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