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基线肾功能对心房颤动患者不同抗凝剂疗效和安全性的影响——一项队列研究

Impact of baseline renal function on the efficacy and safety of different Anticoagulants in Atrial Fibrillation Patients - A cohort study.

作者信息

Lee Wei-Chieh, Liao Ting-Wei, Fang Hsiu-Yu, Wu Po-Jui, Fang Yen-Nan, Chen Huang-Chung, Lin Yu-Sheng, Chang Shang-Hung, Liu Ping-Yen, Chen Mien-Cheng

机构信息

Institute of Clinical Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.

Division of Cardiology, Department of Internal Medicine, Chi Mei Medical Center, Tainan, Taiwan.

出版信息

Thromb J. 2022 Oct 13;20(1):64. doi: 10.1186/s12959-022-00423-w.

Abstract

BACKGROUND

Vitamin K antagonists and different direct oral anticoagulants (DOACs) have different renal clearance rates. However, the impact of different stages of chronic renal impairment on the efficacy and safety of warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban in atrial fibrillation (AF) patients remains unclear.

METHODS

This study enrolled AF patients from the Chang Gung Research Database. The study endpoints included thromboembolic events, major/fatal bleeding, gastrointestinal (GI) bleeding and intracranial hemorrhage (ICH). The risks of time to study endpoints between groups were compared using a Cox proportional hazards regression model with adjustment.

RESULTS

This study enrolled 3525 patients with moderate renal impairment (30 ≤ creatinine clearance (CrCl) < 60 mL/min), 2846 patients with mild renal impairment (60 ≤ CrCl < 90 mL/min) and 1153 patients with CrCl ≥ 90 mL/min. Over the 3.3 ± 0.9 years follow-up period, the cumulative thromboembolic events rates and the cumulative event rates of major/fatal bleeding and ICH did not differ among the warfarin and different DOAC groups at different stages of chronic renal impairment. The annual incidences of thromboembolic events, major/fatal bleeding, GI bleeding, and ICH were similar among the warfarin and different DOAC groups at different stages of renal impairment.

CONCLUSION

There did not appear to be major differences in bleeding or thromboembolic risk compared to warfarin in AF patients across a range of degree of renal failure when appropriate dose reductions of the DOACs are made.

摘要

背景

维生素K拮抗剂和不同的直接口服抗凝剂(DOACs)具有不同的肾脏清除率。然而,慢性肾功能损害的不同阶段对华法林、达比加群、利伐沙班、阿哌沙班和依度沙班在心房颤动(AF)患者中的疗效和安全性的影响仍不明确。

方法

本研究纳入了长庚研究数据库中的AF患者。研究终点包括血栓栓塞事件、严重/致命出血、胃肠道(GI)出血和颅内出血(ICH)。使用Cox比例风险回归模型进行调整,比较各组达到研究终点的时间风险。

结果

本研究纳入了3525例中度肾功能损害患者(肌酐清除率(CrCl)为30≤CrCl<60 mL/min)、2846例轻度肾功能损害患者(60≤CrCl<90 mL/min)和1153例CrCl≥90 mL/min的患者。在3.3±0.9年的随访期内,在慢性肾功能损害的不同阶段,华法林组和不同DOAC组之间的累积血栓栓塞事件发生率以及严重/致命出血和ICH的累积事件发生率没有差异。在肾功能损害的不同阶段,华法林组和不同DOAC组之间血栓栓塞事件、严重/致命出血、GI出血和ICH的年发生率相似。

结论

在对DOACs进行适当剂量调整后,在一系列肾功能衰竭程度的AF患者中,与华法林相比,出血或血栓栓塞风险似乎没有重大差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2155/9559011/94e38d60968f/12959_2022_423_Fig1_HTML.jpg

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