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

BACKGROUND: Observational 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. METHODS: The 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). RESULTS: Between 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. CONCLUSIONS: For 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 REGISTRATION: Cognitive Impairment Related to Atrial Fibrillation Prevention Trial (GIRAF), NCT01994265 .

Impact of cardiology referral: clinical outcomes and factors associated with physicians' adherence to recommendations.

OBJECTIVES: Cardiology referral is common for patients admitted for non-cardiac diseases. Recommendations from cardiologists may involve complex and aggressive treatments that could be ignored or denied by other physicians. The purpose of this study was to compare the outcomes of patients who were given recommendations during cardiology referrals and to examine the clinical outcomes of patients who did not follow the recommendations. METHODS: We enrolled 589 consecutive patients who received in-hospital cardiology consultations. Data on recommendations, implementation of suggestions and outcomes were collected. RESULTS: Regarding adherence of the referring service to the recommendations, 77% of patients were classified in the adherence group and 23% were classified in the non-adherence group. Membership in the non-adherence group (p<0.001; odds ratio: 10.25; 95% CI: 4.45-23.62) and advanced age (p = 0.017; OR: 1.04; 95% CI: 1.01-1.07) were associated with unfavorable outcomes. Multivariate analysis identified four independent predictors of adherence to recommendations: follow-up notes in the medical chart (p<0.001; OR: 2.43; 95% CI: 1.48-4.01); verbal reinforcement (p = 0.001; OR: 1.86; 95% CI: 1.23-2.81); a small number of recommendation (p = 0.001; OR: 0.87; 95% CI: 0.80-0.94); and a younger patient age (p = 0.002; OR: 0.98; 95% CI: 0.96-0.99). CONCLUSIONS: Poor adherence to cardiology referral recommendations was associated with unfavorable clinical outcomes. Follow-up notes in the medical chart, verbal reinforcement, a limited number of recommendations and a patient age were associated with greater adherence to recommendations.

Impact of cardiology referral: clinical outcomes and factors associated with physicians' adherence to recommendations

OBJECTIVES: Cardiology referral is common for patients admitted for non-cardiac diseases. Recommendations from cardiologists may involve complex and aggressive treatments that could be ignored or denied by other physicians. The purpose of this study was to compare the outcomes of patients who were given recommendations during cardiology referrals and to examine the clinical outcomes of patients who did not follow the recommendations. METHODS: We enrolled 589 consecutive patients who received in-hospital cardiology consultations. Data on recommendations, implementation of suggestions and outcomes were collected. RESULTS: Regarding adherence of the referring service to the recommendations, 77% of patients were classified in the adherence group and 23% were classified in the non-adherence group. Membership in the non-adherence group (p<0.001; odds ratio: 10.25; 95% CI: 4.45-23.62) and advanced age (p = 0.017; OR: 1.04; 95% CI: 1.01-1.07) were associated with unfavorable outcomes. Multivariate analysis identified four independent predictors of adherence to recommendations: follow-up notes in the medical chart (p<0.001; OR: 2.43; 95% CI: 1.48-4.01); verbal reinforcement (p = 0.001; OR: 1.86; 95% CI: 1.23-2.81); a small number of recommendation (p = 0.001; OR: 0.87; 95% CI: 0.80-0.94); and a younger patient age (p = 0.002; OR: 0.98; 95% CI: 0.96-0.99). CONCLUSIONS: Poor adherence to cardiology referral recommendations was associated with unfavorable clinical outcomes. Follow-up notes in the medical chart, verbal reinforcement, a limited number of recommendations and a patient age were associated with greater adherence to recommendations. .

Perioperative cardiovascular evaluation: heads or tails?

When dealing with surgical patients, a perioperative evaluation is essential to anticipate complications and institute measures to reduce the risks. Several algorithms and exams have been used to identify postoperative cardiovascular events, which account for more than 50% of perioperative mortality. However, they are far from ideal. Some of these algorithms and exams were proposed before important advances in cardiology, at a time when pharmacological risk reduction strategies for surgical patients were not available. New biomarkers and exams, such as C-reactive protein, brain natriuretic peptide, and multislice computed tomography have been used in cardiology and have provided important prognostic information. The ankle-brachial index is another significant marker of atherosclerosis. However, specific information regarding the perioperative context of all these methods is still needed. The objective of this article is to evaluate cardiovascular risk prediction models after noncardiac surgery.

Perioperative cardiovascular evaluation: heads or tails?

When dealing with surgical patients, a perioperative evaluation is essential to anticipate complications and institute measures to reduce the risks. Several algorithms and exams have been used to identify postoperative cardiovascular events, which account for more than 50% of perioperative mortality. However, they are far from ideal. Some of these algorithms and exams were proposed before important advances in cardiology, at a time when pharmacological risk reduction strategies for surgical patients were not available. New biomarkers and exams, such as C-reactive protein, brain natriuretic peptide, and multislice computed tomography have been used in cardiology and have provided important prognostic information. The ankle-brachial index is another significant marker of atherosclerosis. However, specific information regarding the perioperative context of all these methods is still needed. The objective of this article is to evaluate cardiovascular risk prediction models after noncardiac surgery.