Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Department of Medical Statistics, College of Medicine, Catholic University of Korea, Seoul, Republic of Korea.
Sci Rep. 2019 Apr 30;9(1):6690. doi: 10.1038/s41598-019-43224-4.
It is unclear whether the two once-daily dosing non-vitamin K antagonist oral anticoagulants (NOACs), edoxaban and rivaroxaban, have similar effectiveness and safety in Asian patients with non-valvular atrial fibrillation (AF). This study aimed to compare the effectiveness and safety of edoxaban and rivaroxaban in a Korean population with non-valvular AF. Using the Korean National Health Insurance Service database from January 2014 to December 2016, we compared the risk of ischemic stroke, intracranial hemorrhage (ICH), hospitalization for gastrointestinal (GI) bleeding, hospitalization for major bleeding, all-cause death, and composite outcome in a 3:1 propensity score matched cohort in patients with AF who were naïve to rivaroxaban (n = 12,369) and edoxaban (n = 4,123). Hazard ratios for the six clinical outcomes were analyzed using Cox regression analysis with rivaroxaban as the reference. Baseline characteristics were balanced between the two groups (median age, 71 years; median CHADS-VASc score, 3; 56% of patients received a reduced dose). Edoxaban users showed comparable results in all six clinical outcomes (all p = nonsignificant) when compared to rivaroxaban users for total, standard, and reduced doses. We provide for the first time the comparison of effectiveness and safety between the two once-daily NOACs in a large-scale Asian AF population. In both standard and reduced dose regimens, edoxaban showed comparable effectiveness and safety compared to rivaroxaban.
目前尚不清楚每日一次给药的两种非维生素 K 拮抗剂口服抗凝药（NOAC），即依度沙班和利伐沙班，在亚洲非瓣膜性心房颤动（AF）患者中的有效性和安全性是否相似。本研究旨在比较依度沙班和利伐沙班在韩国非瓣膜性 AF 人群中的疗效和安全性。本研究使用了韩国国家健康保险服务数据库，纳入了 2014 年 1 月至 2016 年 12 月期间，从未使用过利伐沙班（n = 12369）和依度沙班（n = 4123）的 AF 患者的 3：1 倾向评分匹配队列，比较了缺血性脑卒中、颅内出血（ICH）、胃肠道（GI）出血住院、大出血住院、全因死亡和复合结局的风险。采用 Cox 回归分析，以利伐沙班为参照，分析了 6 个临床结局的风险比。两组患者的基线特征均衡（中位年龄 71 岁；中位 CHADS-VASc 评分 3；56%的患者接受了低剂量治疗）。与利伐沙班相比，依度沙班使用者在所有 6 个临床结局（所有 p 值均无统计学意义）中均显示出相当的结果，无论是否使用标准剂量或低剂量。本研究首次在大规模亚洲 AF 人群中比较了两种每日一次的 NOAC 的疗效和安全性。在标准和低剂量治疗方案中，依度沙班与利伐沙班相比，具有相当的疗效和安全性。
