Abstract 14075: Comparative Effectiveness of Dabigatran versus Warfarin in Patients With Non-Valvular Atrial Fibrillation
Background: In clinical trials, dabigatran has been shown to be efficacious for stroke prevention in non-valvular atrial fibrillation (NVAF) patients. However, the ‘real-world’ effectiveness and risks of dabigatran compared to warfarin in these patients have not been well described.
Methods: We used data from the US MarketScan Commercial and Medicare Supplemental databases in 2010-2011, which include claims information on >45 million individuals. We selected patients with NVAF initiating oral anticoagulants after their diagnosis, and with at least 6 months of enrollment before first anticoagulant use. Patients initiating dabigatran were matched with up to 5 warfarin users by age, sex, and time since database enrollment. Outcomes of interest (ischemic stroke, intracranial bleeding, and myocardial infarction (MI)) were defined according to validated algorithms. Information on other comorbidities and medication use was obtained from inpatient, outpatient, and pharmacy claims. Propensity score-adjusted Cox proportional hazards regression was used to estimate the association of dabigatran use vs warfarin with each outcome of interest.
Results: The analysis included 28,151 dabigatran and 92,633 warfarin users with NVAF. During an average 7-month follow-up, 368 ischemic strokes, 101 intracranial bleeds, and 381 MIs were identified. Rate of ischemic stroke and MI was similar in patients initiating dabigatran compared to those on warfarin. However, rate of intracranial bleeding was 61% lower in patients using dabigatran compared to warfarin users (Table).
Conclusion: In this large patient population, compared to warfarin, dabigatran was associated with lower risk of intracranial bleeding and similar risk of ischemic stroke and MI. These results are comparable to those reported in the RE-LY trial, suggesting that effectiveness of dabigatran in the ‘real-world’ is similar to that described in RE-LY.
- © 2013 by American Heart Association, Inc.