUHQRIXUWKHU9/67HYHQWVLQ either group between 2 and 3 years.
Results:0HDQGXUDWLRQRIIROORZXSLVGD\V7KHUHZHUHVLJQL¿FDQW differences between SES and PES group in rates of family history of coronary artery disease (SES 24.6%, PES 37.0%, p=0.03), diabetes (SES 28.8%, PES 18.5%, p=0.05) and chronic total occlusion (3.4% vs 15.2%, p=0.001). At \HDUVPRUWDOLW\LQ6(6DQG3(6JURXSZDVDQG ORJUDQNS ZKLOH795UDWHZDVDQGUHVSHFWLYHO\ ORJUDQNS The composite endpoint of MACE was found comparable between 2 groups DQG ORJUDQN S &R[ UHJUHVVLRQ DQDO\VLV UHYHDOHG presentation for acute myocardial infarction (hazard ratio [HR] 3.22 [95%CI: 1.59-6.50]), chronic total occlusion (HR 2.23 [95%CI: 1.15-4.31]) and number of stents (HR1.24 [95%CI: 1.05-1.47]) as independent predictors of MACE, while stent type was not. Conclusion: 7KUHH\HDU DIWHU WKH SURFHGXUH WKHUH DUH QR VLJQL¿FDQW differences in MACE rate between SES and PES when used in patients with in-stent restenosis.
Table 1. Long-term Outcomes Relative to On 12m vs. On 6m/Off 12m DUAPT Outcomes at 2 years
On 12m (N=279)
On 6m/Off 12m (N=506)
P value
Death (cardiac) MI
0.0% (0)
1.2% (6)
0.94
3.2% (9)
2.4% (12)
0.57
Death (cardiac) + MI
3.2% (9)
3.6% (18)
0.59
$5&'H¿QLWH3UREDEOH
0.7% (2)
0.4% (2)
0.42
MACE
11.8% (33)
8.9% (45)
0.28
Outcomes at 3 years
(N=275)
(N=497)
Death (cardiac)
0.0% (0)
1.6% (8)
0.95
MI
3.6% (10)
2.6% (13)
0.54 0.50
Death (cardiac) + MI
3.6% (10)
4.2% (21)
$5&'H¿QLWH3UREDEOH
0.7% (2)
0.4% (2)
0.42
MACE
13.8% (38)
11.1% (55)
0.35
TCT-444 United States (US) and Outside US Outcomes of the Off-label use of Bare Metal Stents compared to Drug Eluting Stents: A Meta-Analysis Nirat Beohar Northwestern University Medical School, Chicago, IL Background: Whether US and Outside US (OUS) outcomes of Off-label PCI utilizing bare metal stents (BMS) or drug eluting stents (DES) differ is unclear. Methods: A meta-analytical of was performed of 44,845 patients (149 studies, %06Q '(6Q IRUWKHVDIHW\DQGHI¿FDF\RI86DQG286 outcomes of DES compared to BMS. Off-label use for BMS and DES was GH¿QHGE\LQIRUPDWLRQIRUXVHGH¿QLWLRQVIRU'(65HJLVWU\GDWDEDVHVDQG randomized clinical trials (from May 2000- April 2008) reporting lesion VSHFL¿FRXWFRPHVZLWKDPLQLPXPIROORZXSRIPRQWKVZHUHLQFOXGHG Lesion subtypes were left main, ostial, bifurcation, in-stent restenosis, VDSKHQRXVYHLQJUDIWORQJOHVLRQVVPDOOYHVVHOVWRWDORFFOXVLRQVDQGFDOFL¿HG lesions. Results:
MACE: major adverse cardiovascular events
Conclusion: Following treatment with ZES, late adverse outcomes do not VLJQL¿FDQWO\GLIIHUEHWZHHQSDWLHQWVDGKHUHQWWR'8$37DWPYHUVXVP 7KHVH¿QGLQJVQRWRQO\GHPRQVWUDWHWKHRYHUDOOORQJWHUPVDIHW\ZLWK=(6EXW also suggest favorable long-term safety among ZES patients who discontinue DUAPT prior to 1 year.
1 Year Outcomes of DES vs. BMS in Off-Label Use (mean%, 95% CI) DES
OUS BMS
DES
Death
1.99 (1.2-2.8)
2.9 (2.6-3.2)
2.79 (2.57-3.1)
2.02 (1.8-2.3)
Long-term Outcomes After Treatment Of In-stent Restenosis With Bare-metal Stent And Drug-eluting Stent: Insights From Research And T-search Registry
Death or MI
9 (6.2-11.8)
5.24 (4.7-5.8)
7.35 (6.6-8.1)
3.21 (2.8-3.6)
Yoshinobu Onuma, Neville Kukureja, Joost Daemen, Nieves Gonzalo, Evelyn Regar, Henricus J Duckers, Robert Jan M van Geuns, Martin van der Ent, Peter de Jaegere, Pim J de Feyter, Wim van der Giessen, Ron van Domburg, Patrick W Serruys Thorax center, Rotterdam, Netherlands
Thrombosis
0.93 (0.3-1.5)
0.75 (0.6-0.9)
0.93 (0.4-1.5)
1.42 (0.99-1.8)
TLR
17.79 (16.1-19.5)
4.9 (4.4-5.4)
19.37 (18.3-20.4)
6.31 (5.8-6.8)
Objectives: Drug-eluting stents (DES) have been shown to be superior to conventional brachytherapy, the only FDA-approved treatment for in-stent restenosis for treatment of stenting. Although sirolimus-eluting (SES) and paclitaxel-eluting stents (PES) are commonly used for treatment of in-stent UHVWHQRVLVOLWWOHLVNQRZQUHJDUGLQJORQJWHUPRXWFRPHDIWHUVWHQWLPSODQWDWLRQ DQGUHODWLYHHI¿FDF\RI6(6RU3(6 Methods: Between April 2002 and December 2004, 302 consecutive patients with in-stent restenotic lesion were treated with either SES (n=118; April 2002 to February 2003) or PES (n=184; March 2003 to December 2004). The occurrence of death (obtain from municipal civil registries) and clinical events were collected. Primary endpoint was a composite of major adverse events (MACE: all-cause death, myocardial infarction irrespective of the stented vascular territory or target-vessel revascularization). Survival curves were generated by the Kaplan-Meier method, and survival among groups was FRPSDUHG ZLWK WKH ORJUDQN WHVW &R[ PXOWLYDULDWH UHJUHVVLRQ DQDO\VLV ZDV performed to identify independent predictor of MACE event.
MACE
25.17 (23.3-27.1)
14.26 (13.5-15.05)
18.71 (17.9-19.6)
9.18 (8.7-9.7)
The American Journal of Cardiology®
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October 12-17, 2008
Conclusion: 1. For Off-label use in the US, DES death and thrombosis rate were similar to BMS, however, the death or MI, TLR and MACE rates were lower for DES compared to BMS. 2. For Off-label use OUS, DES thrombosis rates were similar to BMS, however death, death or MI, TLR and MACE rates were higher for DES compared to BMS. 3. Comparing US to OUS for DES, Off-label usage showed higher death, death or MI, and MACE rates, but lower thrombosis and TLR rates. 4. Comparing US to OUS for BMS, Off-label usage showed similar death, death or MI, thrombosis and TLR rates but higher MACE rates. Important geographical differences may exist in Offlabel PCI outcomes and merit further investigation.
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US only BMS
TCT-443
http://www.aievolution.com/tct0801
TCT-445 Comparison of Sirolimus-Eluting Stents With and Without Polymeric Coating: A Serial Angiography and Intravascular Ultrasound Study
E L E C T RO N I C A B S T R AC T S
Daniel Chamié, J. Ribamar Costa, Jr., Alexandre Abizaid, J. Fábio Almiro Silva, Fausto Feres, Andréa S. Abizaid, Luiz Fernando Tanajura, Luiz Alberto P. Mattos, Rodolfo Staico, Ricardo Costa, Amanda G.M.R. Sousa, J. Eduardo Sousa Institute Dante Pazzanese of Cardiology, Sao Paulo, Brazil Background: Recent concerns regarding drug-eluting stents (DES) longterm safety have been raised. Although synthetic polymers in DES may SURYLGH EHWWHU UHOHDVH NLQHWLFV RI WKH GUXJ WKHLU SHUPDQHQW SUHVHQFH KDYH EHHQ DVVRFLDWHG ZLWK DQ LQWHQVH LQÀDPDWRU\ UHVSRQVH DQG H[DFHUEDWHG positive vessel remodeling. Recently, association between exacerbated vessel enlargement and very late DES thrombosis has been demonstrated. In this UHJDUG QHZHU JHQHUDWLRQV RI '(6 KDYH EHHQ GHYHORSHG 7KH 9HVWDV\QF VLUROLPXVHOXWLQJ VWHQW 9(6 FRPELQHV D VWDLQOHVV VWHHO SODWIRUP ZLWK D nanothin-microporous hydroxyapatite surface coating impregnated with a polymer-free sirolimus formulation (55 -g) that elutes the drug for more than GD\V2QFHWKHDEVHQFHRISRO\PHUPD\LQÀXHQFHWKHHI¿FDF\RID'(6 ZHDLPWRFRPSDUHWKHHI¿FDF\RIWKLVQRYHOGHYLFHZLWKWKDWRIWKHSHUPDQHQW polymer sirolimus-eluting Cypher™ stent (SES). Methods: Fifteen patients (pts) with single de novo lesions <14 mm length, in native vessels with 3.0 to 3.5 mm in diameter, were consecutively treated ZLWK9(6GXULQJPD\DQGFRPSDUHGWRDK\VWRULFDOFRKRUWRIDQRWKHU pts treated with SES that matched the same inclusion criteria. Angiographic DQGLQWUDYDVFXODUXOWUDVRXQG ,986 GDWDZHUHREWDLQHGLPPHGLDWHO\SRVW SURFHGXUHDQGVHULDOO\DWPRQWKDQGDWPRQWKIROORZXS3ULPDU\ end-points are the comparison of in-stent late loss (LL) by QCA and % of LQWLPDOK\SHUSODVLD ,+ E\,986$OODQJLRJUDSKLFDQG,986DQDO\VLVZHUH SHUIRUPHG³LQKRXVH´DWRXUFRUHODERUDWRU\E\WZRH[SHULHQFHGRSHUDWRUV blinded to the type of stents and time frame of analysis. Results: Baseline clinical characteristics were similar between groups. The 9(6JURXSKDGYHVVHOVRIVPDOOHUGLDPHWHU PPvs. S $WPRQWKIROORZXSLQVWHQW//ZDV 9(6 YV 6(6 S DQG,986,+REVWUXFWLRQZDV 9(6 YV 6(6 S $WDPHDQIROORZXSRIPRQWKVLQVWHQW// ZDV 9(6 YV 6(6 S DQGWKH,986,+ REVWUXFWLRQZDV 9(6 YV 6(6 S 7KHUHZHUHQR cases of binary restenosis in both groups. Conclusion: 7KH SUHVHQW DQDO\VLV VKRZV WKDW WKH QRYHO 9HVWDV\QF VWHQW LV effective in reducing IH formation up to 10-month follow-up. The absence RISRO\PHUGLGQRWKDYHLPSDFWRQWKHHI¿FDF\RIWKLVWKLUGJHQHUDWLRQ'(6 compared to the Cypher™ stent. Longer-term follow-up with a larger number RISDWLHQWVLVZDUUDQWHGWRFRQ¿UPLWVHI¿FDF\DQGVDIHW\SUR¿OH TCT-446 Vascular Response to Overlapping Everolimus-eluting stents: Comparison with Paclitaxel-eluting Stents Hiromasa Otake1, Junya Ako1, Masao Yamasaki1, Ichizo Tsujino1, Takao Shimohama1, Takao Hasegawa1, Ryota Sakurai1, Katsuhisa Waseda1, Paul G Yock1, Yasuhiro Honda1, Krishnankutty Sudhir2, Gregg W Stone3, Peter J Fitzgerald1 1 Stanford University, Palo Alto, CA; 2Abbott Vascular, Santa Clara, CA; 3 Cardiovascular Rsch Foundation, New York, NY Background: Increased drug dose in the Everolimus-eluting stent (EES) overlap region might be associated with adverse vessel response. We sought to clarify vessel response to overlapping EES versus Paclitaxel-eluting stent (PES) implantation. Methods : )URP WKH 6WDQIRUG 8QLYHUVLW\ ,986 &RUH /DERUDWRU\ database, a total of 74 patients treated with overlapping EES (n=36) and PES (n=38) ZKR XQGHUZHQW PRQWKV IROORZ XS ' ,986 ZHUH HQUROOHG 9ROXPH
170i
LQGH[ YROXPHOHQJWK ZDVFDOFXODWHGIRUQHRLQWLPD 19, VWHQW 69, YHVVHO 99, DQGSHULVWHQWSODTXH 39, 1,9ZDVFDOFXODWHGDV19,[69, 9HVVHO UHVSRQVH ZDV DVVHVVHG DW WKH SUR[LPDO DQG GLVWDO VLQJOH VWHQW VWUXW regions and the overlap region. Results: 2YHUDOO ((6 VKRZHG VLJQL¿FDQWO\ OHVV QHRLQWLPDO K\SHUSODVLD 1,+ WKDQ3(6&RPSDUHGZLWK3(6((6VKRZHGVLJQL¿FDQWVXSSUHVVLRQRI NIH at the proximal and distal single strut regions, and a trend toward lower 1,+DWWKHRYHUODSUHJLRQ 7DEOH 99,DQG39,LQFUHDVHGDWDOOUHJLRQVLQ3(6 whereas no changes were observed LQ((6H[FHSWIRUWKHLQFUHDVHLQ39,DW the distal region. At the overlap region, PES showed greater vessel expansion over time than EES (Table). One late incomplete stent apposition (LISA) case was observed in PES at the distal region, however LISA did not occur at the overlapping of EES and PES. EES
PES
39DOXH
Overall
0.02
Proximal region
0.049
Overlap region
0.09
Distal region
0.02
Proximal region
0.049
Overlap region
0.27
Distal region
0.81
Proximal region
0.09
Overlap region
0.049
Distal region
0.65
1,9
'HOWD3HULVWHQW39,PPPP
'HOWD99,PPPP
Conclusion:'HWDLOHG,986DQDO\VLVFRQ¿UPHGJUHDWHU suppression of NIH in the proximal and distal region with EES, without vessel expansion in the overlapping region, as compared with PES. TCT-447 Long-Term Outcomes of Sirolimus Eluting Stents for the Treatment of Saphenous Vein Graft Disease Robert M Minutello, Smita Aggarwal, Dmitriy N Feldman, Linda J Cuomo, Christopher L Gade, Issam Moussa, Geoffrey Bergman, Shing C Wong Weill Cornell Medical College, New York, NY Background: Data regarding outcomes following the use of sirolimusHOXWLQJVWHQWV 6(6 IRUWKHWUHDWPHQWRIVDSKHQRXVYHLQJUDIW 69* GLVHDVH LV FRQÀLFWLQJ ZLWK UHFHQW VWXGLHV VKRZLQJ QR FOHDU RYHUDOO EHQH¿W RI 6(6 compared to bare metal stents (BMS). Methods: :H FRPSDUHG WKH ORQJWHUP VDIHW\ DQG HI¿FDF\ RI 6(6 LQ 69* lesions in 59 consecutive patients immediately after the approval of SES (March, 2003) to 50 consecutive patients who received BMS in an equivalent time period immediately prior to SES approval. Results:Baseline demographic, clinical, and angiographic variables (including DJH YV \HDUVROG 4&$PHDVXUHG69*FDOLEHU YV PP ODUJHVW VWHQWEDOORRQ GLDPHWHU YV PP /9() YV DQG PCI in setting of an MI (17% vs 24%)) were similar between the two groups DOOS 16 ZLWKWKHH[FHSWLRQRIJUDIWDJHEHLQJVLJQL¿FDQWO\ROGHU YV 9.4 years) and average stent length being longer (26 vs. 21 mm) in the SES vs BMS cohort (both p<0.05), all respectively. Mean time to follow-up was similar in both groups (30 months). At one year, patients who received a SES showed a trend (p=0.1) towards a decrease in MACE (24% vs. 36%) driven by target vessel failure, with no difference in mortality rates (9% vs 10%). +RZHYHUDWIROORZXSDFR[SURSRUWLRQDOKD]DUGVPRGHOGLGQRW¿QG6(6WR EHDVLJQL¿FDQWLQGHSHQGHQWQHJDWLYHSUHGLFWRURI0$&( 25 S
The American Journal of Cardiology® |
October 12-17, 2008
| TCT Abstracts/ELECTRONIC
http://www.aievolution.com/tct0801
TCT-449
Moreover, Kaplan-Meier survival curves show the early MACE-free survival EHQH¿WREVHUYHGLQWKH6(6FRKRUWWRGLPLQLVKRYHUWLPHZLWKFRQYHUJHQFHRI the survival curves at follow-up.
Pharmacokinetic Study of Custom NX 36 and NX 60, Biolimus A9 Drug Eluting Stent Catheter System: The CUSTOM PK Trial Miodrag Ostojic1, Dragan Sagic2, Uwe Christians3 Clinical Center Serbia, Belgrade, Serbia2Institut for Cardiovascular Disease Dedinje, Belgrade, Serbia, Belgrade, Serbia3University of Colorado, Denver, CO 1
Background: 7KH &XVWRP 1; 'UXJ (OXWLQJ 6WHQW &DWKHWHU 6\VWHP¶V &XVWRP1; DOORZVIRUin situ customization of the stent length and multiple stent deployments within single catheter insertion. This prospective, nonrandomized, multi-center trial was conducted to assess the safety and SKDUPDFRNLQHWLFVRI%LROLPXV$ %$ DQGDELRDEVRUEDEOHSRO\PHU3/$ post implantation of the customized stent in patients with de novo lesions in native coronary arteries. The co-primary endpoints of the study were BA9 circulating blood concentration at 28 days and 6 months post implantation of WKH&XVWRP1;6\VWHP Methods: Twenty-eight patients who met the inclusion and exclusion criteria ZHUH HQUROOHG LQ WKH &86720 3. 7ULDO 3DWLHQWV¶ FKDUDFWHULVWLFV LQFOXGHG DYHUDJH DJH RI SUHYLRXV 0,V SULRU 3&,V Diabetes Mellitus, 78.6% hypertension, 60.7% family history of CAD, and KLVWRU\RIVPRNLQJ1LQHWHHQSDWLHQWVKDGVLQJOHOHVLRQVWUHDWHGDQG nine patients had multiple lesions treated. Blood samples were drawn at 15 WLPHSRLQWVWRGHWHUPLQHWKHSKDUPDFRNLQHWLFVRI%LROLPXV$ DQGFOLQLFDO and safety assessments were performed at six of these 15 time points. Results: The lesion lengths ranged from 8mm to 35mm and the stent lengths UDQJHGIURPPPWRPP7KHDYHUDJHOHVLRQOHQJWKZDV PPDQG DYHUDJHVWHQWOHQJWKZDV PP3DWLHQWV¶PRQWKVIROORZXSKDVEHHQ FRPSOHWHGDQGQRPDMRUDGYHUVHFDUGLDFHYHQWV 0$&( RURWKHUVLJQL¿FDQW cardiovascular events have been reported. Clinical examinations and other laboratory assessments were not indicative of any signs of BA9 toxicity. Blood sample measurements showed that maximum BA9 concentration was reached within 1 hour (60 minutes). BA9 peripheral circulating blood concentration OHYHOV ZHUH TXDQWL¿DEOH LQ DOPRVW DOO WKH SDWLHQWV DW GD\V DQG ZHUH QRW TXDQWL¿DEOHLQDQ\RIWKHSDWLHQWVDWPRQWKV Conclusion: 7KHUHVXOWVVRIDUIXUWKHUHVWDEOLVKDVDIHW\SUR¿OHIRUWKH&XVWRP 1;6\VWHPVIRUWKHLQWHQGHGXVHDQGWKHDEVHQFHRIWR[LFLW\FRQVLGHUDWLRQV regarding systemic exposure to Biolimus A9. The 6-month follow-up clinical GDWD DQG ¿QDO 3. UHVXOWV DQDO\VLV DUH SHQGLQJ DQG ZLOO EH DYDLODEOH IRU presentation at TCT in October 2008.
Conclusion:3&,IRUWKHWUHDWPHQWRI69*GLVHDVHLVDVVRFLDWHGZLWKUHODWLYHO\ high long-term MACE and mortality rates. The use of SES in the treatment RI69*GLVHDVHZKLOHUHGXFLQJ0$&(UDWHVZLWKLQWKH¿UVW\HDUGRHVQRW appear to confer a long-term MACE-free survival advantage over BMS. TCT-448 Clinical Outcome Of Patients Treated By A Last Generation Cobaltchromium Stent In The Drug-eluting Stent Era: Results Of The Skice (Skylor In Real World Practice) Registry France sco Burzotta, Carlo Trani, Daniel Todaro, Mario Attilio Mazzari, Italo Porto, Salvatore Brugaletta, Santiago Coroleu, Maria De Vita, Giampaolo Niccoli, Antonio Maria Leone, Rocco Mongiardo, Giovanni Schiavoni, Filippo Crea Policlinico Gemelli, Roma, Italy
The American Journal of Cardiology®
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October 12-17, 2008
TCT-450 Implantation of Drug-Eluting Stents Compared to Bare Metal Stents After Intracoronary Thrombectomy Roland S Wu1, P Boland1, L Higginbotham1, N Dasgupta1, D Fiscela2, K Sfakianakis2, T Franklin-Bond1, K Morgan1, J Stant1, F Esposito1, Piri G1, M Reilly1, S Duru1, L Rabbani2, S Brar1, G Stone2, M Leon2, J W Moses2, G Dangas2, R Mehran2 1 Columbia University Medical Center, New York, NY; 2Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY Background: 7KH HI¿FDF\ DQG VDIHW\ RI GUXJHOXWLQJ VWHQW FRPSDUHG WR bare metal stent implantation in the setting of thrombectomy has not been investigated. We analyzed our clinical and angiographic experience with stent type use in the setting of intracoronary thrombectomy. Methods: From October 2004 to July 2007, 126 consecutive patients underwent coronary thrombectomy on visible thrombus in addition to stent implantation. A total of 87 patients (69%) received a drug-eluting stent (DES) and 39 patients (31%) received a bare metal stent (BMS). Quantitative coronary angiography was performed blinded to the clinical data. Clinical follow-up was obtained through phone contact up to 1 year post-procedure. 0DMRUDGYHUVHFDUGLDFHYHQWV 0$&( ZHUHGH¿QHGDVDOOFDXVHPRUWDOLW\
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Aims: To assess the clinical outcome in unselected patients treated by a new thin-struts cobalt-chromium bare-metal-stent (BMS) in the drug-eluting-stent (DES) era. Methods and Results: SKICE is a single-centre-registry enrolling patients XQGHUJRLQJ SHUFXWDQHRXV FRURQDU\ LQWHUYHQWLRQV 3&, ZLWK 6N\ORU %06 implantation. Clinical and angiographic characteristics were prospectively collected for all patients treated during the study period. Clinical follow-up up to 9-month was obtained for patients enrolled in the registry. Out of 976 consecutive PCI, 458 (47%) were performed using BMS. According to our institution practice, indications for BMS were 1.any clinical condition potentially limiting compliance (CLC) to double antiplatelet therapy, 2.STHOHYDWLRQ P\RFDUGLDO LQIDUFWLRQ 67(0, RU VDSKHQRXV YHLQ JUDIWV 69* interventions, 3.(in the absence of the previously-cited conditions) lesions FRQVLGHUHG DW ORZ UHVWHQRVLV ULVN VKRUW OHVLRQV ODUJH YHVVHOV QR FKURQLF RFFOXVLRQQRELIXUFDWLRQV 2QHKXQGUHG¿IW\SDWLHQWVZHUHWUHDWHGE\6N\ORU on 169 lesions. Base-line characteristics of SKICE patients were similar to patients treated by other BMS during the study and included complex clinical features (25% diabetes, 11% renal failure, 16% STEMI, 15% CLC). At 9-month all-cause death rate was 1.3%, MI rate 2.7% and clinically-driven target vessel revascularization rate 6.7%, resulting in a 8.0% MACE rate. Conclusion: In the DES era, patients with CLC, STEMI, or non-complex angiographic lesions, may have satisfactory clinical outcome when treated by a last-generation cobalt-chromium BMS.
http://www.aievolution.com/tct0801
myocardial infarction, and target vessel revascularization. Results: Baseline characteristics of the two groups were similar. Mean WKURPEXV DUHD DPRQJVW WKH %06 JURXS ZDV VLJQL¿FDQWO\ KLJKHU YV 29mm2; p=0.02). MACE at 30-days and 1-year were similar between the two groups. (Table)
MACE (cumulative) In-Hospital 30 Day 1 year Death In-Hospital 30 Day 1 year
DES (n=87)
BMS (n=39)
p value
7.7% 9.5% 22%
10% 19% 35%
0.73 0.26 0.34
2.2% 3.2% 3.4%
5.1% 9.5% 18%
0.58 0.26 0.07
E L E C T RO N I C A B S T R AC T S
Conclusion: In this study, despite a larger mean thrombus area amongst SDWLHQWVWUHDWHGZLWK%06ZHIRXQGQRVLJQL¿FDQWGLIIHUHQFHLQRYHUDOO0$&( at 1 year when thrombotic lesions were treated with thrombectomy plus either '(6RU%067KHVHUHVXOWVVXJJHVWWKDWVWHQWW\SHLVQRWDVLJQL¿FDQWSUHGLFWRU of outcomes after thrombectomy of highly thrombotic lesions.
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October 12-17, 2008
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TCT Abstracts/ELECTRONIC