Kedhi Elvin, Fabris Enrico, van der Ent Martin, Kennedy Mark W, Buszman Pawel, von Birgelen Clemens, Cook Stéphane, Wedel Hans, Zijlstra Felix
Isala Hartcentrum, Zwolle, the Netherlands.
Isala Hartcentrum, Zwolle, the Netherlands; Cardiovascular Department, University of Trieste, Trieste, Italy.
Am Heart J. 2017 Jun;188:11-17. doi: 10.1016/j.ahj.2017.02.018. Epub 2017 Feb 20.
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.
Six months of DAPT after Resolute Integrity stent implantation in STEMI patients is not inferior to 12 months of DAPT in clinical outcomes.
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.
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.
经皮冠状动脉介入治疗后使用第二代药物洗脱支架（DES）的双联抗血小板治疗（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成本相关，确定最佳DAPT持续时间至关重要。尚无其他随机对照试验评估过在接受第二代DES和最新P2Y12血小板受体抑制剂治疗的ST段抬高型心肌梗死（STEMI）患者中缩短DAPT持续时间的安全性。
STEMI患者植入Resolute Integrity支架后进行6个月的DAPT在临床结局方面不劣于12个月的DAPT。
ST段抬高型心肌梗死药物洗脱支架植入后的双联抗血小板治疗（DAPT-STEMI）试验是一项随机、多中心、国际性、开放标签试验，旨在研究STEMI患者植入Resolute Integrity支架后6个月DAPT与12个月DAPT相比的安全性（非劣效性）。在6个月时接受DAPT且无事件的患者将被随机分组（1:1方式），分为单一治疗（仅服用阿司匹林）与继续DAPT治疗6个月，并随访至首次经皮冠状动脉介入治疗后2年。主要终点是随机分组后18个月时以患者为导向的复合终点，包括全因死亡率、任何心肌梗死、任何血管重建、中风和大出血（净不良临床事件[NACE]）。为了在非劣效性界限为1.66时达到85%的检验效能，共需要纳入1100例患者。
DAPT-STEMI试验旨在评估在接受第二代DES治疗的STEMI患者中，无事件生存6个月后停用DAPT是否不劣于常规的12个月DAPT。
