Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, UK.
Department of Cardiology, Congenital Heart Diseases and Electrotherapy, Division of Medical Sciences in Zabrze, Medical University of Silesia, Katowice, Poland.
Eur J Clin Invest. 2020 May;50(5):e13221. doi: 10.1111/eci.13221. Epub 2020 Mar 30.
ENSURE-AF (NCT02072434) assessed therapy with edoxaban vs enoxaparin-warfarin in patients with nonvalvular atrial fibrillation (AF) undergoing elective electrical cardioversion (ECV).
To evaluate clinical features and primary efficacy (composite of stroke, systemic embolic events, myocardial infarction and cardiovascular mortality during study period) and safety endpoints (composite of major and clinically relevant nonmajor bleeding during on-treatment period) in patients awaiting ECV of AF with a transesophageal echocardiography (TEE)-guided vs a non-TEE-guided strategy.
In this prospective, randomized, open-label, blinded endpoint study, 2199 patients were randomized to edoxaban 60 mg once-daily (30 mg for creatinine clearance 15-50 mL/min, weight ≤60 kg and/or concomitant use of P-glycoprotein inhibitor) or enoxaparin-warfarin. Primary efficacy endpoint and safety endpoint were reported. Associates of TEE use, efficacy endpoint and safety endpoint were explored using multivariable logistic regression.
In total, 589 patients from the edoxaban stratum and 594 from the enoxaparin-warfarin stratum were allocated to the TEE-guided strategy. Primary efficacy was similar regardless of TEE approach (P = .575). There were no significant differences in bleeding rates, regardless of TEE approach (P = .677). Independent predictors of TEE use were as follows: history of ischaemic stroke/ transient ischaemic attack, hypertension and valvular heart disease. Mean CHA DS VASc and HAS-BLED score were independent predictors of the efficacy endpoint whilst mean age was an independent predictor of the safety endpoint.
Thromboembolic and bleeding events were not different between patients undergoing TEE-guided strategy and in those undergoing an optimized conventional anticoagulation approach for ECV of AF.
ENSURE-AF（NCT02072434）评估了非瓣膜性心房颤动（AF）患者在选择性电复律（ECV）前行依度沙班与依诺肝素-华法林治疗的疗效。
评估经食管超声心动图（TEE）指导与非 TEE 指导策略在 AF 行 ECV 患者中的临床特征和主要疗效（研究期间的卒中、全身性栓塞事件、心肌梗死和心血管死亡率复合终点）及安全性终点（治疗期间的主要和临床相关非大出血复合终点）。
在这项前瞻性、随机、开放标签、盲终点研究中，2199 例患者随机分为依度沙班 60mg 每日一次（肌酐清除率 15-50mL/min、体重≤60kg 和/或同时使用 P-糖蛋白抑制剂时为 30mg）或依诺肝素-华法林组。报告主要疗效终点和安全性终点。使用多变量逻辑回归探讨 TEE 使用、疗效终点和安全性终点的相关性。
依度沙班组共有 589 例患者和依诺肝素-华法林组 594 例患者分配至 TEE 指导策略组。无论 TEE 方法如何，主要疗效均相似（P=0.575）。无论 TEE 方法如何，出血发生率均无显著差异（P=0.677）。TEE 使用的独立预测因素如下：缺血性卒中和短暂性脑缺血发作史、高血压和瓣膜性心脏病。平均 CHA2DS2-VASc 和 HAS-BLED 评分是疗效终点的独立预测因素，而平均年龄是安全性终点的独立预测因素。
在行 TEE 指导策略的患者与行优化常规抗凝策略的患者之间，血栓栓塞和出血事件无差异。
