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非维生素K拮抗剂口服抗凝剂用于心房颤动合并既往胃肠道出血患者

Non-Vitamin K Antagonist Oral Anticoagulants in Patients With Atrial Fibrillation and Prior Gastrointestinal Bleeding.

作者信息

Kwon Soonil, Lee So-Ryoung, Choi Eue-Keun, Lee Euijae, Jung Jin-Hyung, Han Kyung-Do, Cha Myung-Jin, Oh Seil, Lip Gregory Y H

机构信息

Department of Internal Medicine, Seoul National University Hospital, Republic of Korea (S.K., S.-R.L., E.-K.C., M.-J.C., S.O.).

Department of Internal Medicine, Seoul National University College of Medicine, Republic of Korea (E.-K.C., S.O., G.Y.H.L.).

出版信息

Stroke. 2021 Jan;52(2):511-520. doi: 10.1161/STROKEAHA.120.030761. Epub 2021 Jan 8.

Abstract

BACKGROUND AND PURPOSE

Limited data support the benefits of non-vitamin K oral anticoagulants (NOACs) among atrial fibrillation patients with prior gastrointestinal bleeding (GIB). We aimed to evaluate the effectiveness and safety of NOACs compared with those of warfarin among atrial fibrillation patients with prior GIB.

METHODS

Oral anticoagulant-naive individuals with atrial fibrillation and prior GIB between January 2010 and April 2018 were identified from the Korean claims database. NOAC users were compared with warfarin users by balancing covariates using the inverse probability of treatment weighting method. The primary outcomes were ischemic stroke, major bleeding, and the composite outcome (combined ischemic stroke and major bleeding). Fatal events from each outcome were evaluated as secondary outcomes.

RESULTS

A total of 42 048 patients were included (24 781 in the NOAC group and 17 267 in the warfarin group). The mean time from prior GIB to the initiation of oral anticoagulant was 3.1±2.6 years. After inverse probability of treatment weighting, baseline characteristics were balanced between the two groups (mean age, 72 years; men, 56.8%; and mean CHADS-VASc score, 3.7). Lower risks of ischemic stroke, major bleeding, and the composite outcome were associated with NOAC use than with warfarin use (weighted hazard ratio, 0.608 [95% CI, 0.543-0.680]; hazard ratio, 0.731 [95% CI, 0.642-0.832]; and hazard ratio, 0.661 [95% CI, 0.606-0.721], respectively). For all secondary outcomes, NOACs showed greater risk reductions compared with warfarin.

CONCLUSIONS

NOACs were associated with lower risks of ischemic stroke and major bleeding than warfarin among atrial fibrillation patients with prior GIB.

摘要

背景与目的

仅有有限的数据支持非维生素K口服抗凝剂(NOACs)在既往有胃肠道出血(GIB)的心房颤动患者中的益处。我们旨在评估在既往有GIB的心房颤动患者中,与华法林相比,NOACs的有效性和安全性。

方法

从韩国索赔数据库中识别出2010年1月至2018年4月期间未使用过口服抗凝剂、患有心房颤动且既往有GIB的个体。使用治疗权重逆概率方法平衡协变量,将使用NOACs的患者与使用华法林的患者进行比较。主要结局为缺血性卒中、大出血以及复合结局(缺血性卒中和大出血合并)。将各结局的致命事件评估为次要结局。

结果

共纳入42048例患者(NOAC组24781例,华法林组17267例)。从既往GIB到开始口服抗凝剂的平均时间为3.1±2.6年。经过治疗权重逆概率分析后,两组的基线特征得到平衡(平均年龄72岁;男性占56.8%;平均CHADS-VASc评分3.7)。与使用华法林相比,使用NOACs与缺血性卒中、大出血及复合结局的风险降低相关(加权风险比,0.608[95%CI,0.543 - 0.680];风险比,0.731[95%CI,0.642 - 0.832];风险比,0.661[95%CI,0.606 - 0.721])。对于所有次要结局,与华法林相比,NOACs显示出更大程度的风险降低。

结论

在既往有GIB的心房颤动患者中,与华法林相比,NOACs与缺血性卒中和大出血的风险较低相关。

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