Effectiveness and Safety of Restarting Oral Anticoagulation in Patients with Atrial Fibrillation after an Intracranial H
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ORIGINAL RESEARCH ARTICLE
Effectiveness and Safety of Restarting Oral Anticoagulation in Patients with Atrial Fibrillation after an Intracranial Hemorrhage: Analysis of Medicare Part D Claims Data from 2010–2016 Terri V. Newman1 · Nemin Chen2 · Meiqi He1 · Samir Saba3 · Inmaculada Hernandez1
© Springer Nature Switzerland AG 2019
Abstract Background In patients with atrial fibrillation (AF) who survive an anticoagulant-related intracranial hemorrhage (ICH), the benefits of restarting oral anticoagulation (OAC) remain unclear. Objective In this study, we sought to determine the effectiveness and safety associated with resumption of OAC in atrial fibrillation patients who survive an ICH. Methods Using 2010–2016 Medicare claims data, we identified patients with non-valvular AF who experienced an OACrelated ICH and survived at least 6 weeks after the ICH (n = 1502). The primary outcomes included the composite of ischemic stroke and transient ischemic attack (TIA), thromboembolism (TE), a composite of ischemic stroke/TIA and TE, recurrent ICH, and all-cause mortality. We constructed Cox proportional hazard models to evaluate the association between post-ICH OAC resumption, which was measured in a time-dependent manner, and the risk of primary outcomes, while controlling for a comprehensive list of covariates. Results Among patients who survived an ICH, 69% reinitiated OAC within 6 weeks of the event, and among those who resumed OAC, 83% restarted warfarin. There was no significant difference in the risk of ischemic stroke/TIA (hazard ratio [HR] 0.87, 95% confidence interval [CI] 0.62–1.21), TE (HR 0.85, 95% CI 0.55–1.32), and ischemic stroke/TIA/TE (HR 0.81, 95% CI 0.61–1.07) between post-ICH OAC use and non-use. Post-ICH OAC use was associated with a lower risk of recurrent ICH (HR 0.62, 95% CI 0.41–0.95) and all-cause mortality (HR 0.48, 95% CI 0.37–0.62) compared with non-OAC use. Conclusions In AF patients who survived an ICH, restarting OAC was not associated with a greater risk of recurrent ICH. Evidence from randomized controlled studies is needed to further clarify the clinical benefit of restarting OAC in this highrisk population. Further evaluation of which individuals benefit from restarting OAC is also needed to provide more clinical guidance.
1 Introduction
Electronic supplementary material The online version of this article (https://doi.org/10.1007/s40256-019-00388-8) contains supplementary material, which is available to authorized users. * Terri V. Newman [email protected] 1
Department of Pharmacy and Therapeutics, School of Pharmacy, University of Pittsburgh, 3609 Forbes Ave, Pittsburgh, PA 15216, USA
2
Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA
3
Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, USA
The most common cardiac arrhythmia, atrial fibrillation (AF), is associated with a fivefold increase in the risk of stroke and accounts for 15–20% of all ischemic strokes [1, 2]. O
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