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DOACs vs. Warfarin in Patients With Valvular Atrial Fibrillation
Quick Takes
- DOACs, compared with warfarin, were associated with lower risks for ischemic stroke or systemic embolism and major bleeding events in patients with valvular AF.
- These results suggest that patients with a broad definition of valvular heart disease may be able to safely use DOACs.
- However, given the retrospective nonrandomized nature of the current analysis, prospective validation is indicated.
Study Questions:
What is the effectiveness and safety of direct oral anticoagulants (DOACs) compared with warfarin in patients with valvular atrial fibrillation (AF)?
Methods:
The investigators conducted a new-user retrospective propensity score–matched cohort study using a US-based commercial health care database from January 1, 2010–June 30, 2019. Adults with valvular AF who were newly prescribed DOACs or warfarin were studied. The primary effectiveness outcome was a composite of ischemic stroke or systemic embolism. The primary safety outcome was a composite of intracranial or gastrointestinal bleeding. The authors used propensity score (PS) matching to account for confounding by indication and calculated PS using a logistic regression model that predicted the probability of starting to receive a DOAC versus warfarin and included the 43 baseline covariates.
Results:
Among a total of 56,336 patients with valvular AF matched on propensity score, use of DOACs (vs. warfarin) was associated with lower risk for ischemic stroke or systemic embolism (hazard ratio [HR], 0.64; 95% confidence interval [CI], 0.59-0.70) and major bleeding events (HR, 0.67; 95% CI, 0.63-0.72). The results for the effectiveness and safety outcomes remained consistent for apixaban (HRs, 0.54 [95% CI, 0.47-0.61] and 0.52 [95% CI, 0.47-0.57], respectively) and rivaroxaban (HRs, 0.74 [95% CI, 0.64-0.86] and 0.87 [95% CI, 0.79-0.96], respectively); with dabigatran, results were consistent for the major bleeding outcome (HR, 0.81; 95% CI, 0.68-0.97), but not for effectiveness (HR, 1.03; 95% CI, 0.81-1.31).
Conclusions:
The authors concluded that patients with valvular AF who were new users of DOACs had lower risks for ischemic stroke or systemic embolism and major bleeding than new users of warfarin.
Perspective:
This study reports that DOACs, compared with warfarin, were associated with lower risks for ischemic stroke or systemic embolism and major bleeding events in patients with valvular AF. Furthermore, these findings were robust in several subgroup and sensitivity analyses and consistent within the individual DOACs, including apixaban and rivaroxaban, and for the major bleeding outcome with dabigatran. These results suggest that patients with a broad definition of valvular heart disease may be able to safely use DOACs. However, given the retrospective nonrandomized nature of the current analysis, prospective validation is indicated.
Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Prevention, Valvular Heart Disease, Anticoagulation Management and Atrial Fibrillation, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias
Keywords: Anticoagulants, Antithrombins, Arrhythmias, Cardiac, Atrial Fibrillation, Brain Ischemia, Delivery of Health Care, Embolism, Gastrointestinal Hemorrhage, Heart Valve Diseases, Intracranial Hemorrhages, Secondary Prevention, Stroke, Vascular Diseases, Warfarin
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