Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital, 101 DaeHak-ro, JongRo-gu, Seoul, 110-744, Korea.
Circulation. 2012 Jan 24;125(3):505-13. doi: 10.1161/CIRCULATIONAHA.111.059022. Epub 2011 Dec 16.
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.
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.
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.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00698607.
药物洗脱冠状动脉支架植入后双联抗血小板治疗（DAPT）的最佳持续时间仍未确定。我们旨在检验药物洗脱支架植入后 6 个月 DAPT 是否不劣于 12 个月 DAPT。
我们将 1443 例接受药物洗脱支架植入的患者随机分为接受 6 个月或 12 个月 DAPT（1:1 比例）。主要终点是 12 个月时的靶血管失败，定义为心脏死亡、心肌梗死或缺血驱动的靶血管血运重建的复合终点。12 个月时的靶血管失败发生率在 6 个月 DAPT 组为 4.8%，12 个月 DAPT 组为 4.3%（单侧 95%置信区间上限为 2.4%；P=0.001，具有预先设定的非劣效性边界 4.0%）。虽然支架血栓形成在 6 个月 DAPT 组比 12 个月组更常见（0.9%比 0.1%；风险比，6.02；95%置信区间，0.72-49.96；P=0.10），但两组的死亡或心肌梗死风险无差异（2.4%比 1.9%；风险比，1.21；95%置信区间，0.60-2.47；P=0.58）。在预设的亚组分析中，在糖尿病患者中，6 个月 DAPT 组比 12 个月 DAPT 组靶血管失败发生率更高（风险比，3.16；95%置信区间，1.42-7.03；P=0.005）。
与 12 个月 DAPT 相比，药物洗脱支架植入后 6 个月 DAPT 不会增加 12 个月时的靶血管失败风险。然而，非劣效性边界较宽，且该研究在死亡或心肌梗死方面的效力不足。我们的结果需要在更大的试验中得到证实。
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