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Two-Year Outcomes After Everolimus- or Sirolimus-Eluting Stents in Patients With Coronary Artery Disease in the ISAR-TEST 4 Trial.

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  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. Background Cardiac death, TV MI, TLR, % Death, MI, TVR (%) RR 0.62 [95% CI 0.46-0.82]; P= 0.001 RR 0.69 [95% CI 0.50-0.95]; P= 0.02 • In head-to-head randomized trials, everolimus-eluting stent (EES; Xience) has proven superior to the pacliaxel-eluting stent (PES; Taxus) Xience EES Taxus PES Xience EES Taxus PES SPIRIT IV Stone et al. NEJM 2010 COMPARE Kedhi et al. Lancet 2010

  4. Background • Significant differences exist between first-generation DES • A more appropriate comparator device is sirolimus-eluting stent (SES; Cypher) due to its high antirestenotic efficacy and its similar limus-based drug-elution strategy Schömig JACC 2007; Stettler Lancet 2007; Gurm AHJ 2008

  5. ISAR-TEST 4 Study Algorithm 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 Byrne et al. Eur Heart J 2009

  6. Objectives of ISAR-TEST 4 Primary:To compare the efficacy of biodegradable polymer DESagainst permanent polymer DES Secondary:To compare the efficacy of – everolimus-eluting stent (Xience) and – sirolimus-eluting stent (Cypher) Byrne et al. Eur Heart J 2009

  7. ISAR-TEST 4 EES vs. SES 1304 patients enrolled at 2 centres in Munich, Germany Design • DESIGN: Investigator-initiated, industry-independent, randomized, two-center clinical trial • INCLUSION: • Patients with de novo coronary artery stenosis ≥ 50% AND symptoms or objective evidence of ischaemia • EXCLUSION CRITERIA: Left main stem disease • 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

  8. ISAR-TEST 4 Endpoints Primary:Composite of cardiac death, target vessel MI or TLR at 2 years Secondary:All cause mortality Stent thrombosis (ARC definite/probable) Binary restenosis (in-segment) Late luminal loss (in-stent)

  9. Baseline clinical characteristics, I

  10. Baseline clinical characteristics, II * Due to rounding totals do not equal 100

  11. Angiographic characteristics

  12. Procedural characteristics

  13. Cardiac Death, Target Vessel MI, TLR 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

  14. All Cause Death 10 RR 0.93 [95% CI, 0.61-1.43]; P=0.75 % 8 Sirolimus-eluting stent, 6.7% 6 Everolimus-eluting stent, 6.4% 4 2 0 0 2 4 6 8 10 12 14 16 18 20 22 24 Months after randomization

  15. Definite or Probable Stent Thrombosis 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

  16. Definite Stent Thrombosis EES (0.6%) P=0.17 SES (1.4%)

  17. Target Lesion Revascularization 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

  18. Target Lesion Revascularization P=0.25 % Δ = 1.8% Δ = 2.8% 1 yr 2 yrs 1 yr 2 yrs EES SES

  19. Binary Angiographic Restenosis P=0.03 % 6-8 m 2 yrs* 6-8 m 2 yrs* EES SES * = composite

  20. Binary Angiographic Restenosis P=0.37 % Δ = 2.6% Δ = 3.5% 6-8 m 2 yrs* 6-8 m 2 yrs* EES SES * = composite

  21. Late Lumen Loss to 2 Years n=805 lesions With paired angiogaphic FU 0.5 mm P=0.59 0.4 SES 0.31±.58 0.3 P=0.15 SES 0.17±.33 EES 0.29±.51 0.2 0.1 EES 0.14±.41 0 Data are mean ± SEM Post-PCI 6-8-month 2-year

  22. Conclusions • In a randomized clinical trial with broad inclusion criteria, EES (Xience) and SES (Cypher) provide comparable clinical outcomes out to 2 years • While there was a trend towards superior antirestenotic efficacy with EES (Xience), specifically-powered studies are needed to evaluate the clinical significance of this finding

  23. ISAR-TEST-4Deutsches Herzzentrum, Munich. Germany Thank You

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