Comparison of Zotarolimus-Eluting and Everolimus-Eluting Coronary Stents

作者：Patrick W.J.C. Serruys, Sigmund Silber, Scot Garg, Robert‐Jan van Geuns, Gert Richardt, Paweł Eugeniusz Buszman, Henning Kelbæk, Adrianus Johannes van Boven, Sjoerd H. Hofma, Axel Hans-Peter Linke, Volker Klauß, William C. Wijns, Carlos Macaya, Philippe Garot, Carlo Di Mario, Ganesh Manoharan, Ran Kornowski, Thomas A. Ischinger, Antonio Luca Bartorelli, Jacintha E. Ronden, Marco Bressers, Pierre Gobbens, Manuela Negoita, Frank N. van Leeuwen, Stephan Windecker · 发表于：New England Journal of Medicine · 年份：2010 · DOI：10.1056/nejmoa1004130 · 被引用次数：670 · 研究领域：Coronary Interventions and Diagnostics、Cardiac Imaging and Diagnostics、Acute Myocardial Infarction Research

BACKGROUND: New-generation coronary stents that release zotarolimus or everolimus have been shown to reduce the risk of restenosis. However, it is unclear whether there are differences in efficacy and safety between the two types of stents on the basis of prospectively adjudicated end points endorsed by the Food and Drug Administration. METHODS: In this multicenter, noninferiority trial with minimal exclusion criteria, we randomly assigned 2292 patients to undergo treatment with coronary stents releasing either zotarolimus or everolimus. Twenty percent of patients were randomly selected for repeat angiography at 13 months. The primary end point was target-lesion failure, defined as a composite of death from cardiac causes, any myocardial infarction (not clearly attributable to a nontarget vessel), or clinically indicated target-lesion revascularization within 12 months. The secondary angiographic end point was the extent of in-stent stenosis at 13 months. RESULTS: At least one off-label criterion for stent placement was present in 66% of patients. The zotarolimus-eluting stent was noninferior to the everolimus-eluting stent with respect to the primary end point, which occurred in 8.2% and 8.3% of patients, respectively (P<0.001 for noninferiority). There were no significant between-group differences in the rate of death from cardiac causes, any myocardial infarction, or revascularization. The rate of stent thrombosis was 2.3% in the zotarolimus-stent group and 1.5% in the eve...