经皮冠状动脉介入治疗的心房颤动患者中暂时停用口服抗凝剂:WOEST-3 随机试验的原理和设计。

Temporary omission of oral anticoagulation in atrial fibrillation patients undergoing percutaneous coronary intervention: rationale and design of the WOEST-3 randomised trial.

机构信息

Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands.

Cardiovascular Research Institute Maastricht (CARIM), Maastricht, the Netherlands.

出版信息

EuroIntervention. 2024 Jul 15;20(14):e898-e904. doi: 10.4244/EIJ-D-24-00100.

Abstract

The optimal antithrombotic management of atrial fibrillation (AF) patients who require oral anticoagulation (OAC) undergoing percutaneous coronary intervention (PCI) remains unclear. Current guidelines recommend dual antithrombotic therapy (DAT; OAC plus P2Y inhibitor - preferably clopidogrel) after a short course of triple antithrombotic therapy (TAT; DAT plus aspirin). Although DAT reduces bleeding risk compared to TAT, this is counterbalanced by an increase in ischaemic events. Aspirin provides early ischaemic benefit, but TAT is associated with an increased haemorrhagic burden; therefore, we propose a 30-day dual antiplatelet therapy (DAPT; aspirin plus P2Y inhibitor) strategy post-PCI, temporarily omitting OAC. The study aims to compare bleeding and ischaemic risk between a 30-day DAPT strategy following PCI and a guideline-directed therapy in AF patients requiring OAC. WOEST-3 (ClinicalTrials.gov: NCT04436978) is an investigator-initiated, international, open-label, randomised controlled trial (RCT). AF patients requiring OAC who have undergone successful PCI will be randomised within 72 hours after PCI to guideline-directed therapy (edoxaban plus P2Y inhibitor plus limited duration of aspirin) or a 30-day DAPT strategy (P2Y inhibitor plus aspirin, immediately discontinuing OAC) followed by DAT (edoxaban plus P2Y inhibitor). With a sample size of 2,000 patients, this trial is powered to assess both superiority for major or clinically relevant non-major bleeding and non-inferiority for a composite of all-cause death, myocardial infarction, stroke, systemic embolism or stent thrombosis. In summary, the WOEST-3 trial is the first RCT temporarily omitting OAC in AF patients, comparing a 30-day DAPT strategy with guideline-directed therapy post-PCI to reduce bleeding events without hampering efficacy.

摘要

在需要口服抗凝药物 (OAC) 的接受经皮冠状动脉介入治疗 (PCI) 的心房颤动 (AF) 患者中,最佳的抗血栓管理仍不清楚。目前的指南建议在短程三联抗血栓治疗 (TAT;DAT 加阿司匹林) 后进行双联抗血栓治疗 (DAT;OAC 加 P2Y 抑制剂-优选氯吡格雷)。尽管 DAT 与 TAT 相比降低了出血风险,但这与缺血事件的增加相平衡。阿司匹林提供早期缺血获益,但 TAT 与出血负担增加相关;因此,我们提出在 PCI 后进行 30 天双联抗血小板治疗 (DAPT;阿司匹林加 P2Y 抑制剂) 策略,暂时不使用 OAC。该研究旨在比较 PCI 后 30 天 DAPT 策略与 AF 患者需要 OAC 的指南指导治疗的出血和缺血风险。WOEST-3(ClinicalTrials.gov:NCT04436978)是一项由研究者发起的、国际的、开放标签的、随机对照试验 (RCT)。需要 OAC 的 AF 患者在 PCI 后 72 小时内将被随机分为两组:指南指导治疗组(依度沙班加 P2Y 抑制剂加有限疗程的阿司匹林)或 30 天 DAPT 策略组(P2Y 抑制剂加阿司匹林,立即停用 OAC),然后进行 DAT(依度沙班加 P2Y 抑制剂)。该试验计划纳入 2000 例患者,可评估主要或临床上显著的非主要出血的优越性和所有原因死亡、心肌梗死、卒中和全身性栓塞或支架血栓形成的复合终点的非劣效性。总之,WOEST-3 试验是第一项在 AF 患者中暂时停用 OAC 的 RCT,比较 PCI 后 30 天 DAPT 策略与指南指导治疗,以减少出血事件,同时不影响疗效。

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索