Dabigatran versus warfarin on cognitive outcomes in nonvalvular atrial fibrillation: Results of the GIRAF trial

Presented at the American Heart Association’s Scientific Sessions 2021 by: Bruno Caramelli, MD, PhD - São Paulo, Brazil.

Introduction and methods

Aim of the study

Previous clinical trials have investigated the effects of anticoagulation on stroke, but cognitive outcomes were neglected in these studies. In the past, there were studies on this topic, but these were retrospective or historical cohort studies that suggest that cognitive decline occurs in AF patients and anticoagulation can mitigate this effect. But no prospective study has demonstrated this.

The objective of this study was to examine the effects of dabigatran compared with warfarin on cognitive outcomes in older individuals with atrial fibrillation or atrial flutter.

Study design

In the GIFAF trial, patients with AF or atrial flutter who were ≥70 years and had a CHAD2DS2VASC score ≥1 were included. Major exclusion criteria were recent surgery, kidney failure, contraindications to warfarin or previous psychiatric disorder, neurological diseases or dementia. It was a parallel, randomized, open-label trial that enrolled 200 patients. Patients were randomized to dabigatran (110 or 150 mg bid) or warfarin (once daily, INR 2-3).

Primary outcome

Primary end point was cognitive impairment at two years. Tests to measure cognitive function at baseline and after two years were Montreal cognitive assessment (MOCA score; with global coverage pattern), mini-mental state exam (MMSE score; global), neurophysiological battery (NTB score; attention, memory, language, executive functions) and a computer generated neurophysiological battery (CGNT-score; sustained selective and divided attention).

Main results

• Only the MoCA-score showed a significant difference between the two groups with a more favorable effect in those with warfarin (difference of -0.96, 95%CI:-1.8 to -0.13, P=0.02).
• When looking at effects on different domain’s test (memory, executive function, language and attention) there was no difference between the two groups.

Conclusion

There was no difference in the majority of the cognitive outcome tests between treatment with dabigatran or warfarin in older patients with AF or atrial flutter who did not present with major cerebrovascular events.

Discussion

The discussant Prof. Biykem Bozkurt, MD, PhD (Baylor College of Medicine, Houston, TX, USA) said that the message she got from the study was appropriate treatment regardless of the agent is associated with similar findings. When medication is given according to the guidelines, the efficacy of these agents is comparable.

- Our reporting is based on the information provided at the American Heart Association’s Scientific Sessions 2021 -