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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.

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.

**Background:** Anti-thrombotic prophylaxis is routinely used in patients undergoing elective total hip or knee replacement (THR or TKR) to reduce the risk of venous thromboembolism (VTE). In Spain, pharmacological prophylaxis is performed with low-molecular-weight heparin, enoxaparin being the most commonly used. Rivaroxaban is an oral antithrombotic drug that has shown superior efficacy and similar safety profile compared to enoxaparin regimens in randomized clinical trials. The aim of the study was to estimate the budget impact of increasing the use of rivaroxaban with respect to enoxaparin in the prophylaxis of VTE in patients undergoing elective THR or TKR. **Methods:** A budget impact analysis was conducted in order to estimate the economic cost from an increase of rivaroxaban use versus enoxaparin by 10%, 20%, and 30% over the 3 years of the time horizon (2015, 2016, and 2017) for the THR and TKR populations. Data related to rate of thromboembolic events, major bleeding events and use of resources (local or general anesthesia and nurse care after surgery) were obtained from the Xarelto® for VTE Prophylaxis After Hip or Knee Arthroplasty (XAMOS) study, an international, non-interventional, observational, open-label study in unselected patients undergoing THR or TKR surgery in routine practice. The study included a total of 17 701 patients from 252 centers in 37 countries, including Spain, Italy, France and United Kingdom, among others. Two cohorts where considered (patients undergoing THR or TKR) with two arms (patients treated with rivaroxaban or enoxaparin). The Spanish patients enrolled in the XAMOS study were 262 with THR and 538 with TKR. Thromboembolic events, major bleeding rates and health care resources were considered from both the international and the Spanish population. Health care resources including pharmacologic prophylaxis, anesthesia and nurse care costs (Euros 2014) were estimated from the Spanish National Healthcare System (NHS) perspective. The annual cost associated with each cohort was estimated based on the mean cost per patient and the estimated distribution of use of rivaroxaban or enoxaparin in the base case scenario and alternative scenario (increase of rivaroxaban use) over the 3 years. A one-way sensitivity analysis was conducted to evaluate the effect that the uncertainty of the input parameters may have on the results of the impact budget. **Results:** The difference in cost per patient undergoing THR or TKR with rivaroxaban versus enoxaparin was -€140.69 including event rates and resource use from the Spanish XAMOS population, and -€110.54 when considering event rates and resource use from the multinational XAMOS population (including but not limited to European [Spain, France, Italy, United Kingdom, Portugal, etc.], American [Canada, Mexico, Colombia, Venezuela, etc.], Asian [China, etc.] and Australian countries). In the analysis per cohort (THR or TKR), the impact of increasing the use of rivaroxaban in the THR cohort, was -€1106, -€2875, and -€5607 for 2015, 2016, and 2017, considering the data from the Spanish XAMOS population, and -€869, -€2259, and -€4405 considering the data from the multinational population. Considering the TKR cohort, the impact was -€2271, -€5904, and -€11 513, and -€1784, €4639, and -€9046, respectively. **Conclusions:** The present analysis shows that, according to effectiveness data from the XAMOS study (Spanish and multinational cohorts), an increase in the usage of rivaroxaban in VTE prophylaxis would lead to significant direct cost reduction in elective THR and TKR patients.