小柯机器人

比利时哈塞尔特大学Pascal Vranckx研究组与德国帕德博恩圣文森兹医院Andreas Goette研究组合作，评估了房颤患者经皮冠状动脉介入治疗（PCI）后应用依度沙班联合P2Y12抑制剂的安全性。相关论文2019年9月3日在线发表于《柳叶刀》。

ENTRUST-AF PCI是一项随机、多中心、开放标签、非劣效性、临床3b期试验。2017年2月24日至2018年5月7日，研究组在18个国家的186个地点招募了1506名参与者，年龄均大于18岁，患房颤需要口服抗凝剂，且因稳定冠状动脉疾病或急性冠状动脉综合征而成功施行PCI。在PCI术后的4小时至5天，参与者按1：1随机分组，其中751名服用依度沙班+P2Y12抑制剂治疗12个月（依度沙班组），755名服用维生素K拮抗剂（VKA）+P2Y12抑制剂+阿司匹林治疗1-12个月（VKA组）。

若患者的肌酐清除率为15-50 mL/min，或体重≤60千克，或同时服用特异性强P-糖蛋白抑制剂，则将依度沙班的用量减半。PCI术后到开始治疗的平均时间为45.1 h。12个月时，依度沙班组中有128例（17%）发生大出血或临床相关的非大出血（CRNM）（年化事件发生率20.7%），VKA组中有152例（20%，年化事件发生率25.6%），危险比为0.83。

研究总结说，对于行PCI的房颤患者，依度沙班与VKA方案相比缺血事件的发生率无显著差异，并未进一步加大出血风险。

附：英文原文

Title: Edoxaban-based versus vitamin K antagonist-based antithrombotic regimen after successful coronary stenting in patients with atrial fibrillation (ENTRUST-AF PCI): a randomised, open-label, phase 3b trial

Author: Prof Pascal Vranckx, MD,Prof Marco Valgimigli, MD,Prof Lars Eckardt, MD,Prof Jan Tijssen, PhD,Prof Thorsten Lewalter, MD,Giuseppe Gargiulo, MD,Prof Valerii Batushkin, MD,Gianluca Campo, MD,Zoreslava Lysak, MD,Igor Vakaliuk, MD,Prof Krzysztof Milewski, MD,Petra Laeis, PhD,Paul-Egbert Reimitz, PhD,Rüdiger Smolnik, MD,Wolfgang Zierhut, MD,Prof Andreas Goette, MD

Issue&Volume: September 3, 2019

Summary：

Background

We aimed to assess the safety of edoxaban in combination with P2Y12 inhibition in patients with atrial fibrillation who had percutaneous coronary intervention (PCI).

Methods

ENTRUST-AF PCI was a randomised, multicentre, open-label, non-inferiority phase 3b trial with masked outcome evaluation, done at 186 sites in 18 countries. Patients had atrial fibrillation requiring oral anticoagulation, were aged at least 18 years, and had a successful PCI for stable coronary artery disease or acute coronary syndrome. Participants were randomly assigned (1:1) from 4 h to 5 days after PCI using concealed, stratified, and blocked web-based central randomisation to either edoxaban (60 mg once daily) plus a P2Y12 inhibitor for 12 months or a vitamin K antagonist (VKA) in combination with a P2Y12 inhibitor and aspirin (100 mg once daily, for 1–12 months). The edoxaban dose was reduced to 30 mg per day if one or more factors (creatinine clearance 15–50 mL/min, bodyweight ≤60 kg, or concomitant use of specified potent P-glycoprotein inhibitors) were present. The primary endpoint was a composite of major or clinically relevant non-major (CRNM) bleeding within 12 months. The primary analysis was done in the intention-to-treat population and safety was assessed in all patients who received at least one dose of their assigned study drug. This trial is registered with ClinicalTrials.gov, NCT02866175, is closed to new participants, and follow-up is completed.

Findings

From Feb 24, 2017, through May 7, 2018, 1506 patients were enrolled and randomly assigned to the edoxaban regimen (n=751) or VKA regimen (n=755). Median time from PCI to randomisation was 45·1 h (IQR 22·2–76·2). Major or CRNM bleeding events occurred in 128 (17%) of 751 patients (annualised event rate 20·7%) with the edoxaban regimen and 152 (20%) of 755 patients (annualised event rate 25·6%) patients with the VKA regimen; hazard ratio 0·83 (95% CI 0·65–1·05; p=0·0010 for non-inferiority, margin hazard ratio 1·20; p=0·1154 for superiority).

Interpretation

In patients with atrial fibrillation who had PCI, the edoxaban-based regimen was non-inferior for bleeding compared with the VKA-based regimen, without significant differences in ischaemic events.

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