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

Hyeon-Cheol GwonJoo-Yong HahnKyung Woo ParkYoung Bin SongIn-Ho ChaeDo-Sun LimKyoo-Rok HanJin-Ho ChoiSeung-Hyuk ChoiHyun-Jae KangBon-Kwon KooTaehoon AhnJung-Han YoonMyung-Ho JeongTaek-Jong HongWoo-Young ChungYoung-Jin ChoiSeung-Ho HurHyuck-Moon KwonDong-Woon JeonByung-Ok KimSi-Hoon ParkNam-Ho LeeHui-Kyung JeonYangsoo JangHyo-Soo Kim
Keimyung Author(s)
Dept. of Internal Medicine (내과학)
Issue Date
School of Medicine
Circulation, Vol.125(3) : 505-513, 2012
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: Unique identifier: NCT00698607. Key Words: drug-eluting stents platelet aggregation inhibitors stents thrombosis
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