Abstract
Background
Compelling evidence showing a link between atrial fibrillation (AF) and cognitive
decline and dementia is accumulating.
Methods
Blinded Randomized Trial of Anticoagulation to Prevent Ischemic Stroke and Neurocognitive Impairment in Atrial Fibrillation (BRAIN-AF) is a prospective, multicentric, double-blind, randomized-controlled
trial, recruiting patients with nonvalvular AF and a low risk of stroke. Patients
with a high risk of bleeding will be excluded from the study. Participants will be
randomized to receive either rivaroxaban (15 mg daily) or standard of care (placebo
in patients without vascular disease or acetylsalicylic acid 100 mg daily in patients
with vascular disease).
Results
The primary outcome is the composite of stroke, transient ischemic attack, and cognitive
decline (defined by a decrease in the Montreal Cognitive Assessment score ≥ 3 at any
follow-up visit after baseline). Approximately 3250 patients will be enrolled in approximately
130 clinical sites until 609 adjudicated primary outcome events have occurred.
Conclusions
BRAIN-AF determines whether oral anticoagulation therapy with rivaroxaban compared
with standard of care reduces the risk of stroke, transient ischemic attack, or cognitive
decline in patients with nonvalvular AF and a low risk of stroke.
Résumé
Contexte
Les données probantes montrant l’existence d’un lien entre la fibrillation auriculaire
(FA) et le déclin cognitif et la démence sont de plus en plus nombreuses.
Méthodologie
L’étude BRAIN-AF (Blinded Randomized trial of Anticoagulation to prevent Ischemic stroke and Neurocognitive impairment in Atrial Fibrillation) est une étude prospective multicentrique à double insu et à répartition aléatoire
menée auprès de patients présentant une FA non valvulaire et un faible risque d’accident
vasculaire cérébral (AVC). Les patients présentant un risque élevé d’hémorragie seront
exclus de l’étude. Les participants seront répartis aléatoirement pour recevoir soit
du rivaroxaban (à raison de 15 mg par jour), soit un traitement de référence (placebo
chez les patients ne présentant pas de maladie vasculaire et acide acétylsalicylique
à 100 mg par jour chez les patients présentant une maladie vasculaire).
Résultats
Le paramètre principal regroupe l’AVC, l’ischémie cérébrale transitoire et le déclin
cognitif (défini par une baisse ≥ 3 du score à l’échelle MoCa [Montreal Cognitive Assessment, Évaluation cognitive de Montréal] à n’importe quelle visite de suivi après le début
de l’étude). Environ 3 250 patients seront recrutés dans quelque 130 centres, et l’étude
se poursuivra jusqu’à ce que 609 événements confirmés correspondant au paramètre principal
soient survenus.
Conclusions
L’étude BRAIN-AF vise à comparer l’efficacité du traitement anticoagulant à prise
orale par le rivaroxaban et du traitement de référence à l’égard de la réduction du
risque d’AVC, d’ischémie cérébrale transitoire et de déclin cognitif chez les patients
présentant une FA non valvulaire et un faible risque d’AVC.
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Article info
Publication history
Published online: May 06, 2019
Accepted:
April 26,
2019
Received:
March 18,
2019
Footnotes
See page 1075 for disclosure information.
Identification
Copyright
© 2019 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.
