Efficacy and safety of edoxaban in patients early after surgical bioprosthetic valve implantation or valve repair: A randomized clinical trial
Efficacy and safety of edoxaban in patients early after surgical bioprosthetic valve implantation or valve repair: A randomized clinical trial
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DOI：
10.1016/j.jtcvs.2021.01.127
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发表时间：
2022-12-13
影响因子：
6
通讯作者：
Hong, Geu-Ru
中科院分区：
文献类型：
--
作者：
Shim, Chi Young;Seo, Jiwon;Hong, Geu-Ru
目的：在接受外科生物瓣膜植入或瓣膜修复术的患者中，建议早期华法林抗凝。目前尚不清楚非维生素K拮抗剂口服抗凝剂是否可以完全替代华法林。本研究旨在比较依度沙班与华法林在外科生物瓣膜植入术或瓣膜修复术后早期患者中的有效性和安全性。方法：探索依度沙班在心脏瓣膜修复术或生物瓣膜置换术后患者中的有效性和安全性研究是一项前瞻性、随机（1：1）、开放标签、临床试验，于2017年12月至2019年9月进行。患者被随机分配接受依度沙班（60 mg或30 mg，每日一次）或华法林在外科生物瓣膜植入术或瓣膜修复术后的前3个月。主要疗效结局是死亡、临床血栓栓塞事件或无症状心内血栓形成的复合结局。主要的安全性结果是大出血的发生率。结果：在220名参与者中，218名（每组109名）被纳入改良的意向治疗分析。4例患者（3.7%）服用华法林，无患者服用依度沙班（风险差异，-0.0367; 95%置信区间，-0.0720至-0.0014;非劣效性P <0.001）。1例患者发生主要安全性结局（0.9%）服用华法林和3例患者（2.8%）服用依度沙班（风险差，0.0183; 95%置信区间，-0.0172至0.0539;非劣效性P = 0.013）。依度沙班在预防血栓栓塞方面不劣于华法林。lism，并且在手术生物瓣膜植入或瓣膜修复后的前3个月内大出血风险可能相当。
Objective: Early warfarin anticoagulation is recommended in patients undergoing surgical bioprosthetic valve implantation or valve repair. It is unclear whether non-vitamin K antagonist oral anticoagulants can be a full alternative to warfarin. This study aimed to compare efficacy and safety of edoxaban with warfarin in patients early after surgical bioprosthetic valve implantation or valve repair.Methods: The Explore the Efficacy and Safety of Edoxaban in Patients after Heart Valve Repair or Bioprosthetic Valve Replacement study was a prospective, random-ized (1:1), open-label, clinical trial conducted from December 2017 to September 2019. Patients were randomly assigned to receive edoxaban (60 mg or 30 mg once daily) or warfarin for the first 3 months after surgical bioprosthetic valve im-plantation or valve repair. The primary efficacy outcome was a composite of death, clinical thromboembolic events, or asymptomatic intracardiac thrombosis. The pri-mary safety outcome was the occurrence of major bleeding.Results: Of 220 participants, 218 (109 per group) were included in the modified intention-to-treat analysis. The primary efficacy outcome occurred in 4 patients (3.7%) taking warfarin and none taking edoxaban (risk difference,-0.0367; 95% confidence interval, -0.0720 to-0.0014; P < .001 for noninferiority). The primary safety outcome occurred in 1 patient (0.9%) taking warfarin and 3 patients (2.8%) taking edoxaban (risk difference, 0.0183; 95% confidence interval, -0.0172 to 0.0539; P = .013 for noninferiority).Conclusions: Edoxaban is noninferior to warfarin for preventing thromboembo-lism and is potentially comparable for risk of major bleeding during the first 3 months after surgical bioprosthetic valve implantation or valve repair.