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Two-Year Outcomes After Everolimus- or Sirolimus-Eluting Stents in Patients With Coronary Artery Diseasein the ISAR-TEST 4 Trial Robert A. Byrne, Adnan Kastrati, Klaus Tiroch, Steffen Massberg, Anna Wieczorek, Karl-Ludwig Laugwitz, Stefanie Schulz, Jürgen Pache, Massimiliano Fusaro, Melchior Seyfarth, Albert Schömig, Julinda Mehilli Deutsches Herzzentrum & 1. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität, Munich. Germany
Presenter Disclosure Information: Nothing to disclose
Intracoronary Stenting and Angiographic Results:Test Efficacy of 3 Limus-Eluting Stents - 4 2603 patients with de novo lesions Biodegradable polymer DES (BP-DES) n=1299 Permanent polymer DES (PP-DES:Xience & Cypher) n=1304 6-8 month & 2 year FU angiography 24-month clinical follow-up ISAR-TEST 4 Study Algorithm Byrne et al. Eur Heart J 2009
ISAR-TEST 4 EES vs. SES 1304 patients enrolled at 2 centres in Munich, Germany Design ,[object Object]
INCLUSION: 	Patients with de novo coronary artery stenosis ≥ 50% AND symptoms or objective evidence of ischaemia ,[object Object], 	Cardiogenic shock 652 treated with EES (Xience) 652 treated with SES (Cypher) Angio follow-up at 6-8 months in 77%† Angio follow-up at 6 months in 79%† Angio follow-up at 2 years in 70%† Angio follow-up at 2 years in68%† Clinical follow-up at 2 years in 94%* Clinical follow-up at 2 years in 95%* † of eligible * of incomplete, median FU = 12 [3-16] mos
100 RR 0.85 [95% CI, 0.65-1.11], P=0.23 % 80 60 40 Sirolimus-eluting stent, 18.8% 20 Everolimus-eluting stent, 16.0% 0 0 2 4 6 8 10 12 14 16 18 20 22 24 Months after randomization Cardiac Death, Target Vessel MI, TLR
5 RR 0.75 [95% CI, 0.32-1.78], P=0.52 % 4 3 Sirolimus-eluting stent, 1.9% 2 Everolimus-eluting stent, 1.4% 1 0 0 2 4 6 8 10 12 14 16 18 20 22 24 Months after randomization Definite or Probable Stent Thrombosis
Definite Stent Thrombosis EES (0.6%) P=0.17 SES (1.4%)
100 RR 0.73 [95% CI, 0.52-1.01], P=0.06 % 80 60 40 Sirolimus-eluting stent, 13.5% 20 Everolimus-eluting stent, 9.9% 0 0 2 4 6 8 10 12 14 16 18 20 22 24 Months after randomization Target Lesion Revascularization
[object Object]

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Two-Year Outcomes After Everolimus- or Sirolimus-Eluting Stents in ISAR-TEST 4 Trial

  • 1. Two-Year Outcomes After Everolimus- or Sirolimus-Eluting Stents in Patients With Coronary Artery Diseasein the ISAR-TEST 4 Trial Robert A. Byrne, Adnan Kastrati, Klaus Tiroch, Steffen Massberg, Anna Wieczorek, Karl-Ludwig Laugwitz, Stefanie Schulz, Jürgen Pache, Massimiliano Fusaro, Melchior Seyfarth, Albert Schömig, Julinda Mehilli Deutsches Herzzentrum & 1. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität, Munich. Germany
  • 2. Presenter Disclosure Information: Nothing to disclose
  • 3. Intracoronary Stenting and Angiographic Results:Test Efficacy of 3 Limus-Eluting Stents - 4 2603 patients with de novo lesions Biodegradable polymer DES (BP-DES) n=1299 Permanent polymer DES (PP-DES:Xience & Cypher) n=1304 6-8 month & 2 year FU angiography 24-month clinical follow-up ISAR-TEST 4 Study Algorithm Byrne et al. Eur Heart J 2009
  • 4.
  • 5.
  • 6. 100 RR 0.85 [95% CI, 0.65-1.11], P=0.23 % 80 60 40 Sirolimus-eluting stent, 18.8% 20 Everolimus-eluting stent, 16.0% 0 0 2 4 6 8 10 12 14 16 18 20 22 24 Months after randomization Cardiac Death, Target Vessel MI, TLR
  • 7. 5 RR 0.75 [95% CI, 0.32-1.78], P=0.52 % 4 3 Sirolimus-eluting stent, 1.9% 2 Everolimus-eluting stent, 1.4% 1 0 0 2 4 6 8 10 12 14 16 18 20 22 24 Months after randomization Definite or Probable Stent Thrombosis
  • 8. Definite Stent Thrombosis EES (0.6%) P=0.17 SES (1.4%)
  • 9. 100 RR 0.73 [95% CI, 0.52-1.01], P=0.06 % 80 60 40 Sirolimus-eluting stent, 13.5% 20 Everolimus-eluting stent, 9.9% 0 0 2 4 6 8 10 12 14 16 18 20 22 24 Months after randomization Target Lesion Revascularization
  • 10.
  • 11. While there was a trend towards superior antirestenotic efficacy with Xience EES, specifically-powered studies are needed to evaluate the clinical significance of this findingConclusions