Abstract 13884: Comparative Effectiveness and Safety of Dabigatran vs. Warfarin in Patients With Atrial Fibrillation - Evidence From Real World Practice
Background: Dabigatran is a novel oral anticoagulant approved recently for stroke prevention in atrial fibrillation (AF) in North America. We aimed to assess the effectiveness and safety of dabigatran in real world practice, soon after its approval.
Methods: We conducted a population-based cohort study using administrative data of patients with AF, linking between hospital discharge databases and prescription drug claims in Quebec, Canada. Three sets of propensity scores were calculated based on patients’ baseline characteristics (for all dabigatran user, 110mg users, and 150mg users). Dabigatran users were compared to warfarin users with respect to their risk of stroke, bleeding, myocardial infarction (MI), and all-cause mortality.
Results: The cohort consisted of 10,657 dabigatran users and 49,202 warfarin users, followed for a median of 7 months. Dabigatran users who filled the 150mg bid dose had lower baseline risk for stroke and bleeding compared to patients who filled the 110mg bid dose (CHADS2≥2: 55.2% vs. 82.8%; HAS-BLED≥3: 33.9% vs. 47.7%, respectively). In multivariable Cox regression analyses adjusted for propensity score, dabigatran use was not associated with a difference in risk of stroke (adjusted HR: 0.96, 95%CI: 0.80, 1.14) or bleeding (adjusted HR: 0.91 95%CI: 0.81, 1.01), when compared to warfarin use. There was a trend toward higher MI rates among dabigatran users compared to warfarin users, that was not statistically significant (adjusted HR: 1.19 95%CI: 0.92, 1.55). All-cause mortality was lower among dabigatran users compared to warfarin users (adjusted HR: 0.65, 95%CI: 0.59, 0.72).
Conclusion: In the current population-based observational study comparing dabigatran to warfarin use, we found no difference in the risk of stroke, bleeding, or MI, however, dabigatran was associated with lower all-cause mortality.
- © 2013 by American Heart Association, Inc.