Francisco Rodríguez-Salvanés

Impacto de un tratamiento integral e intensivo de factores de riesgo sobre la mortalidad cardiovascular en prevencion secundaria: estudio MIRVAS

INTRODUCTION AND OBJECTIVES The aim was to determine whether secondary prevention involving the comprehensive and intensive treatment of cardiovascular risk factors reduces cardiovascular events and cardiovascular mortality at 3-year follow up. METHODS The study design comprised a randomized, controlled, open trial in a routine clinical practice setting. In total, 247 patients who presented with acute coronary syndrome or stroke were selected. They were randomized to comprehensive and intensive treatment of cardiovascular risk factors (n=121) or to follow-up based on usual care (n=126). The main study outcomes were the number of cardiovascular events and cardiovascular mortality at 3-year follow-up. The percentage of patients in whom each risk factor was successfully controlled was a secondary outcome. RESULTS Overall, 88.8% of patients assigned to the intensive treatment group had a low-density lipoprotein cholesterol level <100mg/dl compared with 56.4% of the usual-care group (relative risk [RR]=1.57; 95% confidence interval [CI], 1.28-1.93), and 75.7% of diabetics had a hemoglobin A(1c) <7% compared with 28.6% of the usual-care group (RR=2.65; 95% CI, 1.13-6.19). There were four deaths due to cardiovascular causes and 26 nonfatal events in the intensive treatment group versus 17 deaths and 54 nonfatal events in the usual-care group. The cumulative survival rate at 3 years was 97.4% in the intervention group and 85.5% in the control group (p=.003). CONCLUSIONS Secondary prevention involving comprehensive and intensive treatment of cardiovascular risk factors reduced both morbidity and mortality at 3-year follow up.

Incidencia a diez años de infarto de miocardio fatal y no fatal en la población anciana de Madrid

Introduccion y objetivos Estimar las tasas de incidencia y mortalidad por infarto de miocardio (IM) y enfermedad coronaria (EC) en la poblacion anciana de Madrid. Metodos En 1995 se establecio una cohorte de base poblacional formada por 1.297 individuos de edad superior a 64 anos y sin enfermedades cardiovasculares. Se investigaron todos los casos de infarto de miocardio mortales y no mortales hasta diciembre de 2004 y se clasificaron segun los criterios OMS-MONICA. Resultados Los varones presentaron incidencias acumulativas significativamente superiores de episodios isquemicos (p Conclusiones La incidencia de infarto de miocardio mortal y no mortal es muy alta en la poblacion anciana de Madrid. Las tasas de incidencia y de mortalidad aumentan de manera muy notable con la edad a partir de los 64 anos. Los varones presentan unas tasas mas altas que las mujeres de cualquier edad, pero las diferencias entre los sexos disminuyen con la edad.

Oral versus intramuscular administration of vitamin B12 for the treatment of patients with vitamin B12 deficiency: a pragmatic, randomised, multicentre, non-inferiority clinical trial undertaken in the primary healthcare setting (Project OB12).

BackgroundThe oral administration of vitamin B12 offers a potentially simpler and cheaper alternative to parenteral administration, but its effectiveness has not been definitively demonstrated. The following protocol was designed to compare the effectiveness of orally and intramuscularly administered vitamin B12 in the treatment of patients ≥65 years of age with vitamin B12 deficiency.Methods/designThe proposed study involves a controlled, randomised, multicentre, parallel, non-inferiority clinical trial lasting one year, involving 23 primary healthcare centres in the Madrid region (Spain), and patients ≥65 years of age. The minimum number of patients required for the study was calculated as 320 (160 in each arm). Bearing in mind an estimated 8-10% prevalence of vitamin B12 deficiency among the population of this age group, an initial sample of 3556 patients will need to be recruited.Eligible patients will be randomly assigned to one of the two treatment arms. In the intramuscular treatment arm, vitamin B12 will be administered as follows: 1 mg on alternate days in weeks 1 and 2, 1 mg/week in weeks 3–8,and 1 mg/month in weeks 9–52. In the oral arm, the vitamin will be administered as: 1 mg/day in weeks 1–8 and 1 mg/week in weeks 9–52. The main outcome variable to be monitored in both treatment arms is the normalisation of the serum vitamin B12 concentration at weeks 8, 26 and 52; the secondary outcome variables include the serum concentration of vitamin B12 (in pg/ml), adherence to treatment, quality of life (EuroQoL-5D questionnaire), patient 3satisfaction and patient preferences. All statistical tests will be performed with intention to treat and per protocol. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in analyses.DiscussionThe results of this study should help establish, taking quality of life into account, whether the oral administration of vitamin B12 is an effective alternative to its intramuscular administration. If this administration route is effective, it should provide a cheaper means of treating vitamin B12 deficiency while inducing fewer adverse effects. Having such an alternative would also allow patient preferences to be taken into consideration at the time of prescribing treatment.Trial registrationThis trial has been registered with ClinicalTrials.gov, number NCT 01476007, and under EUDRACT number 2010-024129-20.

Trombosis venosa profunda en miembros inferiores en un servicio de urgencias. Utilidad de un modelo clínico de estratificación de riesgo

Fundamento La trombosis venosa profunda (TVP) es un proceso de dificil diagnostico. Se pretendeevaluar la utilidad y efectividad diagnostica de un cuestionario de estratificacion de riesgoclinico y de una estrategia diagnostica aplicadas a pacientes con sospecha de TVP en miembrosinferiores (MMII) en un servicio de urgencias. Pacientes y metodo Estudio prospectivo de 569 pacientes que acudieron al servicio de urgenciascon sospecha de TVP en MMII durante 14 meses. Se les aplico un cuestionario que estratificaen grupos de probabilidad pretest (alta, moderada o baja) segun sintomas-signos, factoresde riesgo y diagnosticos alternativos. Se diagnostico TVP mediante una estrategia que combinael modelo de estratificacion con eco-Doppler inicial y repeticion del eco-Doppler a los pacientesde riesgo medio-alto y primer eco-Doppler negativo, con seguimiento clinico (tres meses). Resultados La probabilidad clinica era baja en 203 pacientes (35,7%), media en 186(32,7%) y alta en 180 (31,6%). Se diagnostico TVP a 153 pacientes (26,9%), al 96% con elprimer eco-Doppler, 3,5% con el segundo y 0,7% por seguimiento clinico. Presentaban bajoriesgo 22 pacientes (11%; intervalo de confianza [IC] del 95%, 7-16%); en 43 (23%; IC del95%, 17-30%) el riesgo era medio y en 88 (49%; IC del 95%, 41-56%), alto. La diferencia deprevalencia de TVP entre categorias fue significativa (p Conclusiones El modelo de estratificacion clinico utilizado es valido, util y sencillo, aunque insuficientecomo unica herramienta para tomar decisiones. La estrategia diagnostica utilizada esefectiva, pero poco eficiente.

Ten-Year Incidence of Fatal and Non-Fatal Myocardial Infarction in the Elderly Population of Madrid

INTRODUCTION AND OBJECTIVES To determine the incidence of and mortality due to myocardial infarction and coronary heart disease in the elderly population of Madrid, Spain. METHODS The study involved a population-based cohort of 1297 individuals aged over 64 years without cardiovascular disease who were recruited in 1995. All cases of fatal and non-fatal myocardial infarction recorded up until December 2004 were investigated and classified using WHO-MONICA (World Health Organization-Multinational MONItoring of trends and determinants in CArdiovascular disease) criteria. RESULTS Men had a significantly higher cumulative incidence of ischemic events (P< .001) and sudden death (P< .001), and a non-significantly higher risk of myocardial infarction (6.30%; 95% confidence interval [CI], 4.33%-8.76%) than women (4.90%; 95% CI, 3.54%-6.70%; P=.181). While the risk of myocardial infarction increased with age (P< .05), gender differences tended to narrow. The incidence was higher in men (889/100 000 person-years) than women (610/100,000 person-years; P< .001) and increased with age (P< .01). This increase was progressive in women but not in men. The mortality rate was also higher in men (472/100,000 person-years; 95% CI, 248-697) than women (328/100,000 person-years; 95% CI, 188-469; P< .001), and was six times higher in the 385-year-old age group than in those aged 65-74 years (P< .001). CONCLUSIONS The incidence of fatal and non-fatal myocardial infarction was very high in the elderly population of Madrid. Both incidence and mortality rates increased dramatically with age after 64 years. Rates were higher in men than women at all ages, though gender differences decreased with age.

Inflammation biomarkers in blood as mortality predictors in community-acquired pneumonia admitted patients: Importance of comparison with neutrophil count percentage or neutrophil-lymphocyte ratio

Introduction The increase and persistence of inflammation in community-acquired pneumonia (CAP) patients can lead to higher mortality. Biomarkers capable of measuring this inadequate inflammatory response are likely candidates to be related with a bad outcome. We investigated the association between concentrations of several inflammatory markers and mortality of CAP patients. Material and methods This was a prospective study of hospitalised CAP patients in a Spanish university hospital. Blood tests upon admittance and in the early-stage evolution (72–120 hours) were carried out, where C-reactive protein, procalcitonin, proadrenomedullin, copeptin, white blood cell, Lymphocyte Count Percentage (LCP), Neutrophil Count Percentage (NCP) and Neutrophil/Lymphocyte Ratio (NLR) were measured. The outcome variable was mortality at 30 and 90 days. Statistical analysis included logistic regression, ROC analysis and area-under-curve test. Results 154 hospitalised CAP patients were included. Patients who died during follow-up had higher levels of procalcitonin, copeptin, proadrenomedullin, lower levels of LCP, and higher of NCP and NLR. Remarkably, multivariate analysis showed a relationship between NCP and mortality, regardless of age, severity of CAP and comorbidities. AUC analysis showed that NLR and NCP at admittance and during early-stage evolution achieved a good diagnostic power. ROC test for NCP and NLR were similar to those of the novel serum biomarkers analysed. Conclusions NLR and NCP, are promising candidate predictors of mortality for hospitalised CAP patients, and both are cheaper, easier to perform, and at least as reliable as the new serum biomarkers. Future implementation of new biomarkers would require comparison not only with classic inflammatory parameters like White Blood Cell count but also with NLR and NCP.

A cluster-randomised clinical trial comparing two cardiovascular health education strategies in a child population: the Savinghearts project.

BackgroundThis paper describes a methodology for comparing the effects of an eduentertainment strategy involving a music concert, and a participatory class experience involving the description and making of a healthy breakfast, as educational vehicles for delivering obesity-preventing/cardiovascular health messages to children aged 7–8 years.Methods/designThis study will involve a cluster-randomised trial with blinded assessment. The study subjects will be children aged 7–8 years of both sexes attending public primary schools in the Madrid Region. The participating schools (n=30) will be randomly assigned to one of two groups: 1) Group MC, in which the children will attend a music concert that delivers obesity-preventing/cardiovascular health messages, or 2) Group HB, in which the children will attend a participatory class providing the same information but involving the description and making of a healthy breakfast. The main outcome measured will be the increase in the number of correct answers scored on a knowledge questionnaire and in an attitudes test administered before and after the above interventions. The secondary outcome recorded will be the reduction in BMI percentile among children deemed overweight/obese prior to the interventions. The required sample size (number of children) was calculated for a comparison of proportions with an α of 0.05 and a β of 0.20, assuming that the Group MC subjects would show values for the measured variables at least 10% higher than those recorded for the subjects of Group HB. Corrections were made for the design effect and assuming a loss to follow-up of 10%. The maximum sample size required will be 2107 children. Data will be analysed using summary measurements for each cluster, both for making estimates and for hypothesis testing. All analyses will be made on an intention-to-treat basis.DiscussionThe intervention providing the best results could be recommended as part of health education for young schoolchildren.Trial registrationClinicaltrials.gov: NCT01418872

Development and validation of a risk stratification model for prediction of disability and hospitalisation in patients with heart failure: a study protocol

Background Chronic heart failure (CHF) reduces quality of life and causes hospitalisation and death. Identifying predictive factors of such events may help change the natural history of this condition. Aim To develop and validate a stratification system for classifying patients with CHF, according to their degree of disability and need for hospitalisation due to any unscheduled cause, over a period of 1 year. Methods and analysis Prospective, concurrent, cohort-type study in two towns in the Madrid autonomous region having a combined population of 1 32 851. The study will include patients aged over 18 years who meet the following diagnostic criteria: symptoms and typical signs of CHF (Framingham criteria) and left ventricular ejection fraction (EF)<50% or structural cardiac lesion and/or diastolic dysfunction in the presence of preserved EF (EF>50%). Outcome variables will be(a) Disability, as measured by the WHO Disability Assessment Schedule V.2.0 Questionnaire, and (b) unscheduled hospitalisations. The estimated sample size is 557 patients, 371 for predictive model development (development cohort) and 186 for validation purposes (validation cohort). Predictive models of disability or hospitalisation will be constructed using logistic regression techniques. The resulting model(s) will be validated by estimating the probability of outcomes of interest for each individual included in the validation cohort. Ethics and dissemination The study protocol has been approved by the Clinical Research Ethics Committee of La Princesa University Teaching Hospital (PI-705). All results will be published in a peer-reviewed journal and shared with the medical community at conferences and scientific meetings.