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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

Title
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
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
박시훈
SCOPUS Author ID
박시훈scopus
Issue Date
2012
Journal Title
Circulation
ISSN
0009-7322JCR Link
Citation
vol. 125, no. 3, pp. 505 - 513
Indexed
SCI; SCIE; SCOPUS WOS scopus
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. © 2011 American Heart Association, Inc.
DOI
10.1161/CIRCULATIONAHA.111.059022
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의학전문대학원 > 의학과 > Journal papers
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