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Thromb Haemost
DOI: 10.1055/a-2544-7919
Review Article

Safety and Efficacy of Factor Xa Inhibitors in Atrial Fibrillation Patients on Dialysis: Evidence from Four Randomized Controlled Trials

Wulamiding Kaisaier   *
1   Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, People's Republic of China
,
Yili Chen   *
1   Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, People's Republic of China
,
Gregory Y.H. Lip 
2   Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom
3   Department of Clinical Medicine, Aalborg University, Aalborg, Denmark
,
Chen Liu
1   Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, People's Republic of China
,
Wengen Zhu
1   Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, People's Republic of China
› Institutsangaben
Funding This study was funded by the National Natural Science Foundation of China (82370383, 82100273); Guangdong Natural Science Foundation (2024A1515013289; 2023A1515012798); Key R and D Projects of Guangzhou Science and Technology Program (2023B03J1243); and Young Doctor “Sailing” Project (SL2024A04J01866).
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Abstract

Atrial fibrillation (AF) is prevalent in dialysis-dependent patients, who face higher risks of thromboembolism and bleeding. Although vitamin K antagonists (VKAs) are commonly used for anticoagulation, the benefits of factor Xa (FXa) inhibitors over VKAs in this population are unclear. This systematic review aims to compare the efficacy and safety of VKAs and FXa inhibitors based on randomized controlled trials (RCTs). We conducted a systematic search of PubMed and Embase for RCTs comparing FXa inhibitors and VKAs up to November 2024. The primary safety outcome was major bleeding, and the primary efficacy outcome was stroke or systemic embolism (SSE). Risk ratios (RRs) and 95% confidence intervals (CIs) were calculated using random-effects models. This meta-analysis included 486 dialysis-dependent AF patients from 4 RCTs, with a median follow-up of 26 weeks to 1.88 years. FXa inhibitors were associated with a reduced risk of major bleeding compared to VKAs (RR = 0.64, 95% CI = 0.42–0.99; p = 0.04), but no significant difference in SSE (RR = 0.46, 95% CI = 0.20–1.02; p = 0.06). FXa inhibitors also showed a significantly lower risk of intracranial bleeding (RR = 0.40, 95% CI = 0.17–0.96; p = 0.04), but no differences in other outcomes, including gastrointestinal bleeding, hemorrhagic stroke, ischemic stroke, acute coronary syndrome, and mortality. This systematic review and meta-analysis suggest that FXa inhibitors may offer a safer alternative to VKAs for AF patients on dialysis, with a lower risk of bleeding and similar risks of stroke and mortality.

Keywords

atrial fibrillation - dialysis - anticoagulants - factor Xa inhibitors

Data Availability Statement

The data supporting the findings of this meta-analysis are available from the corresponding author upon reasonable request. The original datasets from the included RCTs (AXADIA-AFNET 8, RENAL-AF, Valkyrie trial, and SAFE-D) can be accessed via the respective trial databases or through direct contact with the authors of the studies.


Authors' Contribution

W.K. and Y.C. contributed equally to the study design, data collection, and manuscript drafting. Y.C. and C.L. assisted with data analysis and literature review. G.Y.H.L. provided input on study methodology and clinical interpretation. W.Z. supervised the study and reviewed the manuscript. All authors approved the final manuscript.


* These authors are co-first authors.


Supplementary Material



Publikationsverlauf

Eingereicht: 09. Januar 2025

Angenommen: 22. Februar 2025

Accepted Manuscript online:
24. Februar 2025

Artikel online veröffentlicht:
24. März 2025

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