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AbstractBackgroundDirect factor Xa inhibitors have been extensively prescribed for multiple indications; however, hemodialysis patients have been excluded from most of the randomized controlled trials (RCTs) of direct factor Xa inhibitors. Therefore, the efficacy and safety of direct factor Xa inhibitors versus vitamin K antagonists (VKAs) in hemodialysis patients is uncertain.MethodsA systematic review and meta-analysis of RCTs was conducted by systematically searching PubMed, EMBASE, Web of Science, SCOPUS, and Cochrane through November 25, 2022. We used the fixed-effect model to pool the risk ratio (RR) with a 95% confidence interval (CI). RevMan v5.4 software was used to pool dichotomous outcomes using RR and continuous outcomes using mean difference presented with the corresponding CI.ResultsThree RCTs with a total of 341 patients were included in our analysis. There was no difference between direct factor Xa inhibitors and VKAs regarding all-cause mortality (RR, 0.99; 95% CI [0.76, 1.30]; P = 0.96), cardiovascular mortality (RR, 1.35; 95% CI [0.71, 2.60]; P = 0.36), noncardiovascular mortality (RR, 0.75; 95% CI [0.53, 1.05]; P = 0.09), sudden mortality (RR, 1.33; 95% CI [0.53, 3.33]; P = 0.54), any cerebrovascular event (RR, 0.52; 95% CI [0.21, 1.29]; P = 0.16), ischemic stroke (RR, 0.51; 95% CI [0.19, 1.37]; P = 0.18), and hemorrhagic stroke (RR, 0.61; 95% CI [0.10, 3.70]; P = 0.59).ConclusionIn patients with atrial fibrillation who are on hemodialysis, direct factor Xa inhibitors and VKAs were similar in terms of efficacy and safety outcomes. However, evidence is still sparse, warranting dedicated RCTs.