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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
- 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
- Gwon H.-C.; Hahn J.-Y.; Park K.W.; Song Y.B.; Chae I.-H.; Lim D.-S.; Han K.-R.; Choi J.-H.; Choi S.-H.; Kang H.-J.; Koo B.-K.; Ahn T.; Yoon J.-H.; Jeong M.-H.; Hong T.-J.; Chung W.-Y.; Choi Y.-J.; Hur S.-H.; Kwon H.-M.; Jeon D.-W.; Kim B.-O.; Park S.-H.; Lee N.-H.; Jeon H.-K.; Jang Y.; Kim H.-S.
- Ewha Authors
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- vol. 125, no. 3, pp. 505 - 513
- SCI; SCIE; SCOPUS
- 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. © 2011 American Heart Association, Inc.
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