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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.

Aims The 2019 European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) dyslipidaemia guidelines recommend achievement of low-density lipoprotein cholestrol (LDL-C) goals based on an individual’s risk. We aimed to evaluate the impact of guideline adoption with statin, ezetimibe, and statin plus ezetimibe fixed-dose combination (FDC) on LDL-C goal achievement and incidence of major adverse cardiovascular events (MACE) across six countries. Methods and results A simulation model with a five-year horizon (2020–2024) was developed based on Institute for Health Metrics and Evaluation Global Burden of Disease Study database with a business-as-usual (BAU) scenario representing status quo, intervention scenario-1 representing treatment with statin and ezetimibe as separate agents, and intervention scenario-2 representing treatment with statin or statin plus ezetimibe FDC. MACE was defined as the composite of myocardial infarction, ischaemic stroke, and cardiovascular death. The mean population LDL-C was reduced from 4.25 mmol/L in the BAU scenario, to 3.65 mmol/L and 3.59 mmol/L in intervention scenarios-1 and -2, respectively. Compared with BAU, intervention scenarios-1 and-2 resulted in relative reduction of MACE by 5.4% and 6.4% representing ∼3.7 and 4.4 million MACE averted, respectively, across six countries over 5 years. The absolute benefit in terms of MACE averted was highest for China, whereas France had highest relative reduction in MACE with both intervention scenarios compared with BAU. Conclusion The 2019 ESC/EAS guideline-based treatment intensification with strategies based on statin, ezetimibe, and statin plus ezetimibe FDC is estimated to result in a substantial population-level benefit in terms of MACE averted compared with BAU.

The aim of the study was to evaluate the performance of the 2MACE in patients with atrial fibrillation (AF) treated with rivaroxaban and to improve the accuracy of 2MACE.This was a post-authorization and observational study of AF adults treated with rivaroxaban for ≥ 6 months. The primary endpoint was any of the major adverse cardiac events (MACE), namely, cardiovascular death, non-fatal myocardial infarction, and myocardial revascularization. The area under the curve (AUC) was calculated to evaluate the performance of 2MACE, and a new score, 2MACER to predict MACE.A total of 1433 patients were included (74.2 ± 9.7 years, CHA₂DS₂-VASc 3.5 ± 1.5, 26.9% 2MACE ≥ 3). The annual event rates (follow-up 2.5 years) were 1.07% for MACE, 0.66% for thromboembolic events and 1.04% for major bleeding. Patients with 2MACE ≥ 3 (vs.3) had higher risk of stroke/systemic embolism/transient ischemic attack (odds ratio [OR] 5.270; 95% CI 2.216-12.532), major bleeding (OR 4.624; 95% CI 2.163-9.882), MACE (OR 3.202; 95% CI 1.548-6.626) and cardiovascular death (OR 3.395; 95% CI 1.396-8.259). 2MACE was recalculated giving 1 more point to patients with baseline a glomerular filtration rate50 mL/min/1.73 m² (2MACER); 2MACER vs. 2MACE: IDI 0.1%, p = 0.126; NRI 23.9%, p = 0.125; AUC: 0.651 (95% CI 0.547-0.755) vs. 0.638 (95% CI 0.534-0.742), respectively; p = 0.361.In clinical practice, AF patients anticoagulated with rivaroxaban exhibit a low risk of events. 2MACE score acts as a modest predictor of a higher risk of adverse outcomes in this population. 2MACER did not significantly increase the ability of 2MACE to predict MACE.

There is currently a degree of divergence among the main clinical practice guidelines on the management of risk factors for peripheral arterial disease (PAD). This project aims to gain understanding of the management of PAD risk factors in clinical practice and to reach a multidisciplinary consensus on the strategies to be followed in order to optimize its identification, treatment, and follow-up.A multidisciplinary consensus following the Delphi methodology.Professionals (n = 130) with extensive experience in PAD participated in this consultation. The results suggest that in order to optimize the control of risk factors, efforts should be aimed at: (1) promoting the involvement and awareness of all specialists in the identification of and screening for the disease; (2) guaranteeing the possibility of evaluating the ankle-brachial index (ABI) in all the medical specialties involved; (3) promoting strategies for patients to quit smoking through the use of drugs, programs, or referrals to specialized units; (4) promoting an appropriate Mediterranean-based diet and the prescription of daily exercise; (5) raising awareness of the importance of ensuring LDL cholesterol values below 70 mg/dL, especially in symptomatic but also in asymptomatic patients (55 mg/dL following the publication of the ESC/EAS guide); (6) recommending the use of antiplatelet therapy in asymptomatic patients with diabetes mellitus (DM) and/or a pathological ABI; and (7) protocolizing the annual evaluation of ABI in high-risk patients.This document presents the 22 agreed-upon strategies which are intended to help professionals optimize multidisciplinary management of PAD risk factors.

Aim: To analyze the frequency and variables related to inappropriate rivaroxaban dosage in clinical practice and its impact on outcomes after 2 years. Materials & methods: Postauthorization, observational, multicenter study, in which atrial fibrillation patients, treated with rivaroxaban ≥6 months were included. Results: A total of 1421 patients (74.2 ± 9.7 years, CHA 2 DS 2 -VASc 3.5 ± 1.6) were included. Overall, 22.9% received rivaroxaban 15 mg. The proper dose of rivaroxaban was taken by 83.3% (9.7% underdosed, 7.0% overdosed). Older age and renal insufficiency were associated with inadequate rivaroxaban dosage. There was a trend toward higher all-cause mortality among underdosed patients (adjusted hazard ratio 1.39; 95% CI 0.75–2.58), and more bleedings in overdosed patients (2.29 vs 0.80 events/100 patient-years; p = 0.14). Conclusion: In clinical practice, rivaroxaban is properly dosed in most patients.

Purpose Many patients at very-high risk of cardiovascular (CV) events would benefit from lipid lowering therapies (LLT) intensification to decrease their risk. This study aimed to identify the real-world secondary prevention patients potentially eligible for proprotein convertase subtilisin–kexin type 9 inhibitors (PCSK9i) in Spain. Methods Retrospective cohort study included adult patients registered in the IQVIA Spanish Electronic Medical Records outpatient database (2014–2020), diagnosed with myocardial infarction (MI), unstable angina (UA), ischaemic stroke (IS), transient ischaemic attack (TIA), or peripheral artery disease (PAD) and with ≥ 1 low-density lipoprotein cholesterol (LDL-C) or total cholesterol measurements. Longitudinal data were collected from the initial diagnosis to the end of the study period or follow-up loss. Results The study included 9,516 patients, 63.9% male, mean (SD) age 67.7 (12.5) years and mean LDL-C 117.3 (38.8) mg/dL. MI, IS, and PAD were the most severe events reported, during the study period (28.5%,18.7%, and 29.3% of patients, respectively). At the time of last available LDL-C assessment (≥ 3 months post-event), 64.4% patients were on LLT. Of those, 45.4% were on high-, 46.9% on moderate-, and 7.7% on low-intensity LLT. Overall, 9.6% patients achieved LDL-C 100 mg/dL (LDL-C reimbursement threshold for PCSK9i in Spain). Conclusion Up to 82% of atherosclerotic CV disease patients do not achieve LDL-C levels recommended by the 2019 ESC/EAS guidelines despite being on optimized LLT therapy. In 17.9% of these patients LDL-C levels exceed 100 mg/dL, being eligible for PCSK9i in Spain.

Objective To determine the management of dyslipidemia in primary care after the publication of the American College of Cardiology/American Heart Association (ACC/AHA) 2013 guidelines and Valencian government's algorithm. Method We conducted a cross-sectional descriptive study that employed a survey of primary care physicians of the Community of Valencia between January and October 2016. Results A total of 199 physicians (mean age, 48.9 ± 11.0 years; experience, 21.3 ± 11.1 years) participated in the survey. The most followed guidelines were those of the European Society of Cardiology (37.5% of respondents) and Valencian government (23.4% of respondents). Some 6.3% of the respondents followed the 2013 ACC/AHA guidelines, and 88.0% established objectives based on LDL cholesterol and cardiovascular risk. The choice of lipid-lowering drug was based on its LDL cholesterol lowering capacity (28.6% of respondents), on the Valencian government's algorithm (23.4%) and on the drug's safety (20.4%). Statins, ezetimibe and fibrates were the preferred hypolipemiant agents, and their combination (51% of respondents) and dosage increases (35%) were the strategies employed for poor control. Lipid profile and transaminase and creatine kinase levels were measured every 6 (59.5%, 52.3% and 54.3% of respondents, respectively) or 12 months (25.1%, 29.2% and 30.3%, respectively). Forty-one percent of the respondents were aware of the controversy surrounding the 2013 ACC/AHA guidelines. Although 60% of the respondents acknowledged its relevance, only 21% changed their daily practices accordingly. Conclusions The Valencian government's algorithm had a greater impact than the 2013 ACC/AHA guidelines in primary care in Valencia. Areas for improvement included the low use of validated guidelines and risk tables and the streamlining of laboratory test periodicity.

Background: Cardiovascular (CV) diseases are the leading cause of mortality globally. Reducing low-density lipoprotein cholesterol (LDL-C) is a proven strategy to decrease risk of acute CV events. The study aimed to estimate a PCSK9i-eligible population in Spain. Methods: We conducted a retrospective cohort study based on real-world data from the IQVIA Spanish Electronic Medical Records primary care database. Adult (≥18 y.o.) patients registered in the database between 2014 and 2020, diagnosed with myocardial infarction (MI), unstable angina (UA), ischemic stroke (IS), transient ischemic attack (TIA) or peripheral artery disease (PAD) and with at least 1 measurement of LDL-C or total cholesterol were included in the study and followed up for up to 12 months from the initial diagnosis. Results: The study included 9,516 patients; mean (SD) age was 67.7 (12.5) years, 63.9% were male and mean LDL-C was 117.3 (38.8) mg/dL. In the study population 28.5% of patients suffered an MI as most severe event during the study period, 10.0% had UA, 18.7% were diagnosed with IS, 13.6% with TIA, and 29.3% with PAD. At the time of last available LDL-C assessment (≥3 months after diagnosis), 64.4% of patients were on lipid lowering therapy (LLT). Of those, 45.4% were on high-intensity LLT (high-intensity statins with/without ezetimibe or PCSK9 inhibitors), 46.9% on moderate-intensity statins, and 7.7% on low-Intensity LLT (low-intensity statins, ezetimibe alone or non-statin LLT). Overall, 12.9% of treated patients achieved LDL-C levels 100 mg/dL (LDL-C reimbursement threshold for PCSK9i in Spain). Conclusions: More than 85% of patients at very-high risk of cardiovascular events in our cohort do not achieve LDL-C 100 mg/dL despite being treated with maximally tolerated LLT and, therefore, would be eligible for using PCSK9i within Spanish reimbursement criteria.

Resumen Introduccion y objetivos Estimar los beneficios en salud y el coste-efectividad de una intervencion con un policomprimido (acido acetilsalicilico 100 mg, atorvastatina 20 mg y ramipril 10 mg) para la prevencion secundaria de eventos cardiovasculares desde la perspectiva del Sistema Nacional de Salud espanol en comparacion con la monoterapia multiple. Metodos Se utilizo una version adaptada de un modelo de Markov publicado recientemente y desarrollado y validado en Microsoft Excel para evaluar el coste-efectividad del policomprimido frente a sus monocomponentes combinados en un horizonte temporal de 10 anos. La poblacion incluida en el modelo tenia antecedentes de infarto de miocardio y una media de edad de 64,7 anos, y la mayoria eran varones. Los parametros de entrada se obtuvieron de una revision sistematica de la literatura que informara sobre eficacia, adherencia, utilidades y costes. Los resultados del modelo se expresan en eventos evitados, costes incrementales, anos de vida incrementales, anos de vida ajustados por calidad incrementales y la razon de coste-efectividad incremental. Resultados En 10 anos, la utilizacion de un policomprimido cardiovascular en lugar de sus monocomponentes evitaria 46 eventos cardiovasculares no fatales y 11 fatales por cada 1.000 pacientes tratados. Ademas, el policomprimido es una estrategia mas efectiva y mas barata. En el analisis probabilistico del caso base, se observa un 90,9% de probabilidad de que el policomprimido sea una estrategia coste-efectiva para una disposicion a pagar 30.000 euros por ano de vida ajustado por calidad comparada con la monoterapia multiple. Conclusiones Se demuestra que el policomprimido es una estrategia coste-efectiva para el Sistema Nacional de Salud espanol con potencial beneficio clinico.

Resumen El tratamiento farmacologico de la fibrilacion auricular recae en dos aspectos fundamentales, la prevencion del ictus mediante la anticoagulacion oral y el control de la arritmia en si, fundamentalmente control de la frecuencia cardiaca o del ritmo. En la presente revision se repasan los principales anticoagulantes, desde los clasicos antagonistas de la vitamina K hasta los mas recientes anticoagulantes directos, y se revisan las principales caracteristicas de cada uno de ellos. Tambien se revisan los distintos tratamientos para controlar la frecuencia cardiaca, asi como los farmacos antiarritmicos utilizados tanto para lograr la reversion a ritmo sinusal como para mantenerlo una vez conseguido.

Resumen Introduccion y objetivos Estimar el coste-efectividad de rosuvastatina frente a simvastatina, atorvastatina y pitavastatina en Espana, de acuerdo con las guias europeas de tratamiento de las dislipidemias, en pacientes con alto y muy alto riesgo cardiovascular. Metodos Modelo de Markov de coste-efectividad a largo plazo de rosuvastatina versus simvastatina, atorvastatina y pitavastatina, en pacientes de alto y muy alto riesgo cardiovascular definido por 5 factores (sexo, edad, habito tabaquico, nivel de colesterol inicial, presion arterial sistolica) segun el sistema SCORE. La ratio coste-efectividad incremental se expresa en euros por ano de vida ajustado por calidad y se calcula desde la perspectiva del Sistema Nacional de Salud. Resultados Los resultados indican que rosuvastatina se asocia a un beneficio mayor que las otras estatinas en todos los perfiles considerados. Rosuvastatina es mas coste-efectiva con respecto a simvastatina en pacientes con riesgo SCORE ≥ 8% en mujeres y ≥ 6% en hombres, mientras que entre 5% y los valores indicados su coste-efectividad depende del nivel basal de c-LDL del paciente. Rosuvastatina resulta mas coste-efectiva frente a atorvastatina a partir de un riesgo SCORE de 11% en mujeres y 10% en hombres. Rosuvastatina resulta dominante frente a pitavastatina, tanto en mujeres como en hombres con riesgo alto y muy alto en el sistema SCORE. Conclusiones Rosuvastatina es una terapia coste-efectiva en el tratamiento de la hipercolesterolemia, frente a simvastatina, atorvastatina y pitavastatina, especialmente en determinados perfiles de pacientes con factores de riesgo cardiovascular alto y muy alto segun el sistema SCORE en Espana.

Introduction and objectives To estimate the health benefits and cost-effectiveness of a polypill intervention (aspirin 100 mg, atorvastatin 20 mg, ramipril 10 mg) compared with multiple monotherapy for secondary prevention of cardiovascular events in adults with a history of myocardial infarction from the perspective of the Spanish National Health System. Methods An adapted version of a recently published Markov model developed and validated in Microsoft Excel was used to compare the cost-effectiveness of the polypill with that of its combined monocomponents over a 10-year time horizon. The population included in the model had a mean age of 64.7 years; most were male and had a history of myocardial infarction. The input parameters were obtained from a systematic literature review examining efficacy, adherence, utilities, and costs. The results of the model are expressed in events avoided, incremental costs, incremental life years, incremental quality-adjusted life years, and the incremental cost-effectiveness ratio. Results Over a 10-year period, use of the cardiovascular polypill instead of its monocomponents simultaneously would avoid 46 nonfatal and 11 fatal cardiovascular events per 1000 patients treated. The polypill would also be a more effective and cheaper strategy. Probabilistic analysis of the base case found a 90.9% probability that the polypill would be a cost-effective strategy compared with multiple monotherapy at a willingness-to-pay of 30 000 euros per quality-adjusted life year. Conclusions The polypill would be a cost-effective strategy for the Spanish National Health System with potential clinical benefits.

Introduction and objectives. Coronary flow reserve (CFR) is impaired not only in ischemic heart disease, but also in cardiac diseases that may or may not course with heart failure. The aim of the present study was to determine if the severity of heart failure can influence CFR impairment. Methods. Forty patients with non-ischemic heart disease and heart failure were studied 41 times. Four groups were established: 1. 10 patients in functional class III-IV; 2. 10 patients in functional class II not taking beta-blockers; 3. 11 patients in class II treated with carvedilol, and 4. 10 patients in class I. These patients had a history of heart failure and systolic dysfunction. Myocardial blood flow (MBF) was measured with positron emission tomography (PET) and N-13 ammonia at rest (r) and during adenosine triphosphate (ATP) infusion. Results. MBF and CFR were significantly higher in group 4 (1.95 ± 0.58 and 2.40 ± 0.95 ml/min/g) than in group 1 (1.02 ± 0.52 and 1.46 ± 0.48 ml/min/g). CFR tended to be higher in groups 2 (1.73 ± 0.72), and 3 (1.89 ± 0.75) vs group 1. No significant correlation was found between CFR and the following variables: age, systolic blood pressure, ventricular mass index, ventricular volume indexes, and ejection fraction. Conclusions. Coronary microvascular function is impaired in non-ischemic heart failure, and the impairment is related to functional class, regardless of the underlying responsible heart disease.

We aimed to assess whether atropine administration is safe and feasible in patients unable to reach the minimal heart rate (HR) required (80% of age-predicted HR) in myocardial scintigraphic studies after exercise stress testing (EST).We studied 108 patients who underwent myocardial perfusion scintigraphy after EST; 0.5 mg of atropine was administered to those showing signs of fatigue before reaching minimal HR (group A, n = 44). The scintigraphic results for group A were compared with those of patients who spontaneously achieved minimal HR (group B, n = 64). Coronary angiographic results, if available, and clinical follow-up were also compared. In group A, atropine increased HR by 13.7 +/- 7.4 beats/min. The percentage of maximal age-related HR achieved was 83.3% +/- 7.5%; 74% achieved minimal HR. No major adverse effects occurred. When groups A and B were compared, baseline and peak HR, rate pressure product, and maximal metabolic equivalents achieved were higher in group B. There were no differences in number of perfusion studies positive for ischemia (group A, 26/44, and group B, 30/64; P =.2), coronary lesions, or clinical follow-up.Atropine added to EST in patients who cannot achieve their 80% age-related HR is a safe and potentially useful method for myocardial perfusion studies.

To estimate the cost-effectiveness of rosuvastatin versus simvastatin, atorvastatin and pitavastatin in Spain, according to the European guidelines for the treatment of dyslipidemias in patients with high and very high cardiovascular risk.A Markov long-term cost-effectiveness model of rosuvastatin versus simvastatin, atorvastatin and pitavastatin in patients with high and very high cardiovascular risk defined according to 5 factors (sex, age, smoking habit, baseline cholesterol level, and systolic blood pressure) using the SCORE system. The incremental cost-effectiveness ratio is expressed in euros per quality adjusted life years and is calculated according to the perspective of the Spanish National Health System.Rosuvastatin is associated with a greater health benefit than the other statins across the considered profiles. Rosuvastatin is cost-effective compared to simvastatin in patients with SCORE risk ≥8% in females and ≥6% in males, while between 5% and the indicated values its cost-effectiveness is conditional to the patient baseline c-LDL level. Rosuvastatin is more cost-effective versus atorvastatin in female profiles associated with a SCORE risk≥11% and male profiles with SCORE risk ≥10%. Rosuvastatin is superior versus pitavastatin in both female and male profiles with high and very high cardiovascular risk.Rosuvastatin is a cost-effective therapy in the treatment of hypercholesterolemia versus simvastatin, atorvastatin and pitavastatin, especially in specific profiles of patients with high and very high cardiovascular risk factors, according to the SCORE system, in Spain.

We describe the surgical procedure of orthotopic heart transplantation (OHT) in a recipient with persistent left superior vena cava (LSVC) and isolated noncompaction of the left ventricle. The bicaval anastomosis technique was performed using and isolating his native coronary sinus to let the left superior vena cava drain into his own inferior vena cava through the native coronary sinus.