Evidence map›Paper›PMID 36284318›Full record

Trial reportBMC medicine2022

Effects of dabigatran versus warfarin on 2-year cognitive outcomes in old patients with atrial fibrillation: results from the GIRAF randomized clinical trial.

Bruno Caramelli, Pai Ching Yu, Francisco A M Cardozo, Iuri R Magalhães, Raphael R Spera, Daniel K Amado, Maria C Escalante-Rojas, Danielle M Gualandro, Daniela Calderaro, Caio A M Tavares and 7 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01994265 (Randomized Clinical Trial for the Prevention of Cognitive Impairment in Atrial Fibrillation Patients Treated With Dabigatran or Warfarin), which is not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01994265 phase4completednot on this map

Randomized Clinical Trial for the Prevention of Cognitive Impairment in Atrial Fibrillation Patients Treated With Dabigatran or Warfarin

TypeinterventionalSponsorUniversity of Sao PauloRan2014 to 2021Enrolled200ConditionsAtrial FibrillationArmsWarfarin, Dabigatran
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
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  6. The Impact of Cognitive Impairment on Cardiovascular Disease.Journal of the American College of Cardiology · 2025
    Review
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  10. Article
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  14. Cardiovascular Statistics - Brazil 2023.Arquivos brasileiros de cardiologia · 2024
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Bruno CaramelliUnidade de Medicina Interdisciplinar em Cardiologia, Instituto do Coração, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Av. Dr. Enéas C de Aguiar 44, São Paulo, 05403-000, Brazil. bcaramel@usp.br.ORCID 0000-0001-6718-8456
Pai Ching YuUnidade de Medicina Interdisciplinar em Cardiologia, Instituto do Coração, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Av. Dr. Enéas C de Aguiar 44, São Paulo, 05403-000, Brazil.
Francisco A M CardozoUnidade de Medicina Interdisciplinar em Cardiologia, Instituto do Coração, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Av. Dr. Enéas C de Aguiar 44, São Paulo, 05403-000, Brazil.
Iuri R MagalhãesUnidade de Medicina Interdisciplinar em Cardiologia, Instituto do Coração, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Av. Dr. Enéas C de Aguiar 44, São Paulo, 05403-000, Brazil.
Raphael R SperaGrupo de Neurologia Cognitiva e do Comportamento, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Daniel K AmadoGrupo de Neurologia Cognitiva e do Comportamento, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Maria C Escalante-RojasUnidade de Medicina Interdisciplinar em Cardiologia, Instituto do Coração, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Av. Dr. Enéas C de Aguiar 44, São Paulo, 05403-000, Brazil.
Danielle M GualandroUnidade de Medicina Interdisciplinar em Cardiologia, Instituto do Coração, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Av. Dr. Enéas C de Aguiar 44, São Paulo, 05403-000, Brazil.
Daniela CalderaroUnidade de Medicina Interdisciplinar em Cardiologia, Instituto do Coração, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Av. Dr. Enéas C de Aguiar 44, São Paulo, 05403-000, Brazil.
Caio A M TavaresInstituto do Coração, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Flavio A Borges-JuniorBehavioral and Cognitive Neurology Research Group, Faculdade de Medicina Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.
Adriana F PastanaUnidade de Medicina Interdisciplinar em Cardiologia, Instituto do Coração, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Av. Dr. Enéas C de Aguiar 44, São Paulo, 05403-000, Brazil.
Mariana G MatheusUnidade de Medicina Interdisciplinar em Cardiologia, Instituto do Coração, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Av. Dr. Enéas C de Aguiar 44, São Paulo, 05403-000, Brazil.
Sonia M D BruckiGrupo de Neurologia Cognitiva e do Comportamento, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Ana Carolina O RodriguesBehavioral and Cognitive Neurology Research Group, Faculdade de Medicina Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.
Ricardo NitriniGrupo de Neurologia Cognitiva e do Comportamento, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Paulo CaramelliBehavioral and Cognitive Neurology Research Group, Faculdade de Medicina Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundObservational studies support a role for oral anticoagulation to reduce the risk of dementia in atrial fibrillation patients, but conclusive data are lacking. Since dabigatran offers a more stable anticoagulation, we hypothesized it would reduce cognitive decline when compared to warfarin in old patients with atrial fibrillation.

methodsThe GIRAF trial was a 24-month, randomized, parallel-group, controlled, open-label, hypothesis generating trial. The trial was done in six centers including a geriatric care unit, secondary and tertiary care cardiology hospitals in São Paulo, Brazil. We included patients aged ≥ 70 years and CHA2DS2-VASc score > 1. The primary endpoint was the absolute difference in cognitive performance at 2 years. Patients were assigned 1:1 to take dabigatran (110 or 150 mg twice daily) or warfarin, controlled by INR and followed for 24 months. Patients were evaluated at baseline and at 2 years with a comprehensive and thorough cognitive evaluation protocol of tests for different cognitive domains including the Montreal Cognitive Assessment (MoCA), Mini-Mental State Exam (MMSE), a composite neuropsychological test battery (NTB), and computer-generated tests (CGNT).

resultsBetween 2014 and 2019, 5523 participants were screened and 200 were assigned to dabigatran (N = 99) or warfarin (N = 101) treatment. After adjustment for age, log of years of education, and raw baseline score, the difference between the mean change from baseline in the dabigatran group minus warfarin group was - 0.12 for MMSE (95% confidence interval [CI] - 0.88 to 0.63; P = 0.75), 0.05 (95% CI - 0.07 to 0.18; P = 0.40) for NTB, - 0.15 (95% CI - 0.30 to 0.01; P = 0.06) for CGNT, and - 0.96 (95% CI - 1.80 to 0.13; P = 0.02) for MoCA, with higher values suggesting less cognitive decline in the warfarin group.

conclusionsFor elderly patients with atrial fibrillation, and without cognitive compromise at baseline that did not have stroke and were adequately treated with warfarin (TTR of 70%) or dabigatran for 2 years, there was no statistical difference at 5% significance level in any of the cognitive outcomes after adjusting for multiple comparisons.

trial registrationCognitive Impairment Related to Atrial Fibrillation Prevention Trial (GIRAF), NCT01994265 .

Indexed as

Atrial FibrillationStrokeAgedAnticoagulantsBrazilCognitionDabigatranHumansWarfarinAnticoagulantsDabigatranWarfarinAtrial fibrillationCognitive scoresDabigatranDementiaElderlyWarfarin

Identifiers

PMID36284318
PMCPMC9598018

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.