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亚洲患者不同类型药物的非维生素 K 口服抗凝剂二级预防的有效性和安全性。

Effectiveness and safety of secondary prevention of non-vitamin K oral anticoagulants use by drug type in Asian patients.

机构信息

Department of Neurology, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, Korea.

Department of Neurology, Seoul National University College of Medicine, Seoul, Korea.

出版信息

Int J Stroke. 2023 Oct;18(8):927-936. doi: 10.1177/17474930231176715. Epub 2023 May 21.

Abstract

BACKGROUND

Although widely used in clinical fields, real-world data on the role of warfarin and non-vitamin K oral anticoagulants (NOACs) for the secondary prevention of thromboembolic complications in ischemic stroke patients with nonvalvular atrial fibrillation (NVAF) are scarce.

AIMS

This retrospective cohort study compared the effectiveness and safety of secondary prevention of NOAC and warfarin in ischemic stroke patients with NVAF.

METHODS

From the Korean National Health Insurance Service Database, we included 16,762 oral anticoagulants-naive acute ischemic stroke patients with NVAF between July 2016 and June 2019. The main outcomes included ischemic stroke, systemic embolism, major bleeding, and all-cause of death.

RESULTS

In total, 1717 warfarin and 15,025 NOAC users were included in the analysis. After 1:8 propensity score matching, during the observation period, all types of NOACs had a significantly lower risk of ischemic stroke and systemic embolism than warfarin (edoxaban: adjusted hazard ratio [aHR], 0.80; 95% confidence interval [CI], 0.68-0.93, rivaroxaban: aHR, 0.82; 95% CI, 0.70-0.96, apixaban: aHR, 0.79; 95% CI, 0.69-0.91, and dabigatran: aHR, 0.82; 95% CI, 0.69-0.97). Edoxaban (aHR, 0.77; 95% CI, 0.62-0.96), apixaban (aHR, 0.73; 95% CI, 0.60-0.90), and dabigatran (aHR, 0.66; 95% CI, 0.51-0.86) had lower risks of major bleeding and all-cause of death.

CONCLUSIONS

All NOACs were more effective than warfarin in the secondary prevention of thromboembolic complications in ischemic stroke patients with NVAF. Except for rivaroxaban, most NOACs demonstrated a lower risk of major bleeding and all-cause of death than warfarin.

摘要

背景

尽管在临床领域得到广泛应用,但关于非维生素 K 口服抗凝剂(NOAC)在非瓣膜性心房颤动(NVAF)缺血性脑卒中患者中的二级预防作用的真实世界数据仍较为缺乏。

目的

本回顾性队列研究比较了 NVAF 缺血性脑卒中患者中,NOAC 与华法林在二级预防中的有效性和安全性。

方法

我们从韩国国家健康保险服务数据库中纳入了 2016 年 7 月至 2019 年 6 月期间 16762 例口服抗凝剂初治的急性 NVAF 缺血性脑卒中患者。主要结局包括缺血性脑卒中、全身性栓塞、大出血和全因死亡。

结果

共纳入 1717 例华法林和 15025 例 NOAC 使用者进行分析。经 1:8 倾向评分匹配后,在观察期间,所有类型的 NOAC 发生缺血性脑卒中及全身性栓塞的风险均显著低于华法林(依度沙班:校正后危险比[aHR],0.80;95%置信区间[CI],0.68-0.93;利伐沙班:aHR,0.82;95%CI,0.70-0.96;阿哌沙班:aHR,0.79;95%CI,0.69-0.91;达比加群:aHR,0.82;95%CI,0.69-0.97)。依度沙班(aHR,0.77;95%CI,0.62-0.96)、阿哌沙班(aHR,0.73;95%CI,0.60-0.90)和达比加群(aHR,0.66;95%CI,0.51-0.86)发生大出血和全因死亡的风险较低。

结论

在 NVAF 缺血性脑卒中患者的二级预防中,所有 NOAC 均优于华法林。除利伐沙班外,大多数 NOAC 发生大出血和全因死亡的风险均低于华法林。

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