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非瓣膜性心房颤动患者肾功能与直接口服抗凝剂治疗安全性和疗效的荟萃分析

Meta-analysis of safety and efficacy for direct oral anticoagulation treatment of non-valvular atrial fibrillation in relation to renal function.

机构信息

Department of Cardiovascular Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou 510120, China.

Department of gastroenterology, Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai 519000, China.

出版信息

Thromb Res. 2017 Dec;160:41-50. doi: 10.1016/j.thromres.2017.10.013. Epub 2017 Oct 26.

Abstract

INTRODUCTION

We performed a meta-analysis of the safety and efficacy of anticoagulation treatment for atrial fibrillation (AF) in relation to renal function. We also examined the change in estimated glomerular filtration rate (eGFR) from baseline and compared the outcomes for patients with stable and worsening renal function.

MATERIALS AND METHODS

We selected studies that used randomized controlled trials in which outcomes for direct oral anticoagulants (DOACs) (dabigatran, rivaroxaban, apixaban, or edoxaban) were compared with those for warfarin in AF patients with normal, mild or moderate renal function, except the severe one (creatinine clearance<30).

RESULTS

We assessed five clinical trials, involving 72,608 patients. Pooled analysis indicated that the risk of stroke was lower for DOACs than for warfarin among patients with mild renal impairment (Risk ratio, 0.79; 95% confidence interval, 0.68-0.91) and moderate renal impairment (0.80, 0.69-0.92). No major differences were found in patients with normal renal function. Additionally, DOACs were associated with fewer major bleeds among patients with normal (0.77, 0.70-0.84), mild (0.86, 0.77-0.95), and moderate renal impairment (0.73, 0.65-0.82). Among those treated with DOACs, a lower dosage was associated with lower risk of major bleeding (0.75, 0.68-0.83) and higher risk of stroke or systemic embolism (1.28, 1.12-1.47). Further, DOACs tended to be associated with a lower estimated glomerular filtration rate (eGFR) than warfarin even after 30months. Finally, we found significant differences in the risk of stroke (2.09, 1.64-2.68) and major bleeding (2.01, 1.66-2.42) between patients with stable and worsening renal function.

CONCLUSIONS

DOACs have a greater clinical benefit than warfarin with respect to renal function. They are associated with a comparatively lower risk of stroke and major bleeding, as well lower eGFR. This suggests these agents are a better choice in patients with renal disease.

摘要

简介

我们对与肾功能相关的房颤(AF)抗凝治疗的安全性和疗效进行了荟萃分析。我们还观察了从基线开始的估算肾小球滤过率(eGFR)的变化,并比较了肾功能稳定和恶化的患者的结局。

材料和方法

我们选择了使用随机对照试验的研究,其中比较了直接口服抗凝剂(DOAC)(达比加群、利伐沙班、阿哌沙班或依度沙班)与 AF 患者中正常、轻度或中度肾功能(除严重肾功能外,清除率<30)的华法林的结果。

结果

我们评估了五项临床试验,涉及 72608 名患者。汇总分析表明,在轻度肾功能不全患者中(风险比,0.79;95%置信区间,0.68-0.91)和中度肾功能不全患者(0.80,0.69-0.92)中,DOAC 发生卒中的风险低于华法林。在肾功能正常的患者中未发现显著差异。此外,在肾功能正常(0.77,0.70-0.84)、轻度(0.86,0.77-0.95)和中度肾功能不全(0.73,0.65-0.82)的患者中,DOAC 相关的大出血发生率较低。在接受 DOAC 治疗的患者中,较低的剂量与大出血风险降低(0.75,0.68-0.83)和卒中或全身性栓塞风险增加(1.28,1.12-1.47)相关。此外,即使经过 30 个月,DOAC 也往往与比华法林更低的估算肾小球滤过率(eGFR)相关。最后,我们发现肾功能稳定和恶化的患者之间的卒中风险(2.09,1.64-2.68)和大出血风险(2.01,1.66-2.42)存在显著差异。

结论

DOAC 在肾功能方面优于华法林,具有更大的临床获益。它们与较低的卒中风险和大出血风险相关,以及较低的 eGFR。这表明这些药物在肾功能障碍患者中是更好的选择。

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