An Updated Meta-Analysis of DOACs vs. VKAs in Atrial Fibrillation Patients With Bioprosthetic Heart Valve

Abstract

Background: Current guidelines recommend the utilization of direct-acting oral anticoagulants (DOACs) in patients with non-valvular atrial fibrillation (AF). However, the optimal anticoagulation strategy for AF patients with bioprosthetic heart valves (BPHV) remains controversial. Therefore, we conducted this meta-analysis to explore the effect of DOACs versus vitamin K antagonists (VKAs) in this population. Methods: We systematically searched the PubMed and Embase databases until November 2021 for studies reporting the effect of DOACs versus VKAs in AF patients with BPHV. Adjusted risk ratios (RRs) and 95% confidence intervals (CIs) were pooled using the random-effects model with an inverse variance method. Results: We selected four randomized clinical trials and seven observational studies (2236 DOAC- and 6403 VKAs-users). Regarding the effectiveness outcomes, there were no significant differences between DOACs and VKAs in stroke or systemic embolism (RR = 0.74, 95%CI: 0.50–1.08), ischemic stroke (RR = 1.08, 95%CI: 0.76–1.55), all-cause death (RR = 0.98, 95%CI: 0.86–1.12), and cardiovascular death (RR = 0.85, 95%CI: 0.40–1.80). In terms of the safety outcomes, DOACs was associated with lower risks of major bleeding (RR = 0.70, 95%CI: 0.59–0.82) and intracranial bleeding (RR = 0.42, 95%CI: 0.26–0.70), but the risks of any bleeding (RR = 0.85, 95%CI: 0.65–1.13) and gastrointestinal bleeding (RR = 0.92, 95%CI: 0.73–1.17) are not significantly different when compared with VKAs. The subgroup analysis with follow-up as a covariate revealed that the DOACs had lower risks of SSE (RR = 0.59, 95%CI: 0.37–0.94) and major bleeding (RR = 0.69, 95%CI: 0.58–0.81) in patients with a mean follow-up of more than 24 months, but no statistical differences were found in patients with the follow-up less than 24 months (SSE: RR = 1.10, 95%CI: 0.92–1.32; major bleeding: RR = 0.91, 95%CI: 0.42–2.01). Conclusions: In AF with BPHV, patients on DOACs experienced a reduced risk of major bleeding and intracranial bleeding compared with VKAs, while the risks of stroke, cardiovascular death, and all-cause mortality were similar.