Key result
Dabigatran and warfarin resulted in similarly low rates of cognitive impairment and zero incident dementia at 2 years in patients with non-valvular atrial fibrillation.
Why the study?
AF is associated with cognitive impairment and dementia, and while observational trials suggest anticoagulation impacts long-term dementia risk, prospective randomized data were needed.
Does dabigatran etexilate reduce incident dementia or moderate cognitive decline compared to warfarin in patients with moderate- to high-risk non-valvular atrial fibrillation?
RCT (n=101)
Open-label with blinded endpoint assessment
Randomized
No
Does dabigatran etexilate reduce incident dementia or moderate cognitive decline compared to warfarin in patients with moderate- to high-risk non-valvular atrial fibrillation?
In a vanguard RCT of patients with non-valvular AF, dabigatran and warfarin showed similar efficacy with no incident dementia or stroke observed over 2 years, suggesting no significant difference in cognitive outcomes between the two anticoagulation strategies.
Answers are grounded in this paper and cite their sources.
Either agent is acceptable for cognitive safety in nonvalvular AF; extends prior data with randomized confirmation of equivalence.
Background: Atrial fibrillation (AF) is associated with a risk for cognitive impairment and dementia, which is more pronounced in patients with a history of clinical stroke. Anticoagulation use and efficacy impact long-term risk of dementia in AF patients in observational trials. Methods: The cognitive decline and dementia in patients with non-valvular atrial fibrillation (CAF) Trial was a randomized, prospective, open-label vanguard clinical study with blinded endpoint assessment involving patients with moderate- to high-risk (CHADS2 or CHA2DS2-Vasc scores of ≥2) non-valvular AF assigned to dabigatran etexilate or warfarin. The primary endpoint was incident dementia or moderate cognitive decline at 24 months. Results: A total of 101 patients were enrolled [mean age:73.7 ± 6.0 years, male: 54(53.5%)]. Prior stroke and stroke risk factors were similar between groups. Average INR over the study was 2.41 ± 0.68 in the warfarin group. No patient experienced a stroke or developed dementia. Mini-Mental Status Evaluation, Hachinski Ischemic scale, cognitive subscale of the Alzheimer's Disease Assessment Scale, Disability Assessment for Dementia, Quality of Life Improvement as assessed by Minnesota Living with Heart Failure Scale and the Anti-Clot Treatment Scale Quality of Life Survey scores did not vary at baseline or change over 2 years. Biomarker analysis indicated a similar efficacy of anticoagulation strategies. Conclusion: Use of dabigatran and well-managed warfarin therapy were associated with similar risks of stroke, cognitive decline, and dementia at 2 years, suggestive that either strategy is acceptable. The results of this Vanguard study did not support the pursuit of a larger formally powered study.
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Bunch et al. (2022) conducted an RCT in Non-valvular atrial fibrillation (n=101). Dabigatran etexilate vs. Warfarin was evaluated on Cognitive impairment (moderate cognitive decline via ADAS-cog11 or DAD scores) at 24 months (p=0.23). Dabigatran and warfarin resulted in similarly low rates of cognitive impairment and zero incident dementia at 2 years in patients with non-valvular atrial fibrillation.
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