American Heart Association

American Heart Association

Source:

Caramelli B, et al. LBS.01. Prevention to Intervention in Atrial Arrhythmias. Presented at: American Heart Association Scientific Sessions; Nov. 13-15, 2021 (virtual meeting).



Disclosures: GIRAF was partially funded by Boehringer Ingelheim Do Brasil Química E Farmacêutica. Bozkurt reports consulting for Amgen, Baxter, Bristol Myers Squibb, Relypsa, Sanofi Aventis and scPharmaceuticals; serving on the clinical event committee for a trial sponsored by Abbott; and serving on the data safety monitoring committee for a trial sponsored by LivaNova.

November 14, 2021
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Cognitive outcomes similar at 2 years with dabigatran vs warfarin in older adults with AF

Source:

Caramelli B, et al. LBS.01. Prevention to Intervention in Atrial Arrhythmias. Presented at: American Heart Association Scientific Sessions; Nov. 13-15, 2021 (virtual meeting).



Disclosures: GIRAF was partially funded by Boehringer Ingelheim Do Brasil Química E Farmacêutica. Bozkurt reports consulting for Amgen, Baxter, Bristol Myers Squibb, Relypsa, Sanofi Aventis and scPharmaceuticals; serving on the clinical event committee for a trial sponsored by Abbott; and serving on the data safety monitoring committee for a trial sponsored by LivaNova.

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In the GIRAF trial, older adults with atrial fibrillation or atrial flutter who were treated with dabigatran or warfarin had similar cognitive outcomes at 2 years, researchers reported at the American Heart Association Scientific Sessions.

“Previous studies demonstrated that anticoagulation is good for the prevention of stroke, but cognitive outcomes were somehow neglected. I consider cognitive outcomes as the final frontier in clinical trials including patients with atrial fibrillation. The only studies we have in the past are retrospective cohort studies that suggested cognitive decline is present in patients with atrial fibrillation and that anticoagulation can mitigate this effect, but no prospective study until now has addressed this issue,” Bruno Caramelli, MD, associate professor of medicine at the University of São Paulo, Brazil, said during a press conference at the American Heart Association Scientific Sessions.

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The parallel, open-label GIRAF trial randomly assigned 200 patients aged 70 years or older (mean age, 75 years; 60% men) with AF or atrial flutter and a CHA2DS2-VASc score greater than 1 to treatment with dabigatran (Pradaxa, Boehringer Ingelheim) or warfarin.

Cognitive evaluations were performed at baseline and 2 years by neurologists who were blinded to the study. Tests included the Montreal Cognitive Assessment and Mini-Mental State Exam to evaluate global function; the Neuropsychological Battery test of attention memory, language and executive functions; and a computer-generated neuropsychological exam to evaluate sustained, selective and divided attention.

At 2 years, adjusted mean score changes from baseline among patients assigned dabigatran compared with warfarin were:

  • Mini-Mental State Exam (–0.69 vs. –0.57; difference, –0.12; 95% CI, –0.88 to 0.63; P = .75);
  • Montreal Cognitive Assessment (–0.39 vs. 0.58; difference, –0.96; 95% CI, –1.8 to –0.13; P = .02);
  • Neuropsychological Battery test (0.02 vs. –0.03; difference, –0.05; 95% CI, –0.07 to 0.18; P = .4); and
  • computer-generated neuropsychological exam (–0.06 vs. 0.09; difference, –0.15; 95% CI, –0.3 to 0.006; P = .06).

The researchers observed no difference between the groups at 2 years in changes in specific cognitive domains such as memory, executive function, language or attention.

“In all, the patients with atrial fibrillation or atrial flutter who did not present major cerebrovascular events and were adequately treated with warfarin or dabigatran for 2 years, there was no difference in the majority of the cognitive outcomes," Caramelli said.

Biykem Bozkurt

Discussing the trial, Biykem Bozkurt, MD, PhD, FHFSA, FACC, FAHA, FESC, Mary and Gordon Cain Chair and Professor of Medicine, director of the Winters Center for HF Research and associate director of the Cardiovascular Research Institute at Baylor College of Medicine; the W.A. “Tex” and Deborah Moncrief Jr., Chair and medicine chief at DeBakey VA Medical Center; and immediate past president of the Heart Failure Society of America, said GIRAF is an “intriguing study, both from the questions that it posed as well as its design.

“The concept of dabigatran being comparable to warfarin, to prevent stroke, but having lower risk of major bleeding complications being a more stable agent for anticoagulation, of course, raises the question of whether it could reduce cognitive dysfunction by a reduction of microvascular thrombosis. But when patients are effectively treated with anticoagulant agents, the results were not different,” Bozkurt said.