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 Gwon, Joo Yong Hahn, Kyung Woo Park, Young Bin Song, In Ho Chae, Do Sun Lim, Kyoo Rok Han, Jin Ho Choi, Seung Hyuk Choi, Hyun Jae Kang, Bon Kwon Koo, Taehoon Ahn, Jung Han Yoon, Myung Ho Jeong, Taek Jong Hong, Woo Young Chung, Young Jin Choi, Seung Ho Hur, Hyuck Moon Kwon, Dong Woon JeonByung Ok Kim, Si Hoon Park, Nam Ho Lee, Hui Kyung Jeon, Yangsoo Jang, Hyo Soo Kim

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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.

Original languageEnglish
Pages (from-to)505-513
Number of pages9
JournalCirculation
Volume125
Issue number3
DOIs
Publication statusPublished - 2012 Jan 24

Keywords

  • drug-eluting stents
  • platelet aggregation inhibitors
  • stents
  • thrombosis

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

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    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., ... Kim, H. S. (2012). 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. Circulation, 125(3), 505-513. https://doi.org/10.1161/CIRCULATIONAHA.111.059022