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非维生素K拮抗剂口服抗凝药与华法林在心房颤动合并肾衰竭血液透析患者中的疗效及安全性:一项对照随机试验的荟萃分析

Efficacy and safety of non-vitamin K antagonist oral anticoagulants versus warfarin in atrial fibrillation and kidney failure under hemodialysis: A meta-analysis of controlled randomized trials.

作者信息

Chang Ting-Yung, Chan Yi-Hsin, Chao Tze-Fan, Lin Chin-Yu, Lin Yenn-Jiang, Chang Shih-Lin, Lo Li-Wei, Hu Yu-Feng, Chung Fa-Po, Chen Shih-Ann

机构信息

Heart Rhythm Center, Division of Cardiology, Department of Medicine Taipei Veterans General Hospital Taipei Taiwan.

Division of Cardiology Taipei Veterans General Hospital Taipei Taiwan.

出版信息

J Arrhythm. 2025 May 19;41(3):e70094. doi: 10.1002/joa3.70094. eCollection 2025 Jun.

Abstract

BACKGROUND

Atrial fibrillation (AF)-related strokes are associated with disability and mortality. Stroke prevention with non-vitamin K antagonist oral anticoagulants (NOACs) and vitamin K antagonists (VKAs) is the cornerstone of holistic management of AF. However, the safety and efficacy of NOACs in patients with AF on hemodialysis remain uncertain. This meta-analysis aimed to evaluate currently available data to determine the potential utility of NOACs in AF patients with kidney failure receiving hemodialysis.

METHODS

We searched the literature for randomized clinical trials comparing NOACs to VKA therapy in this population.

RESULTS

About the Principal Efficacy Outcome, NOACs Did Not Decrease the Risk Compared to Warfarin (Relative Risk [RR] 0.79, 95% CI 0.45-1.37) while a Significant Heterogeneity Was Noted ( = 0.03). In the Valkyrie Study, Rivaroxaban Had better Cardiovascular Outcome than Warfarin (RR 0.57, 95% CI 0.43-0.75). For the Principal Safety Outcome, the Risk Was Similar between NOACs and Warfarin (RR 0.81, 95% CI 0.52-1.27) without Significant Heterogeneity ( = 0.11). The Pooled Event Rate of 3 Trials Disclosed a High Risk of all-Cause Mortality (39.9% for NOACs, 34.6% for Warfarin) and Cardiovascular Mortality (10.1% for NOACs, 8.5% for Warfarin) for AF Patients with Kidney Failure Receiving Hemodialysis Even on Oral Anticoagulants.

CONCLUSION

Our results suggest that NOACs (rivaroxaban or apixaban) are as safe and effective as VKAs in patients with AF and kidney failure with hemodialysis. Even on oral anticoagulants, these patients remain at high risk of cardiovascular events and all-cause mortality. Integrated care and holistic management are important for this high-risk population.

摘要

背景

心房颤动(AF)相关卒中与残疾和死亡率相关。使用非维生素K拮抗剂口服抗凝药(NOACs)和维生素K拮抗剂(VKAs)预防卒中是房颤整体管理的基石。然而,NOACs在接受血液透析的房颤患者中的安全性和有效性仍不确定。这项荟萃分析旨在评估现有数据,以确定NOACs在接受血液透析的肾衰竭房颤患者中的潜在效用。

方法

我们检索了比较该人群中NOACs与VKA治疗的随机临床试验文献。

结果

关于主要疗效结局,与华法林相比,NOACs并未降低风险(相对风险[RR]0.79,95%置信区间0.45-1.37),同时观察到显著异质性(I² = 0.03)。在武神研究中,利伐沙班的心血管结局优于华法林(RR 0.57,95%置信区间0.43-0.75)。对于主要安全性结局,NOACs与华法林之间的风险相似(RR 0.81,95%置信区间0.52-1.27),无显著异质性(I² = 0.11)。3项试验的合并事件发生率显示,即使接受口服抗凝治疗,接受血液透析的肾衰竭房颤患者全因死亡率(NOACs为39.9%,华法林为34.6%)和心血管死亡率(NOACs为10.1%,华法林为8.5%)风险仍很高。

结论

我们的结果表明,在接受血液透析的房颤和肾衰竭患者中,NOACs(利伐沙班或阿哌沙班)与VKAs一样安全有效。即使接受口服抗凝治疗,这些患者心血管事件和全因死亡率风险仍很高。综合护理和整体管理对这一高危人群很重要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/30ef/12087299/2d22755bdc5d/JOA3-41-e70094-g001.jpg

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