St. Vincenz-Hospital Paderborn, Am Busdorf 2, Paderborn, Germany.
Working Group: Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg, Germany.
Europace. 2018 Dec 1;20(12):1936-1943. doi: 10.1093/europace/euy141.
The EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of atrial fibrillation (ENSURE-AF) (NCT02072434) study was a multicentre prospective, randomized, open-label, blinded-endpoint evaluation (PROBE) trial comparing edoxaban with enoxaparin/warfarin followed by warfarin alone in 2199 non-valvular atrial fibrillation patients undergoing electrical cardioversion and showed comparable rates of bleeding and thromboembolism between treatments. This prespecified ancillary analysis investigated the impact of edoxaban therapy on treatment satisfaction and utilization of healthcare services.
The Perception of Anticoagulant Treatment Questionnaire (PACT-Q2) was completed by study patients on Day 28 post-cardioversion. Higher scores represent greater satisfaction. Healthcare resource utilizations were collected from randomization to Day 28 post-cardioversion. Data from patients who received at least one dose of study drugs were analysed. Patients treated with edoxaban were more satisfied than enoxaparin/warfarin in both PACT-Q treatment satisfaction and convenience scores (P < 0.001 for both). Differences in treatment satisfaction scores were greater in patients who underwent non-transoesophageal echocardiography (TOE)-guided cardioversion than in patients who underwent TOE-guided cardioversion. Edoxaban was associated with fewer clinic visits (4.75 visits vs. 7.60 visits; P < 0.001) and fewer hospital days (3.43 days vs. 5.41 days; P < 0.05). Rates of hospitalizations and emergency room visits were not significantly different. Overall, edoxaban therapy was estimated to reduce healthcare costs by €107.73, €437.92, €336.75, and $246.32 per patient in German, Spanish, Italian, and US settings, respectively.
The convenience of edoxaban therapy over warfarin in patients undergoing cardioversion may provide greater treatment satisfaction and cost savings to the healthcare system.
在正在接受心房颤动电复律的患者中，依度沙班与华法林相比（ENSURE-AF）（NCT02072434）研究是一项多中心前瞻性、随机、开放标签、盲终点评估（PROBE）试验，比较了依度沙班与依诺肝素/华法林相比，随后单独使用华法林在 2199 例非瓣膜性心房颤动患者中进行电复律，结果显示两种治疗方法的出血和血栓栓塞发生率相当。这项预设的辅助分析研究了依度沙班治疗对治疗满意度和医疗服务利用的影响。
在电复律后第 28 天，研究患者完成了抗凝治疗感知问卷（PACT-Q2）。得分越高表示满意度越高。从随机分组到电复律后第 28 天收集了医疗资源的使用情况。对至少接受一剂研究药物的患者进行了数据分析。依度沙班治疗的患者在 PACT-Q 治疗满意度和便利性评分方面均优于依诺肝素/华法林（两者均 P < 0.001）。非经食管超声心动图（TOE）引导的电复律患者的治疗满意度评分差异大于 TOE 引导的电复律患者。依度沙班与更少的就诊次数（4.75 次 vs. 7.60 次；P < 0.001）和更少的住院天数（3.43 天 vs. 5.41 天；P < 0.05）相关。住院和急诊就诊的发生率无显著差异。总体而言，依度沙班治疗估计可分别使德国、西班牙、意大利和美国的每位患者的医疗保健费用降低 107.73、437.92、336.75 和 246.32 欧元。
与华法林相比，依度沙班治疗在接受电复律的患者中更方便，可能会提高治疗满意度并为医疗系统节省成本。
