Abstract Body (Do not enter title and authors here): Background
Direct oral anticoagulants (DOACs) are efficient alternatives to vitamin K antagonists (VKAs). However, little is known about their efficacy and safety profile in patients who underwent bioprosthetic valve replacement either surgically or through a transcatheter approach. This meta-analysis aims to compare the efficacy and safety of DOACs versus VKAs in bioprosthetic valve replacement.
Methods
PubMed, Cochrane Central, and ScienceDirect were searched from inception to May 2025. The primary outcome of interest was incidence of stroke or systemic embolism. All-cause mortality, major bleeding, stroke(any), clinically relevant non-major bleeding and intracranial hemorrhage were secondary outcomes of interest. Risk ratios (RRs) were pooled using the random effects model for the dichotomous outcomes and forest plots were generated using Review Manager software version 5.4.1.
Results
We included eight RCTs in the pooled analysis. DOACs significantly reduced the incidence of stroke or systemic embolism compared to VKA in patients who underwent surgical or catheterized bioprosthetic valve placement (RR=0.47; 95%CI:[0.26, 0.88]; p=0.02; I² = 0%). However, on subgroup analysis, only Rivaroxaban showed a significant reduction in stroke or systemic embolism incidence (RR=0.25; 95%CI:[0.07, 0.89]; p =0.03). DOACs and VKA have comparable safety profile in terms of major bleeding (RR=0.93; 95%CI:[0.50, 1.73]; p=0.81), although the incidence of major bleeding is increased in patients taking DOACs who had bioprosthetic valve implanted via catheterization (RR=1.44; 95%CI:[1.08, 1.93]; p =0.01). There is no significant difference between DOACs and VKA in terms of all-cause mortality (RR=0.94; 95%CI:[0.75, 1.17]; p=0.57), clinically relevant non-major bleeding (RR=1.17; 95%CI:[0.97, 1.40]; p=0.10), intracranial hemorrhage (RR=0.71; 95%CI:[0.40, 1.26]; p=0.25) and stroke (any) (RR=0.65; 95%CI:[0.32, 1.31]; p=0.23).
Conclusion
Direct oral anticoagulants appear to be a safe and effective alternative to VKAs, reducing the risk of stroke or systemic embolism in patients who underwent bioprosthetic valve placement. More high-quality RCTs are required for improved treatment guidance.