Blinded Randomized trial of Anticoagulation to prevent Ischemic stroke and Neurocognitive impairment in Atrial Fibrillation - BRAIN-AF

Nov 16, 2024
Font Size
A
A
A
Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
Canadian Institutes of Health Research, Heart and Stroke Foundation of Canada, Canadian Stroke Prevention Intervention Network, Montreal Heart Institute Foundation, Bayer Inc.
Date Presented:
11/16/2024
Date Published:
11/16/2024
Original Posted Date:
11/16/2024
References

Contribution To Literature:

The BRAIN-AF trial failed to show that rivaroxaban prevents cognitive decline, stroke, or TIA among patients with AF.

Description:

The goal of the trial was to evaluate the impact of rivaroxaban compared with placebo on preventing cognitive decline, stroke, or transient ischemic attack (TIA) among patients with atrial fibrillation (AF).

Study Design

  • Randomized
  • Parallel

Patients with AF were randomized to rivaroxban 15 mg daily (n = 611) vs. placebo (n = 624).

  • Total number of enrollees: 1,235
  • Duration of follow-up: mean 3.7 years
  • Mean patient age: 53 years
  • Percentage female: 26%

Inclusion criteria:

  • 30-62 years of age
  • AF documentation within 2 years

Exclusion criteria:

  • Prior stroke or TIA
  • Hypertension
  • Diabetes
  • Congestive heart failure
  • Increased risk of bleeding
  • Reversible cause of AF
  • Known diagnosis of dementia
  • Chronic kidney disease

Principal Findings:

The primary outcome, cognitive decline (defined by a ≥2-point reduction in Montreal Cognitive Assessment [MoCA] score compared to baseline), stroke, or TIA per year, was: 7.0% in the rivaroxaban group vs. 6.4% in the placebo group (hazard ratio 1.10, 95% confidence interval 0.86-1.40, p = 0.46).

Secondary outcomes:

  • Stroke, TIA, or systemic embolism: 2.5% in the rivaroxaban group vs. 2.7% in the placebo group
  • Major bleeding: 0.3% in the rivaroxaban group vs. 0.8% in the placebo group

Interpretation:

Among patients with AF, rivaroxaban compared with placebo failed to prevent cognitive decline, stroke, or TIA.

References:

Presented by Dr. Lena Rivard at the American Heart Association Scientific Sessions, Chicago, IL, November 16, 2024.

Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Anticoagulation Management and Atrial Fibrillation, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: Anticoagulants, Atrial Fibrillation, Stroke, AHA24, AHA Annual Scientific Sessions


< Back to Listings