Six-month versus twelve-month dual antiplatelet therapy after implantation of drug-eluting stents: '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

Research output: Contribution to journalArticle

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.

Original languageEnglish
JournalCirculation
DOIs
Publication statusAccepted/In press - 2011 Dec 27
Externally publishedYes

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. (Accepted/In press). Six-month versus twelve-month dual antiplatelet therapy after implantation of drug-eluting stents: 'EXCELLENT' randomized, multicenter study. Circulation. https://doi.org/10.1161/CIRCULATIONAHA.111.CIRCULATIONAHA.111.059022