Sistema de Salut de Catalunya
Institut Català de la Salut
[Sharma M] Department of Medicine (Neurology), McMaster University, Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON, Canada. [Smith EE] Department of Clinical Neurosciences, University of Calgary, Calgary, AB, Canada. [Pearce LA] St. Catharines, Ontario, Canada. [Perera KS] Department of Medicine (Neurology), McMaster University, Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON, Canada. [Kasner SE] Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA. [Yoon BW] Department of Neurology, Seoul National University Hospital, Seoul, Korea. [Puig J] Department of Radiology, Girona Biomedical Research Institute, Hospital Universitari de Girona Dr. Josep Trueta, Institut Català de la Salut (ICS), Girona, Spain
Departament de Salut
2024-03-14T11:26:30Z
2024-03-14T11:26:30Z
2021
2022-08
Rivaroxabán; Aspirina; Infart cerebral
Rivaroxabán; Aspirina; Infarto cerebral
Rivaroxabán; Aspirin; Brain infarct
Background: Covert brain infarcts are associated with important neurological morbidity. Their incidence in patients with embolic stroke of undetermined source (ESUS) is unknown. Aims: To assess the incidence of covert brain infarcts and cerebral microbleeds using MRI in a prospective substudy of the NAVIGATE ESUS randomized trial and to evaluate the effects of antithrombotic therapies. Methods: At 87 sites in 15 countries, substudy participants were randomly assigned to receive rivaroxaban 15 mg daily or aspirin 100 mg daily and underwent brain MRI near randomization and after study termination. The primary outcome was incident brain infarct (clinical ischemic stroke or covert brain infarct). Brain infarcts and microbleeds were ascertained centrally by readers unaware of treatment. Treatment effects were estimated using logistic regression. Results: Among the 718 substudy participants with interpretable, paired MRIs, the mean age was 67 years and 61% were men with a median of 52 days between the qualifying ischemic stroke and randomization and a median of seven days between randomization and baseline MRI. During the median (IQR) 11 (12) month interval between scans, clinical ischemic strokes occurred in 27 (4%) participants, while 60 (9%) of the remaining participants had an incident covert brain infarct detected by MRI. Assignment to rivaroxaban was not associated with reduction in the incidence of brain infarct (OR 0.77, 95% CI 0.49, 1.2) or of covert brain infarct among those without clinical stroke (OR 0.85, 95% CI 0.50, 1.4). New microbleeds were observed in 7% and did not differ among those assigned rivaroxaban vs. aspirin (HR 0.95, 95% CI 0.52-1.7). Conclusions: Incident covert brain infarcts occurred in twice as many ESUS patients as a clinical ischemic stroke. Treatment with rivaroxaban compared with aspirin did not significantly reduce the incidence of covert brain infarcts or increase the incidence of microbleeds, but the confidence intervals for treatment effects were wide.Registration: https://www.clinicaltrials.gov. Unique identifier: NCT02313909.
The NAVIGATE ESUS trial and the MRI Substudy were sponsored by Bayer AG.
Article
English
Anticoagulants; Aspirina; Infart cerebral; CHEMICALS AND DRUGS::Organic Chemicals::Sulfur Compounds::Thiophenes::Rivaroxaban; CHEMICALS AND DRUGS::Organic Chemicals::Hydrocarbons::Hydrocarbons, Cyclic::Hydrocarbons, Aromatic::Benzene Derivatives::Phenols::Hydroxybenzoates::Salicylates::Aspirin; DISEASES::Nervous System Diseases::Central Nervous System Diseases::Brain Diseases::Cerebrovascular Disorders::Brain Ischemia::Brain Infarction; COMPUESTOS QUÍMICOS Y DROGAS::compuestos orgánicos::compuestos de azufre::tiofenos::rivaroxabán; COMPUESTOS QUÍMICOS Y DROGAS::compuestos orgánicos::hidrocarburos::hidrocarburos cíclicos::hidrocarburos aromáticos::derivados del benceno::fenoles::hidroxibenzoatos::salicilatos::aspirina; ENFERMEDADES::enfermedades del sistema nervioso::enfermedades del sistema nervioso central::enfermedades cerebrales::trastornos cerebrovasculares::isquemia cerebral::infarto encefálico::infarto cerebral
Sage Publications
International Journal of Stroke;17(7)
https://doi.org/10.1177/17474930211058012
Attribution-NonCommercial 4.0 International
http://creativecommons.org/licenses/by-nc/4.0/
