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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 ; Hyo-Soo Kim ; Yangsoo Jang ; Hui-Kyung Jeon ; Nam-Ho Lee ; Si-Hoon Park ; Byung-Ok Kim ; Dong-Woon Jeon ; Hyuck-Moon Kwon ; Seung-Ho Hur ; Young-Jin Choi ; Woo-Young Chung ; Taek-Jong Hong ; Myung-Ho Jeong ; Jung-Han Yoon ; Taehoon Ahn ; Bon-Kwon Koo ; Hyun-Jae Kang ; Seung-Hyuk Choi ; Jin-Ho Choi ; Kyoo-Rok Han ; Do-Sun Lim ; In-Ho Chae ; Young Bin Song ; Kyung Woo Park 
Citation
 Circulation, Vol.125(3) : 505~513, 2012 
Journal Title
 Circulation 
ISSN
 0009-7322 
Issue Date
2012
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.
URI
http://ir.ymlib.yonsei.ac.kr/handle/22282913/89949
DOI
10.1161/CIRCULATIONAHA.111.059022
Appears in Collections:
1. 연구논문 > 1. College of Medicine > Dept. of Internal Medicine
Yonsei Authors
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