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在接受血液透析的心房颤动和慢性肾脏病患者中,直接口服抗凝剂与维生素K拮抗剂的疗效和安全性:一项采用序贯试验分析的随机对照试验的系统评价和荟萃分析

Efficacy and safety of DOACs vs vitamin K antagonists in patients with atrial fibrillation and chronic kidney disease undergoing hemodialysis: A systematic review and meta-analysis of randomized controlled trials with trial sequential analysis.

作者信息

Bulhões Elísio, Antunes Vanio L J, Alexandre Carlos, Defante Maria L R, Mazetto Roberto, Oliveira Vinicius Martins Rodrigues, Sousa Pedro Antônio, Guida Camila, Scanavacca Mauricio Ibrahim, Darrieux Francisco

机构信息

Faculty of Higher Superior of the Amazon Reunida, Medicine Department, Pará, Brazil.

Federal University of Health Sciences of Porto Alegre, Medicine Department, Porto Alegre, Brazil.

出版信息

Heart Rhythm. 2025 May;22(5):1210-1217. doi: 10.1016/j.hrthm.2025.02.009. Epub 2025 Feb 7.

DOI:10.1016/j.hrthm.2025.02.009
PMID:39923948
Abstract

BACKGROUND

Atrial fibrillation (AF) is a relatively prevalent arrhythmia in patients with kidney failure requiring dialysis who face a high risk of stroke and bleeding and for whom anticoagulation is a challenging decision. Although direct oral anticoagulants (DOACs) may offer advantages over vitamin K antagonists (VKAs), their use in this patient profile remains unclear.

OBJECTIVE

We conducted a systematic review and meta-analysis to compare DOACs and VKAs in patients with AF undergoing dialysis.

METHODS

PubMed, Embase, and Cochrane Central databases were analyzed. The outcomes analyzed were total stroke (a composite of ischemic and hemorrhagic stroke), ischemic stroke, all-cause death, cardiovascular death, myocardial infarction, major bleeding, clinically relevant nonmajor bleeding and gastrointestinal bleeding. Risk ratios (RRs) with 95% confidence intervals (CIs) were calculated using a random effects model. R software version 4.3.2 R Studio for Statistical Computing, Vienna, Austria) was used for statistical analyses. Heterogeneity was assessed with I statistics.

RESULTS

The final analysis included 486 patients from 4 randomized controlled trial studies. The median follow-up ranged from 5.8 to 18 months. Although a reduction in total stroke was observed in the group receiving DOACs (RR 0.40; 95% CI 0.17-0.92; P = .031; I = 0%), no significant difference was found between the groups for ischemic stroke (RR 0.42; 95% CI 0.17-1.04; P = .062; I = 0%). In addition, a statistically significant reduction in major bleeding was noted in the DOAC group (RR 0.64; 95% CI 0.41-0.98; P = .044; I = 0%). However, no significant differences were observed among the groups for all-cause death (RR 0.88; 95% CI 0.57-1.35; P = .567; I = 47%), cardiovascular death (RR 1.13; 95% CI 0.60-2.10; P = .700; I = 0%), or clinically relevant nonmajor bleeding (RR 1.11; 95% CI 0.67-1.84; P = .669; I = 0%).

CONCLUSION

In this meta-analysis, DOACs were associated with a lower risk of total stroke and major bleeding. However, DOACs and VKA groups exhibited similar rates of ischemic stroke, all-cause and cardiovascular death, clinically relevant nonmajor bleeding, and gastrointestinal bleeding.

摘要

背景

心房颤动(AF)在需要透析的肾衰竭患者中是一种相对常见的心律失常,这些患者面临着高卒中风险和出血风险,抗凝治疗是一个具有挑战性的决策。尽管直接口服抗凝剂(DOACs)可能比维生素K拮抗剂(VKAs)具有优势,但其在这类患者中的应用仍不明确。

目的

我们进行了一项系统评价和荟萃分析,以比较接受透析的房颤患者使用DOACs和VKAs的情况。

方法

对PubMed、Embase和Cochrane Central数据库进行分析。分析的结局包括总卒中(缺血性卒中和出血性卒中的综合)、缺血性卒中、全因死亡、心血管死亡、心肌梗死、大出血、临床相关非大出血和胃肠道出血。使用随机效应模型计算95%置信区间(CIs)的风险比(RRs)。使用R软件版本4.3.2(奥地利维也纳用于统计计算的R Studio)进行统计分析。用I统计量评估异质性。

结果

最终分析纳入了来自4项随机对照试验研究的486例患者。中位随访时间为5.8至18个月。尽管接受DOACs治疗的组总卒中有所减少(RR 0.40;95% CI 0.17 - 0.92;P = 0.031;I = 0%),但两组在缺血性卒中方面未发现显著差异(RR 0.42;95% CI 0.17 - 1.04;P = 0.062;I = 0%)。此外,DOAC组大出血有统计学意义的减少(RR 0.64;95% CI 0.41 - 0.98;P = 0.044;I = 0%)。然而,在全因死亡(RR 0.88;95% CI 0.57 - 1.35;P = 0.567;I = 47%)、心血管死亡(RR 1.13;95% CI 0.60 - 2.10;P = 0.700;I = 0%)或临床相关非大出血(RR 1.11;95% CI 0.67 - 1.84;P = 0.669;I = 0%)方面,两组之间未观察到显著差异。

结论

在这项荟萃分析中,DOACs与较低的总卒中和大出血风险相关。然而,DOAC组和VKA组在缺血性卒中、全因和心血管死亡、临床相关非大出血以及胃肠道出血方面的发生率相似。

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