TCT-371: Impact of Post-intervention Minimal Stent Area on Long-Term Patency of Paclitaxel-Eluting Stents: An Integrated Intravascular Ultrasound Analysis from the TAXUS IV, V, and VI and TAXUS ATLAS WH, LL, and DS Trials

TCT-371: Impact of Post-intervention Minimal Stent Area on Long-Term Patency of Paclitaxel-Eluting Stents: An Integrated Intravascular Ultrasound Analysis from the TAXUS IV, V, and VI and TAXUS ATLAS WH, LL, and DS Trials

http://www.aievolution.com/tct0901/ TUESDAY, SEPTEMBER 22, 2009, 8:00AM - 10:00AM TCT-369 stent thrombosis after drug-eluting stent (DES) implantat...

276KB Sizes 0 Downloads 22 Views

http://www.aievolution.com/tct0901/

TUESDAY, SEPTEMBER 22, 2009, 8:00AM - 10:00AM

TCT-369

stent thrombosis after drug-eluting stent (DES) implantation. Whether socioeconomic status or co-morbid conditions confound the contribution of AA race to development of stent thrombosis is unclear. MethodsSDWLHQWVZLWKGH¿QLWH'(6WKURPERVLV 67 ZHUHFRPSDUHGWR 7127 patients who underwent DES implantation who did not develop stent thrombosis (NoST). Multivariable Cox regression analysis was performed adjusting for co-morbidities, clopidogrel compliance, and median household income, to assess the impact of AA race on development of stent thrombosis. Results: On univariate analysis, patients with stent thrombosis were more OLNHO\WREH$$ 67YV1R67S DQGKDYHKLVWRU\RI diabetes (50.0% ST vs. 33.8% NoST, p<0.001). Clopidogrel compliance at the time of the index event was greater in AA versus Non-AA population, although WKH GLIIHUHQFH ZDV QRW VLJQL¿FDQW $$  1RQ$$  S   After multivariate analysis, including adjustment for median income and clopidogrel compliance (Table), AA race emerged as an independent predictor RI FXPXODWLYH GH¿QLWH VWHQW WKURPERVLV DW  \HDUV )XUWKHU PXOWLYDULDWH analysis revealed AA race as an independent predictor of both early (HR 2.30 >@S  DQGODWH +5>@S  67

/RQJWHUP6DIHW\$QG(I¿FDF\2I'UXJHOXWLQJ6WHQWV)RU7KH Treatment Of Previous Bare-metal And Drug-eluting Stents Restenosis: Insights From The Desire-ISR Registry José de Ribamar Costa, Jr., Amanda Sousa, Adriana Moreira, Ricardo Costa, Galo Maldonado, Manuel Cano, Cantidio Campos, Cantidio Campos, Mariana Carballo, Cesar Jardim, J Eduardo Sousa Hospital do Coração, São Paulo, Brazil Background: DES are the 1st choice to treat BMS ISR, replacing all other DYDLODEOH SHUFXWDQHRXV DSSURDFKHV $OWKRXJK PDUNHGO\ UHGXFHG '(6 ,65 VWLOORFFXUVDQGKDVEHHQRIWHQWUHDWHGZLWKDQRWKHU'(6GHVSLWHWKHODFNRI UREXVWGDWDVXSSRUWLQJWKHVDIHW\DQGHI¿FDF\RIWKLVDSSURDFK:HVRXJKW to compare the long-term clinical outcomes of pts with BMS and DES ISR treated with another DES deployment. Methods: Between May 2002 and May 2008 a total of 158 pts with BMS ISR and 58 pts with DES ISR were consecutively treated with DES and enrolled in this single-center registry. Pts treated in the setting of AMI and lesions in SVG were excluded. Results: %DVHOLQH FOLQLFDO DVSHFWV GLG QRW VLJQL¿FDQWO\ GLIIHU EHWZHHQ WKH groups. The exception was the higher incidence of DM in the DES cohort  YV  S   0HDQ WLPH EHWZHHQ ¿UVW SURFHGXUH DQG UHVWHQRVLV ZDV VLJQL¿FDQW ORQJHU LQ WKH '(6 FRKRUW “ GD\V YV “ GD\V S   5HJDUGLQJ DQJLRJUDSKLF ¿QGLQJV '(6,65 ZDV PRUH IUHTXHQWO\ focal (83% vs. 36%, p<0.001) and located in smaller diameter vessels (2.84 ± 0.38mm vs. 2.98 ± 0.35mm, p=0.01). Cypher was used in most cases of ERWK FRKRUWV EXW VLJQL¿FDQWO\ PRUH LQ WKH %06,65 JURXS  YV 93.1%, p=0.004). Complete follow-up (median 3.2 years) was obtained in DOOFDVHV7KHFXPXODWLYHLQFLGHQFHRI0$&(ZDVPDUNHGO\KLJKHUDPRQJ DES-ISR patients exclusively due to more frequent need for repeat lesion revascularization among those patients(10.3% vs.3.1%, p=0.03). No case of GH¿QLWHSUREDEOHVWHQWWKURPERVLVZDVREVHUYHGLQERWKJURXSV

Clopidogrel Cessation

HR

95% CI

p Value

3.5

1.8-6.5

0.0001 <0.0001

African-American

2.5

1.6-3.8

Household Income

1.0

1.0-1.0

0.2214

CRI

0.9

0.5-1.6

0.7349

Diabetes

1.6

1.1-2.5

0.0172

Previous PCI

1.9

1.3-2.9

0.0020

Conclusions 7KLV LV WKH ¿UVW VWXG\ GHPRQVWUDWLQJ $$ UDFH DV DQ independent predictor of ST. AA subjects had a trend towards higher clopidogrel compliance and ST was independent of SES. Further LQYHVWLJDWLRQLQWRSRWHQWLDOPHFKDQLVPVRIWKLVLQÀXHQFHPXVWEHSXUVXHG 0XOWLYDULDWH&R[SURSRUWLRQDOKD]DUGPRGHORIFXPXODWLYHGH¿QLWHGUXJ eluting stent thrombosis at 3 years TCT-371 Impact of Post-intervention Minimal Stent Area on Long-Term Patency of Paclitaxel-Eluting Stents: An Integrated Intravascular Ultrasound Analysis from the TAXUS IV, V, and VI and TAXUS ATLAS WH, LL, and DS Trials

Conclusions: PCI of BMS or DES ISR with the implant of another DES represents a simple and safe approach with sustained long-term results. However, the recurrence of restenosis is considerably higher among patients with prior DES restenosis. Novel DES and other strategies as IVUS-guided PCI may be useful in this scenario.

We investigated the predictive value of the intravascular ultrasound (IVUS) measured post-intervention minimum stent area (MSA) on long-term paclitaxel-eluting stent (PES) patency compared to bare metal stents (BMS). Background: Stent underexpansion is a strong predictor for restenosis after sirolimus-eluting stent implantation, but the implication of underexpansion in 3(6LVVWLOOXQNQRZQ Methods: From the combined TAXUS IV, V, and VI and TAXUS ATLAS WH, LL, and DS trials, 1580 patients (PES: 1098, BMS: 482) in IVUS substudies were analyzed. The MSA that best predicted angiographic in-stent restenosis (ISR; % diameter stenosis >50%) was determined. Results: The post-intervention IVUS MSA was similar in PES and BMS (6.6±2.5mm2 vs. 6.7±2.3 mm2, p=0.92). At 9-month follow-up, angiographic ISR was lower in the PES-treated group versus the BMS-treated group (10% vs. 31%, p<0.0001). Using multivariable logistic regression analysis, postintervention IVUS MSA was the independent predictor of subsequent ISR in ERWK3(6DQG%06JURXSV 2GGV5DWLR>@p=0.0002 for PES, DQG2GGV5DWLR>@p=0.0002 for BMS). The ability of the post-

TCT-370 African American Race is a Correlate of Stent Thrombosis In the Drug-eluting Stent Era Sara D Collins, Rebecca Torguson, Michael A Gaglia, Jr., Asmir Syed, Itsik Ben-Dor, Gilles Lemesle, Gabriel Maluenda, Kimberly Kaneshige, Zhenyi Xue, Joseph Lindsay, Kenneth Kent, William O Suddath, Lowell Satler, Ron Waksman Cardiovascular Research Institute, Washington, DC Background: It has been suggested that African American (AA) race predicts

The American Journal of Cardiology®

|

September 21-25, 2009

|

TCT Abstracts/POSTER

137D

P O S T E R A B S T R AC T S

Hiroshi Doi1, Akiko Maehara1, Gary S. Mintz1, Alan Yu2, Hong Wang2, Lazar Mandinov2, Jeffrey J. Popma3, Stephen G. Ellis4, Eberhard Grube5, Keith D. Dawkins2, Neil J. Weissman6, Gregg W. Stone1 1 Cardiovascular Research Foundation, New York, NY;2Boston 6FLHQWL¿F&RUSRUDWLRQ1DWLFN0$3St. Elizabeth Medical Center, Boston, MA;4Cleveland Clinic, Cleveland, OH;5Heart Center Siegburg, Siegburg, Germany6Washington Hospital Center, Washington DC, DC

http://www.aievolution.com/tct0901/

TUESDAY, SEPTEMBER 22, 2009, 8:00AM - 10:00AM

intervention IVUS MSA to predict ISR was further assessed using receiver operating characteristic analysis. The post-intervention IVUS MSA was found to be a fair discriminator between patients with and without ISR in both PES (c=0.6382) and BMS (c=0.6373). Finally, the optimal thresholds of postintervention IVUS MSA that best predicted stent patency at 9 months were 5.7mm2 for PES and 6.4mm2 for BMS. Conclusion: Post-intervention MSA measured by IVUS can predict longterm stent patency after both PES and BMS implantation. TCT-372 6DIHW\DQG(I¿FDF\RI'UXJ(OXWLQJ6WHQWVIRU7UHDWPHQWRI&DUGLDF Allograft Vasculopathy: A Prospective Clinical and Angiographic Study

P O S T E R A B S T R AC T S

Martin K C Ng1, Jennifer Tremmel2, Fumiaki Ikeno3, David P Lee3, Alan C. Yeung3, William F. Fearon3 1 Royal Prince Alfred Hospital, Sydney, Australia2Stanford University Medical Center, Sydney, CA;3Stanford University Medical Center, Stanford, CA Background: Cardiac allograft vasculopathy (CAV) is a leading cause of morbidity and mortality in patients after cardiac transplantation. Percutaneous coronary intervention (PCI) for treatment of CAV has been limited by higher rates of restenosis than encountered in native atherosclerotic lesions. To date, WKHVDIHW\DQGHI¿FDF\RIGUXJHOXWLQJVWHQWV '(6 LQWKHFRQWH[WRI&$9LV XQNQRZQ Methods: Consecutive cardiac transplant recipients who underwent PCI for de novo CAV were divided into one of two groups: those receiving DES or bare metal stents (BMS). Baseline clinical characteristics, rejection episodes and procedural details were compared. End-points included angiographic late loss & in-stent restenosis, target lesion revascularization (TLR), myocardial infarction and cardiac death at 1 year. Results: 7KLUW\IRXU SDWLHQWV UHFHLYLQJ  VWHQWV ZHUH LGHQWL¿HG  '(6 16 BMS). Baseline clinical characteristics, immunosuppression regimen, FDUGLDFULVNIDFWRUVIUHTXHQF\RIUHMHFWLRQDQGSURFHGXUDOGHWDLOVZHUHVLPLODU between DES and BMS groups. At 12-month angiographic follow-up, the PHDQODWHOXPLQDOORVVZDVVLJQL¿FDQWO\ORZHULQWKH'(6JURXSWKDQLQWKH BMS group (0.19 ± 0.18mm for DES vs 0.76 ± 0.25mm for BMS, P=0.03). This ¿QGLQJZDVDVVRFLDWHGZLWKDORZHUUDWHRILQVWHQWUHVWHQRVLV IRU'(6 vs 33% for BMS) and a lower rate of TLR at 1 year (0% for DES vs 23% for BMS, P=0.04). DES implantation was also associated with a lower composite rate of cardiac death and non-fatal myocardial infarction at 1 year (11% for DES vs 38% for BMS, P=0.04). Conclusion: DES are safe and effective in suppression of neointimal hyperplasia following PCI for cardiac allograft vasculopathy, thereby reducing the rate of target lesion revascularization. Compared to bare metal stents in CAV, DES implantation was associated with a reduced composite rate of cardiac death and non-fatal myocardial infarction. TCT-373 Impact of Diabetes on Angiographic And Clinical Outcomes of Revascularization With Biolimus-eluting Stent With Biodegradable Polymer and Sirolimus-eluting Stent With Durable Polymer. LEADERS Trial Substudy Axel Linke1, Karsten Lenk1, Patrick W. Serruys2, Gerrit-Anne van Es3, Pawel Buszman4, Thomas Ischinger5, Volker Klauss6, Franz Eberli7, Roberto Corti7, William Wijns8, Marie-Claude Morice9, Carlo di Mario10, Peter Juni11, Gerhard Schuler1, Stephan Windecker11 1 University of Leipzig, Leipzig, Germany2The Department of Interventional Cardiology Thoraxcenter, Rotterdam, Netherlands3Cardialysis B.V, Rotterdam, Netherlands4Medical University of Silesia, Katowice, Poland5Hospital Bogenhausen, Munich, Germany6University Hospital Munich, Munich, Germany7University Hospital, Zurich, Switzerland8Onze Lieve Vrouw Ziekenhuis, Aalst,

138D

Belgium9Institut Cardiovasculaire, Paris-Sud, Paris, France10Royal Brompton Hospital, London, United Kingdom11Bern University Hospital, Bern, Switzerland Background: One disadvantage of sirolimus might be its effect to override the down-regulation of AKT-signalling pathway in insulin resistance, which was associated with an attenuation of the anti-migratory capacity of sirolimus in the presence of hyperglycemia. These effects in conjunction with a delayed endothelialisation in the presence of a durable polymer carry the theoretical ULVNRIDQLQIHULRUDQJLRJUDSKLFRXWFRPHDVFRPSDUHGWRDELROLPXVHOXWLQJ stent with a biodegradable polymer in patients with diabetes mellitus. 7KHUHIRUH LW ZDV DLP RI WKLV SUHVSHFL¿HG DQDO\VLV WR DVVHVV WKH LPSDFW RI diabetes on angiographic and clinical outcomes of stenting with biolimus eluting degradable polymer stent and sirolimus eluting permanent polymer stent within a randomized multicenter trial (LEADERS). Methods: A total of 1,707 “all-comers” patients were randomized to ELROLPXV %(6 DQGVLUROLPXV 6(6 HOXWLQJVWHQWVDQGDVWUDWL¿HGDQDO\VLVRI angiographic and clinical outcomes at 9 months and 1 year, respectively was performed according to the presence of diabetes. Results: Of 1,707 patients 223 patients in the BES group with 337 lesions and 191 patients in the SES group with 281 lesions had diabetes mellitus (24.3 % of the patient cohort). 81 patients in the BES group and 77 patients in the SES group had insulin-dependent diabetes mellitus. Patients with diabetes were ROGHUZHUHPRUHOLNHO\WRKDYHK\SHUWHQVLRQK\SHUFKROHVWHUROHPLDKLVWRU\ RI SUHYLRXV 0, DQG SUHYLRXV &$%* S  7KHUH ZDV QR VLJQL¿FDQW difference in overall MACE rate (13.5% vs 8.2%; p=0.42) or TLR rate (8.2 % vs 4.9%; p=0.79) between patients with and without diabetes, and there was no difference between insulin-dependent and non-insulin-dependent patients with regard to the above-mentioned parameters either. However, in patients with insulin-dependent diabetes mellitus, rate of death and cardiac death was 0 % after BES implantation as compared to 9.1% and 6.5 %, respectively, after SES implantation at 12 months follow up (p<0.01). In nondiabetic patients, at angiographic follow-up there was no difference with regard to in-stent restenosis between the BES (20.54±16.60%) and the SES group (20.68±16.88%). However, in diabetic patients in-stent restenosis was “LQWKH%(6DQGWKHUHIRUHVLJQL¿FDQWO\ORZHUDVFRPSDUHGWR 33.57±25.42% in the SES group (p=0.01). Conclusions: In patients with diabetes mellitus, BES eluting stents appear to be superior as compared to SES eluting stents with regard to angiographic outcome in an “all-comer” patient population. TCT-374 Angiographic Late Lumen Loss and Intima Hyperplasia After Sirolimus-Eluting and Zotarolimus-Eluting Stent Implantation in Diabetic Patients. The Diabetes and Drug-Eluting Stent (DiabeDES III) Intravascular Ultrasound and Angiography Trial Lisette Okkels Jensen1, Michael Maeng2, Per Thayssen1, Anton Villadsen3, Hans Erik Boetker2, Lars R Krusell2, Knud Erik Pedersen1, Jens Aaroe3, Thomas Vesterlund3, Knud N Hansen1, Jan Ravkilde3, Jens F Lassen2, Morten Madsen4, Hans H Tilsted3, Leif Thuesen2 1 Odense University Hospital, Odense, Denmark2Aarhus University Hospital, Skejby, Denmark3Aarhus University Hospital, Aalborg, Denmark4Aarhus University, Aarhus, Denmark Background:3DWLHQWVZLWKGLDEHWHVKDYHLQFUHDVHGULVNRILQVWHQWUHVWHQRVLV after coronary stent implantation due to neointimal hyperplasia (NIH). The aim of this study was to use volumetric intravascular ultrasound (IVUS) and quantitative coronary angiography (QCA) to evaluate the effects of sirolimuseluting Cypher™ (SES) stents and zotarolimus-eluting Endeavor™ (ZES) stents on in-stent neointima formation and angiographic late lumen loss in diabetic patients. Methods: In the DiabeDES III trial, 123 patients were randomized to SES or ZES stent implantation. IVUS and QCA data were available in 94 patients, including 46 SES and 48 ZES patients at ten-month follow-up. IVUS endpoints included in-stent % volume obstruction and NIH volume.

The American Journal of Cardiology® |

September 21-25, 2009

|

TCT Abstracts/POSTER