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J Am Coll Cardiol. 2013;61(5):536-44.

Safety and efficacy of second-generation everolimus-eluting Xience V stents versus zotarolimus-eluting resolute stents in real-world practice: patient-related and stent-related outcomes from the multicenter prospective EXCELLENT and RESOLUTE-Korea registries.

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제1저자 박경우 · 교신저자 김효수

소속 (1)
  1. Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.

Abstract

OBJECTIVES This study sought to compare the safety and efficacy of the Xience V/Promus everolimus-eluting stent (EES) (Abbott Vascular, Temecula, California) with the Endeavor Resolute zotarolimus-eluting stent (ZES-R) (Medtronic Cardiovascular, Santa Rosa, California) in "all-comer" cohorts.

BACKGROUND Only 2 randomized controlled trials have compared these stents.

METHODS The EXCELLENT (Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting) and RESOLUTE-Korea registries prospectively enrolled 3,056 patients treated with the EES and 1,998 patients treated with the ZES-R, respectively, without exclusions. Stent-related composite outcomes (target lesion failure [TLF]) and patient-related composite outcomes were compared in crude and propensity score-matched analyses.

RESULTS Of 5,054 patients, 3,830 (75.8%) had off-label indication (2,217 treated with EES and 1,613 treated with ZES-R). The stent-related outcome (82 [2.7%] vs. 58 [2.9%], p = 0.662) and the patient-related outcome (225 [7.4%] vs. 153 [7.7%], p = 0.702) did not differ between EES and ZES-R, respectively, at 1 year, which was corroborated by similar results from the propensity score-matched cohort. The rate of definite or probable stent thrombosis (18 [0.6%] vs. 7 [0.4%], p = 0.306) also was similar. In multivariate analysis, off-label indication was the strongest predictor of TLF (adjusted hazard ratio: 2.882; 95% confidence interval: 1.226 to 6.779; p = 0.015).

CONCLUSIONS In this robust real-world registry with unrestricted use of EES and ZES-R, both stents showed comparable safety and efficacy at 1-year follow-up. Overall incidences of TLF and definite stent thrombosis were low, even in the patients with off-label indication, suggesting excellent safety and efficacy of both types of second-generation drug-eluting stents.

Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

그 밖의 정보
출판 형태
Comparative Study, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't
저널
Journal of the American College of Cardiology · eISSN 1558-3597
전자 출판
2012-12-26
MeSH
Aged · Cohort Studies · Coronary Thrombosis / epidemiology / prevention & control · Drug-Eluting Stents / adverse effects · Everolimus · Female · Follow-Up Studies · Humans · Korea / epidemiology · Male · Middle Aged · Prospective Studies · Registries · Sirolimus / administration & dosage / adverse effects / analogs & derivatives · Treatment Outcome
Substances
Everolimus · zotarolimus · Sirolimus