BACKGROUND: Non-stenotic intracranial and systemic atherosclerosis are associated with ischemic stroke. We report frequency and response to anticoagulant vs. antiplatelet prophylaxis of patients with embolic stroke of undetermined source (ESUS) who have non-stenotic intracranial atherosclerosis and/or systemic atherosclerosis. METHODS: Exploratory analysis of the international NAVIGATE ESUS randomized trial comparing rivaroxaban 15mg daily with aspirin 100mg daily in 7213 patients with recent ESUS. Among participants with results of intracranial arterial imaging with either computed tomographic angiography (CTA) or magnetic resonance angiography (MRA), the frequency and predictors of non-stenotic intracranial and systemic atherosclerosis and responses to antithrombotic therapy were assessed. RESULTS: Among 4723 participants with available intracranial CTA or MRA results (65% of the trial cohort), the prevalence of intracranial atherosclerosis was 16% (n=739). Patient features independently associated with intracranial atherosclerosis included East Asian region (odds ratio 2.7, 95%CI 2.2,3.3) and cervical carotid plaque (odds ratio 2.3, 95%CI 1.9,2.7), among others. The rate of recurrent ischemic stroke averaged 4.8%/year among those with intracranial atherosclerosis vs. 5.0.%/year for those without (HR 0.95, 95%CI 0.65, 1.4). Among those with intracranial atherosclerosis, the recurrent ischemic stroke rate was higher if assigned to rivaroxaban (5.8%/year) vs. aspirin (3.7%/year), but the difference was not statistically significant (HR 1.6, 95%CI 0.78, 3.3). There was trend for the effect of antithrombotic treatments to be different according to the presence or absence of intracranial atherosclerosis (pinteraction=0.09). Among participants with evidence of systemic atherosclerosis by either history or imaging (n=3820), recurrent ischemic stroke rates were similar among those assigned to rivaroxaban (5.5%/year) vs. aspirin (4.9%/year)(HR 1.1, 95%CI 0.84, 1.5). CONCLUSIONS: East Asia region was the strongest factor associated with intracranial atherosclerosis. There were no statistically significant differences between rivaroxaban and aspirin prophylaxis for recurrent ischemic stroke in patients with non-stenotic intracranial atherosclerosis and/or systemic atherosclerosis.

Bayer AG Wuppertal Germany

Biostatistics Consultant Minot ND USA

Clinica Alemana de Santiago Universidad del Desarrollo Santiago Chile

Complejo Medico de la PFA Churruca Visca Buenos Aires Argentina

Department of Medicine McMaster University Population Health Research Institute Hamilton Health Sciences Hamilton Ontario Canada

Department of Medicine University of Thessaly Larissa Greece

Department of Neurology Bichat Hospital Paris University Paris France

Department of Neurology Semmelweis University Budapest Hungary

Department of Neurology Seoul National University Hospital Seoul Korea

Department of Neurology University of Pennsylvania Philadelphia PA USA

Hospital Interzonal General de Agudos Eva Peron Buenos Aires Argentina

Institute for Neurological Research FLENI Buenos Aires Argentina

Instituto Cardiologico Banfield Buenos Aires Argentina

International Clinical Research Center and Neurology Department St Anne's University Hospital and Masaryk University Brno Czech Republic

International University of Health and Welfare Sanno Hospital and Sanno Medical Center Tokyo Japan

Medical Faculty Hospital St John of God Sigmund Freud Private University Vienna Austria

Pharmaceuticals Clinical Development Thrombosis Bayer U S LLC Whippany NJ USA

Population Health Research Institute Hamilton Health Sciences Hamilton Ontario Canada

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