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达比加群酯与维生素 K 拮抗剂在房颤患者直流电复律中的应用:一项真实世界倾向性评分匹配研究。

Direct Current Cardioversion in Atrial Fibrillation Patients on Edoxaban Therapy Versus Vitamin K Antagonists: a Real-world Propensity Score-Matched Study.

机构信息

University of the Study of Campania "Luigi Vanvitelli" - Monaldi Hospital, P.zzale E. Ruggeri, 80131, Naples, Italy.

Department of Cardiology, Health Authority Naples, Naples, Italy.

出版信息

Cardiovasc Drugs Ther. 2021 Oct;35(5):1003-1007. doi: 10.1007/s10557-020-07078-7. Epub 2020 Sep 18.

Abstract

PURPOSE

The purpose of the present study was to compare the long-term effectiveness and safety of newly initiated anticoagulation with edoxaban (EDO) versus uninterrupted vitamin K antagonist (VKA) therapy in patients with atrial fibrillation (AF) scheduled for transesophageal echocardiogram (TEE)-guided direct electrical current cardioversion (DCC).

METHODS

A propensity score-matched cohort observational study was performed comparing the safety and effectiveness of edoxaban versus well-controlled VKA therapy among a cohort of consecutive non-valvular AF patients scheduled for DCC. The primary safety outcome was major bleeding. The primary efficacy outcome was the composite of stroke, transient ischemic attack (TIA), and systemic embolism (SE).

FINDINGS

A total of 130 AF patients receiving edoxaban 60-mg (EDO) treatment were compared with the same number of VKA recipients. The cumulative incidence of major bleedings was 1.54% in the EDO group and 3.08% in the VKA group (P = 0.4). The cumulative incidence of thromboembolic events was 1.54% in the EDO group and 2.31% in the VKA group (P = 0.9). A non-significant trend in improved adherence was observed between the EDO and VKA groups with a total anticoagulant therapy discontinuation rate of 4.62% (6/130) vs 6.15% (8/130), respectively (P = 0.06).

IMPLICATIONS

Our study provides the evidence of a safe and effective use of edoxaban in this clinical setting, justified by no significant difference in major bleedings and thromboembolic events between edoxaban and well-controlled VKA treatments.

摘要

目的

本研究旨在比较新发抗凝治疗与华法林(VKA)不间断治疗在拟行经食管超声心动图(TEE)引导直流电复律(DCC)的心房颤动(AF)患者中的长期有效性和安全性。

方法

采用倾向评分匹配的队列观察性研究,比较了连续非瓣膜性 AF 患者 DCC 前接受依度沙班与良好控制的 VKA 治疗的安全性和有效性。主要安全性结局为大出血。主要疗效结局为卒中、短暂性脑缺血发作(TIA)和全身性栓塞(SE)的复合事件。

结果

共比较了 130 例接受依度沙班 60mg(EDO)治疗的 AF 患者与相同数量的 VKA 患者。EDO 组大出血的累积发生率为 1.54%,VKA 组为 3.08%(P=0.4)。EDO 组血栓栓塞事件的累积发生率为 1.54%,VKA 组为 2.31%(P=0.9)。EDO 组和 VKA 组的抗凝治疗停药率分别为 4.62%(6/130)和 6.15%(8/130),提示两组之间的依从性有改善的趋势,但无统计学意义(P=0.06)。

结论

我们的研究为这一临床环境中依度沙班的安全有效使用提供了证据,依度沙班与良好控制的 VKA 治疗在大出血和血栓栓塞事件方面无显著差异。

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