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%).

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.