Impact of heart failure on the clinical profile and outcomes in patients with atrial fibrillation treated with rivaroxaban. Data from the EMIR study

Background: The aim of this study was to analyze the impact of the presence of heart failure (HF) on the clinical profile and outcomes in patients with atrial fibrillation (AF) anticoagulated with rivaroxaban. Methods: Observational and non-interventional study that included AF adults recruited from 79 Spanish centers, anticoagulated with rivaroxaban ≥ 6 months before inclusion. Data were analyzed according to baseline HF status. Results: Out of 1,433 patients, 326 (22.7%) had HF at baseline. Compared to patients without HF, HF patients were older (75.3 ± 9.9 vs. 73.8 ± 9.6 years; p = 0.01), had more diabetes (36.5% vs. 24.3%; p < 0.01), coronary artery disease (28.2% vs. 12.9%; p < 0.01), renal insufficiency (31.7% vs. 22.6%; p = 0.01), higher CHA2DS2-VASc (4.5 ± 1.6 vs. 3.2 ± 1.4; p < 0.01) and HAS-BLED (1.8 ± 1.1 vs. 1.5 ± 1.0; p < 0.01). After a median follow-up of 2.5 years, among HF patients, annual rates of stroke/ /systemic embolism/transient ischemic attack, major adverse cardiovascular events (MACE) (non-fatal myocardial infarction, revascularization and cardiovascular death), cardiovascular death, and major bleeding were 1.2%, 3.0%, 2.0%, and 1.4%, respectively. Compared to those patients without HF, HF patients had greater annual rates of MACE (3.0% vs. 0.5%; p < 0.01) and cardiovascular death (2.0% vs. 0.2%; p < 0.01), without significant differences regarding other outcomes, including thromboembolic or bleeding events. Previous HF was an independent predictor of MACE (odds ratio 3.4; 95% confidence interval 1.6–7.3; p = 0.002) but not for thromboembolic events or major bleeding. Conclusions: Among AF patients anticoagulated with rivaroxaban, HF patients had a worse clinical profile and a higher MACE risk and cardiovascular mortality. HF was independently associated with the development of MACE, but not with thromboembolic events or major bleeding. (Cardiol J 2022; 29, 6: 936–947)

Reducing residual thrombotic risk in patients with peripheral artery disease : impact of the COMPASS trial

Altres ajuts: Writing and editorial assistance was funded by Bayer Hispania.Patients with peripheral artery disease (PAD) are at a high risk not only for the classical cardiovascular (CV) outcomes (major adverse cardiovascular events; MACE) but also for vascular limb events (major adverse limb events; MALE). Therefore, a comprehensive approach for these patients should include both goals. However, the traditional antithrombotic approach with only antiplatelet agents (single or dual antiplatelet therapy) does not sufficiently reduce the risk of recurrent thrombotic events. Importantly, the underlying cause of atherosclerosis in patients with PAD implies both platelet activation and the initiation and promotion of coagulation cascade, in which Factor Xa plays a key role. Therefore, to reduce residual vascular risk, it is necessary to address both targets. In the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial that included patients with stable atherosclerotic vascular disease, the rivaroxaban plus aspirin strategy (versus aspirin) markedly reduced the risk of both CV and limb outcomes, and related complications, with a good safety profile. In fact, the net clinical benefit outcome composed of MACE; MALE, including major amputation, and fatal or critical organ bleeding was significantly reduced by 28% with the COMPASS strategy, (hazard ratio: 0.72; 95% confidence interval: 0.59-0.87). Therefore, the rivaroxaban plus aspirin approach provides comprehensive protection and should be considered for most patients with PAD at high risk of such events

Valor pronóstico de un nuevo modelo de evaluación clínica de pacientes ambulatorios con insuficiencia cardiaca

[Resumen] Introducción y objetivos. Estudiar el valor pronóstico de un modelo de 5 ítems clínicos basado en las recomendaciones IC-BERG para la evaluación en consulta de pacientes ambulatorios con insuficiencia cardiaca (IC). Métodos. Estudio observacional basado en la cohorte histórica de pacientes con IC remitidos a una consulta monográfica entre 2010 y 2019. Se evaluó la presencia de 5 ítems clínicos de riesgo: NYHA III-IV, signos de congestión, ingreso por descompensación en el último año, dosis diaria de furosemida ≥ 40 mg o equivalente y NT-proBNP ≥ 1.000 pg/ml. Se estudió la incidencia de desenlaces clínicos adversos mediante el método de Kaplan-Meier y la regresión de Cox. Resultados. Se estudiaron 1.909 pacientes, que presentaban una media de 2,29 ítems de riesgo. El análisis de Kaplan-Meier mostró una tendencia incremental entre un mayor número de ítems de riesgo y el desenlace combinado muerte o ingreso por IC, la mortalidad global y la mortalidad cardiovascular (p < 0,001). Las hazard ratio ajustadas para el desenlace muerte o ingreso por IC, estimadas por regresión multivariante de Cox, fueron de 1,47 (IC95%, 1-2,15), 2,03 (IC95%, 1,41-2,92), 2,98 (IC95%, 2,08-4,28), 5,07 (IC95%, 3,51-7,32) y 7,73 (IC95%, 5,21-11,45) para pacientes con 1, 2, 3, 4 o 5 ítems de riesgo, respectivamente. El peso proporcional de las causas cardiovasculares de muerte, y en especial la IC, fue mayor en los pacientes con mayor número de ítems de riesgo. Conclusiones. Este estudio apoya el valor pronóstico de un modelo de evaluación clínica para pacientes ambulatorios con IC basado en las recomendaciones IC-BERG.[Abstract] Introduction and objectives. To assess the prognostic value of a 5-item clinical model based in the IC-BERG recommendations to evaluate ambulatory patients with heart failure (HF) in the clinic. Methods. Observational study based on the historical cohort of patients with HF referred to a specific facility since 2010 to 2019. The presence of 5 clinical ítems was evaluated: NYHA III-IV class, signs of congestion, admission due to decompensation in the previous year, daily dose ≥ 40 mg furosemide or equivalent, and NT-proBNP ≥ 1,000 pg/ml. The incidence of adverse clinical events was assessed by means of the Kaplan-Meier method and multivariable Cox's regression. Results. We studied 1909 patients, whose mean number of clinical ítems indicating risk was 2.29. Kaplan-Meier survival analysis showed an incremental trend between an increasing number of clinical ítems of risk and the combined event death or admission due to HF, overall mortality, and cardiovascular mortality (P < .001). Adjusted hazard-ratio for the combined end-point death or admission due to HF, as estimated by means of multivariable Cox's regression, were 1.47 (95%CI, 1–2.15), 2.03 (95%CI, 1.41–2.92), 2.98 (95%CI, 2.08–4.28), 5.07 (95%C,: 3.51–7.32), and 7.73 (95%CI, 5.21–11.45) for patients who showed 1, 2, 3, 4, or 5 clinical ítems indicating risk, respectively. The proportional weight of cardiovascular causes of risk, especially refractory HF, was higher in patients with a higher number of clinical ítems of risk. Conclusions. This study supports the prognostic value of a 5-item clinical model based on IC-BERG recommendations in ambulatory patients with HF

Impact of heart failure on the clinical profile and outcomes in patients with atrial fibrillation treated with rivaroxaban. Data from the EMIR study

Background: The aim of this study was to analyze the impact of the presence of heart failure (HF) on the clinical profile and outcomes in patients with atrial fibrillation (AF) anticoagulated with rivaroxaban. Methods: Observational and non-interventional study that included AF adults recruited from 79 Spanish centers, anticoagulated with rivaroxaban ≥ 6 months before inclusion. Data were analyzed according to baseline HF status. Results: Out of 1,433 patients, 326 (22.7%) had HF at baseline. Compared to patients without HF, HF patients were older (75.3 ± 9.9 vs. 73.8 ± 9.6 years; p = 0.01), had more diabetes (36.5% vs. 24.3%; p &lt; 0.01), coronary artery disease (28.2% vs. 12.9%; p &lt; 0.01), renal insufficiency (31.7% vs. 22.6%; p = 0.01), higher CHA2DS2-VASc (4.5 ± 1.6 vs. 3.2 ± 1.4; p &lt; 0.01) and HAS-BLED (1.8 ± 1.1 vs. 1.5 ± 1.0; p &lt; 0.01). After a median follow-up of 2.5 years, among HF patients, annual rates of stroke/systemic embolism/transient ischemic attack, MACE-non-fatal myocardial infarction, revascularization and cardiovascular death-, cardiovascular death, and major bleeding were 1.2%, 3.0%, 2.0%, and 1.4%, respectively. Compared to those patients without HF, HF patients had greater annual rates of MACE (3.0% vs. 0.5%; p &lt; 0.01) and cardiovascular death (2.0% vs. 0.2%; p &lt; 0.01), without significant differences regarding other outcomes, including thromboembolic or bleeding events. Previous HF was an independent predictor of MACE (odds ratio 3.4; 95% confidence interval 1.6-7.3; p = 0.002) but not for thromboembolic events or major bleeding. Conclusions: Among AF patients anticoagulated with rivaroxaban, HF patients had a worse clinical profile and a higher MACE risk and cardiovascular mortality. HF was independently associated with the development of MACE, but not with thromboembolic events or major bleeding

Programa de intervención para mejorar la prevención secundaria del infarto de miocardio: resultados del estudio PRESENTE (PREvención SEcuNdaria TEmprana)

Introducción y objetivos. La prevención secundaria del infarto de miocardio no se realiza de forma adecuada. En España, los estudios PREVESE aportaron datos sobre este problema. El objetivo de este estudio ha sido comprobar el efecto de un sencillo programa de intervención realizado durante la estancia hospitalaria. Pacientes y método. Se ha incluido, al alta hospitalaria, a un total de 4.174 pacientes postinfarto de 110 hospitales, con una edad media de 63,7 años y un 73% de varones, a los que se ha determinado un perfil lipídico en las primeras 24 h del ingreso y se ha realizado una entrevista informativa, acompañados de sus familiares, con entrega de material educativo; posteriormente fueron revisados a los 6 meses. Resultados. A los 6 meses se revisó al 82,9% de los pacientes y el 10% no pudo ser localizado. Se observó una mejoría de la presión arterial, el peso y el índice de masa corporal medios de la muestra, así como de los estilos de vida. Al alta hospitalaria, el 87% recibió tratamiento con estatinas, el 59,4% con bloqueadores beta, el 51,8% con inhibidores o bloqueadores de la angiotensina y el 94,1% con antiagregantes plaquetarios, prescripciones que se mantuvieron a los 6 meses. Los valores lipídicos mejoraron sustancialmente. Conclusiones. Con la instauración de un programa sencillo de intervención dirigido a los pacientes y a sus familiares y la realización de un lipidograma durante las primeras 24 h del ingreso se han mejorado las medidas de prevención secundaria al alta y su mantenimiento a los 6 meses. Se ha constatado una buena aceptación del programa por parte de los pacientes