Prospective, Randomized Trial of Paclitaxel- versus Sirolimus- Eluting Stents for Treatment of...

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Prospective, Randomized Trial of Paclitaxel- versus Sirolimus- Eluting Stents for Treatment of Coronary Restenosis in Sirolimus-Eluting Stents Robert A. Byrne, Julinda Mehilli, Klaus Tiroch, Stefanie Schulz, Steffen Massberg, Karl-Ludwig Laugwitz, Albert Schmig, Adnan Kastrati Deutsches Herzzentrum & 1. Medizinische Klinik, Klinikum rechts der Isar, Technische Universitt, Munich. Germany ISAR-DESIRE 2 Slide 2 ISAR DESIRE 2 Background The widespread adoption of DES therapy has led to significant absolute numbers of patients presenting with DES-restenosis It is estimated that up to 200,000 cases per annum occur in USA Slide 3 ISAR DESIRE 2 Background The optimal treatment strategy for in- stent restenosis is based on the axiom: maximize acute gain minimize late loss ISAR-DESIRE JAMA 2005; RIBS-II JACC 2006 TAXUS-V-ISR JAMA 2006; SISR JAMA 2006 In BMS-restenosis this has most effectively been accomplished by DES Slide 4 ISAR DESIRE 2 Background In DES-restenosis the most effective management strategy is unclear While repeat DES implantation seems preferable, optimal stent type is not known Different DES (hetero-DES) Same DES (homo-DES) Lee et al. AJC 2006; Cosgrave et al. AHJ 2007 Garg et al. CCI 2007; Byrne et al. Rev Esp Card 2008 Slide 5 ISAR DESIRE 2 Background SES have proven superior to PES in subsets of patients with high-risk features The comparative performance of both stents in SES treatment failure is not known ISAR-DESIRE JAMA 2005; ISAR-DIABETES NEJM 2005 SIRTAX NEJM 2005; ISAR-SMART-3 EHJ 2006; Schmig et al. JACC 2007 Slide 6 ISAR DESIRE 2 Study Objective To compare the anti-restenotic efficacy of SES (Cypher) versus PES (Taxus) in patients with SES-restenosis Slide 7 ISAR DESIRE 2 Study Organization 450 patients enrolled at two centres in Munich, Germany Angiographic follow-up at 6-8 months (84.8%) Clinical follow- up at 12 months Angiographic follow-up at 6-8 months (84.9%) SES (Cypher) n = 225 PES (Taxus) n = 225 Design DESIGN: Randomized, open- label, active-control trial INCLUSION CRITERIA: 1. In-SES restenosis > 50% 2. Symptoms/signs of ischaemia EXCLUSION CRITERIA: 1. Cardiogenic shock 2. Lesion in LMCA or graft 3. Acute myocardial infarction PRIMARY ENDPOINT: In-stent late loss Slide 8 ISAR DESIRE 2 Baseline Characteristics SES n = 225 PES n = 225 Age (years)66.467.1 Female20.825.7 Diabetes mellitus38.233.8 Clinical presentation Stable80.083.3 ACS20.016.7 Patients Numbers shown are percentages Slide 9 ISAR DESIRE 2 Baseline Characteristics SES n = 243 PES n = 240 Vessel size2.78 .47 2.75 .48 Lesion length12.7 8.3 12.5 7.7 Initial SES Cypher38.738.3 ISAR stent61.361.7 Lesions Numbers shown are meanSD or percentages Slide 10 ISAR DESIRE 2 Baseline Characteristics SES n = 243 (%) PES n = 240 (%) Focal margin21.018.8 Focal body37.534.6 Multifocal6.67.5 Diffuse/proliferative30.035.8 Occlusive4.93.3 Lesions Restenosis Morphology Slide 11 ISAR DESIRE 2 30-Day Results SES n = 225 PES n = 225 Death00.4 Myocardial infarction1.31.8 TLR 00 Death/MI/TLR 1.31.8 Stent thrombosis00 Numbers shown are percentages; P = ns for all comparisons Slide 12 ISAR DESIRE 2 Primary Endpoint P = 0.75 Late Luminal Loss mm Slide 13 ISAR DESIRE 2 Secondary Endpoint Binary Restenosis P = 0.69 % Slide 14 ISAR DESIRE 2 Secondary Endpoint TLR 0 10 20 30 40 50 0246810 12 rate, % months SES 16.6% PES 14.6% P = 0.52 Slide 15 ISAR DESIRE 2 Death, MI or Stent Thrombosis rate, % months 0 10 20 30 40 50 024681012 SES 6.1% P = 0.98 Safety Endpoint PES 6.3% Slide 16 ISAR DESIRE 2 Death, MI or TLR rate, % months 0 10 20 30 40 50 024681012 Major Adverse Cardiac Events P = 0.71 SES 20.4% PES 19.6% Slide 17 ISAR DESIRE 2 Conclusions Repeat DES implantation for DES- restenosis is safe out to 1 year In cases of SES-restenosis, both SES and PES are associated with a comparable degree of anti-restenotic efficacy Slide 18 ISAR DESIRE 2 Late Luminal Loss mm SES (Cypher) Efficacy ISAR-DESIRE JAMA 2005; ISAR-DIABETES NEJM 2005 ISAR-SMART-3 EHJ 2006 Slide 19 ISAR DESIRE 2 Conclusions Drug resistance at an individual patient level may play a contributory role in the somewhat lower anti-restenotic efficacy of SES in this study Slide 20 Thank You ISAR DESIRE 2