Division of Cardiology, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea.
Department of Biostatistics, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea.
PLoS One. 2022 Jun 14;17(6):e0268113. doi: 10.1371/journal.pone.0268113. eCollection 2022.
Non-vitamin K direct oral anticoagulant (DOAC) is effective for prevention of embolic events in nonvalvular atrial fibrillation (AF) patients. However, the effectiveness and safety of DOAC in AF patients who have bioprosthetic heart valve (BPHV) is largely unknown.
We retrospectively identified patients with AF and BPHV, using the diagnostic code and medical device and surgery information from the Korean National Health Insurance Service database, between 2013 and 2018. A 1:2 propensity score-matched cohort (n = 724 taking warfarin; n = 362 taking DOAC) was constructed and analyzed for the primary clinical outcome, a composite of ischemic stroke and systemic embolism. Important secondary outcomes included major bleeding, all-cause death, and the net clinical outcome, defined as a composite of all embolic events, major bleeding, and death.
The mean age was 78.9±6.8 years old, and 45% (n = 489) were male. The mean CHA2DS2-VASc score was 4.7±1.4. DOAC was non-inferior to warfarin for preventing ischemic stroke and systemic embolism (hazard ratio [HR] 1.14, 95% confidence interval [CI] 0.56-2.34), major bleeding (HR 0.80, 95% CI 0.32-2.03) and all-cause death (HR 1.09, 95% CI 0.73-1.63). As for the net clinical outcome, DOAC was also similar to warfarin (HR 1.06, 95% CI 0.76-1.47). These outcomes were not different in various subgroups analyzed.
In this nationwide Korean AF population with a BPHV, DOAC was at least as effective and safe as warfarin for the prevention of systemic embolic events. These results suggest that DOAC may be an excellent alternative to warfarin in AF patients with BPHV.
非维生素 K 直接口服抗凝剂（DOAC）可有效预防非瓣膜性心房颤动（AF）患者的栓塞事件。然而，DOAC 在生物瓣心脏瓣膜（BPHV）的 AF 患者中的有效性和安全性在很大程度上尚不清楚。
我们使用韩国国家健康保险服务数据库中的诊断代码和医疗器械及手术信息，回顾性地确定了 2013 年至 2018 年间患有 AF 和 BPHV 的患者。构建并分析了 1：2 倾向评分匹配队列（n = 724 例服用华法林；n = 362 例服用 DOAC），主要临床结局为缺血性卒中和全身性栓塞的复合结局。重要的次要结局包括大出血、全因死亡和净临床结局，定义为所有栓塞事件、大出血和死亡的复合结局。
平均年龄为 78.9±6.8 岁，45%（n = 489）为男性。平均 CHA2DS2-VASc 评分为 4.7±1.4。DOAC 在预防缺血性卒中和全身性栓塞（风险比 [HR] 1.14，95%置信区间 [CI] 0.56-2.34）、大出血（HR 0.80，95% CI 0.32-2.03）和全因死亡（HR 1.09，95% CI 0.73-1.63）方面与华法林无差异。对于净临床结局，DOAC 与华法林也相似（HR 1.06，95% CI 0.76-1.47）。在分析的各个亚组中，这些结果没有差异。
在这项韩国全国性的 AF 合并 BPHV 人群中，DOAC 在预防全身性栓塞事件方面至少与华法林同样有效且安全。这些结果表明，DOAC 可能是 BPHV 的 AF 患者的一种极好的替代华法林的选择。
