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Comparing the Direct Oral Anticoagulants versus Vitamin K Antagonists in Bioprosthetic Valves: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

  • 2026-01
  • Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis 32
    • Muhammad Hassan Waseem
    • Zain Ul Abideen
    • Ameer Haider Cheema
    • Kanza Farhan
    • Hafsa Arshad Azam Raja
    • Muhammad Zubair Tahir
    • Fahad Saleem
    • Amna Nadeem
    • Pawan Kumar Thada

Study Design

Type
Meta-Analysis
Sample size
n = 3,863
Population
3863 patients with bioprosthetic valve procedures
Methods
Pooled risk ratios with 95% confidence intervals under random effects model using Review Manager; quality assessment with Cochrane RoB 2.0 tool
BackgroundReplacing bioprosthetic valves is common but can cause coagulation issues. This study assesses the safety and efficacy of Direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) in bioprosthetic valve procedures.MethodsPubMed, Cochrane Central, and ScienceDirect were searched till May 2025. The risk ratios (RRs) were pooled with 95% confidence intervals (CIs) under the random effects model using Review Manager software. The quality assessment was conducted using the Cochrane risk of bias (RoB 2.0) tool.ResultsEight randomized controlled trials involving 3863 patients were included in the meta-analysis. DOACs were associated with a significant reduction in the risk of stroke or systemic embolism compared with VKAs (RR = 0.48; 95%CI: [0.26, 0.88]; p = .02). The rate of major bleeding was similar between the DOACs and VKAs (RR = 0.92; 95%CI: [0.49, 1.72]; p = .79). There was no significant difference in the incidence of any stroke between the two groups (RR = 0.65; 95%CI: [0.32, 1.31]; p = .23). The occurrence of clinically relevant non-major bleeding (RR = 1.17; 95%CI: [0.97, 1.40]; p = .10), all-cause mortality (RR = 0.94; 95%CI: [0.75, 1.17]; p = .57), and intracranial hemorrhage (ICH) (RR = 0.71; 95%CI: [0.40, 1.26]; p = .25) were comparable between the groups.ConclusionDOACs seem safe after bioprosthetic valve implantation, lowering the risk of stroke or systemic embolism. However, rates of major bleeding, clinically relevant non-major bleeding, any stroke, ICH, and all-cause mortality were comparable between DOACs and VKAs.

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