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2010 t4xicy2j tct lbct_press


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2010 t4xicy2j tct lbct_press

  1. 1. Two-Year Outcomes After Everolimus- or Sirolimus-Eluting Stents in Patients With Coronary Artery Diseasein the ISAR-TEST 4 Trial<br />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<br />Deutsches Herzzentrum & 1. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität, Munich. Germany<br />
  2. 2. Presenter Disclosure Information:<br />Nothing to disclose<br />
  3. 3. Intracoronary Stenting and Angiographic Results:Test Efficacy of 3 Limus-Eluting Stents - 4<br />2603 patients with de novo lesions<br />Biodegradable polymer DES<br />(BP-DES)<br />n=1299<br />Permanent polymer DES<br />(PP-DES:Xience & Cypher)<br />n=1304<br />6-8 month & 2 year FU angiography<br />24-month clinical follow-up<br />ISAR-TEST 4 Study Algorithm<br />Byrne et al. Eur Heart J 2009<br />
  4. 4. ISAR-TEST 4 EES vs. SES<br />1304 patients enrolled at 2 centres in Munich, Germany<br />Design<br /><ul><li>DESIGN: Investigator-initiated, industry-independent, randomized, two-center clinical trial
  5. 5. INCLUSION: </li></ul> Patients with de novo coronary artery stenosis ≥ 50% AND symptoms or objective evidence of ischaemia<br /><ul><li>EXCLUSION CRITERIA: Left main stem disease</li></ul> Cardiogenic shock<br />652 treated with EES (Xience)<br />652 treated with SES (Cypher)<br />Angio follow-up at 6-8 months in 77%†<br />Angio follow-up at 6 months in 79%†<br />Angio follow-up at 2 years in 70%†<br />Angio follow-up at 2 years in68%†<br />Clinical follow-up at 2 years in 94%*<br />Clinical follow-up at 2 years in 95%*<br />† of eligible<br />* of incomplete, median FU = 12 [3-16] mos<br />
  6. 6. 100<br />RR 0.85 [95% CI, 0.65-1.11], P=0.23<br />%<br />80<br />60<br />40<br />Sirolimus-eluting stent, 18.8%<br />20<br />Everolimus-eluting stent, 16.0%<br />0<br />0<br />2<br />4<br />6<br />8<br />10<br />12<br />14<br />16<br />18<br />20<br />22<br />24<br />Months after randomization<br />Cardiac Death, Target Vessel MI, TLR<br />
  7. 7. 5<br />RR 0.75 [95% CI, 0.32-1.78], P=0.52<br />%<br />4<br />3<br />Sirolimus-eluting stent, 1.9%<br />2<br />Everolimus-eluting stent, 1.4%<br />1<br />0<br />0<br />2<br />4<br />6<br />8<br />10<br />12<br />14<br />16<br />18<br />20<br />22<br />24<br />Months after randomization<br />Definite or Probable Stent Thrombosis<br />
  8. 8. Definite Stent Thrombosis<br />EES<br />(0.6%)<br />P=0.17<br />SES<br />(1.4%)<br />
  9. 9. 100<br />RR 0.73 [95% CI, 0.52-1.01], P=0.06<br />%<br />80<br />60<br />40<br />Sirolimus-eluting stent, 13.5%<br />20<br />Everolimus-eluting stent, 9.9%<br />0<br />0<br />2<br />4<br />6<br />8<br />10<br />12<br />14<br />16<br />18<br />20<br />22<br />24<br />Months after randomization<br />Target Lesion Revascularization<br />
  10. 10. <ul><li>In a randomized clinical trial with broad inclusion criteria, Xience EES and Cypher SES stents provide comparable clinical outcomes out to 2 years
  11. 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 finding</li></ul>Conclusions<br />
  12. 12. ISAR-TEST-4Deutsches Herzzentrum, Munich. Germany<br />Thank You<br />