Six-Month versus Twelve-Month Dual Antiplatelet Therapy after Implantation of Drug-Eluting Stents: ‘EXCELLENT’ Randomized, Multicenter Study.

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Six-Month versus Twelve-Month Dual Antiplatelet Therapy after Implantation of Drug-Eluting Stents: 'EXCELLENT' Randomized, Multicenter Study.

Circulation. 2011 Dec 16;

Authors: Gwon HC, Hahn JY, Park KW, Song YB, Chae IH, Lim DS, Han KR, Choi JH, Choi SH, Kang HJ, Koo BK, Ahn T, Yoon JH, Jeong MH, Hong TJ, Chung WY, Choi YJ, Hur SH, Kwon HM, Jeon DW, Kim BO, Park SH, Lee NH, Jeon HK, Jang Y, Kim HS

Abstract
BACKGROUND: The optimal duration of dual antiplatelet therapy (DAPT) after implantation of drug-eluting coronary stents (DES) remains undetermined. We aimed to test whether 6-month DAPT would be noninferior to 12-month DAPT after implantation of DES. METHODS AND RESULTS: We randomly assigned 1443 patients undergoing implantation of DES to receive 6-month or 12-month DAPT (in a 1:1 ratio). The primary end point was a target vessel failure (TVF) defined as the composite of cardiac death, myocardial infarction, or ischemia-driven target vessel revascularization at 12 months. Rates of TVF 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 one-sided 95% confidence interval [CI], 2.4%; P=0.001 for noninferiority with a pre-defined noninferiority margin of 4.0%). Although stent thrombosis tended to occur more frequently in the 6-month DAPT group than in 12-month one (0.9% versus 0.1%; hazard ratio 6.02, 95% CI 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% CI 0.60-2.47; P=0.58). In the prespecified subgroup analysis, TVF occurred more frequently in the 6-month DAPT group than in the 12-month one (hazard ratio 3.16; 95% CI 1.42-7.03; P=0.005) among diabetic patients. CONCLUSIONS: Six-month DAPT did not increase the risk of TVF at 12 months after implantation of DES compared with 12-month DAPT. However, noninferiority margin was wide, and the study was underpowered for death or myocardial infarction. Our results need to be confirmed in larger trials.

PMID: 22179532 [PubMed - as supplied by publisher]

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