Six months versus 12 months dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction (DAPT-STEMI): randomised, multicentre, non-inferiority trial.
Six months versus 12 months dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction (DAPT-STEMI): randomised, multicentre, non-inferiority trial.
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DOI：
10.1136/bmj.k3793
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发表时间：
2018-10-02
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影响因子：
--
通讯作者：
Zijlstra F
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文献类型：
--
作者：
Kedhi E;Fabris E;van der Ent M;Buszman P;von Birgelen C;Roolvink V;Zurakowski A;Schotborgh CE;Hoorntje JCA;Eek CH;Cook S;Togni M;Meuwissen M;van Royen N;van Vliet R;Wedel H;Delewi R;Zijlstra F
旨在证明在无事件ST段抬高型心肌梗死（STEMI）患者中，将双联抗血小板治疗（DAPT）限制为6个月与DAPT持续12个月相比，临床结局非劣效。前瞻性、随机、多中心、非劣效性试验。接受直接经皮冠状动脉介入治疗（PCI）和第二代佐他莫司洗脱支架治疗的STEMI患者。年龄在18 - 85岁之间的STEMI患者接受了第二代药物洗脱支架植入的直接PCI。直接PCI术后6个月无事件的患者在此时间点随机分组。正在服用DAPT且在6个月时无事件的患者以1：1的比例随机分配至单次抗血小板治疗（SAPT）（即仅阿司匹林）或DAPT再治疗6个月。然后对所有随机分配的患者再随访18个月（即，直接PCI后24个月）。主要终点是随机化后18个月时全因死亡率、任何心肌梗死、任何血运重建、卒中和心肌梗死大出血溶栓的复合终点。2011年12月19日至2015年6月30日期间，共有1100例患者入组试验。870例患者接受随机分配：432例接受SAPT，438例接受DAPT。4.8%接受SAPT的患者发生主要终点，6.6%接受DAPT的患者发生主要终点（风险比0.73，95%置信区间0.41 - 1.27，P=0.26）。符合非劣效性（非劣效性P=0.004），因为95%置信区间上限1.27小于预先规定的非劣效性界值1.66。在使用第二代药物洗脱支架行直接PCI后6个月无事件STEMI患者中，6个月DAPT不劣于12个月DAPT。Clinicaltrials.gov NCT01459627。
To show that limiting dual antiplatelet therapy (DAPT) to six months in patients with event-free ST-elevation myocardial infarction (STEMI) results in a non-inferior clinical outcome versus DAPT for 12 months. Prospective, randomised, multicentre, non-inferiority trial. Patients with STEMI treated with primary percutaneous coronary intervention (PCI) and second generation zotarolimus-eluting stent. Patients with STEMI aged 18 to 85 that underwent a primary PCI with the implantation of second generation drug-eluting stents were enrolled in the trial. Patients that were event-free at six months after primary PCI were randomised at this time point. Patients that were taking DAPT and were event-free at six months were randomised 1:1 to single antiplatelet therapy (SAPT) (ie, aspirin only) or to DAPT for an additional six months. All patients that were randomised were then followed for another 18 months (ie, 24 months after the primary PCI). The primary endpoint was a composite of all cause mortality, any myocardial infarction, any revascularisation, stroke, and thrombolysis in myocardial infarction major bleeding at 18 months after randomisation. A total of 1100 patients were enrolled in the trial between 19 December 2011 and 30 June 2015. 870 were randomised: 432 to SAPT versus 438 to DAPT. The primary endpoint occurred in 4.8% of patients receiving SAPT versus 6.6% of patients receiving DAPT (hazard ratio 0.73, 95% confidence interval 0.41 to 1.27, P=0.26). Non-inferiority was met (P=0.004 for non-inferiority), as the upper 95% confidence interval of 1.27 was smaller than the prespecified non-inferiority margin of 1.66. DAPT to six months was non-inferior to DAPT for 12 months in patients with event-free STEMI at six months after primary PCI with second generation drug-eluting stents. Clinicaltrials.gov NCT01459627.
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