A prospective, randomized, open-label trial of 6-month versus 12-month dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction: Rationale and design of the "DAPT-STEMI trial"
A prospective, randomized, open-label trial of 6-month versus 12-month dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction: Rationale and design of the "DAPT-STEMI trial"
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DOI：
10.1016/j.ahj.2017.02.018
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发表时间：
2017-06-01
影响因子：
4.8
通讯作者：
Zijlstra, Felix
中科院分区：
文献类型：
--
作者：
Kedhi, Elvin;Fabris, Enrico;Zijlstra, Felix
背景：第二代药物洗脱支架（DES）经皮冠状动脉介入治疗后双重抗血小板治疗（DAPT）的最佳持续时间尚不清楚。由于延长DAPT与更高的出血风险和医疗保健成本相关，因此确定最佳DAPT持续时间至关重要。没有其他随机对照试验评估了ST段抬高型心肌梗死（STEMI）患者接受第二代DES和最新P2 Y12血小板受体抑制剂治疗后较短DAPT持续时间的安全性。假设STEMI患者在Resolute Integrity支架植入后6个月的DAPT在临床结局方面不劣于12个月的DAPT。ST段抬高型心肌梗死洗脱支架植入（DAPT-STEMI）试验是一项随机、多中心、国际、开放标签试验，旨在检查STEMI患者中Resolute Integrity支架植入后6个月DAPT与12个月DAPT相比的安全性（非劣效性）。6个月时接受DAPT治疗的无事件患者将在单药（仅阿司匹林）与DAPT之间随机分配（1：1方式），再接受6个月，并随访至直接经皮冠状动脉介入治疗后2年。主要终点是随机分组后18个月的全因死亡率、任何心肌梗死、任何血运重建、卒中和大出血（净不良临床事件[NACE]）的患者导向复合终点。为了达到85%的非劣效性限制为1.66的权力，共1100名入组patients.Summary的DAPT-STEMI试验的目的是评估STEMI患者治疗与第二代DES是否停止DAPT后6个月的无事件生存期是非劣效于常规12个月DAPT。
Background The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention with second-generation drug eluting stents (DESs) is unclear. Because prolonged DAPT is associated with higher bleeding risk and health care costs, establishing optimal DAPT duration is of paramount importance. No other randomized controlled trials have evaluated the safety of shorter DAPT duration in ST-elevation myocardial infarction (STEMI) patients treated with second generation DESs and latest P2Y12 platelet receptor inhibitors.Hypothesis Six months of DAPT after Resolute Integrity stent implantation in STEMI patients is not inferior to 12 months of DAPT in clinical outcomes.Study design The Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation In ST-elevation Myocardial Infarction (DAPT-STEMI) trial is a randomized, multicenter, international, open-label trial designed to examine the safety (noninferiority) of 6-month DAPT after Resolute Integrity stent implantation in STEMI patients compared with 12-month DAPT. Event-free patients on DAPT at 6month will be randomized (1:1 fashion) between single (aspirin only) versus DAPT for an additional 6 months and followed until 2 years after primary percutaneous coronary intervention. The primary end point is a patient-oriented composite endpoint of all-cause mortality, any myocardial infarction, any revascularization, stroke, and major bleeding (net adverse clinical events [NACE]) at 18 months after randomization. To achieve a power of 85% for a noninferiority limit of 1.66, a total of 1100 enrolled patients are required.Summary The DAPT-STEMI trial aims to assess in STEMI patients treated with second-generation DESs whether discontinuation of DAPT after 6 months of event-free survival is noninferior to routine 12-month DAPT.