Atrial Fibrillation, Anti-coagulants and Cognitive Decline: Results of the BRAIN-AF Study

Congress Review | Curated Abstracts | AHA 2024

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Published on MedED: 25 November 2024
Originally Published: 16 November 2024
Sourced: AHA Scientific Sessions 2024
Type of article: In Brief
MedED Catalogue Reference: MCABC003
Category: Cardiovascular Disease
Cross Reference: Neurology
Keywords: CVD, stroke, AFib

Key Takeaway

The risk of stroke is low in patients with Atrial Fibrillation, who are under 65 years of age and have no additional risk factors, supporting current guidelines against the use of anti-coagulants in this group.

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Presented at AHA Scientific Sessions 2024 as a Research Abstract..This summary does not represent the original research, nor is it intended to replace the original research. Content Disclaimer

Atrial fibrillation (AF) is the most common arrhythmia worldwide, with a significant impact on healthcare systems. In Africa, the number of patients with AF has increased exponentially, with recent projections suggesting that by 2050, the continent will have more people with AF than China, the United States, or India.¹

Although numerous observational studies have reported an association between AF and cognitive decline, this study, the Blinded Randomized Trial of Anticoagulation to Prevent Ischemic Stroke and Neurocognitive Impairment in Atrial Fibrillation (BRAIN-AF) study, is the first large trial focused on assessing if anticoagulant therapy can reduce the risk of cognitive decline, stroke or TIA among adults with AFib, but no other risk factors for stroke.

These findings were presented as an Abstract at the American Heart Association (AHA) conference in 2024. They should be considered as preliminary until the research is published in a peer-reviewed publication.

Study Hypothesis

This prospective, multi-centre, randomized, double-blinded clinical trial aimed to compare the efficacy and safety of rivaroxaban - a commonly used anti-coagulant - with standard care in reducing stroke, transient ischemic attack (TIA) and neurocognitive decline in patients with non-valvular AF, who were at low risk for stroke.

Participants

The trial enrolled 1,235 adults with AF, aged 30 to 62, from 53 health centers across Canada.

26% were women, and 96% were adults.

At baseline, none of the participants had the standard indications for anticoagulation therapy, for example, prior stroke or TIA, hypertension, diabetes, heart failure, or being older than 65 years of age.

Study Design

Participants were randomized (1:1) to receive either rivaroxaban (15 mg daily) or a placebo, with those having vascular disease also receiving low-dose aspirin (100 mg daily).

They were then monitored yearly for cognitive decline (a decline of two or more points on the Montreal Cognitive Assessment), stroke or TIA.

Primary Endpoint:
A composite of stroke, TIA, and neurocognitive decline, defined by a decrease in MoCA score of ≥2 points at follow-up.

Secondary Endpoints: included:

o Death (total and cardiovascular),

o Composite of stroke, TIA, and systemic embolic events,

o Neurocognitive decline,

o Hospitalization for cardiovascular events or bleeding events,

o Major clinical bleeding events.

Results

The trial was initially designed to have a follow-up period of 5 years but was terminated early, after 3.7 years, due to a lack of benefit from rivaroxaban.

The Data Safety and Monitoring Committee concluded that continuing the trial was futile, given the absence of any clear benefit from the study medication.

Nonetheless, the following were recorded:

One in five participants experienced cognitive decline, stroke, or TIA, with cognitive decline contributing to 91% of the primary outcomes, and 1 in 200 participants experiencing major bleeding.

Stroke incidence was low among participants, occurring at a rate of 0.8% per year (less than 1 in 100).

No significant differences were observed in the rates of cognitive decline, stroke, or TIA between participants receiving rivaroxaban and those on placebo.

The combined annual rate of outcomes was 7% in the rivaroxaban group compared to 6.4% in the placebo group.

The findings suggest that anticoagulation therapy does not provide a significant benefit in preventing these outcomes in younger adults with AF, with no additional stroke risk factors.

Study Implications

The study's findings have important implications for clinical practice.

Younger adults with AF are often overtreated with anticoagulation, while older individuals who have indications for anticoagulation are frequently undertreated.

This study supports current guidelines by confirming that younger individuals with AF and no other stroke risk factors have a low rate of stroke and do not benefit from anticoagulation to prevent cognitive decline.

It is not known whether other interventions such as ablation of AFib could have a positive impact on cognition in this population.

The researchers noted that while the study used a low dose of rivaroxaban, it remains uncertain whether a higher dose or alternative medications could have been more effective.

Conclusion

The BRAIN-AF study found that prescribing anti-coagulants to adults younger than 65 with AF but no other stroke risk factors did not reduce the risk of cognitive decline, stroke, or transient ischemic attack. These results suggest a more targeted approach to anticoagulation therapy in this population is needed.

Limitations

The trial used a low dose of rivaroxaban to maximize safety. It remains unknown whether a higher dose of rivaroxaban or a different molecule would have been effective when the study medication was not.

Clinical Trial Registration Information

ClinicalTrials.gov. (n.d.). Blinded randomized trial of anticoagulation to prevent ischemic stroke and neurocognitive impairment in AF (BRAIN-AF). Retrieved November 27, 2024, from https://clinicaltrials.gov/study/NCT02387229

AHA Scientific Sessions 2024 News Release

16 Nov 2024 | AHA Newsroom | Blood thinners didn’t reduce cognitive decline in adults 65 and younger with AFib | American Heart Association Scientific Sessions 2024, Late-Breaking Science Abstract 4158515

Funding

Canadian Institutes of Health Research, Heart and Stroke Foundation of Canada, Canadian Stroke Prevention Intervention Network, Montreal Heart Institute Foundation, Bayer Inc.

References

1. Bonny, A., Ngantcha, M., Scholtz, W., Chin, A., Nel, G., Anzouan-Kacou, J. B., Karaye, K. M., Damasceno, A., & Crawford, T. C. (2019). Cardiac Arrhythmias in Africa: Epidemiology, Management Challenges, and Perspectives. Journal of the American College of Cardiology, 73(1), 100–109. https://doi.org/10.1016/j.jacc.2018.09.084

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