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.

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%).

Conclusions: 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.