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Safety and Effectiveness of Apixaban Versus Warfarin in Japanese Patients with Nonvalvular Atrial Fibrillation Stratified by Renal Function: A Retrospective Cohort Study
American Journal of Cardiovascular Drugs ( IF 2.8 ) Pub Date : 2023-10-17 , DOI: 10.1007/s40256-023-00611-7
Takeshi Morimoto 1 , Haruhiko Hoshino 2 , Yukako Matsuo 3 , Tatsuki Ibuki 4 , Kayoko Miyata 3 , Yukihiro Koretsune 5
Affiliation  

Background

We previously conducted a retrospective cohort study using chart review of oral anticoagulant-naïve Japanese patients with nonvalvular atrial fibrillation (NVAF) that assessed the risk of major bleeding and stroke/systemic embolism (SE) events of apixaban versus warfarin.

Methods

In this subgroup analysis, we compared the risk of major bleeding and stroke/SE events by stratifying patients into four subgroups matched 1:1 using propensity score matching (PSM) according to baseline creatinine clearance (CrCl; mL/min): ≥ 15 to < 30, ≥ 30 to < 50, ≥ 50 to < 80, and ≥ 80.

Results

Of the 7074 patients in the apixaban group and 4998 in the warfarin group eligible for inclusion in the analysis, 4385 were included in each group after PSM. Incidence rates of major bleeding and stroke/SE events were generally lower with apixaban versus warfarin across the CrCl subgroups. When all patients with a CrCl change of < 0 mL/min per year during the study period (apixaban, n = 3871; warfarin, n = 2635) were stratified into four subgroups based on the magnitude of CrCl decline (median CrCl change [mL/min] per year: − 1.09, − 3.48, − 7.54, and − 36.92 for apixaban, and − 1.10, − 3.65, − 7.85, and − 40.40 for warfarin), the incidence rates of major bleeding and stroke/SE events generally increased with an increasing CrCl decline per year in both groups.

Conclusions

In Japanese patients with NVAF, the safety and effectiveness of apixaban and warfarin were consistent across different renal subgroups, including those with severe renal impairment. Our results highlight the importance of monitoring renal function variations over time in patients with NVAF.

ClinicalTrials.gov identifier

NCT03765242.



中文翻译:

按肾功能分层的日本非瓣膜性心房颤动患者中阿哌沙班与华法林的安全性和有效性:一项回顾性队列研究

背景

我们之前对未接受过口服抗凝药物的日本非瓣膜性心房颤动 (NVAF) 患者进行了一项回顾性队列研究,该研究评估了阿哌沙班与华法林的大出血和卒中/全身性栓塞 (SE) 事件的风险。

方法

在此亚组分析中,我们根据基线肌酐清除率 (CrCl;mL/min) 将患者分为 1:1 匹配的四个亚组,比较大出血和中风/SE 事件的风险:≥ 15 至< 30、≥ 30 至 < 50、≥ 50 至 < 80、以及 ≥ 80。

结果

在符合分析条件的阿哌沙班组 7074 名患者和华法林组 4998 名患者中,PSM 后每组均纳入 4385 名患者。在 CrCl 亚组中,阿哌沙班组的大出血和卒中/SE 事件的发生率普遍低于华法林组。当研究期间每年 CrCl 变化 < 0 mL/min 的所有患者(阿哌沙班,n  = 3871;华法林,n  = 2635)根据 CrCl 下降幅度(中位 CrCl 变化 [mL])分为四个亚组/min]每年:阿哌沙班为-1.09、-3.48、-7.54和-36.92,华法林为-1.10、-3.65、-7.85和-40.40),大出血和卒中/SE事件的发生率一般在两组中,随着每年 CrCl 下降的增加而增加。

结论

在日本 NVAF 患者中,阿哌沙班和华法林的安全性和有效性在不同肾脏亚组(包括严重肾功能不全的患者)中是一致的。我们的结果强调了监测 NVAF 患者肾功能随时间变化的重要性。

ClinicalTrials.gov 标识符

NCT03765242。

更新日期:2023-10-17
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