Outcomes of patients with atrial fibrillation and ischemic stroke while on oral anticoagulation.

The prognosis of patients with atrial fibrillation (AF) and ischemic stroke while taking oral anticoagulation is poorly understood. This study aimed to characterize the outcomes of patients following a stroke event while on oral anticoagulation. Individual participant data from five pivotal randomized trials of antithrombotic therapy in AF were used to assess the outcomes of patients with a post-randomization ischemic stroke while on study medication (warfarin, standard-, or lower-dose direct oral anticoagulant regimen) during trial follow-up. The primary outcome was recurrent ischemic stroke after the first post-randomization ischemic stroke. The primary analysis included 1163 patients with a first post-randomization ischemic stroke while on study medication (median age 73 years, 39.3% female, 35.4% history of stroke before trial enrollment). During a median continued follow-up of 337 days, 74 patients had a recurrent ischemic stroke [cumulative incidence at 1 year: 7.0%, 95% confidence interval (CI) 5.2%-8.7%]. The cumulative incidence of mortality at 3 months after stroke was 12.4% (95% CI 10.5%-14.4%). Consistent results for the incidence of recurrent ischemic stroke at 1 year were obtained in an analysis accounting for the competing risk of death (6.2%, 95% CI 4.8%-7.9%) and in a landmark analysis excluding the first 2 weeks after the index stroke and only including patients without permanent study drug discontinuation since then (6.8%, 95% CI 4.6%-8.9%). Patients with AF and ischemic stroke while on oral anticoagulation are at increased risk of recurrent ischemic stroke and death. These patients currently have an unmet medical need.

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Déclaration de conflit d'intérêts

Conflict of interest A.P.B. has nothing to disclose. S.H.H. reports consulting and lecture fees from Bayer AG, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, and Pfizer. J.W.E. reports institutional research grants and honoraria from AstraZeneca, Bayer AG, Boehringer Ingelheim, Bristol Myers Squibb/Pfizer, Daiichi Sankyo, Eli Lilly and Company, GlaxoSmithKline, Janssen, and Sanofi. A.P.C. has nothing to disclose. R.P.G. reports honoraria for CME programs and lectures from Artivion, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly and Company, Janssen, Pfizer, SAJA Pharmaceuticals, Samsung, and Servier; grants and personal fees from Amgen, Daiichi Sankyo, and Merck; and grants from Anthos Therapeutics outside the submitted work. C.B.G. reports personal fees from Bayer AG and Boston Scientific; grants and personal fees from Boehringer Ingelheim, Bristol Myers Squibb, Janssen, and Pfizer; grants from Daiichi Sankyo during the conduct of the study; personal fees from AbbVie, Espero, Medscape, Medtronic Inc., Merck, the National Institutes of Health, Novo Nordisk, Roche, Rho Pharmaceuticals, CeleCor, Correvio, Philips, Abiomed, and Anthos Therapeutics; grants from Akros, AstraZeneca, the US Food and Drug Administration, GlaxoSmithKline, Medtronic Foundation, and Apple; and grants and personal fees from Novartis and The Medicines Company outside the submitted work. J.H. reports salary support from T32 training grant T32HL069749. Z.H. reports lecture fees from Boehringer Ingelheim, Bristol Myers Squibb, Pfizer, and Roche Diagnostics and consulting fees from Boehringer Ingelheim, Bristol Myers Squibb, Merck Sharp & Dohme, Pfizer, and Roche Diagnostics. He receives research support from the Swedish Society for Medical Research (S17–0133), the Swedish Heart-Lung Foundation (20200722), and Uppsala University Hospital, Sweden.. D.A.M. reports being a member of the Thrombolysis in Myocardial Infarction (TIMI) Study Group, which has received institutional research grant support through Brigham and Women’s Hospital from Abbott, Amgen, Anthos Therapeutics, AstraZeneca, Bayer HealthCare Pharmaceuticals Inc., Daiichi Sankyo, Eisai, Intarcia, MedImmune, Merck, Novartis, Pfizer, Quark Pharmaceuticals, Regeneron Pharmaceuticals Inc., Roche, Siemens Healthcare Diagnostics Inc., The Medicines Company, and Zora Biosciences. M.R.P. reports research grants from Bayer AG, Janssen, HeartFlow, and the National Heart, Lung, and Blood Institute (NHBLI) and advisory board/consulting from Bayer AG, Janssen, and Novartis. D.J.S. reports institutional research funding from the Swiss Heart Foundation, the Swiss National Science Foundation, the Bangerter-Rhyner Foundation, and Portola/Alexion Pharmaceuticals. A.S. reports research support from the National Institutes of Health (NIH) [National Institute of Neurological Disorders and Stroke (NINDS) U01NS102289 and National Institute on Aging (NIA) UF1NS120871), Canadian Institutes for Health Research, Heart and Stroke Foundation of Canada, and the Marta and Owen Boris Foundation. He has additionally received research support from Daiichi Sankyo, Bristol Myers Squibb, Bayer AG, and Servier Canada, as well as advisory/speakers bureau honoraria from Daiichi Sankyo, Bayer AG, Takeda Pharmaceutical Company, and Servier Canada. L.W. reports institutional research grants from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb/Pfizer, GlaxoSmithKline, Roche Diagnostics, and Merck & Co and consulting fees from Abbott. He holds two patents involving GDF-15 licensed to Roche Diagnostics (EP2047275B1 and US8951742B2). Q.Y. has nothing to disclose. S.J.C. reports institutional research grants and honoraria from Boehringer Ingelheim, Portola/Alexion Pharmaceuticals, Bristol Myers Squibb/Pfizer, Bayer AG, and Daiichi Sankyo.