Predictive value of bleeding risk scores in elderly patients with atrial fibrillation and oral anticoagulation.

BACKGROUND: The predictive value of bleeding risk scores for atrial fibrillation in older patients is not as well known. The goal of this study was to evaluate the predictive value of HASBLED, ORBIT and ATRIA for major bleeding (MB) and intracranial hemorrhage (ICH) in patients ≥ 75 years with atrial fibrillation and oral anticoagulation (OAC). METHODS: A retrospective unicenter study including patients ≥ 75 years with atrial fibrillation (AF) and OAC. A total of 7613 patients ≥ 75 years with AF and OAC included between 2014 and 2018 (registry: NCT04364516). We analyzed the discriminative value of HASBLED, ATRIA and ORBIT scores for bleeding endpoints (major bleeding as primary endpoint and intracerebral hemorrhage as secondary). Cox regression was used to predict major bleeding with each scale and also for searching other variables potentially predictor of major bleeding. Model discrimination was assessed using Harrell's C-statistic. Calibration was assessed with goodness-of-fit test proposed by Gronnesby and Borgan. RESULTS: During a mean follow up of 4.0 years (IQR: 2.4-5.7 years), 729 patients developed MB (2.61 per 100 patients/year) and 243 patients developed ICH (0.85 per 100 patients/year). Three scores showed a low discrimination for major bleeding, being ORBIT the best (HASBLED C statistic = 0.557; ATRIA C statistic = 0.568; ORBIT C statistic = 0.595) and also a low discrimination for ICH (HASBLED C statistic = 0.509; ATRIA C statistic = 0.522; ORBIT C statistic = 0.526). Among the variables that are part of the scores and other baseline characteristics, after multivariable adjustment only sex (male), dementia, prior admission for bleeding, anemia and liver disease were found as a predictors of MB. CONCLUSIONS: In older patients under oral anticoagulation with atrial fibrillation, the risk scores HASBLED, ATRIA and ORBIT showed a weak discrimination for major bleeding and intracranial hemorrhage. Therefore, other better alternatives should be evaluated for this purpose.

Comparison of Outcomes in Patients With Atrial Fibrillation Under Oral Anticoagulation Therapy Analyzed by Body Weight (<60, 60 to 100, and >100 kg).

There is limited knowledge regarding the efficacy and safety of fixed-dose oral anticoagulants in overweight patients because of the possible increased risk of embolism and hemorrhage. This study aimed to evaluate embolic, hemorrhagic, and mortality events in anticoagulated patients, administered both antivitamin K and direct oral anticoagulants based on the body weight (<60 kg, 60 to 100 kg and >100 kg). A retrospective registry-based cohort study including all consecutive patients with a diagnosis of atrial fibrillation between January 2014 and January 2018 in the health area of Vigo (Galicia, Spain) was used (CardioCHUVI-AF registry; ClinicalTrials.gov identifier: NCT04364516). The final cohort comprised 11,821 AF patients. The cohort was classified into 3 categories: low body weight ([LBW], <60 kg, 924 patients); middle body weight (60 to 100 kg, 9,546 patients); and high body weight ([HBW], >100 kg, 958 patients). Outcomes were predicted using the Fine and Gray model and Cox proportional hazards model when appropriate. Middle body weight was the reference group. No association was found between the weight and major bleeding in the univariate analyses: LBW with a sub-distribution hazard ratio (sHR) of 1.13 (95% confidence interval [CI] 0.92 to 1.41), and HBW with an sHR of 1.02 (95% CI 0.83 to 1.26). Stroke/systemic embolism events occurred in 817 patients (6.6%). In the univariate analyses, we found an association between weight and risk of stroke/systemic embolism: LBW sHR 1.37 (95% CI 1.09 to 1.72), and HBW sHR 0.66 (95% CI 0.49 to 0.89) but no association was found in the multivariable model. The same situation was observed with all-cause death: in the univariable model, LBW presented a hazard ratio of 1.48 (95% CI 1.31 to 1.68) and the HBW group presented a hazard ratio of 0.53 (95%CI 0.44 to 0.63) whereas no significant association was found in the multivariable model. We conclude that in our registry, extreme weights were not related to more events during follow-up.

Effect of mitral regurgitation on stroke risk in patients with non-rheumatic atrial fibrillation.

BACKGROUND: Atrial fibrillation (AF) carries a thrombotic risk related to blood stasis in the left atrium. In patients with rheumatic valve disease and AF, the presence of severe mitral regurgitation (MR) has been shown to reduce the risk of atrial thrombosis and stroke. However, in patients without rheumatic disease, the results are controversial. AIM: To analyse the association between MR and the incidence of stroke in patients with non-rheumatic AF. METHODS: We analysed data from the retrospective CardioCHUVI-AF registry, which includes 15,720 patients with AF (without mechanical prostheses or rheumatic valvular disease) in the Vigo area of Spain, during 2014-2018. We grouped the patients according to MR grades: 0-2 (n=15,194) and 3-4 (n=526). We performed univariate and multivariable competitive risk analyses to analyse the association between MR and stroke, with death as the competitive event. RESULTS: During a median (interquartile range [IQR]) follow-up of 4.9 (2.8-4.9) years, 859 patients (5.5%) suffered a stroke. The stroke incidence was 1.3 per 100 person-years (95% confidence interval [95% CI]: 1.2-1.4), with no difference between the MR groups. In univariate analysis, no relationship was observed between MR grade and stroke (subdistribution hazard ratio [sHR]: 1.12, 95% CI: 0.79-1.60; P=0.53); likewise after multivariable analysis (sHR: 0.98, 95% CI: 0.68-1.41; P=0.90). This same relationship was evaluated in subgroups of interest (patients with and without: oral anticoagulation, CHA2DS2-VASc≥2, prior heart failure, aortic valve disease, left ventricular ejection fraction≤40%, and moderate-severe left atrial dilation), with results consistent with the overall population. CONCLUSION: In our large registry of patients with non-rheumatic AF, we did not find a protective effect of grade 3-4 MR on the risk of stroke.