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American heart journal · Jan 2013
Randomized Controlled Trial Comparative StudyComparative efficacy of 2 zotarolimus-eluting stent generations: resolute versus endeavor stents in patients with coronary artery disease.
- Tomohisa Tada, Robert A Byrne, Salvatore Cassese, Lamin King, Stefanie Schulz, Julinda Mehilli, Albert Schömig, and Adnan Kastrati.
- Deutsches Herzzentrum, Technische Universität, Lazarettstrasse 36. Munich, Germany.
- Am. Heart J. 2013 Jan 1; 165 (1): 80-6.
BackgroundThe Resolute zotarolimus-eluting stent (R-ZES) utilizes the same metallic platform and anti-restenotic drug as the Endeavor zotarolimus-eluting stent (E-ZES) but is coated with a more biocompatible polymer with enhanced drug-release kinetics. The aim of this study was to compare the long-term clinical outcomes of 2 zotarolimus-eluting stent generations.MethodsIn two randomized trials with broad inclusion criteria (ISAR-TEST 2 and ISAR-TEST 5), 1,000 patients were treated with R-ZES and 339 patients treated with E-ZES. In both trials follow-up angiography was scheduled at 6 to 8 months. The efficacy endpoint of interest was target lesion revascularization and the safety endpoints were the combined incidence of cardiac death or myocardial infarction related to target vessel as well as the incidence of definite stent thrombosis at 2-year follow-up.ResultsThe incidence of target lesion revascularization at 2 years was 12.0% in the R-ZES group and 16.0% in the E-ZES (HR 0.72 [95% CI: 0.52-1.00], P = .052). The incidence of cardiac death or myocardial infarction was 5.5% vs. 4.8% (HR 1.15, [95% CI: 0.66-2.02], P = .62) and of definite stent thrombosis was 0.4% vs. 0.6% (HR 0.68, [95% CI: 0.12-3.72], P = .66), respectively. All measures of angiographic restenosis were in favor of the R-ZES; in-stent late lumen loss was 0.29 ± 0.56 with the R-ZES versus 0.58 ± 0.55 with the E-ZES (P < .0001).ConclusionsComparison of the 2 Food and Drug Administration-approved zotarolimus-eluting stents suggested that the R-ZES as compared to the E-ZES displayed overall superior antirestenotic efficacy. Both devices were associated with a similar low risk of adverse safety events through 2 years.Copyright © 2013 Mosby, Inc. All rights reserved.
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