J Innov Card Rhythm Manag. 2025 Jul 15;16(7):6355-6373. doi: 10.19102/icrm.2025.16075. eCollection 2025 Jul.
ABSTRACT
Atrial fibrillation (AF) is a major sequela after bioprosthetic valve replacement (BPVR) in patients with valvular heart disease. This study evaluates the data compiled from different meta-analyses in an umbrella review. We investigated the anticoagulation efficacy of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) in patients with AF and BPVR. A comprehensive search of the Cochrane Database of Systematic Reviews, EMBASE, and PubMed was completed to find papers published up until June 2024 that could be included in this umbrella review. Randomized controlled trials (RCTs) and retrospective observational/cohort studies were primarily identified as the foundation of meta-analyses and peer-reviewed systematic reviews. The quality of the included publications was determined using the AMSTAR 2 tool and the Cochrane Collaboration’s risk-of-bias tool, while the overall certainty of the evidence was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology. A total of 20 systematic reviews and meta-analyses of RCTs and observational studies were included in this umbrella review. Among the primary outcomes, the pooled analysis exhibited a significant reduction in all-cause mortality (risk ratio [RR], 0.95; 95% confidence interval [CI], 0.91-1.00; P = .05; I2 = 0%), risk of major/life-threatening bleeding (RR, 0.73; 95% CI, 0.66-0.82; P ≤ .00001; I2 = 66%), and stroke/thromboembolism (RR, 0.74; 95% CI, 0.67-0.82; P = .00001; I2 = 0%) in patients who were administered DOAC pharmacotherapy as compared to VKAs. The only primary outcome that demonstrated clinically insignificant results was all-cause stroke (RR, 0.9; 95% CI, 0.79-1.04; P = .16; I2 = 54%). Secondary outcomes such as intracranial bleeding, any bleeding, and minor or clinically insignificant bleeding all showed a significantly decreased risk in the DOAC group versus the VKA group. Only two outcomes revealed an increased risk of cardiovascular events and risk of ischemic stroke in patients who received DOACs; however, these outcomes were statistically insignificant. According to our analysis, DOACs exhibit a superior safety and efficacy profile to that of VKAs when it comes to treating patients with BPVR. DOACs do not require continuous monitoring; therefore, they could be an effective substitute for VKAs in these individuals.
PMID:40766961 | PMC:PMC12320913 | DOI:10.19102/icrm.2025.16075
