Abstract
Background
Direct oral anticoagulants (DOACs) have shown comparable efficacy and a superior safety profile in clinical trials for patients with venous thromboembolism (VTE). However, further study is needed to assess DOACs’ effectiveness and safety compared to warfarin in a real-world context. Thus, this meta-analysis compares the effectiveness and safety of warfarin and DOACs in patients with VTE.
Method
A systematic review of the literature using PubMed and EMBASE was conducted from inception until June 2024. We examined observational studies that compared safety and effectiveness between DOACs and warfarin when used in treating VTE and reported adjusted hazard ratios (HRs) and/or odds ratios (ORs) for recurrent VTE, major bleeding, clinically relevant non-major bleeding, gastrointestinal bleeding, intracranial hemorrhage, and death from any cause. We then estimated the pooled effect using the random-effects model for meta-analysis.
Results
A total of 25 studies were included in the current meta-analysis. DOAC therapy was associated with significantly lower risks of recurrent VTE (HR 0.76, 95% confidence interval [CI] 0.69–0.85), major bleeding (HR 0.77, 95% CI 0.72–0.83), clinically relevant non-major bleeding (HR 0.82, 95% CI 0.77–0.88), and gastrointestinal bleeding (HR 0.75, 95% CI 0.68–0.83) compared to warfarin. However, no statistically significant difference was observed in all-cause mortality between the two groups (HR 0.96, 95% CI 0.83–1.10).
Conclusion
This meta-analysis found that DOACs are associated with a significant reduction in VTE recurrence in addition to the known favorable safety profile when compared to warfarin.
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Acknowledgements
The authors would like to extend their appreciation to King Saud University for funding this work through the Researcher Supporting Project (RSP2024R77), King Saud University, Riyadh, Saudi Arabia.
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Walaa A. Alshahrani, Razan S. Alshahrani, Munirah A. Alkathiri, Saeed M. Alay, Abdulrahman M. Alabkka, Saleh A. Alaraj, Majed S. Al Yami, Waad A. Altayyar, Osamah M. Alfayez, Manar S. Basoodan, Abdulaali R. Almutairi, and Omar A. Almohammed declare that they have no potential conflicts of interest that might be relevant to the contents of this manuscript.
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The author OAA received funds from the Researcher Supporting Project (number RSP2024R77), King Saud University, Riyadh, Saudi Arabia, to support the publication of this article. The funding agency played no role in designing the study, conducting the analysis, interpreting the data, or writing the manuscript.
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All listed authors have significantly contributed to the research, providing direct and intellectual input throughout the process. WAA: Investigation, resources, data curation, writing—original draft. RSA: Investigation, methodology, validation, writing—reviewing and editing. MAA: Validation, writing—reviewing and editing. SMA: Investigation, resources, data curation, writing—original draft. AMA: Investigation, resources, data curation, writing—original draft. SAA: Investigation, resources, data curation, writing—original draft. MSA: Validation, resources, writing—reviewing and editing. ARA: Investigation, methodology, validation, formal analysis, data curation, software, writing—reviewing and editing, supervision. WAA: Investigation, resources, data curation. OMA: Investigation, methodology, validation, writing—reviewing and editing. MSB: Investigation, data curation, writing—reviewing and editing OAA: Validation, methodology, validation, supervision, writing—reviewing and editing.
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Alshahrani, W.A., Alshahrani, R.S., Alkathiri, M.A. et al. Safety and Effectiveness of Direct Oral Anticoagulants Versus Warfarin in Patients with Venous Thromboembolism using Real-World Data: A Systematic Review and Meta-Analysis. Am J Cardiovasc Drugs (2024). https://doi.org/10.1007/s40256-024-00677-x
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DOI: https://doi.org/10.1007/s40256-024-00677-x