Key result
Direct oral anticoagulants were associated with a significantly lower risk of major bleeding compared with warfarin in patients with nonvalvular atrial fibrillation (HR 0.78).
Why the study?
Randomized trial findings of lower bleeding risk with DOACs versus warfarin in AF may not extrapolate to the general population.
Do direct oral anticoagulants reduce bleeding risk compared to warfarin in patients with nonvalvular atrial fibrillation in real-world observational settings?
Meta-Analysis (n=2,356,201)
Do direct oral anticoagulants reduce bleeding risk compared to warfarin in patients with nonvalvular atrial fibrillation in real-world observational settings?
Hazard Ratio: 0.78 (95% CI 0.71–0.85)
p-value: p=<0.001
In real-world observational studies, DOACs are associated with a lower risk of bleeding compared to warfarin in patients with nonvalvular atrial fibrillation, though this benefit is driven by apixaban and dabigatran rather than rivaroxaban.
Introduction In randomized trials in atrial fibrillation (AF) patients on direct oral anticoagulants (DOACs) have a lower risk of bleeding compared with warfarin. However, data from randomized trials may not extrapolate to general population. We aimed to determine the risk of bleeding in patients on DOACs in observational studies. Materials and Methods Observational studies from 1990 to January 2019 were included. A pooled effect hazard ratio (HR) was calculated with a random effects model using the generic inverse variance method. Subgroup analyses according to previous anticoagulants exposure, study type, funding source, and DOAC type (direct thrombin inhibitors vs. factor Xa inhibitors) were conducted. Results A total of 35 studies comprising 2,356,201 patients were included. The average pooled HR for observational data was 0.78 (95% confidence interval [CI] 0.71, 0.85). There were no statistically significant differences in pooled HR by previous exposure to anticoagulants, DOAC type (direct thrombin vs. factor Xa inhibitors), study type, and funding source. Among patients receiving factor Xa inhibitors, patients on apixaban had a lower risk of bleeding compared with warfarin (HR 0.60, 95% CI 0.50, 0.71, p < 0.001) in contrast to those on rivaroxaban (HR 0.98, 95% CI 0.91, 1.06, p = 0.60). Conclusion In observational studies, AF patients on DOACs experience less bleeding events compared with warfarin; however, apixaban and dabigatran, but not rivaroxaban, have a lower risk of bleeding than warfarin.
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Wang et al. (2020) conducted a meta-analysis in Nonvalvular Atrial Fibrillation (n=2,356,201). Direct oral anticoagulants (DOACs) vs. Warfarin was evaluated on Major bleeding risk (HR 0.78, 95% CI 0.71, 0.85, p=<0.001). Direct oral anticoagulants were associated with a significantly lower risk of major bleeding compared with warfarin in patients with nonvalvular atrial fibrillation (HR 0.78).
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