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Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: the Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting (EXCELLENT) randomized, multicenter study.

Authors
 Hyeon-Cheol Gwon  ;  Joo-Yong Hahn  ;  Kyung Woo Park  ;  Young Bin Song  ;  In-Ho Chae  ;  Do-Sun Lim  ;  Kyoo-Rok Han  ;  Jin-Ho Choi  ;  Seung-Hyuk Choi  ;  Hyun-Jae Kang  ;  Bon-Kwon Koo  ;  Taehoon Ahn  ;  Jung-Han Yoon  ;  Myung-Ho Jeong  ;  Taek-Jong Hong  ;  Woo-Young Chung  ;  Young-Jin Choi  ;  Seung-Ho Hur  ;  Hyuck-Moon Kwon  ;  Dong-Woon Jeon  ;  Byung-Ok Kim  ;  Si-Hoon Park  ;  Nam-Ho Lee  ;  Hui-Kyung Jeon  ;  Yangsoo Jang  ;  Hyo-Soo Kim 
Citation
 CIRCULATION, Vol.125(3) : 505-513, 2012 
Journal Title
CIRCULATION
ISSN
 0009-7322 
Issue Date
2012
Keywords
drug-eluting stents ; platelet aggregation inhibitors ; stents ; thrombosis
Abstract
BACKGROUND: The optimal duration of dual antiplatelet therapy (DAPT) after implantation of drug-eluting coronary stents remains undetermined. We aimed to test whether 6-month DAPT would be noninferior to 12-month DAPT after implantation of drug-eluting stents.

METHODS AND RESULTS: We randomly assigned 1443 patients undergoing implantation of drug-eluting stents to receive 6- or 12-month DAPT (in a 1:1 ratio). The primary end point was a target vessel failure, defined as the composite of cardiac death, myocardial infarction, or ischemia-driven target vessel revascularization at 12 months. Rates of target vessel failure at 12 months were 4.8% in the 6-month DAPT group and 4.3% in the 12-month DAPT group (the upper limit of 1-sided 95% confidence interval, 2.4%; P=0.001 for noninferiority with a predefined noninferiority margin of 4.0%). Although stent thrombosis tended to occur more frequently in the 6-month DAPT group than in the 12-month group (0.9% versus 0.1%; hazard ratio, 6.02; 95% confidence interval, 0.72-49.96; P=0.10), the risk of death or myocardial infarction did not differ in the 2 groups (2.4% versus 1.9%; hazard ratio, 1.21; 95% confidence interval, 0.60-2.47; P=0.58). In the prespecified subgroup analysis, target vessel failure occurred more frequently in the 6-month DAPT group than in the 12-month group (hazard ratio, 3.16; 95% confidence interval, 1.42-7.03; P=0.005) among diabetic patients.

CONCLUSIONS: Six-month DAPT did not increase the risk of target vessel failure at 12 months after implantation of drug-eluting stents compared with 12-month DAPT. However, the noninferiority margin was wide, and the study was underpowered for death or myocardial infarction. Our results need to be confirmed in larger trials.

CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00698607.
Files in This Item:
T201200104.pdf Download
DOI
10.1161/CIRCULATIONAHA.111.059022
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kwon, Hyuck Moon(권혁문) ORCID logo https://orcid.org/0000-0001-9901-5015
Jang, Yang Soo(장양수) ORCID logo https://orcid.org/0000-0002-2169-3112
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/89949
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