Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents.
Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents.
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洗脱支架后十二或30个月的双重抗血小板治疗。
DOI：
10.1056/nejmoa1409312
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发表时间：
2014-12-04
期刊：
影响因子：
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通讯作者：
DAPT Study Investigators
中科院分区：
文献类型：
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作者：
Mauri L;Kereiakes DJ;Yeh RW;Driscoll-Shempp P;Cutlip DE;Steg PG;Normand SL;Braunwald E;Wiviott SD;Cohen DJ;Holmes DR Jr;Krucoff MW;Hermiller J;Dauerman HL;Simon DI;Kandzari DE;Garratt KN;Lee DP;Pow TK;Ver Lee P;Rinaldi MJ;Massaro JM;DAPT Study Investigators
建议在冠状动脉支架植入术后进行双重抗血小板治疗，以预防血栓并发症，但治疗超过 1 年的益处和风险尚不确定。受试者在药物洗脱冠状动脉支架手术后入组。服用噻吩并吡啶（硫酸氢氯吡格雷 [Plavix] 或普拉格雷 [Effient/Efient]）与阿司匹林 12 个月后，受试者被随机分配至继续服用噻吩并吡啶或安慰剂 18 个月；全部继续服用阿司匹林。共同主要有效性终点是 12 至 30 个月时的支架血栓形成和主要不良心脑血管事件（死亡、心肌梗死或中风的复合事件）。主要安全终点是中度或重度出血。受试者 (N=9,961) 被随机分配继续服用噻吩并吡啶组或安慰剂组。持续噻吩并吡啶可减少支架内血栓形成（0.4% vs. 1.4%，风险比 0.29，95% 置信区间 [CI] 0.17-0.48，P<0.001）和主要不良心脑血管事件（4.3% vs. 5.9%，风险比 0.71，95% CI 0.59-0.85， P<0.001）。心肌梗塞发生率降低（2.1% vs. 4.1%，风险比 0.47，P<0.001）。持续服用噻吩并吡啶组和安慰剂组的全因死亡率分别为 2.0% 和 1.5%（风险比 1.36，95% CI 1.00-1.85，P=0.052）。持续使用噻吩并吡啶会导致中度或重度出血增加（2.5% vs. 1.6%，P=0.001）。在噻吩并吡啶停药后 3 个月内，两组均观察到支架内血栓形成和心肌梗死的风险增加。与单用阿司匹林相比，药物洗脱支架放置一年以上的双重抗血小板治疗可显着降低支架内血栓形成和主要不良心脑血管事件的风险，但与出血增加相关。
Dual antiplatelet therapy is recommended after coronary stenting to prevent thrombotic complications, yet the benefits and risks of treatment beyond 1 year are uncertain. Subjects were enrolled after a drug-eluting coronary stent procedure. After 12 months of thienopyridine (clopidogrel bisulfate [Plavix] or prasugrel [Effient/Efient]) with aspirin, subjects were randomized to continued thienopyridine or placebo for another 18 months; all continued aspirin. The co-primary effectiveness end points were stent thrombosis and major adverse cardiovascular and cerebrovascular events (a composite of death, myocardial infarction, or stroke) at 12 to 30 months. The primary safety end point was moderate or severe bleeding. Subjects (N=9,961) were randomized to continued thienopyridine or placebo. Continued thienopyridine reduced stent thrombosis (0.4% vs. 1.4%, hazard ratio 0.29, 95% confidence interval [CI] 0.17-0.48, P<0.001) and major adverse cardiovascular and cerebrovascular events (4.3% vs. 5.9%, hazard ratio 0.71, 95% CI 0.59-0.85, P<0.001). Myocardial infarction was reduced (2.1% vs. 4.1%, hazard ratio 0.47, P<0.001). Rates of all-cause mortality in the continued thienopyridine and placebo groups were 2.0 and 1.5%, respectively (hazard ratio 1.36, 95% CI 1.00-1.85, P=0.052). Moderate or severe bleeding was increased with continued thienopyridine (2.5% vs. 1.6%, P=0.001). An elevated hazard for stent thrombosis and myocardial infarction was observed in both groups during the 3 months following thienopyridine discontinuation. Dual antiplatelet therapy beyond one year after drug-eluting stent placement significantly reduced the risks of stent thrombosis and major adverse cardiovascular and cerebrovascular events compared with aspirin alone, but was associated with increased bleeding.