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直接口服抗凝剂在接受透析的慢性肾病合并非瓣膜性心房颤动患者中的安全性和有效性:一项荟萃分析。

The safety and efficacy of direct oral anticoagulants among chronic kidney disease patients on dialysis with non-valvular atrial fibrillation: a meta-analysis.

作者信息

Mapili Jerahmeel Aleson L, Lim Lloyd Christopher S, Velando Bianca M, Aherrera Jaime Alfonso M

机构信息

Division of Cardiovascular Medicine, Department of Medicine, University of the Philippines - Philippine General Hospital, Manila, Philippines.

出版信息

Front Cardiovasc Med. 2023 Sep 18;10:1261183. doi: 10.3389/fcvm.2023.1261183. eCollection 2023.

Abstract

BACKGROUND

Individuals with chronic kidney disease (CKD) on dialysis are at an increased risk of stroke and embolic events especially in the presence of atrial fibrillation (AF). Vitamin K antagonists (VKA), including warfarin, have been used for decades for anticoagulation among CKD patients on dialysis with AF but recent evidence has shown increased bleeding. Direct oral anticoagulants (DOAC) have been emerging as an alternative to VKA which, based on several observational cohort studies, are at least as efficacious and safe as VKA. This meta-analysis looked into the safety and efficacy of DOACs compared to VKA among CKD patients on dialysis with non-valvular AF.

METHODOLOGY

This study used a random-effects meta-analysis using RevMan 5.4. PubMed, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and ClinicalTrials.gov were searched from their dates of inception to June 2023. The risk of bias was assessed using Cochrane RoB2 and the certainty of evidence was assessed using GRADE.

RESULTS

This meta-analysis showed that DOACs when compared to VKA have no significant difference in terms of risk for major bleeding (RR = 0.81, 95% CI 0.46-1.43), ischemic stroke (RR = 0.5, 95% CI 0.19-1.35), and cardiovascular death (RR = 1.34, 95% CI 0.69-2.60).

DISCUSSION

This meta-analysis adds to the growing body of evidence supporting that the use of DOACs has similar efficacy and safety outcomes in CKD patients on dialysis with non-valvular AF patients compared to VKA. The findings need to be replicated in larger and more adequately powered clinical trials in order to ascertain its level of evidence.

摘要

背景

接受透析的慢性肾脏病(CKD)患者发生中风和栓塞事件的风险增加,尤其是在存在心房颤动(AF)的情况下。维生素K拮抗剂(VKA),包括华法林,数十年来一直用于接受透析的CKD合并AF患者的抗凝治疗,但最近的证据表明出血风险增加。直接口服抗凝剂(DOAC)已逐渐成为VKA的替代药物,基于多项观察性队列研究,DOAC至少与VKA一样有效且安全。这项荟萃分析研究了在接受透析的非瓣膜性AF的CKD患者中,DOAC与VKA相比的安全性和有效性。

方法

本研究使用RevMan 5.4进行随机效应荟萃分析。检索了PubMed、EMBASE、Cochrane对照试验中央登记册、Cochrane系统评价数据库和ClinicalTrials.gov,检索时间从其创建日期至2023年6月。使用Cochrane RoB2评估偏倚风险,使用GRADE评估证据的确定性。

结果

这项荟萃分析表明,DOAC与VKA相比,在大出血风险(RR = 0.81,95%CI 0.46 - 1.43)、缺血性中风(RR = 0.5,95%CI 0.19 - 1.35)和心血管死亡(RR = 1.34,95%CI 0.69 - 2.60)方面无显著差异。

讨论

这项荟萃分析增加了越来越多的证据,支持在接受透析的非瓣膜性AF的CKD患者中,使用DOAC与VKA具有相似的疗效和安全性结果。这些发现需要在更大规模、更有充分统计学效力的临床试验中进行重复验证,以确定其证据水平。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8531/10545858/528d1eb4107f/fcvm-10-1261183-g001.jpg

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