Bifurcation Lesions

Bifurcation Lesions

MONDAY 10/17/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) Bifurcation Lesions Exhibit Halls A and B Monday, October 17, 2005, 9:00 am - 5:00 pm (Abstr...

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MONDAY 10/17/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) Bifurcation Lesions Exhibit Halls A and B Monday, October 17, 2005, 9:00 am - 5:00 pm (Abstract Nos. 179-193) TCT-179 Bifurcation Coronary Lesions Treated with a Novel Biolimus A9Eluting, Self-Expanding, Bifurcated Stent - Angiographic Results from the Prospective, Non-Randomized, Multicenter AXXESS Plus Trial Ricardo A Costa1, Alexandre Abizaid2, Ralph Muller3, Alexandra J Lansky1, Roxana Mehran1, Ken Mori1, Ecaterina Cristea1, Bindu Patel1, Ramona Pop1, Maria Corral1, Brett Trauthen4, Stefan Verheye5, Franz J Neumann6, Fausto Feres2, Dougal McLean7, Eberhard Grube3 1 Cardiovascular Research Foundation and Columbia University Medical Center, New York, NY;2Institute Dante Pazzanese of Cardiology, Sao Paulo, Brazil3Siegburg Heart Center, Siegburg, Germany4DEVAX Inc, Irvine, CA;5AZ Middleheim Hospital, Antwerp, Belgium6Herzzentrum Bad Krozingen, Bad Krozingen, Germany7Christchurch Hospital, Christchurch, New Zealand The AXXESSTM Plus Biolimus-A9-coated stent (DEVAX, Inc.) has a conical shape that permits deployment in the main vessel (MV) and its side branch (SB) ostium. It allows subsequent treatment (PTCA and/or DES) in the distal MV and/or SB. We report the angiographic results of the AXXESS PLUS registry. Methods: 136 pts were enrolled at 13 clinical sites. Angiographic inclusion criteria included lesions >50% DS within 5mm of a bifurcation in vessels 2.5 to 4.0mm in diameter in the MV and ≥2.25mm in the SB. Treatment included 4 modalities: type I - cone stent in the bifurcation carina only; type II - cone stent in the carina + stent in the distal MV; type III - cone stent in the carina + SB stent; type IV - cone stent in the carina + distal MV and SB stents. The 1ary efficacy endpoint was in-stent late loss at FU. Results: Stents were implanted as follows: 19.1% type I, 27.9% type II, 12.5% type III, and 40% type IV. Device success (defined as the ability to place and deploy the study stent without failure or complications) was 96.3%. QCA is shown in the Table. At 6 months angiographic FU (available in 53 pts to date), restenosis at the SB stent occurred in only 2 lesions (1 at the ostium and 1 at the distal stent location). Overall, in-stent restenosis rate was 9.4%. Conclusions: The AXXESSTM stent for treatment of bifurcation lesions appear to be effective compared to historical controls, warranting randomized evaluation to standard bifurcation lesion therapy. Complete angio FU will be presented. Variable MV SB Lesion length, mm 17.3±7.4 7.4±3.6 2.9±0.4 2.4±0.3 Reference diameter, mm Preprocedure MLD, mm 0.7±0.3 0.9±0.4 Preprocedure %DS 74.9±8.4 62.8±14.6 Final MLD*, mm 2.8±0.5 2.4±0.4 Final %DS* 7.2±12.1 7.8±6.8 Acute Gain*, mm 2.0±0.5 1.7±0.3 FU MLD*, mm 2.7±0.6 2.1±0.5† FU %DS* 7.4±20.7 14.5±18.8† Late Loss*, mm 0.1±0.6 0.3±0.4† Restenosis*, % (n) 5.7 (3/53) 8.3 (2/24) † † *In-stent measures; reflects only SB lesions that received stents.

P value <0.0001 <0.0001 0.01 <0.0001 0.0005 0.76 0.0003 0.0001 0.16 0.09 0.64

TCT-180 Drug Eluted Stents in Bifurcation Lesions: Improved Long Term Results Abid R Assali, Igal Teplitsky, Shmuel Fuchs, Hana Vaknin-Assa, David Brosh, Ran Kornowski Rabin Medical Center, Petah-Tikva, Israel

drug eluted stents [DES] [CYPHER] for improving long-term results in bifurcation lesions treated with percutaneous coronary intervention (PCI). Background: PCI treatment of coronary bifurcation lesions remains challenging with increased risk of in-stent restenosis especially if both branches are diseased. Limited information is available on long-term results if DES is used to treat both branches. . Methods & Results: We prospectively followed all patients who underwent PCI for symptomatic true bifurcation lesions at our center. In this study we included only pts treated by stenting of both arms of the bifurcation lesion. 38 patients were treated using bare metal stents [BMS] and 13 patients using DES. Conclusions: Our preliminary results clearly show that for the treatment of true bifurcation lesions, stenting both branches using the DES Cypher is associated with improved long term patency as compared to bare metal stents. BMS 38 61±12 71% 82% 13% 58% 71% 80% 2.6% 7.9% 39%

Number Age (years) Male Acute coronary syndrome Diabetes mellitus LAD/DIAGONAL Final Kissing Balloon Anti GP 2b/3a 6 month death Stent thrombosis 6 month ISR

DES 13 64±13 92% 77% 23% 69% 70% 100% 0% 0% 0%

P-value 0.7 0.1 0.7 0.4 0.7 0.6 0.005 0.4 0.3 0.005

TCT-181 Impact of Sirolimus-Eluting Stents on the One-Year Outcome of Patients with Bifurcation Lesions: Multicenter Registry in Asia Sunao Nakamura1, Jang-Ho Bae2, Yeo H Cahyadi3, Wasan Udayachalerm4, Damras Tresukosol5, Sudaratana Tansuphaswadikul6 1 New Tokyo Hospital, Matsudo, Japan2Konyang University Hospital, Daejeon, Republic of Korea3Husada Hospital, Jakarta, Indonesia4King Chulalongkorn Memorial Hospital, Bangkok, Thailand5Siriraj Hospital, Bangkok, Thailand6Chest Disease Institute, Bangkok, Thailand Background: Previous clinical study utilizing Sirolimus-eluting stents (SES) in simple coronary lesions demonstrated an impressive reduction in intimal hyperplasia and restenosis. However, long-term efficacy of SES in treating patients with true bifurcation lesions is still unknown. A prospective Asian multicenter registry was set up in five high volumes Asian centers to evaluate the efficacy of SES in the treatment of bifurcation lesions. Methods: A total of 698 patients, 806 lesions (male 71.6%, mean age 69.2) with bifurcation lesions (defined as a more than 50% stenosis in both parent vessel and side branch, LMT/bifurcation 12.5%, LAD/diagonal 49.6%, LCX/ OM 21.1%, and RCA/PD 16.8%) were treated with 4 strategies: stenting both vessels utilizing SES with Y-stenting (n=271), stenting the parent vessel utilizing SES and balloon angioplasty of the side branch (n=280) and stenting both vessels utilizing SES with crushing stenting with (n=185) or without (n=70) post kissing ballooning (KB). We evaluated immediate and long-term clinical results by 6 and 12 months coronary angiography. Results: See table for clinical results. Conclusion: Our results suggest that stenting both vessels utilizing SES with Y-stenting or crushing stenting with post kissing ballooning can dramatically reduce the restenosis rate at follow-up. Y-stenting

Single stenting 280 0

Number of lesions 271 MACE at 30 days (%) 0 Angiographic restenosis rate (12 mo) Both vessels (%) 3.7 4.3 Parent vessel (%) 3.7 4.3 Side branch (%) 9.6 *21.4 TLR: any vessels (%) 7.4 *20.7 p<0.05 vs Y-stenting, crushing stenting (KB+).

Crushing stenting (KB+) 185 0

Crushing stenting (KB-) 70 0

3.8 3.8 7.6 4.8

8.6 10.0 *20.0 *20.0

Objective: The purpose of this study was to evaluate the efficacy of

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MONDAY 10/17/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) TCT-182 Impact of Paclitaxel-Eluting Stents on the One-Year Outcome of Patients with Bifurcation Lesions: Multicenter Registry in Asia Sunao Nakamura1, Jang-Ho Bae2, Yeo H Cahyadi3, Wasan Udayachalerm4, Damras Tresukosol5, Sudaratana Tansuphaswadikul6 1 New Tokyo Hospital, Matsudo, Japan2Konyang University Hospital, Daejeon, Republic of Korea3Husada Hospital, Jakarta, Indonesia4King Chulalongkorn Memorial Hospital, Bangkok, Thailand5Siriraj Hospital, Bangkok, Thailand6Chest Disease Institute, Bangkok, Thailand Background: Previous clinical study utilizing Paclitaxel-eluting stents (TAXUS™) in simple coronary lesions demonstrated an impressive reduction in intimal hyperplasia and restenosis. However, long-term efficacy of TAXUS™ in treating patients with true bifurcation lesions is still unknown. A prospective Asian multicenter registry was set up in five high volumes Asian centers to evaluate the efficacy of TAXUS™ in the treatment of bifurcation lesions. Methods: A total of 708 patients, 821 lesions (male 70.6%, mean age 68.2) with bifurcation lesions (defined as a more than 50% stenosis in both parent vessel and side branch, LMT/bifurcation 13.2%, LAD/diagonal 50.2%, LCX/ OM 20.5%, and RCA/PD 16.1%) were treated with 4 strategies: stenting both vessels utilizing TAXUS™ with Y-stenting (n=204), stenting the parent vessel utilizing TAXUS™ and balloon angioplasty of the side branch (n=284) and stenting both vessels utilizing TAXUS™ with crushing stenting with (n=278) or without (n=55) post kissing ballooning (KB). We evaluated immediate and long-term clinical results by 6 and 12 months coronary angiography. Results: See table for clinical results. Conclusion: Our results suggest that stenting both vessels utilizing TAXUS™ with Y-stenting or crushing stenting with post kissing ballooning can dramatically reduce the restenosis rate at follow-up. Y-stenting

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

Single stenting 284 0

Number of patients 204 MACE at 30 days (%) 0 Angiographic restenosis rate (12 mo) Both vessels (%) 3.5 3.4 Parent vessel (%) 3.5 3.4 Side branch (%) 4.9 *18.6 TLR: any vessels (%) 4.9 *16.7 p<0.05 vs Y-stenting, crushing stenting (KB+).

Crushing stenting (KB+) 278 0

Crushing stenting (KB-) 55 0

3.6 3.6 6.5 6.5

3.6 3.6 *18.2 *18.2

wave myocardial infarction (MI), defined as CK-MB>3 times the upper limit of normal, occurred in 2 (6.4%) patients. One-month follow-up was available in all patients and subacute thrombosis occurred in 1 (3.2%) patient with protein S deficiency. Twenty-one patients were eligible for 6-month follow-up and control angiography was available in 16 (76%) of them. Focal angiographic restenosis (diameter stenosis>50%) at the ostium of the side branch was found in 2 (12.5%) cases. At follow-up there were no deaths. The rates of target lesion revascularization, target vessel revascularization (TVR), and major adverse cardiac events (defined as death, Q-wav MI, and TVR) were 9.5%, 14.2%, and 19%, respectively. Conclusions: The use of the “culottes” technique with DES appears safe and has a high angiographic success rate and low rate of restenosis compared to historical data with bare metal stents. These preliminary observations need to be confirmed in larger studies. TCT-184 The Effects of Drug Eluting Stent on the Fate of Side Branch of Coronary Artery Luyue Gai, Sr. Chinese PLA General Hospital, Beijing, China Background: Studies have demonstrated that instent restenosis compromises side branch. Drug eluting stent (DES)reduces instent restenosis. The study was performed to compare the fate of the side branch after BMS and DES. Methods: Two hundred and thirty-six patients who had coronary stent implantation and follow-up angiograms were included in the study. The angiograms before, immediately after and at follow-up were analyzed retrospectively. The changes of the side branches covered by the stents were evaluated. Results: Although half the side branch covered by the stents was compromised, the acute occlusion was only around 10% immediately after the stenting. The differences were not significant among the three stents. At the follow-up, most of the occluded side branches were recanalized. There was no significant differences in the changes of stenosis of the side branch among the three stents, although severer stenosis was observed in the BMS. . However, when comparison was made between the side branches from the instent restenosis and those from the non restenotic segment, much better outcome was observed in the latter . Table 1 Changes of side branches in DES and BMS Table 2 Effects of instent restenosis on the late outcome of side branch

TCT-183 Is the “Culottes” Technique Safe and Effective for the Treatment of Bifurcation Lesions with the Use of Drug-Eluting Stents? Ioannis Iakovou, Flavio Airoldi, Iassen Michev, Matteo Montorfano, Giuseppe M Sangiorgi, John Cosgrave, Antonio Colombo, Carlo Di Mario EMO, Centro Cuore Columbus, Milano, Italy Background: In studies with bare metal stents the use of the “culottes” technique for the treatment of bifurcations has been associated with high rates of restenosis and adverse events. Data regarding this technique with the use of drug-eluting stents (DES) are limited. The aim of this study was to evaluate the immediate and long-term outcome of the “culottes” technique with DES. Methods: The “culottes” technique uses two stents and leads to full coverage of the ostium at the expense of an excess of metal covering the proximal end of the bifurcation. Final kissing balloon inflation is performed at the end of the procedure to optimize the final angiographic result. Between April 2002 to December 2004, 31 patients (31 bifurcations) were treated with the “culottes” technique with the use of DES (9 with sirolimous-eluting stents and 22 with paclitaxel-eluting stents). Thirty-six percent of the patients were diabetics and 27% had unstable angina; 18% of the bifurcations involved in-stent restenotic lesions. Results: Angiographic success was achieved in all patients. Non-Q

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Aggravated ostial stenosis Improved ostial stenosis Late occlusion

branch from instent restenosis n=95 26.32 (25/95) 10.53 (10/95) 5.88 (5/85)

branch from non restenosis n=563 4.82 (27/563) 19.54 (110/563) 0.78 (4/510)

P value 0.000 0.043 0.004

In conclusion, DES compromises side branch in the same way as the BMS. By inhibiting neointimal growth, however, it improves the late outcome of the side branches. TCT-185 Bifurcation Lesions in the Coronary Arteries: Early Experiences with a Novel 3-Dimensional Imaging and Quantitative Analysis before and after Stenting Danny Dvir1, Hadar Marom2, Ran Kornowski3 1 Sheeba Medical Center, Ramat Gan, Israel2Paieon Medical, Rosh Hayin, Israel3Rabin Medical Center, Petach-Tikva, Israel Background: Treating coronary bifurcation lesions is technically challenging. Conventional 2-dimensional angiography lacks the ability to image properly the true bifurcation geometry or its plaque distribution. The objectives of this study were 1) to reconstruct in

The American Journal of Cardiology© OCTOBER 16-21, 2005 TCT ABSTRACTS/Poster

MONDAY 10/17/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) 3-dimensions (3D) coronary bifurcation lesions, and 2) to analyze geometrical changes before and immediately following stenting. Methods: The CardiOp (Paieon Medical) is a system for 3D reconstruction of the coronary vessels. We conducted a retrospective evaluation of 27 patients (74% men, age 71±13 years) with bifurcation lesions in the coronary arteries undergoing angioplasty procedures. Angulations between bifurcation branches were measured, before and after stenting. Results: Of the 27 bifurcations studied, 26 were successfully reconstructed. Side branch involvement was found in 67% of the cases. Pre and post-stenting comparison was evaluated in 18 cases with excellent imaging. Angulation between the distal main branch and the side branch before stenting was significantly higher than that measured after stenting (71°±17 and 58°±18, respectively; p<0.01). There were no other significant changes in the geometry after stenting. Conclusion: 3D reconstructions may provide new insight into bifurcation analysis in space. These algorithms may serve as an important tool for planning of interventional procedures and accurate appreciation of interventional results in complex bifurcation lesions scenario.

TCT-187 Incidence and Implications of Incomplete “Crush” Stent Apposition after Sirolimus-Eluting Treatment of Coronary Bifurcation Lesions - An Intravascular Ultrasound (IVUS) Analysis Ricardo A Costa, Stephane G Carlier, Gary S Mintz, Kenichi Fujii, Jose Ribamar Costa, Jr., Masashi Kimura, Koichi Sano, Kaoru Tanaka, Ecaterina Cristea, Yangbo Na, Alexandra J Lansky, George D Dangas, Roxana Mehran, Michael Collins, Edward M Kreps, Gregg W Stone, Jeffrey W Moses, Martin B Leon Cardiovascular Research Foundation and Columbia University Medical Center, New York, NY Objective: Bench studies report incomplete apposition of stent struts at the carina after crush bifurcation stenting. Methods: 25 pts had IVUS in both the main vessel (MV) and side branch (SB) after successful crush stenting+final kissing inflations. Incomplete crushing (IC) was defined as incomplete apposition of SB or MV stent struts against the MV wall proximal to the carina (Figure). Results: In 20 non-LM lesions, IC was found in 60%. IC was associated with stent underexpansion at the SB ostium (Table). Conclusions: IC of stent struts against the MV wall proximal to the carina is a common finding after crush stenting in non-LM bifurcation lesions and is associated with SM ostial stent underexpansion. IC may affect drug delivery and, especially in the setting of ostial SB underexpansion, contribute to restenosis. Variable

TCT-186 No Touch is as Effective as Stenting and Ballooning in Managing Compromised Side Branch Luyue Gai, Sr. Chinese PLA General Hospital, Beijing, China Background Stenting across a side branch results in ostial compromise in 50% of patients. Various interventional techniques have been invented to reduce the ostial stenosis without much benefit. We hypothesized that side branches had extensive collateral communication with neighboring vessels; therefore they might not need treatment even if they were compromised. Methods Seventy-eight patients with compromised side branch (>2mm ) after stenting were included in the study. The No Touch management was compared with stenting and ballooning. Pts were followed by clinic visit and coronary angiography 6 months after the procedure. Results The best immediate results were achieved with the stenting, followed by PTCA and No Touch. At the follow-up, however, the side branch stenosis in the stenting group increased from 10.0±21.2% to 53.3±41.1%. It remained almost unchanged in the PTCA and No Touch groups. There were no significant differences in the MACE among the three groups . Although DES improved the long term angiographic results, MACE were almost the same . The Effects of DES on the ostial stenosis in the side branches

Stenting group (N=17) PTCA group (N=14) No touch (N=47) P value

Side branch ostial stenosis% Baseline* Immediately Follow-up 64.05±20.59 10.00±21.21 53.37±41.11 82.14±17.18 57.5±28.87 46.43±32.49 76.21±20.59 76.21±20.59 68.39±26.27 0.077 0.000 0.057

p Main Vessel (MV) value IC CC

Side Branch (SB) p value IC CC

IVUS Proximal Reference EEM CSA, mm2 12.1±6.3 0.5 Lumen CSA, mm2 8.4±4.0 7.0±3.6 0.5 Distal Reference 2 EEM CSA, mm 9.4±4.6 10.4±5.5 0.7 7.0±3.5 6.9±3.7 Lumen CSA, mm2 7.2±3.4 6.9±3.3 0.9 5.3±2.6 4.9±2.6 Minimum Stent CSA, mm2 6.3±1.7 6.8±2.1 0.6 3.9±0.9 4.1±1.3 SB Ostium (5mm) Stent 4.2±0.8 4.3±1.6 CSA, mm2 Stent Expansion, % 0.3 77.1±7.6 IC=incomplete crush; CC=complete crush; EEM=external elastic membrane; CSA=cross-sectional area

1.0 0.8 0.7 0.9 0.04

A B S T R A C T S

MACE% 52.94 28.57 38.98 0.412

* After main vessel stenting and before treatment of side branch. Conclusion Stenting of the side branch with BMS is worse than the PTCA and No Touch in terms of long-term angiographic results. Stenting with DES improves the angiographic results, but has no significant clinical benefit in comparison to PTCA and No Touch..

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MONDAY 10/17/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) TCT-188 Cardiac Troponin T and I and Creatine Kinase-MB as Markers of Myocardial Injury Following Routine Stenting of both Main Vessel and Side Branch versus Optional Side Branch Stenting in Bifurcation Lesions Kjell Nikus1, Saila Vikman1, Matti Niemelä2, Stefan James3, Jens Flensted Lassen4, Andrejs Erglis5, Jan Skov Jensen6, Terje Steigen7, Pål Gunnes8, Jens Aaroe9, Antti Ylitalo10, Steffen Helqvist11, Iwar Sjögren12, Oliver Meyerdierks13, Leif Thuesen4, for the Nordic Bifurcation Study Group 1 Heart Center Tampere University Hospital, Tampere, Finland2Oulu University Hospital, Oulu, Finland3Uppsala University Hospital, Uppsala, Sweden4Aarhus University Hospital, Aarhus, Denmark5Latvian Centre of Cardiology, Riga, Latvia6Gentofte Hospital, Hellerup, Denmark7Tromsö University Hospital, Tromsö, Norway8Feiring Heart Clinic, Feiring, Norway9Aalborg Hospital, Aalborg, Denmark10Central Hospital in Pori, Pori, Finland11Rigshospitalet, Copenhagen, Denmark12Falun Hospital, Falun, Sweden13Ullevål Hospital, Oslo, Norway

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Background: Treatment strategies of bifurcation lesions may differ in respect to rate of rise in biochemical markers of myocardial damage. Methods: A randomized Nordic multicenter study of sirolimus-eluting stents compared routine stenting of both main vessel and side branch (MV+SB) with a strategy of routine main vessel stenting and optional treatment of side branch (MV). ST-elevation myocardial infarction (MI) patients (<24 h) were excluded. CK-MB and/or TnT/I were measured before and 12-18 h post-procedure. Preliminary data from 200 patients is reported. Complete data of 414 patients will be presented at the TCT. Results: Twenty patients were excluded because marker values after the procedure were missing. There was no statistically significant difference between the two groups in the proportion of patients with any or more than 3-fold post-procedural rise of CK-MB and/or TnT/I (Table). An inhospital major adverse cardiac event (cardiac death, stent thrombosis, procedure related MI, target lesion revascularization) occurred in 12/91 (13%) in the MV+SB group and in 6/89 (7%) in the MV group, p=0.216. Conclusion: After bifurcation stenting, any elevation of myocardial biomarkers is frequent, while in-hospital major adverse cardiac events are rare, independent of stent technique. Stenting of both main vessel and side branch compared to stenting of main vessel with optional stenting of side branch appears to be more often associated with minor myocardial damage and early clinical events.

N Biomarkers elevated preprocedure Biomarkers with >3x increase post-procedure No elevation of biomarkers Any elevation of biomarkers

Stent in main vessel and side branch 91 22 (24%)

Stent in main vessel only 89 20 (23%)

23 (25%) 50 (55%) 41 (45%)

17 (19%) 57 (64%) 32 (36%)

p-value NS NS NS NS

TCT-189 Procedural and Long-Term Results of Taxus Stent in Complex Bifurcation Lesions. A Single Center Registry Gabriele L F Gasparini, Guido Belli, Paolo Pagnotta, Dennis Zavalloni, Marco L. Rossi, Marco Ferlini, Annachiara Aldrovandi, Melania Scatturin, Patrizia Presbitero Isituto Clinico Humanitas, Rozzano - Milano, Italy Background: Treatment of bifurcation lesions with paclitaxel-eluting stents (PES) is still associated with a high restenosis rates. In fact, several techniques have been tested with variable results. In-stent restenotic bifurcation lesions represent a very difficult subset to treat, with long term efficacy of PES still unknown. A prospective single-center registry was established to evaluate the efficacy of PES in the treatment of complex true bifurcation

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lesions and in the subgroup of patients with in-stent bifurcation restenosis. Methods: A total of 123 patients with 126 bifurcation lesion treated with PESstents (defined as >50% stenosis in both vessels) were prospectively included in our registry. Bifurcation lesion were treated with two strategies: stenting of both vessels or stenting of the parent vessel and balloon angioplasty of the side branch. Combined antiplatelet therapy was continued for 12 months. Immediate and long-term clinical and angiographic outcome (mean followup: 9 months) was analyzed in the whole population and in the subgroup of patients treatd in bifurcations at the site of previuos in-stent restenosis Results: See Table for results. Overall Patients Bifurcations - treated with 1 stent - treated with 2 stents Diabetes Mean lesion length (mm) Mean main vessel diameter (mm) Mean side branch diameter (mm) Mean stent length (mm) Mean stent diameter (mm) Angiographic success Procedural MACE Restenosis rate: - both vessels - parent vessel alone - side branch alone TLR (any vessel)

123 126 88 (70%) 38 (30%) 42 (36.5%) 13.9 3.0 2.4 19.9 3.01 99.5% 0% 8% 5.5% 4.75% 0% 8%

Group 1 True Bifurcation 90 93 76 (82%) 17 (18%) 29 (33%) 12.7 3.04 2.5 18.7 3.05 99% 0% 9.5% 4.75% 4.75% 0% 9.5%

Group 2 Restenotic Bifurcation 33 33 12 (36%) 21 (64%) 13 (40%) 15.2 2.96 2.3 20.9 2.96 100% 0% 6.3% 6.3% 0% 0% 6.3%

MACE: major adverse cardiac events; TLR: target lesion revascularization. Conclusion: Treatment of high risk bifurcation lesions with the Taxus stent is feasible, with high success rates and adequate access to the side branch. In-stent restenotic lesions at bifurcations can also be successfully treated with comparable results. TCT-190 Outcome of Drug-Eluting Stents for Coronary Bifurcations: Insight Into the Crushed Stent Technique Vinod Raxwal1, Kamal Gupta2, Robert Candipan1, James Vacek1, Peter Tadros1 1 Kansas University Medical Center, Kansas City,, KS;2Kansas City VA Medical Center/Kansas University, Kansas City,, KS Background: Drug eluting stents (DES) have demonstrated marked reduction in restenosis following percutaneous coronary intervention (PCI) of non-bifurcation lesions. Utilization of DES in bifurcation lesions employing “Crushed Stent Technique” has not been well studied. Methods: We studied patients with bifurcation lesions who underwent PCI using crush technique with DES in our laboratory from 2003 to 2005. A total of 65 patients (49 male, 16 female) with mean age 64 ± 12 years were studied. Results: Mean follow up was 7 ± 5 months. HTN was present in 74%, diabetes in 28%, dyslipidemia in 94% and 20% were currently smoking. Average length of stented segment was 58 ± 25 mm with total stents 3 ± 1. Stress testing was performed for evaluation of angina in 42% patients. Coronary angiogram was performed in 25% patients. During the follow up period 13(20%) patients had restenosis, the crushed stent arm had significant restenosis in all patients and 44% of them had significant restenosis in both limbs. Restenosis rate was 18% without a final kiss balloon dilatation versus 21% with a final kiss balloon dilatation (p=NS). One patient had a subacute stent thrombosis. One patient had an acute stent thrombosis who also had thrombosis of a non-bifurcation stent. Fifteen percent patients underwent target vessel revascularization of which 4(40%) had CABG. Conclusion: The crush technique for bifurcating lesions seems to be an effective treatment-utilizing DES. Final Kiss Balloon dilatation did not appear to affect the restenosis rate.

The American Journal of Cardiology© OCTOBER 16-21, 2005 TCT ABSTRACTS/Poster

MONDAY 10/17/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) Outcome of Drug-Eluting Stents for Coronary Bifurcations N Restenosis Final Kiss balloon dilatation Restenosis No Final Kiss balloon dilatation Target Vessel Revascularization Sirolimus eluting stent Final Kiss balloon dilatation Restenosis Paclitaxel eluting stent Final Kiss balloon dilatation Restenosis

65 10(21%) 3(18%) 10(15%) 33(51%) 26(79%) 6(18%) 32(49%) 22(69%) 7(22%)

TCT-191 Impact of Guidewire Positioning on Stent Expansion in Bifurcation Lesions Mamoru Nanasato1, Campbell Rogers2, Haruo Hirayama1 1 Nagoya Daini Red Cross Hospital, Nagoya, Japan2Brigham and Women’s Hospital, Boston, MA Background: Bifurcation stenting has traditionally produced relatively poor results. Little information exists concerning how the site of guidewire entry into a “jailed” side branch may effects stent configuration and lumen area. Methods: An in vitro experiment was performed in a bifurcation model. A balloon expandable stent was deployed in the main vessel across the side branch opening. In 5 cases, a guidewire was advanced into the side branch through a stent cell overlying the proximal aspect of the side branch opening. In another 5 cases, a guidewire was advanced through s stent cell overlying the distal aspect of the side branch opening. A second balloon catheter was then inflated within stent struts at the ostium of the side branch. Intravascular ultrasound (IVUS) was performed to measure minimal stent or lumen cross-sectional area (CSA). Subsequently, the stent was dilated with kissing balloon inflation, and IVUS again performed. Results: After balloon inflation at the ostium of the side branch, IVUS showed that stent struts protruded into the main vessel in all cases of the proximal guidewire group. The distal guidewire group had significantly larger minimal stent CSA after side branch balloon inflation (11.84 ± 0.80mm2 vs. 9.37 ± 0.85mm2, p = 0.0015). Kissing balloon inflation reduced the protrusion of the stent struts into the main vessel in the proximal guidewire group, resulting in equivalent minimal stent CSA on both groups (12.55 ± 0.91mm2 vs. 11.42 ± 1.21 mm2, p = 0.13). Conversely, kissing balloon inflation significantly reduced side branch minimal lumen CSA in the proximal guidewire group from 6.39 ± 0.14 mm2 to 6.51 ± 0.54 mm2 (p = 0.013), leaving significantly larger side branch minimal lumen CSA in the distal guidewire group (6.35 ± 0.21 mm2 vs. 5.61 ± 0.54 mm2, p = 0.02). Conclusions: The point of passage of a guidewire into a “jailed” side branch influenced the stent deformity and minimal lumen CSA in the side branch even after kissing balloon inflation. TCT-192

bifurcation lesions were included : age 65±11 years, diabetes 28%, multivessels diseases 63% and unstable angina 36%. The lesion involved the LAD-Diagonal bifurcation in 62 % of cases, and was a Type 1 or 4 (true bifurcation lesion) in 76% of cases. The MB was stented in 100% of cases (stent length 20.5±5.5 mm), SB in 15% (stent length 11.3 ± 2.8 mm). Final kissing balloon inflation was performed in 85% of cases. Angiographic success was obtained in 99% for the MB, and 87% for both branches (Table1). In hospital, 3 patients died (2 had hemoragic complications), 10 had non Q-wave MI (4.4%), 1 had Q-wave MI (0.4%). For the first 92 patients at 8 month follow-up, 2 died suddenly, there was no additional MI. The target lesion revascularisation (TLR) rate was 3.2%. Conclusion : Preliminary results suggest that treatment of bifurcation lesions with PES using a SB PTS approach in the real world, is safe and effective, with a very promising rate of TLR. Table 1 : RVD : reference vessel diameter, MLD : minimal luminal diameter Lesion Length MLD pre MLD post MLD post MLD post 12.8±5.3 0.76±0.46 2.72±0.49 2.72±0.49 2.72±0.49 5.7±5.3 1.12±0.71 1.98±0.91 1.98±0.91 1.98±0.91

TCT-193 Bifurcation Stenting with the Crush Technique is Associated with a High Adverse Event Rate if Used to Treat the Distal Left Main Stem Angela Hoye1, Ioannis Iakovou2, Lei Ge2, Carlos A G van Mieghem3, Andrew T L Ong3, John Cosgrave2, Giuseppe M Sangiorgi2, Flavio Airoldi2, Matteo Montorfano2, Iassen Michev2, Alaide Chieffo2, Mauro Carlino2, Nicola Corvaja2, Jiro Aoki3, Gaston A Rodriguez Granillo3, Marco Valgimigli3, Georgios Sianos3, Willem J van der Giessen3, Pim J de Feyter3, Patrick W Serruys3, Antonio Colombo2 1 Castle Hill Hospital, Kingston-upon-Hull, United Kingdom2EMO Centro Cuore Columbus, Milan, Italy3Thoraxcenter, Rotterdam, The Netherlands Introduction: The “crush” technique has been proposed as a strategy utilizing drug-eluting stents that ensures complete coverage of bifurcation lesions, however, the long-term outcomes are unknown. Methods and Results: We identified 231 consecutive patients who underwent “crush” stenting for 241 de novo bifurcation lesions. Sirolimuseluting stents were used in 137(56.8%), and paclitaxel-eluting stents in 104(43.2%). Therapy was undertaken in the left main stem (LMS) in 47 (20.3%) patients. At 9 months, the overall rate of survival-free of target lesion revascularization (TLR) was 90.3%; the only independent predictor of TLR was LMS therapy (OR 4.97; 95%CI 2.00 to 12.37, p=0.001). Conclusions: The crush technique of bifurcation stenting with drug-eluting stents is associated with a low rate of TLR for most lesions; however, efficacy appears significantly reduced in LMS bifurcation lesions, and further research is needed before the technique can be routinely recommended in this group.

Provisional T-Stenting Strategy Using Paclitaxel-Eluting Stent for Coronary Bifurcation Lesion Treatment. The SURF Registry O. Darremont1, P. Brunel2, T. Lefèvre3, J. Balcells3, Jl. Leymarie1, B. Fischer1, E. Bressolette2, Y. Louvard3, MC. Morice3 1 Clinique St Augustin, Bordeaux, France2NCN, Nantes, France3ICPS, Massy, France Background: « Side branch (SB) provisional T stenting (PTS)» is a simple and effective technique for coronary bifurcation lesion treatment using bare metal stents. The safety and effectiveness of this strategy using paclitaxel-eluting stent (PES) remains unknown. Methods: Data were collected in all consecutive patients treated with PES with a PTS strategy, excluding acute MI and distal left main lesion. The acute clinical and angiographic results and the 8-month clinical status coupled with stress test were assessed. Results: Between january and december 2004, 224 patients with 227

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