Dabigatran versus Warfarin on Cognitive Outcomes in Non- valvular Atrial Fibrillation: Results of the GIRAF Trial

<p>1. GIRAF trial was created with a multicenter, randomized, prospective parallel, active-controlled blinded design and conducted in 6 centers in Brazil., the trial assessed multiple cognitive outcomes in a cohort of patients randomized to 110 or 150 mg of dabigatran twice daily or once-daily warfarin.</p> <p>2. The trial enrolled and randomized 200 patients. For inclusion in the trial, patients needed to have confirmed atrial fibrillation or atrial flutter, a CHA2DS2-VASc Score greater than 1, and be aged 70 years or older.</p> <p>3. Exclusion criteria for the trial included a history of valvular heart disease, previous stroke, dementia or any severe neurological or psychiatric disease, major recent surgery, recent bleeding events, active cancer, warfarin contraindication, a creatinine clearance less than 30 mL/min, active liver disease, and a LVEF below 35%.</p> <p>4. Cognitive function assessments occurred at 1- and 2-year follow-up visits. Specific function assessments used in the study included MoCA, MMSE, Geriatric Depression Scale, semantics verbal fluency, phonemic verbal fluency, Digit Symbol Substitution Test (DSST), Boston Naming Test short version, and clock-drawing test. Participants also underwent brain MRI at baseline and after 2 years to identify potential cerebrovascular events.</p> <p>5. Upon analysis, 2-year results suggested there was less than half a point difference between the warfarin and dabigatran groups in assessments of memory, executive functions, language, and attention from baseline, but investigators noted these differences were not statistically significant. A statistically significant difference was observed for differences in MoCA score between the 2 groups, with a mean difference in change of -0.96 (with 0.02 p value of significance) favoring warfarin. Investigators also pointed out no participants were diagnosed with dementia during the follow-up period.</p> <p>6. Thus, there was no significant difference in the majority of cognitive outcomes with warfarin or dabigatran at 2