The BRAIN-AF trial evaluated whether 15 mg of rivaroxaban daily could prevent cognitive decline, stroke, or TIA in patients with atrial fibrillation (AF) and low thromboembolic risk (CHA2DS2-VASc score 0-1).
The trial was stopped early for futility after an interim analysis showed a 1.2% probability of achieving a statistically significant treatment effect.
Cognitive decline occurred at a high rate in both the rivaroxaban and placebo groups (7.0% vs. 6.4% per year), suggesting that factors beyond macro-thromboembolism may drive neurocognitive impairment in low-risk AF populations.
Safety outcomes remained favorable, with low annual rates of major bleeding in both the treatment and control arms.
Background: The Interplay Between Atrial Fibrillation and Cognition
