Abstract
Direct oral anticoagulants (DOACs) are at least as efficacious and safe as warfarin among non-valvular atrial fibrillation (NVAF) patients; limited evidence is available regarding NVAF patients with heart failure (HF). US Medicare enrollees with NVAF and HF initiating DOACs (apixaban, rivaroxaban, dabigatran) or warfarin were selected. Propensity score matching and Cox models were used to estimate the risk of stroke/systemic embolism (SE), major bleeding (MB), and major adverse cardiac events (MACE) comparing DOACs versus warfarin and DOACs versus DOACs. We identified 10,570 apixaban-warfarin, 4,297 dabigatran-warfarin, 15,712 rivaroxaban-warfarin, 4,263 apixaban-dabigatran, 10,477 apixaban-rivaroxaban, and 4,297 dabigatran-rivaroxaban matched pairs. Compared to warfarin, apixaban had lower rates of stroke/SE (hazard ratio = 0.64, 95% confidence interval = 0.48–0.85), MB (hazard ratio = 0.66, 0.58–0.76), and MACE (hazard ratio = 0.73,0.67–0.79); dabigatran and rivaroxaban had lower rates of MACE (hazard ratio = 0.87,0.77–0.99; hazard ratio = 0.84, 0.79–0.89, respectively). Rivaroxaban had a lower stroke/SE rate (hazard ratio = 0.65, 0.52–0.81) and higher MB rate (hazard ratio = 1.18, 1.08–1.30) versus warfarin. Compared to dabigatran and rivaroxaban, apixaban had lower MB (hazard ratio = 0.71, 0.57–0.89; hazard ratio = 0.55, 0.49–0.63) and MACE rates (hazard ratio = 0.80, 0.69–0.93; hazard ratio = 0.86, 0.79–0.94), respectively. All DOACs had lower MACE rates versus warfarin; differences were observed in stroke/SE and MB. Our findings provide insights about OAC therapy among NVAF patients with HF.
Highlights
Dabigatran was associated with a lower rate of major adverse cardiac events (MACE), but no significant difference in stroke/systemic embolism (SE) or major bleeding (MB)
Rivaroxaban was associated with a lower rate of stroke/SE and MACE; rivaroxaban was associated with an increased rate of MB
Our study suggests that apixaban use was associated with a lower rate of stroke/SE and MB, compared to warfarin use, among non-valvular atrial fibrillation (NVAF) patients diagnosed with heart failure (HF), which is consistent with the ARISTOTLE main trial results
Summary
This was a retrospective observational analysis using US fee-for-service Medicare data from the Center for Medicare and Medicaid Services, from January 01, 2012 through September 30, 2015. Medicare data captures comprehensive demographic and clinical information using enrollment records as well as International Classification of Diseases, 9th Revision, Clinical Modification, Healthcare Common Procedure Coding System codes, and National Drug Codes. This observational study was conducted under the provisions of Privacy Rule 45 CFR 164.514(e). For patients with a DOAC prescription, the first DOAC pharmacy claim date during the identification period was designated as the index date. The first warfarin prescription date was designated as the index date for patients prescribed only warfarin and without any DOAC claim. Patients were required to have continuous medical and pharmacy health plan enrollment for 12 months prior to and on the index date as well as an AF and HF diagnosis during the 12 months prior to or on the index date (S1 Table) [23]
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