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Head-to-head: Efficacy of dabigatran versus warfarin on cognitive impairment

Presented by
Prof. Bruno Caramelli, University of São Paulo, Brazil
AHA 2021
Phase 4, GIRAF
Dabigatran treatment in older patients with atrial fibrillation (AF) or atrial flutter did not result in different cognitive outcomes than warfarin treatment after 2 years, as demonstrated in the phase 4 GIRAF trial [1].

AF is associated with cognitive impairment. A recent, retrospective, observational study suggested that anticoagulants may reduce cognitive impairment and dementia in patients with AF [2]. Prof. Bruno Caramelli (University of São Paulo, Brazil) and colleagues conducted a head-to-head comparison of 2 anticoagulants, dabigatran and warfarin, on cognitive outcomes in older patients with AF.

The open-label GIRAF trial (NCT01994265) included 200 patients >70 years without major cerebrovascular comorbidities, who were randomised 1:1 to dabigatran (110/150 mg, twice daily) or warfarin (target INR 2-3, once daily). The primary clinical endpoint was cognitive impairment at 2 years. Notably, the cognitive status of the included patients was extensively assessed at baseline and at 2-years follow-up, including the Montreal Cognitive Assessment (MoCA), Mini-Mental State Examination (MMSE), and 2 other neuropsychological test batteries.

In general, no difference was observed between the 2 treatment groups regarding cognitive status after 2 years of follow-up. The co-primary endpoint MoCA score suggested an advantage of warfarin (adjusted mean change 0.58) over dabigatran (adjusted mean change -0.39; P=0.02) regarding cognitive status, but the other co-primary measures did not show a statistically significant difference: MMSE (P=0.75), NTB (P=0.40), CGNT (P=0.06). In addition, comparing the treatment groups on several cognitive domains (i.e. memory, executive functions, language) did not result in statistical differences between dabigatran and warfarin.

Other randomised trials currently investigating the effects of direct oral anticoagulants on cognitive functioning in patients with AF are the CAF trial (NCT03061006) and the BRAIN-AF trial (NCT02387229).

    1. Caramelli B, et al. Dabigatran versus warfarin on cognitive outcomes in nonvalvular atrial fibrillation: results of the GIRAF trial. LBS03, AHA Scientific Sessions 2021, 13–15 November.

    2. Cadogan SL, et al. Heart. 2021;107(23):1854–1855.


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