Abstract Background: The SAMe-TT2R2 score was introduced to identify atrial fibrillation patients with a high risk of not achieving a good time in therapeutic range (TTR) during vitamin K antagonists (VKA) therapy. Objective: The aim of this study was to evaluate this score in venous thromboembolism (VTE) patients. Patients and methods: A retrospective cohort study of patients receiving care at the outpatient anticoagulation clinic of a tertiary care teaching hospital. Patients were classified as having low (score 0-1) or high risk (score ≥ 2) of not achieving a good TTR. The area under the ROC curve was calculated to assess the ability of the score to predict a TTR ≥ 65%. Adverse event-free survival curves according to the SAMe-TT2R2 score were calculated by the Kaplan-Meier method and compared by the log-rank test. A p-value < 0.05 was considered statistically significant. Results: We investigated 111 patients during a median follow-up of 2.3 (0.7-6.4) years. Mean age was 54.1 ± 15.7 years and 71 (64.0%) were women. Low- and high-risk groups had similar mean TTR (51.9 vs. 49.6%; p = 0.593). The two groups did not differ significantly in the percentage of patients achieving a TTR ≥ 65% (35.6 vs. 25.8%; p = 0.370). The c-statistic was 0.595 (p = 0.113) for TTR ≥ 65%. Adverse event-free survival during anticoagulation was also similar in both groups (p = 0.136). Conclusions: The SAMe-TT2R2 score does not seem to be a useful tool in oral anticoagulation decision-making for patients with VTE and should not be used in this setting.

Resumo Fundamento: O escore HAS-BLED foi desenvolvido para avaliar o risco em um ano de sangramento maior em pacientes com fibrilação atrial (FA) anticoagulados com antagonistas da vitamina K (AVK). Objetivo: O objetivo deste estudo foi avaliar a capacidade do escore HAS-BLED e de seus componentes em predizer sangramento maior em pacientes atendidos em um ambulatório de anticoagulação de um hospital terciário. Métodos: Foi realizado um estudo coorte retrospectivo com pacientes com FA tratados com AVK. Análise de regressão logística foi realizada para avaliar a capacidade de cada componente do escore em predizer sangramento maior. O nível de significância adotado em todos os testes foi de 5%. Resultados: Foram estudados 263 pacientes com média de idade de 71,1 ± 10,5 anos ao longo de um período de tratamento de 237,6 pacientes-ano. A mediana do escore HAS-BLED foi de 2 (1-3). A incidência de sangramento maior foi de 5,7%, sendo mais elevada nos pacientes de alto risco que nos pacientes de baixo risco (9,6 vs. 3,1%; p = 0,052). A área sob a curva ROC foi de 0,70 (p = 0,01). Um ponto de corte ≥ 3 mostrou sensibilidade de 66,7%, especificidade de 62,1%, valor preditivo positivo de 9,6% e valor preditivo negativo de 96,9%. Sobrevida livre de sangramento maior foi menor no grupo de alto risco (p = 0,017). Na análise multivariada, o único preditor independente de sangramento maior entre os componentes do escore foi o uso concomitante de antiplaquetários (OR 5,13, IC95%: 1,55-17,0; p = 0,007). Conclusão: O escore HAS-BLED foi capaz de prever sangramento maior na população de pacientes com FA estudada. Entre os componentes do escore, atenção especial deve ser dada para o uso concomitante de antiplaquetários, que mostrou associação independente. Em pacientes com FA em uso de AVK como terapia anticoagulante, o uso de antiplaquetários deve ser realizado somente naqueles pacientes com avaliação risco-benefício favorável.

Abstract Background: HAS-BLED score was developed to assess 1-year major bleeding risk in patients anticoagulated with vitamin K antagonists (VKA) due to atrial fibrillation (AF). Objective: Of this study was to assess the ability of HAS-BLED score and its components to predict major bleeding in patients treated in an anticoagulation outpatient clinic of a tertiary hospital. Methods: A retrospective cohort study on AF patients treated with VKA was conducted. Logistic regression analysis was performed to evaluate the ability of individual score components to predict major bleeding. The significance level adopted in all tests was 5%. Results: We studied 263 patients with a mean age of 71.1 ± 10.5 years over a period of 237.6 patients-year. Median HAS-BLED score was 2 (1-3). The overall incidence of major bleeding was 5.7%, and it was higher among high-risk HAS-BLED score patients than in low risk patients (9.6 vs. 3.1%; p = 0.052). Area under the ROC curve was 0.70 (p = 0.01). Cut-off point ≥ 3 showed sensibility of 66.7%, specificity of 62.1%, positive predictive value of 9.6% and negative predictive value of 96.9%. Major bleeding-free survival was lower in high-risk group (p = 0.017). In multivariate analysis, concurrent antiplatelet use was the only independent predictor of major bleeding among score components (OR 5.13, 95%CI: 1.55-17.0; p = 0.007). Conclusion: HAS-BLED score was able to predict major bleeding in this cohort of AF patients. Among score components, special attention should be given for concomitant antiplatelet use, which was independently associated to this outcome. Antiplatelets in AF patients under VKA anticoagulation should be used in selected patients with favorable risk-benefit assessment.