RESUMO
Introduction: The screening for atrial fibrillation (AF) scale (SAFE score) was recently developed to provide a prediction of the diagnosis of AF after an ischemic stroke. It includes 7 items: age ≥ 65 years, bronchopathy, thyroid disease, cortical location of stroke, intracranial large vessel occlusion, NT-ProBNP ≥250 pg/mL, and left atrial enlargement. In the internal validation, a good performance was obtained, with an AUC = 0.88 (95% CI 0.84-0.91) and sensitivity and specificity of 83% and 80%, respectively, for scores ≥ 5. The aim of this study is the external validation of the SAFE score in a multicenter cohort. Methods: A retrospective multicenter study, including consecutive patients with ischemic stroke or transient ischemic attack between 2020 and 2022 with at least 24 hours of cardiac monitoring. Patients with previous AF or AF diagnosed on admission ECG were excluded. Results: Overall, 395 patients were recruited for analysis. The SAFE score obtained an AUC = 0.822 (95% CI 0.778-0.866) with a sensitivity of 87.2%, a specificity of 65.4%, a positive predictive value of 44.1%, and a negative predictive value of 94.3% for a SAFE score ≥ 5, with no significant gender differences. Calibration analysis in the external cohort showed an absence of significant differences between the observed values and those predicted by the model (Hosmer-Lemeshow's test 0.089). Conclusions: The SAFE score showed adequate discriminative ability and calibration, so its external validation is justified. Further validations in other external cohorts or specific subpopulations of stroke patients might be required.
RESUMO
Background and aims: The benefits of the PCSK9 inhibitors, alirocumab and evolocumab, in lowering LDL-cholesterol and preventing major adverse cardiac events (MACE) have been demonstrated in pivotal clinical trials. However, few studies of routine clinical practice have been conducted to analyse and compare the efficacy and safety of the two drugs. Methods: Retrospective observational study of patients treated with a PCSK9 inhibitor in five hospitals in Andalusia (southern Spain). Baseline demographic and clinical data, LDL-cholesterol levels and the occurrence of MACEs during the follow-up period were recorded. Results: A total of 141 patients were included in the study: 90 were treated with alirocumab and 51 with evolocumab. The patients' mean age (IQR) was 58 (11) years and 58 (41%) were women. The most frequent concomitant medications were statins, 94 (66.7%), followed by antiplatelet therapy (66%) and ezetimibe (65.2%). The median (IQR) follow-up period was 18 (18) months, with 18 (24) for alirocumab and 11 (18) for evolocumab. At the six-month follow-up visit, LDL-cholesterol values had decreased to pre-treatment levels and remained significantly decreased (p < 0.05) over time, for both drugs, and a greater reduction was achieved in patients with established cardiovascular disease and concomitant treatment with statins. With respect to adverse effects, there were nine MACEs (6.4%), of which seven were with alirocumab (7.8%) and two with evolocumab (3.9%) (p NS). Other adverse effects (9.2%) included local erythema (3.5%), muscle cramps (2.1%), respiratory symptoms (2.1%) and asthaenia (1.4%). Conclusions: The efficacy and safety of alirocumab and evolocumab in routine clinical practice are consistent with the findings of the pivotal clinical trials.
RESUMO
Introducción. La fibrilación auricular (FA) aumenta por cinco el riesgo de ictus. El nuevo esquema de estratificación de riesgo para instauración de anticoagulación oral CHA2-DS2-VASc obtiene mejores resultados en la estratificación del riesgo de ictus frente a la previa escala CHADS2. Objetivo. Evaluar en pacientes con FA conocida e ictus cardioembólico la indicación de anticoagulación oral conforme al riesgo previo embolígeno según la escala CHADS2 y la nueva clasificación CHA2-DS2-VASc, valorando el riesgo hemorrá- gico con la escala HAS-BLED. Pacientes y métodos. Se incluyeron 164 pacientes con FA e ictus cardioembólico, 87 de los cuales tenían FA conocida. Se registró tratamiento precedente anticoagulante y criterios de anticoagulación previos según las escalas CHADS2 y CHA2- DS2-VASc, incluyendo la escala de riesgo hemorrágico HAS-BLED. En anticoagulados se registró un nivel de índice internacional normalizado (INR) en fase aguda del ictus. Resultados. No hubo diferencias significativas en características basales según anticogulación previa, excepto mayor porcentaje de ictus en anticogulados (47%). El 41,3% con FA conocida estaba anticoagulado antes del ictus. De los 52 pacientes no anticoagulados, el 61,5% tenía criterios de anticoagulación previos al ictus según la CHADS2. Usando la CHA2-DS2- VASc, dicho porcentaje aumentó al 94,2% (p < 0,001). El 78,8% de los no anticoagulados presentaba bajo riesgo de sangrado según la escala HAS-BLED. En pacientes anticoagulados, el 67,6% presentaba INR infraterapéutico en el momento del ictus. Conclusión. En nuestro medio, detectamos bajo cumplimiento de escalas de estratificación de riesgo tromboembólico en pacientes con FA para una estrategia óptima de tratamiento. Es preciso su mayor uso para la prevención primaria del ictus y la optimización del tratamiento anticoagulante en pacientes con FA (AU)
Aim. To evaluate in patients with known AF and cardioembolic stroke, the indication of oral anticoagulation under previous risk embolism according to the CHADS2 scale and new classification CHA2-DS2-VASc, assessing the risk of bleeding with HAS-BLED scale. Patients and methods. We included 164 patients with atrial fibrillation and cardioembolic stroke, 87 of them with known AF. It was recorded previous anticoagulant treatment and criteria for prior anticoagulation taking into account CHADS2 scales and CHA2-DS2-VASc, including hemorrhagic risk scale HAS-BLED. In anticoagulated patients INR level was recorded in acute stroke phase. Results. There were no significant differences in baseline patients characteristics according to previous anticoagulation, except higher percentage of previous stroke in anticoagulated patients (47%). 41.3% were anticoagulated with known AF prior to stroke. From 52 non-anticoagulated patients, 61.5% met criteria for anticoagulation prior to stroke as CHADS2. Using CHA2-DS2-VASc, this percentage increased to 94.2% (p <0.001). 78.8% of non-anticoagulated had a low risk of bleeding according to the scale HAS-BLED. In anticoagulated patients, 67.6% had suboptimal INR at the time of stroke. Conclusion. In our study, we found low compliance scales of thromboembolic risk stratification in patients with AF for an optimal treatment strategy. It should be increased its use for primary prevention of stroke and optimization of anticoagulant therapy in patients with AF (AU)
