Six-Month Versus 12-Month Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents

Authors:
  • JHJoo-Yong Hahn
    Joo-Yong Hahn
  • KPKyung Woo Park
    Kyung Woo Park
  • YSYoung Bin Song
    Young Bin Song
  • ICIn-Ho Chae
    In-Ho Chae
  • DLDo-Sun Lim
    Do-Sun Lim
  • KHKyoo-Rok Han
    Kyoo-Rok Han
  • JCJin-Ho Choi
    Jin-Ho Choi
  • HKHyun-Jae Kang
    Hyun-Jae Kang
  • BKBon-Kwon Koo
    Bon-Kwon Koo
  • TATaehoon Ahn
    Taehoon Ahn
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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.

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