Efficacy and safety of DOACs vs vitamin K antagonists in patients with atrial fibrillation and chronic kidney disease undergoing hemodialysis: A systematic review and meta-analysis of randomized controlled trials with trial sequential analysis

Bulhões et al., 2025 | Heart Rhythm | Meta Analysis

Citation

Bulhões Elísio, Antunes Vanio L J, ... Darrieux Francisco. Efficacy and safety of DOACs vs vitamin K antagonists in patients with atrial fibrillation and chronic kidney disease undergoing hemodialysis: A systematic review and meta-analysis of randomized controlled trials with trial sequential analysis. Heart Rhythm. 2025-May;22(5):1210-1217. doi:10.1016/j.hrthm.2025.02.009

Abstract

BACKGROUND: Atrial fibrillation (AF) is a relatively prevalent arrhythmia in patients with kidney failure requiring dialysis who face a high risk of stroke and bleeding and for whom anticoagulation is a challenging decision. Although direct oral anticoagulants (DOACs) may offer advantages over vitamin K antagonists (VKAs), their use in this patient profile remains unclear. OBJECTIVE: We conducted a systematic review and meta-analysis to compare DOACs and VKAs in patients with AF undergoing dialysis. METHODS: PubMed, Embase, and Cochrane Central databases were analyzed. The outcomes analyzed were total stroke (a composite of ischemic and hemorrhagic stroke), ischemic stroke, all-cause death, cardiovascular death, myocardial infarction, major bleeding, clinically relevant nonmajor bleeding and gastrointestinal bleeding. Risk ratios (RRs) with 95% confidence intervals (CIs) were calculated using a random effects model. R software version 4.3.2 R Studio for Statistical Computing, Vienna, Austria) was used for statistical analyses. Heterogeneity was assessed with I2 statistics. RESULTS: The final analysis included 486 patients from 4 randomized controlled trial studies. The median follow-up ranged from 5.8 to 18 months. Although a reduction in total stroke was observed in the group receiving DOACs (RR 0.40; 95% CI 0.17-0.92; P = .031; I2 = 0%), no significant difference was found between the groups for ischemic stroke (RR 0.42; 95% CI 0.17-1.04; P = .062; I2 = 0%). In addition, a statistically significant reduction in major bleeding was noted in the DOAC group (RR 0.64; 95% CI 0.41-0.98; P = .044; I2 = 0%). However, no significant differences were observed among the groups for all-cause death (RR 0.88; 95% CI 0.57-1.35; P = .567; I2 = 47%), cardiovascular death (RR 1.13; 95% CI 0.60-2.10; P = .700; I2 = 0%), or clinically relevant nonmajor bleeding (RR 1.11; 95% CI 0.67-1.84; P = .669; I2 = 0%). CONCLUSION: In this meta-analysis, DOACs were associated with a lower risk of total stroke and major bleeding. However, DOACs and VKA groups exhibited similar rates of ischemic stroke, all-cause and cardiovascular death, clinically relevant nonmajor bleeding, and gastrointestinal bleeding.

Key Findings

The final analysis included 486 patients from 4 randomized controlled trial studies. The median follow-up ranged from 5.8 to 18 months. Although a reduction in total stroke was observed in the group receiving DOACs (RR 0.40; 95% CI 0.17-0.92; P = .031; I2 = 0%), no significant difference was found between the groups for ischemic stroke (RR 0.42; 95% CI 0.17-1.04; P = .062; I2 = 0%). In addition, a statistically significant reduction in major bleeding was noted in the DOAC group (RR 0.64; 95% CI

Outcomes Measured

• Requires manual extraction

Population

MeSH Terms

• Humans
• Administration, Oral
• Anticoagulants
• Atrial Fibrillation
• Hemorrhage
• Randomized Controlled Trials as Topic
• Renal Dialysis
• Renal Insufficiency, Chronic
• Stroke
• Vitamin K

Evidence Classification

• Level: Meta Analysis
• Publication Types: Comparative Study, Journal Article, Meta-Analysis, Systematic Review
• Vertical: vitamin-k

Provenance

• PMID: 39923948
• DOI: 10.1016/j.hrthm.2025.02.009
• PMCID: Not in PMC
• Verified: 2026-04-09 via PubMed E-utilities API

Source extracted via PubMed E-utilities API on 2026-04-09