1. Intracranial and systemic atherosclerosis in the NAVIGATE ESUS trial: Recurrent stroke risk and response to antithrombotic therapy.
- Author
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Ameriso SF, Amarenco P, Pearce LA, Perera KS, Ntaios G, Lang W, Bereczki D, Uchiyama S, Kasner SE, Yoon BW, Lavados P, Firstenfeld A, Mikulik R, Povedano GP, Ferrari J, Mundl H, Berkowitz SD, Connolly SJ, and Hart RG
- Subjects
- Aged, Aspirin adverse effects, Double-Blind Method, Factor Xa Inhibitors adverse effects, Female, Fibrinolytic Agents adverse effects, Humans, Intracranial Arteriosclerosis diagnostic imaging, Intracranial Arteriosclerosis epidemiology, Intracranial Embolism diagnostic imaging, Intracranial Embolism epidemiology, Male, Middle Aged, Peripheral Arterial Disease diagnostic imaging, Peripheral Arterial Disease epidemiology, Platelet Aggregation Inhibitors adverse effects, Prevalence, Recurrence, Risk Assessment, Risk Factors, Rivaroxaban adverse effects, Stroke diagnostic imaging, Stroke epidemiology, Time Factors, Treatment Outcome, Aspirin administration & dosage, Factor Xa Inhibitors administration & dosage, Fibrinolytic Agents administration & dosage, Intracranial Arteriosclerosis drug therapy, Intracranial Embolism prevention & control, Peripheral Arterial Disease drug therapy, Platelet Aggregation Inhibitors administration & dosage, Rivaroxaban administration & dosage, Stroke prevention & control
- Abstract
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 (p
interaction =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., (Copyright © 2020. Published by Elsevier Inc.)- Published
- 2020
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