Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.
Korea University College of Medicine, Seoul, Korea.
JACC Cardiovasc Interv. 2021 Aug 23;14(16):1801-1811. doi: 10.1016/j.jcin.2021.06.003. Epub 2021 Jul 28.
The aim of this study was to determine whether 1 month of dual-antiplatelet therapy (DAPT) followed by aspirin monotherapy after polymer-free drug-coated stent (PF-DCS) implantation is noninferior to 6 to 12 months of DAPT after biodegradable-polymer drug-eluting stent (BP-DES) implantation.
It is necessary to determine the optimal minimal duration of DAPT followed by aspirin monotherapy after percutaneous coronary intervention (PCI).
In this trial, 3,020 patients with coronary artery disease considered for PCI for noncomplex lesions were randomized to 1-month DAPT after PF-DCS (n = 1,507) or 6- to 12-month DAPT after BP-DES (n = 1,513). The primary endpoint was the 1-year composite of cardiac death, nonfatal myocardial infarction, target vessel revascularization, stroke, or major bleeding (noninferiority hypothesis margin of 3%).
The primary endpoint occurred in 88 patients (5.9%) in the 1-month DAPT after PF-DCS group and 98 patients (6.5%) in the 6- to 12-month DAPT after BP-DES group (absolute difference -0.7%; upper limit of 1-sided 97.5% confidence interval: 1.33%; P < 0.001 for noninferiority). The occurrence of major bleeding was not different (1.7% vs 2.5%; P = 0.136). There was no difference in the occurrence of stent thrombosis (0.7% vs 0.8%; P = 0.842).
Among patients who underwent PCI for noncomplex lesions, 1-month DAPT followed by aspirin monotherapy after PF-DCS implantation was noninferior to 6- to 12-month DAPT after BP-DES implantation for the 1-year composite of cardiovascular events or major bleeding. The present findings need to be interpreted in the setting of different types of stents according to antiplatelet strategy. (A Randomized Controlled Comparison Between One Versus More Than Six Months of Dual Antiplatelet Therapy After Biolimus A9-Eluting Stent Implantation; NCT02513810).
本研究旨在确定在聚合物自由药物涂层支架（PF-DCS）植入后行 1 个月双联抗血小板治疗（DAPT），然后改为阿司匹林单药治疗，是否不劣于在生物可降解聚合物药物洗脱支架（BP-DES）植入后行 6-12 个月 DAPT。
有必要确定经皮冠状动脉介入治疗（PCI）后行 DAPT 联合阿司匹林单药治疗的最佳最短时间。
在这项试验中，3020 名患有冠心病且适合行非复杂病变 PCI 的患者被随机分为 PF-DCS 植入后行 1 个月 DAPT（n=1507）或 BP-DES 植入后行 6-12 个月 DAPT（n=1513）。主要终点是 1 年时心脏死亡、非致死性心肌梗死、靶血管血运重建、卒中和大出血的复合终点（非劣效性假设的边界为 3%）。
PF-DCS 植入后 1 个月 DAPT 组有 88 例（5.9%）患者和 BP-DES 植入后 6-12 个月 DAPT 组有 98 例（6.5%）患者发生主要终点事件（绝对差值-0.7%；单侧 97.5%置信区间上限：1.33%；P＜0.001 表示非劣效性）。大出血的发生率无差异（1.7%比 2.5%；P=0.136）。支架血栓形成的发生率也无差异（0.7%比 0.8%；P=0.842）。
在接受非复杂病变 PCI 的患者中，PF-DCS 植入后行 1 个月 DAPT 联合阿司匹林单药治疗与 BP-DES 植入后行 6-12 个月 DAPT 相比，1 年时心血管事件或大出血的复合终点无差异。这些发现需要根据抗血小板策略在不同类型支架的背景下进行解释。（A 随机对照比较比生物可吸收支架植入后双联抗血小板治疗 1 个月与超过 6 个月的疗效；NCT02513810）。
