Safety and efficacy of rivaroxaban versus warfarin in atrial fibrillation with stage 4 to 5 chronic kidney disease including dialysis

Background Patients with atrial fibrillation (AF) and advanced chronic kidney disease (CKD) face elevated risks of stroke and bleeding; yet, optimal anticoagulation remains uncertain due to their exclusion from randomized trials. This systematic review and meta-analysis evaluated rivaroxaban vs warfarin in patients with AF and moderate-to-advanced CKD including dialysis. Methods We searched PubMed/MEDLINE, Embase, and Cochrane CENTRAL through August 2025 for observational studies comparing rivaroxaban with warfarin in adults with nonvalvular AF and CKD stages 4 to 5 including dialysis. Primary outcomes were stroke/systemic embolism and major bleeding. Pooled hazard ratios (HRs) were calculated using random-effects models. Risk of bias was assessed using ROBINS-I, and certainty of evidence was evaluated using GRADE. Results Four observational studies encompassing 31,037 patients of whom 12,160 received rivaroxaban and 18,877 received warfarin. Mean age ranged from 66 to 80 years, with CHA 2 DS 2 -VASc scores ranging from 3.5 to 4.5. Reduced-dose rivaroxaban (10-15 mg daily) was commonly prescribed. Compared with warfarin, rivaroxaban demonstrated a 30% reduction in stroke/systemic embolism (pooled HR, 0.70; 95% CI, 0.54-0.92; P = .009; I 2 = 38.1%) and 17% reduction in major bleeding (HR, 0.83; 95% CI, 0.72-0.97; P = .018). Favorable but nonsignificant trends were observed for intracranial hemorrhage (HR, 0.73; 95% CI, 0.49-1.08) and gastrointestinal bleeding (HR, 0.68; 95% CI, 0.46-1.03). Overall evidence quality was moderate according to GRADE assessment. Conclusion In patients with AF and advanced CKD including dialysis, rivaroxaban may be associated with improved efficacy and safety compared with warfarin. However, heterogeneity in CKD stages and off-label dosing practices necessitate prospective randomized trials to establish definitive treatment recommendations.