Key result
Dabigatran and warfarin resulted in no incident dementia or stroke at 24 months among patients with non-valvular atrial fibrillation.
Why the study?
AF is associated with cognitive impairment and dementia, and observational trials indicate anticoagulation use and efficacy impact this long-term risk.
Does dabigatran etexilate prevent 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
Does dabigatran etexilate prevent incident dementia or moderate cognitive decline compared to warfarin in patients with moderate- to high-risk non-valvular atrial fibrillation?
Absolute Event Rate: 0% vs 0%
In a small vanguard trial of patients with non-valvular AF, dabigatran and well-managed warfarin were associated with similar rates of cognitive decline and dementia over 2 years, with no events observed.
Supports short-term cognitive equivalence of dabigatran and warfarin; extends stroke-prevention data while leaving longer-term dementia effects open.
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, of which 50 received dabigatran and 51 warfarin anticoagulation. The mean age was 73.7±6.0 years and 54(53.5%) were male. 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 to mitigate these risks. The results of this Vanguard study did not support the pursuit of a larger formally powered study.
No takes yet. Share an insight, caveat, or question.
Bunch et al. (2022) conducted an RCT in Non-Valvular Atrial Fibrillation (n=101). Dabigatran etexilate vs. Warfarin was evaluated on Incident dementia or moderate cognitive decline at 24 months. Dabigatran and warfarin resulted in no incident dementia or stroke at 24 months among patients with non-valvular atrial fibrillation.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: