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

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.