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Objective: To analyze the effectiveness and safety of rivaroxaban in patients with atrial fibrillation (AF). Methods: The clinical profile and outcomes of the EMIR study were indirectly compared with those of ROCKET-AF, eight other Spanish observational studies and XANTUS. Results: In EMIR, mean age was 74.2 years and CHA 2 DS 2 -VASc was 3.5. In the rivaroxaban arm of the ROCKET-AF trial, mean age was 73 years and CHADS 2 was 3.5, whereas in the Spanish studies mean age ranged from 74.9 years to 78.4 years and CHA 2 DS 2 -VASc from 3.5 to 4.3. In EMIR, rates of stroke/systemic embolism, major adverse cardiovascular events, cardiovascular death and major bleeding were 0.57, 1.07, 0.63 and 1.04 events/100 patient-years, respectively. In ROCKET-AF, these numbers were 1.7, 3.91, 1.53 and 3.6 events/100 patient-years, respectively. In the Spanish studies, rates of stroke and major bleeding were 0–1.8 and 0.22–4.2 events/100 patient-years, respectively. In XANTUS, rates of stroke, major adverse cardiovascular events and major bleeding were 0.7, 1.8 and 2.1 events/100 patient-years, respectively. Conclusion: Despite the fact that rivaroxaban is prescribed for elderly patients with a high thromboembolic risk, rates of outcomes remain low.

Background Assessing bleeding risk during the decision-making process of starting oral anticoagulation (OAC) therapy in atrial fibrillation (AF) patients is essential. Several bleeding risk scores have been proposed for vitamin K antagonist users but, few studies have focused on validation of these bleeding risk scores in patients taking direct oral anticoagulants (DOACs). The aim was to compare the predictive ability of HAS-BLED and ORBIT bleeding risk scores in AF patients taking rivaroxaban in the EMIR (‘Estudio observacional para la identificación de los factores de riesgo asociados a eventos cardiovasculares mayores en pacientes con fibrilación auricular no valvular tratados con un anticoagulante oral directo [Rivaroxaban]) Study. Methods and results EMIR Study was an observational, multicenter, post-authorization, and prospective study that involved AF patients under OAC with rivaroxaban at least 6 months before enrolment. We analysed baseline clinical characteristics and adverse events after 2.5 years of follow-up and validated the predictive ability of HAS-BLED and ORBIT scores for major bleeding (MB) events. We analysed 1433 patients with mean age of 74.2 ± 9.7 (44.5% female). Mean HAS-BLED score was 1.6 ± 1.0 and ORBIT score was 1.1 ± 1.2. The ORBIT score categorised a higher proportion of patients as ‘low-risk’ (87.1%) compared with 53.5% using the HAS-BLED score. There were 33 MB events (1.04%/year) and 87 patients died (2.73%/year). Both HAS-BLED and ORBIT had a good predictive ability for MB{Area under the curve (AUC) 0.770, [95% confidence interval (CI) 0.693–0.847; P Conclusion In a prospective real-world AF population under rivaroxaban from EMIR registry, the HAS-BLED score had good predictive performance and calibration compared with ORBIT score for MB events. ORBIT score presented worse calibration than HAS-BLED in this DOAC treated population.

Resumen Introduccion y objetivos La prevalencia y la incidencia de la fibrilacion auricular (FA), un importante factor de riesgo de ictus cardioembolico, han aumentado sustancialmente en los ultimos anos. Sin embargo, varios estudios europeos han observado una disminucion en la tasa de ictus cardioembolico asociada con un aumento de la penetracion de los anticoagulantes orales de accion directa (ACOD). Este estudio ecologico evalua la asociacion entre la penetracion de los ACOD y la tasa de incidencia de ictus cardioembolicos en Espana. Metodos Los datos se obtuvieron del Registro de Actividad Sanitaria Especializada del Ministerio de Sanidad de Espana (RAE-CMBD). Los ictus cardioembolicos se identificaron mediante codigos ICD. Las tasas de incidencia se estandarizaron por edad y se ajustaron a la poblacion estandar europea de 2013. Se utilizaron modelos de regresion de Poisson para estimar la asociacion entre la penetracion de los ACOD y la tasa de ictus cardioembolico en pacientes de 65 o mas anos. Resultados La tasa de incidencia ajustada (TI) del ictus cardioembolico aumento desde 2005 (2,20/100.000 personas/ano) hasta 2012 (2,67). A partir de 2012, tras la introduccion de los ACOD para la prevencion del ictus cardioembolico en Espana, la TI se ha mantenido constante o ha disminuido ligeramente (en 2018, 2,66). Los resultados del modelo de regresion de Poisson indican que la penetracion de los ACOD tiene una influencia estadisticamente significativa en la tasa de ictus cardioembolicos de los mayores de 65 anos (RDI = 0,995; IC95%, 0,995-0,996). Conclusiones Los resultados de este estudio muestran una asociacion entre la penetracion de los ACOD y una menor incidencia de ictus cardioembolicos. A pesar de que esta asociacion no implica causalidad, indica que una mayor penetracion de los ACOD podria llevar a un mayor beneficio clinico para los pacientes con FA en Espana.

La fibrilación auricular aumenta hasta en 5 veces el riesgo de ictus. Los ictus cardioembólicos habitualmente son más graves y tienen altas tasas de recurrencias y discapacidad permanente en comparación con los ictus de otras etiologías. En consecuencia, la reducción del riesgo de ictus mediante una adecuada anticoagulación es uno de los principales objetivos en el tratamiento de los pacientes con fibrilación auricular. Los antagonistas de la vitamina K han sido ampliamente superados por los anticoagulantes orales de acción directa, ya que tanto los resultados de los ensayos clínicos como los de los estudios de práctica clínica y, últimamente, estudios poblacionales han demostrado que los anticoagulantes orales de acción directa tienen mayores eficacia (menos ictus y muerte) y seguridad (menos hemorragias intracraneales) que los antagonistas de la vitamina K. Además, durante la pandemia de COVID-19, el empleo preferente de anticoagulantes orales de acción directa frente a los antagonistas de la vitamina K constituye una estrategia clave para garantizar una calidad óptima de la anticoagulación y una mejor protección del paciente contra el SARS-CoV-2, al no precisarse control de la razón internacional normalizada.

Resumen Los pacientes que sobreviven a un cancer tienen una menor supervivencia a largo plazo, en parte debido al incremento de las enfermedades cardiovasculares (ECV). Hasta el 30% de los fallecimientos de pacientes con cancer pueden ser de causa cardiovascular. El cancer puede causar ateroesclerosis por diferentes mecanismos, los mas frecuentes son las secuelas de los farmacos antitumorales, la radioterapia y el trasplante de celulas hematopoyeticas. Los factores de riesgo cardiovascular son prevalentes en los supervivientes de cancer. Estos pacientes deberian ser considerados en alto riesgo cardiovascular. Se aconseja recomendar habitos de vida saludables y un control estricto de los factores de riesgo. Hay una necesidad inmediata para ampliar la disponibilidad de servicios preventivos cardiovasculares de cara a reducir los efectos adversos tardios de la quimioterapia y la radiacion. La intervencion precoz podria ayudar a mejorar el perfil de riesgo cardiovascular.

The increased availability of new cancer treatments in recent years has led to improved prognosis and increased life expectancy for cancer patients, but at the expense of increased cardiovascular risk. For this reason, multidisciplinary teams need to be formed for the joint evaluation of these patients to optimise the cardiovascular health and overall survival of these patients and minimise interruptions to onco-haematological treatments. A wide range of cardiovascular toxicities are associated with the various cancer treatments. The structured control of cardiovascular risk before, during and after oncological treatment will enable strategies for the prevention, early detection and early treatment of cardiotoxicities.

Objective: To analyze impact of implementation of an oral anticoagulation self-monitoring and self-management program among patients with mechanical valve prosthesis. Materials & methods: Observational and retrospective study performed in Hospital Moises Broggi, Barcelona, Spain. The program started on June 2019. The study compared 6-month period before and after the implementation of the program. Results: The study included 44 patients. There was a numerical increase of time in therapeutic range from 53.6 ± 21.3% to 57.1 ± 15.7% (p = 0.30). Proportion of patients with international normalized ratio (INR) >5 significantly decreased from 3.9 to 2.0% (p = 0.04). No significant differences were observed in thromboembolic or bleeding complications. Visits to emergency department decreased from (29.5 to 22.7%; p = 0.41). Conclusion: Oral anticoagulation self-monitoring and self-management program seems an appropriate approach that could provide additional benefits in selected patients with mechanical valve prosthesis.

COVID-19; Direct oral anticoagulant; Telemedicine COVID-19; Anticoagulante oral directo; Telemedicina COVID-19; Anticoagulant oral directe; Telemedicina Compared with face-to-face consultations, telemedicine has many advantages, including more efficient use of healthcare resources, partial relief of the burden of care, reduced exposure to COVID-19, treatment adjustment, organization of more efficient healthcare circuits and patient empowerment. Ensuring optimal anticoagulation in atrial fibrillation patients is mandatory if we want to reduce the thromboembolic risk. Of note, telemedicine is an excellent option for the long-term management of atrial fibrillation patients. Moreover, direct oral anticoagulants may provide an added value in telemedicine (versus vitamin K antagonists), as it is not necessary to monitor anticoagulant effect or make continuous dosage adjustments. In this multidisciplinary consensus document, the role of telemedicine in anticoagulation of this population is discussed and practical recommendations are provided. V Barrios has received consultancy/lecture fees from Bayer, BMS/Pfizer, Boehringer Ingelheim and Daiichi Sankyo. S Cinza-Sanjurjo has received honoraria for presentations from Bayer, Boehringer-Ingelheim, Daiichi Sankyo and Pfizer-BMS; advisory board fees from Bayer, Boehringer-Ingelheim, Daiichi Sankyo and Pfizer-BMS; and funding for studies from Bayer. J García-Alegría reports consulting fees and/or lectures honoraria from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb and Daiichi Sankyo. R Freixa-Pamias has received honoraria for presentations from Bayer, Boehringer-Ingelheim, Daiichi Sankyo and Pfizer-BMS. F Llordachs-Marques. No potential conflicts of interest were declared by the author. CA Molina reports consulting fees and/or honoraria from Novo Nordisk, Bayer, Pfizer, BMS, Daiichi Sankyo and Boehringer Ingelheim. A Santamaría has received honoraria per conferences from Octapharma, Novo Nordisk, Bayer, Pfizer, BMS, Sobi, Shire, Sanofi, LEO Pharma, Rovi, Daiichi Sankyo, Werfen and Ferrer. D Vivas reports no potential conflicts of interest were declared by the author. C Suárez has received speaker and/or advisory fees from Bayer, Pfizer/BMS, Daiichi Sankyo. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

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.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.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%; p0.01), coronary artery disease (28.2% vs. 12.9%; p0.01), renal insufficiency (31.7% vs. 22.6%; p = 0.01), higher CHA₂DS₂-VASc (4.5 ± 1.6 vs. 3.2 ± 1.4; p0.01) and HAS-BLED (1.8 ± 1.1 vs. 1.5 ± 1.0; p0.01). 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%; p0.01) and cardiovascular death (2.0% vs. 0.2%; p0.01), 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.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.

To analyze the temporal trends of atrial fibrillation (AF)-related ischemic stroke (IS) and their relationship with the prescription patterns of antithrombotic treatment from 2013 to 2019 in the Health Assistance Area of a regional hospital.First, a retrospective ecological study of aggregate data to analyze the annual incidence of IS between 2013 and 2019 was performed. Second, we selected those patients diagnosed with AF between 2013 and 2019 and performed a retrospective longitudinal study to assess the role of antithrombotic therapy in the development of AF-related IS.During this period, whereas the annual incidence of IS remained stable (from 1.3 in 2013 to 1.2 cases per 1000 inhabitants in 2019; adjustedThe prescription of oral anticoagulants, particularly direct oral anticoagulants, has increased from 2013 to 2019 in our Health Assistance Area. This increase might partially explain the reduction in AF-related IS.

Resumen La fibrilacion auricular aumenta de manera marcada el riesgo de ictus. Multiples ensayos clinicos y estudios en practica clinica han demostrado que el tratamiento anticoagulante disminuye el riesgo de complicaciones tromboembolicas. Para este tratamiento, los anticoagulantes orales de accion directa (ACOD) ofrecen un mejor perfil de eficacia y seguridad que los antagonistas de la vitamina K. Estudios realizados en paises de nuestro entorno han objetivado en los ultimos anos una reduccion en la incidencia de ictus isquemico, lo que podria estar en relacion con una mayor prescripcion de anticoagulantes orales, sobre todo ACOD. En Espana hay muy poca informacion sobre este tema. Sin embargo, los datos disponibles indican que parece que tambien la mayor prescripcion de anticoagulantes orales, sobre todo ACOD, se asociaria con una significativa reduccion de las incidencias tanto de ictus isquemico como de hemorragias intracraneales. En consecuencia, se deberia recomendar un mayor empleo de los ACOD para los pacientes con fibrilacion auricular, lo que contribuiria no solo a reducir la incidencia de ictus isquemico y de hemorragias intracraneales, sino tambien la carga economica que esto conlleva.

In atrial fibrillation (AF) patients on vitamin K antagonists, a progressive deterioration of renal function is common but there is limited evidence with long-term use of rivaroxaban. Herein, we investigated the change in renal function in AF patients after 2 years of rivaroxaban treatment.The EMIR registry is an observational and multicentre study including AF patients treated with rivaroxaban for at least 6 months prior to inclusion. Changes in analytical parameters were recorded during 2 years of follow-up. Renal function was estimated using the Cockroft-Gault equation.1433 patients (638, 44.5% women, mean age of 74.2 ± 9.7 years) were included. Creatinine clearance (CrCl) was available at baseline and at 2 years in 1085 patients. At inclusion, 33.2% of patients had impaired renal function (CrCl 60 ml/min). At 2 years, we were not able to find changes in the proportion of patients with impaired renal function, which increased to 34.6% (p = 0.290). However, the baseline mean CrCl was 76.0 ± 30.5 ml/min and slightly improved at 2 years (77.0 ± 31.8 ml/min; p = 0.014). Overall, the proportion of patients with CrCl60 ml/min at baseline that had CrCl ≥60 ml/min at 2 years was significantly higher compared to that of patients with CrCl ≥60 ml/min at baseline and CrCl60 ml/min after (22.2% vs. 13.1%; p 0.001) CONCLUSIONS: In AF patients on long-term rivaroxaban therapy, a decrease in renal function was not observed. We even observed a slight improvement in the patients with renal impairment. These results reinforce the idea that rivaroxaban may be a safe option even in patients with renal impairment.

Resumen La fibrilacion auricular es muy frecuente en el paciente anciano. Aunque existe una amplia experiencia con los antagonistas de la vitamina K, el empleo de estos farmacos en el paciente anciano presenta numerosas limitaciones, con una mayor susceptibilidad a las hemorragias y un peor control de la anticoagulacion que en la poblacion general. Los anticoagulantes orales de accion directa han demostrado ser una mejor alternativa terapeutica para los pacientes ancianos, no solo por su mayor simplicidad de uso, sino por sus mayores eficacia y seguridad en comparacion con los antagonistas de la vitamina K, con datos que en general concuerdan con los ensayos clinicos fundamentales. Sin embargo, en el paciente anciano hay una tendencia al uso de dosis inadecuadas, generalmente por infradosificacion, sobre todo con algunos de ellos, lo que conlleva una menor proteccion contra los ictus, sin una clara ventaja antihemorragica. El rivaroxaban se ha estudiado ampliamente en la poblacion anciana y no solo en ensayos clinicos, sino tambien en multitud de estudios en la practica clinica real, con datos muy consistentes. En estos estudios, en comparacion con los antagonistas de la vitamina K, se ha demostrado que el rivaroxaban reduce el riesgo de ictus sin un incremento de las hemorragias mortales, con lo que tiene un beneficio clinico neto favorable en la poblacion con fibrilacion auricular no valvular con mayor riesgo tromboembolico.

Introduction and objectives The incidence and prevalence of atrial fibrillation (AF), a major risk factor for stroke, has increased substantially in the past few years. However, several studies have reported a decline in AF-related stroke rates associated with higher uptake of direct oral anticoagulants (DOACs). This ecological study evaluated the association between DOAC uptake in Spain and the incidence rate (IR) of AF-related ischemic stroke. Methods Data were obtained from the Registry of Activity of Specialized Healthcare of the Spanish Ministry of Health (RAE-MDS). AF-related ischemic strokes were identified using International Classification of Diseases codes. IR were age-standardized and adjusted to the 2013 European standard population. Poisson regression models were used to identify the association between DOAC uptake and AF-related ischemic stroke in patients aged ≥ 65 years. Results Before the use of DOACs, the adjusted IR of AF-related ischemic stroke increased steadily from 2005 (IR = 2.20 per 100 000 person/y) to 2012 (IR = 2.67). Upon DOAC uptake in Spain from 2012 onwards for AF-related ischemic stroke prevention, the IR remained constant or decreased slightly (IR in 2018 = 2.66). Poisson regression showed that DOAC uptake was a significant predictor for the rate of AF-related ischemic stroke in patients older than 65 years (IRR = 0.995; 95%CI, 0.995-0.996). Conclusions This study shows an association between DOAC use and a reduced incidence of AF-related ischemic stroke. While this association is based on aggregate data and cannot demonstrate causality, these findings suggest that higher DOAC uptake could improve health outcomes in AF patients in Spain.

Aim: To analyze the impact of implementing a program integrating cardiology and primary care in clinical practice. Methods: In the integrated care model, every cardiologist was assigned to each primary care center. Results & conclusion: The implementation of the new care model was associated with a significant reduction of 31.2% in requests of first visits. In addition, the delay to the cardiologist consultation significantly decreased by 54.5% for the first visits, and by 57.1% for the follow-up visits. The proportion of patients that achieved recommended low density lipoprotein-cholesterol goals significantly increased from 20.8 to 29.6%. The proportion of patients submitted to anticoagulant therapy significantly increased from 69.3 to 74.2%, as well as the proportion of patients taking direct oral anticoagulants (from 7.9 to 28.4%).