A recent study presented at the American Heart Association’s Scientific Sessions 2024 has found that prescribing anticoagulant medications to adults under 65 with atrial fibrillation (AFib) and no additional stroke risk factors does not decrease the risk of cognitive decline, stroke, or transient ischemic attack (TIA). The findings were shared during the conference held from November 16-18, 2024, in Chicago, a key event for the latest developments in cardiovascular research.
In Canada, anticoagulants like rivaroxaban are typically prescribed for individuals aged 65 and older or those with other stroke risk factors, such as diabetes or high blood pressure. The study, known as the Blinded Randomized Trial of Anticoagulation to Prevent Ischemic Stroke and Neurocognitive Impairment in Atrial Fibrillation (BRAIN-AF), is the first large-scale trial aimed at assessing the effectiveness of these medications in younger adults with AFib who do not have traditional risk factors for stroke.
Dr. Lena Rivard, the study’s lead author and an electrophysiologist at the Montreal Heart Institute, noted, “While many observational studies have linked AFib with cognitive decline, our research indicates that anticoagulation therapy does not mitigate this risk in younger adults. Patients should focus on maintaining cognitive health through a healthy lifestyle and brain-stimulating activities.”
Originally designed for an average follow-up of five years, the BRAIN-AF trial was halted early after an average follow-up of 3.7 years due to a lack of observed benefits from the anticoagulant treatment. The study involved over 1,200 participants, with an average age of 53, all of whom had AFib but lacked the standard indications for anticoagulant therapy. Participants were randomly assigned to receive either 15 mg of rivaroxaban daily or a placebo.
Results showed that one in five participants experienced cognitive decline, stroke, or TIA, with cognitive decline accounting for 91% of these outcomes. The incidence of major bleeding was low, occurring in just 1 in 200 participants, and the overall stroke rate was also low, at 0.8% per year. No significant differences were observed between the rivaroxaban and placebo groups regarding cognitive decline, stroke, or TIA, with rates at 7% per year for those on rivaroxaban compared to 6.4% for the placebo group.
Dr. Rivard emphasized that younger adults with AFib are often overtreated with anticoagulants, while older adults who need them may be undertreated. “Our findings reinforce current guidelines, confirming that younger individuals with AFib and no other stroke risk factors have a low stroke rate, and anticoagulation does not effectively reduce the risk of cognitive decline,” she stated.
The researchers are further analyzing the data, including over 5,700 Montreal Cognitive Assessments, alongside biomarkers and genetic tests collected from participants, to gain deeper insights into cognitive decline in this population. Dr. Rivard added, “While our trial confirmed a high rate of cognitive decline among younger adults, it remains uncertain whether other interventions, such as AFib ablation, could positively impact cognitive function.”
To ensure participant safety, the trial utilized a low dose of rivaroxaban, leaving open the question of whether higher doses or alternative medications might yield different results.
The BRAIN-AF study included 1,235 adults with AFib from 53 health centers across Canada. Participants ranged in age from 30 to 62, with an average age of 53, and 26% were women. None had current indications for anticoagulation therapy, and those with any signs of dementia or high bleeding risk were excluded from the trial.
AFib is the most prevalent heart rhythm disorder in the United States, with projections indicating an increase from approximately 5.2 million cases in 2010 to 12.1 million by 2030, according to the American Heart Association’s 2024 statistics. While AFib is known to elevate stroke risk, emerging evidence suggests it may also contribute to cognitive decline.
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