Department of Cardiology, Teikyo University.
Department of Cardiology, Toyohashi Heart Center.
Circ J. 2020 Dec 25;85(1):19-26. doi: 10.1253/circj.CJ-20-0644. Epub 2020 Nov 13.
This study evaluated the safety of 3-month dual antiplatelet therapy (DAPT) after implantation of a bioresorbable polymer sirolimus-eluting stent (BP-SES) and compared P2Yinhibitor with aspirin monotherapy 3 months after DAPT.
Patients who underwent percutaneous coronary intervention using BP-SES were enrolled and followed for 1 year. Patients with a history of stent thrombosis were excluded. The primary endpoint was a composite of all-cause death, myocardial infarction, stroke (ischemic and hemorrhagic), definite or probable stent thrombosis, and severe bleeding at 12 months. The BP-SES arm of the CENTURY II trial was used as a conventional DAPT group for comparison. After DAPT, patients were maintained on either aspirin (n=846) or a P2Yinhibitor (n=674 patients).In all, 1,695 patients were enrolled in the study across 65 centers. The primary endpoint occurred in 4.3% of patients at 1 year. After propensity score adjustment, the incidence of the primary endpoint was not inferior in those receiving DAPT for 3 months compared with conventional DAPT (5.5%; P<0.0001). The incidence of the primary endpoint and severe bleeding did not differ between the aspirin and P2Yinhibitor monotherapy groups.
After adjustment, 3-month DAPT was not inferior to longer DAPT after BP-SES implantation in terms of net adverse clinical events. There was no difference in bleeding and thrombotic events between P2Yinhibitor and aspirin monotherapy after 3 months DAPT.
本研究评估了生物可吸收聚合物西罗莫司洗脱支架(BP-SES)植入后 3 个月双联抗血小板治疗(DAPT)的安全性,并比较了 DAPT 后 3 个月 P2Y 抑制剂与阿司匹林单药治疗的效果。
纳入接受 BP-SES 经皮冠状动脉介入治疗的患者,并随访 1 年。排除支架血栓形成史的患者。主要终点是 12 个月时全因死亡、心肌梗死、卒(缺血性和出血性)、明确或可能的支架血栓形成以及严重出血的复合终点。CENTURY II 试验的 BP-SES 臂被用作常规 DAPT 组进行比较。DAPT 后,患者继续服用阿司匹林(n=846)或 P2Y 抑制剂(n=674 例)。共有 65 个中心的 1695 例患者入组研究。主要终点在 1 年内发生在 4.3%的患者中。经倾向评分调整后,3 个月 DAPT 组的主要终点发生率并不劣于常规 DAPT 组(5.5%;P<0.0001)。阿司匹林和 P2Y 抑制剂单药治疗组的主要终点和严重出血发生率无差异。
调整后,BP-SES 植入后 3 个月 DAPT 在净不良临床事件方面不劣于更长时间的 DAPT。DAPT 后 3 个月 P2Y 抑制剂和阿司匹林单药治疗在出血和血栓事件方面没有差异。