Drug exposure during pregnancy in primary care: an algorithm and observational study from SIDIAP database, Catalunya, Spain.

OBJECTIVES: To develop an algorithm to identify pregnancy episodes in women at childbearing age using SIDIAP (Information System for the Improvement of Research in Primary Care) data (Catalunya, Spain).To describe drugs dispensed during gestation. DESIGN: Construction of an algorithm to identify all pregnancy episodes occurred from January 2011 to June 2020 in women aged 12-50. The variables used to create the algorithm include first day of last menstrual period, reasons for pregnancy termination and diagnoses registered in the primary healthcare records. Population-based cohort study including the pregnancy episodes identified by the algorithm. SETTING: Catalonia, Spain. PARTICIPANTS: All women aged 12-50 with at least one pregnancy episode occurred during January 2011-June 2020. INTERVENTIONS: No interventions performed. PRIMARY AND SECONDARY OUTCOME MEASURES: Identification of pregnancy episodes through an algorithm and description of drug exposure. RESULTS: We identified 327 865 pregnancy episodes in 250 910 people with a mean age of 31.3 years. During the study period, 83.4% of the episodes were exposed to at least one drug. The most frequent groups dispensed were iron preparations (48% of pregnancy episodes), iodine therapy (40.2%), analgesics and antipyretics (28%), penicillins (19.8%), vitamin B12 plus folic acid (19.7%) and non-steroidal anti-inflammatory drugs (NSAIDs, 15.1%). The supplements were more frequently dispensed at least twice, and the drugs for acute conditions were mainly dispensed only once during the pregnancy episode. CONCLUSIONS: We developed an algorithm to automatically identify the pregnancy periods in SIDIAP.We described prescription drugs used during pregnancy. The most used ones were supplements, analgesics, NSAID or antibiotics.SIDIAP might be an efficient database to study drug safety during pregnancy and the consequences of drug use in the offspring. TRIAL REGISTRATION NUMBER: EUPAS37675.

Sample size requirement in trials that use the composite endpoint major adverse cardiovascular events (MACE): new insights.

BACKGROUND: The real impact of the degree of association (DoA) between endpoint components of a composite endpoint (CE) on sample size requirement (SSR) has not been explored. We estimate the impact of the DoA between death and acute myocardial infarction (AMI) on SSR of trials using use the CE of major adverse cardiac events (MACE). METHODS: A systematic review and quantitative synthesis of trials that include MACE as the primary outcome through search strategies in MEDLINE and EMBASE electronic databases. We limited to articles published in journals indexed in the first quartile of the Cardiac & Cardiovascular Systems category (Journal Citation Reports, 2015-2020). The authors were contacted to estimate the DoA between death and AMI using joint probability and correlation. We analyzed the SSR variation using the DoA estimated from RCTs. RESULTS: Sixty-three of 134 publications that reported event rates and the therapy effect in all component endpoints were included in the quantitative synthesis. The most frequent combination was death, AMI, and revascularization (n = 20; 31.8%). The correlation between death and AMI, estimated from 5 trials¸ oscillated between - 0.02 and 0.31. SSR varied from 14,602 in the scenario with the strongest correlation to 12,259 in the scenario with the weakest correlation; the relative impact was 16%. CONCLUSIONS: The DoA between death and AMI is highly variable and may lead to a considerable SSR variation in a trial including MACE.

Corrigendum: Dynamics of Emergency Cardiovascular Hospital Admissions and In-Hospital Mortality During the COVID-19 Pandemic: Time Series Analysis and Impact of Socioeconomic Factors.

[This corrects the article DOI: 10.3389/fcvm.2022.827212.].

Dynamics of Emergency Cardiovascular Hospital Admissions and In-Hospital Mortality During the COVID-19 Pandemic: Time Series Analysis and Impact of Socioeconomic Factors.

Aims: This study aimed to evaluate the decline in urgent cardiovascular hospital admissions and in-hospital mortality during the COVID pandemic in two successive waves, and to evaluate differences by sex, age, and deprivation index subgroups. Methods and Results: We obtained acute cardiovascular hospital episodes during the years 2019-2020 from region-wide data on public healthcare usage for the population of Catalonia (North-East Spain). We fitted time models to estimate the incidence rate ratios (IRRs) of the acute coronary syndrome (ACS) and acute heart failure (HF) admissions during the first pandemic wave, the between-waves period, and the second wave compared with the corresponding pre-COVID-19 periods and to test for the interaction with sex, age, and area-based socioeconomic level. We evaluated the effect of COVID-19 period on in-hospital mortality. ACS (n = 8,636) and HF (n = 27,566) episodes were defined using primary diagnostic ICD-10 codes. ACS and HF admissions decreased during the first wave (IRR = 0.66, 95%CI: 0.58-0.76 and IRR = 0.61, 95% CI: 0.55-0.68, respectively) and during the second wave (IRR = 0.80, 95%CI: 0.72-0.88 and IRR = 0.76, 95%CI: 0.69-0.84, respectively); acute HF admissions also decreased in the period between waves (IRR: 0.81, 95%CI: 0.74-0.89). The impact was similar in all sex and socioeconomic subgroups and was higher in older patients with ACS. In-hospital mortality was higher than expected only during the first wave. Conclusion: During the first wave of the COVID-19 pandemic, there was a marked decline in urgent cardiovascular hospital admissions that were attenuated during the second wave. Both the decline and the attenuation of the effect have been similar in all subgroups regardless of age, sex, or socioeconomic status. In-hospital mortality for ACS and HF episodes increased during the first wave, but not during the second wave.

Cost-effectiveness of implantable cardioverter-defibrillators for primary prevention of sudden cardiac death.

INTRODUCTION AND OBJECTIVES: Implantable cardioverter-defibrillators (ICD) are a cost-effective alternative for secondary prevention of sudden cardiac death, but their efficiency in primary prevention, especially among patients with nonischemic heart disease, is still uncertain. METHODS: We performed a cost-effectiveness analysis of ICD plus conventional medical treatment (CMT) vs CMT for primary prevention of cardiac arrhythmias from the perspective of the national health service. We simulated the course of the disease by using Markov models in patients with ischemic and nonischemic heart disease. The parameters of the model were based on the results obtained from a meta-analysis of clinical trials published between 1996 and 2018 comparing ICD plus CMT vs CMT, the safety results of the DANISH trial, and analysis of real-world clinical practice in a tertiary hospital. RESULTS: We estimated that ICD reduced the likelihood of all-cause death in patients with ischemic heart disease (HR, 0.70; 95%CI, 0.58-0.85) and in those with nonischemic heart disease (HR, 0.79; 95%CI, 0.66-0.96). The incremental cost-effectiveness ratio (ICER) estimated with probabilistic analysis was €19 171/quality adjusted life year (QALY) in patients with ischemic heart disease and €31 084/QALY in those with nonischemic dilated myocardiopathy overall and €23 230/QALY in patients younger than 68 years. CONCLUSIONS: The efficiency of single-lead ICD systems has improved in the last decade, and these devices are cost-effective in patients with ischemic and nonischemic left ventricular dysfunction younger than 68 years, assuming willingness to pay as €25 000/QALY. For older nonischemic patients, the ICER was around €30 000/QALY.

Clinical Risk Prediction in Patients With Left Ventricular Myocardial Noncompaction.

BACKGROUND: Left ventricular noncompaction (LVNC) is a heterogeneous entity with uncertain prognosis. OBJECTIVES: This study sought to develop and validate a prediction model of major adverse cardiovascular events (MACE) and to identify LVNC cases without events during long-term follow-up. METHODS: This is a retrospective longitudinal multicenter cohort study of consecutive patients fulfilling LVNC criteria by echocardiography or cardiovascular magnetic resonance. MACE were defined as heart failure (HF), ventricular arrhythmias (VAs), systemic embolisms, or all-cause mortality. RESULTS: A total of 585 patients were included (45 ± 20 years of age, 57% male). LV ejection fraction (LVEF) was 48% ± 17%, and 18% presented late gadolinium enhancement (LGE). After a median follow-up of 5.1 years, MACE occurred in 223 (38%) patients: HF in 110 (19%), VAs in 87 (15%), systemic embolisms in 18 (3%), and 34 (6%) died. LVEF was the main variable independently associated with MACE (P < 0.05). LGE was associated with HF and VAs in patients with LVEF >35% (P < 0.05). A prediction model of MACE was developed using Cox regression, composed by age, sex, electrocardiography, cardiovascular risk factors, LVEF, and family aggregation. C-index was 0.72 (95% confidence interval: 0.67-0.75) in the derivation cohort and 0.72 (95% confidence interval: 0.71-0.73) in an external validation cohort. Patients with no electrocardiogram abnormalities, LVEF ≥50%, no LGE, and negative family screening presented no MACE at follow-up. CONCLUSIONS: LVNC is associated with an increased risk of heart failure and ventricular arrhythmias. LVEF is the variable most strongly associated with MACE; however, LGE confers additional risk in patients without severe systolic dysfunction. A risk prediction model is developed and validated to guide management.

Risk of ischaemic stroke associated with antiepileptic drugs: a population-based case-control study in Catalonia.

BACKGROUND: Cerebrovascular disorders have occurred more frequently in some Central Nervous System (CNS) disorders, such as epilepsy. Some CNS drugs have been associated with increased stroke risk. Our aim was to estimate the risk of ischaemic stroke in patients exposed to antiepileptic drugs (AED). METHODS: Population-based matched case-control study using SIDIAP database, based in electronic health records from primary healthcare from Catalonia, Spain. Cases were those patients with a registered diagnosis of first stroke during 2009-2014. Up to 10 controls were selected for each case and matched by sex, age, and geographic area and without a prior diagnosis of stroke. We considered global drug exposure to AED, past and current exposure and exposure in monotherapy to each AED. RESULTS: 2,865 cases and 19,406 controls were exposed to AED during the study period. Global exposure to levetiracetam [(ORadj3.3, CI95 % 2.8-4.0)], phenytoin [ORadj1.5, CI95 % 1.2-41.9)], and valproic acid [(ORadj 1.3, CI95 % 1.1-1.6)], showed significantly association to ischaemic stroke that was also maintained with current exposure of levetiracetam [ORadj4.1, CI95 % 3.3-5.2)] and valproic acid [ORadj1.4, CI95 % 1.1-1.9)]. Current levetiracetam monotherapy showed a very high risk of ischaemic stroke [(ORadj 5.1, CI95 % 3.7-6.9)]. CONCLUSIONS: Drugs used for other conditions than epilepsy (pregabalin, gabapentin) were the most used AED and both did not show a risk. Levetiracetam shows a risk for stroke even when assessed in current monotherapy. The lack of data regarding the link with diagnosis and severity in our study makes it necessary to conduct further studies to confirm or dismiss our results, focussing on levetiracetam.

Clinico-epidemiological characteristics of men and women with a new diagnosis of chronic obstructive pulmonary disease: a database (SIDIAP) study.

BACKGROUND: The risk of developing Chronic Obstructive Pulmonary Disease (COPD), the associated comorbidities and response to bronchodilators might differ in men and women. The objective of this study was to determine the prevalence of COPD and the clinic-epidemiological characteristics of primary care patients with COPD according to gender. METHODS: This is a cross-sectional study using electronic healthcare records Catalonia (Spain), during the 01/01/2012-31/12/2017 period. Patients from the SIDIAP database (System for the Development of Research in Primary Care) were included (5,800,000 patients registered in 279 primary care health centres). Clinic-demographic characteristics, comorbidities and blood tests results were collected for each patient. Adjusted OR (ORa) with logistic regression methods were used to determine variables associated with men and women. RESULTS: From an initial sample of 800,899 people, 24,135 (3%) were considered COPD patients, and 22.9%were women. The most common risk factors in women were bronchiectasis (ORa = 20.5, SD = 19.5-21.6), age > 71 years (ORa = 18.8; SD = 17.3-20.5), cor pulmonale (ORa = 5.2; SD = 4.3-6.7) and lung cancer (ORa = 3.6, SD = 3.2-4.0). Men and women presented the same comorbidities, though the strength of association was different for each gender. CONCLUSIONS: Patients suffering high comorbidity rates. Comorbidities are similar in men and women, although the strength of association varies according to gender. Women are more susceptible to the harmful effects of smoking and present a higher proportion of bronchiectasis and OSAS.

Effect of Clopidogrel and Aspirin vs Aspirin Alone on Migraine Headaches After Transcatheter Atrial Septal Defect Closure: One-Year Results of the CANOA Randomized Clinical Trial.

Importance: Adding clopidogrel to aspirin for 3 months after transcatheter atrial septal defect (ASD) closure results in a lower incidence of new-onset migraine attacks. However, the outcomes at 6- to 12-month follow-up (after clopidogrel cessation at 3 months) remain largely unknown. Objective: To assess the incidence of migraine attacks at 6- and 12-month follow-up after transcatheter ASD closure. Design, Setting, and Participants: This prespecified analysis of a randomized, double-blind clinical trial included patients with no prior history of migraine undergoing ASD closure from 6 university hospitals in Canada from December 2008 to November 2014. Patients were followed up at 3, 6, and 12 months, and a migraine headache questionnaire was administered at each time. Analysis began June 2019. Interventions: Patients were randomized (1:1) to receive dual antiplatelet therapy (aspirin plus clopidogrel; n = 84) vs single antiplatelet therapy (aspirin plus placebo; n = 87) for 3 months following transcatheter ASD closure. After 3 months, only single antiplatelet therapy (aspirin) was pursued. Main Outcomes and Measures: Incidence and severity of migraine attacks at 6- and 12-month follow-up. Results: The mean (SD) age of the study population was 38 (12) years, with 106 women (62%). A total of 27 patients (15.8%) had new-onset migraine attacks within the 3 months following ASD closure (8 of 84 [9.5%] vs 19 of 87 [21.8%] in the initial clopidogrel and placebo groups, respectively; P = .03). After cessation of clopidogrel and aspirin monotherapy, the percentage of patients with migraine attacks decreased over time, with 8 (4.7%) and 4 patients (2.3%) continuing to have migraine attacks at 6 and 12 months, respectively (vs 3 months: P < .001). The severity of migraine attacks progressively decreased over time; no moderate or severe attacks occurred at 6 and 12 months (vs 3 months: P < .001). There were no differences between groups in the rate of migraine attacks at 6 months (initial clopidogrel group: 2 of 84 [2.4%]; initial placebo group: 6 of 87 [6.9%]; P = .28) and 12 months (initial clopidogrel group: 3 of 84 [3.6%]; initial placebo group: 1 of 87 [1.1%]; P = .36) after ASD closure. Only 2 patients (1.2%; 1 patient per group) presented with new-onset migraine attacks after 3 months. Conclusions and Relevance: New-onset migraine attacks after ASD closure improved or resolved spontaneously within 6 to 12 months in most patients. No significant rebound effect was observed after clopidogrel cessation at 3 months. These results demonstrate a low rate of migraine events beyond 3 months following transcatheter ASD closure and support the early discontinuation of clopidogrel therapy if administered. Trial Registration: ClinicalTrials.gov Identifier: NCT00799045.

Prediabetes Is Independently Associated with Subclinical Carotid Atherosclerosis: An Observational Study in a Non-Urban Mediterranean Population.

This was a prospective, observational study to compare the burden of subclinical atherosclerosis as measured by carotid ultrasonography in a cohort of subjects with prediabetes vs. subjects with normal glucose tolerance (NGT) from a non-urban Mediterranean population. Atherosclerosis was assessed through carotid intima-media thickness (c-IMT), the presence/absence of carotid plaques, and plaque number. Among 550 subjects included, 224 (40.7%) had prediabetes. The mean c-IMT and the prevalence of carotid plaque were significantly higher in the prediabetes group compared to the NGT group (0.72 vs. 0.67 mm, p < 0.001; and 37.9% vs. 19.6%; p < 0.001, respectively). Older age, male gender, and increased systolic blood pressure were positively correlated with c-IMT and were independent predictors of the presence of plaques. In contrast, prediabetes and low-density lipoprotein (LDL)-c were predictors of the presence of plaque (odds ratio [OR] = 1.64; 95% confidence interval [CI] = 1.05-2.57; p = 0.03 and OR = 1.01; 95% CI = 1.00-1.02; p = 0.006, respectively) together with tobacco exposure and the leukocyte count (OR = 1.77; 95% CI = 1.08-2.89; p = 0.023 and OR = 1.20; 95% CI = 1.05-1.38; p = 0.008, respectively). In a non-urban Mediterranean population, prediabetes was associated with established subclinical carotid atherosclerosis. These findings could have implications for the prevention and treatment of CV risk in these subjects before the first symptoms of cardiovascular disease appear.

Determinantes del resultado a largo plazo de la estenosis de válvula pulmonar reparada / Determinants of long-term outcome of repaired pulmonary valve stenosis

INTRODUCCIÓN Y OBJETIVOS: Aunque la estenosis de la válvula pulmonar (EVP) se considera una cardiopatía congénita de bajo riesgo, se ha descrito la aparición de complicaciones y necesidad de reintervenir durante el seguimiento. Los objetivos del estudio fueron evaluar los resultados a largo plazo de la EVP reparada e identificar predictores de complicaciones cardiovasculares y reintervención. MÉTODOS: Se estudió a 158 pacientes adultos con EVP reparada (reparaciones practicadas de 1957 a 2010) con seguimiento activo en un centro terciario de referencia. RESULTADOS: Se sometió a cirugía a 95 pacientes (60%) y a valvuloplastia percutánea con balón a 63 (40%). Tras una mediana de seguimiento de 27 [20-33] años, la mayoría de los pacientes (n=134 [84,8%]) estaban en clase funcional I de la New York Heart Association, pero 61 (38.6%) requirieron reintervención, principalmente reemplazo de la valvular pulmonar (n=28 [17,7%]), y 19 (12%) presentaron al menos una complicación cardiovascular: 13 (8,2%), arritmias supraventriculares; 6 (3,8%), insuficiencia cardiaca; 5 (3,2%), accidente cerebrovascular; 1 (0,6%), muerte; 1 (0,6%) tromboembolia, y 1 (0,6%), arritmia ventricular. El análisis multivariante mostró que la edad en el momento de la reparación de la EVP (HR=1,08; IC95%, 1,04-1,12; p <0,001) y la presencia de cianosis antes de la reparación (HR=5,23; IC95%, 1,99-13,78; p = 0,001) fueron predictores independientes de complicaciones cardiovasculares. CONCLUSIONES: Se puede esperar un buen resultado a largo plazo tras de la reparación de la EVP, pero pueden aparecer complicaciones y necesidad de reintervenir. Una edad más avanzada y la presencia de cianosis en el momento de la reparación de la EVP son predictores de complicaciones cardiovasculares e identifican a una población que requiere un control más estricto

INTRODUCTION AND OBJECTIVES: Although pulmonary valve stenosis (PVS) is considered a low risk congenital heart disease, there have been reports of complications and the need for reintervention throughout follow-up. The aims of this study were to evaluate the long-term outcome of repaired PVS and to identify predictors of cardiovascular complications and reintervention. METHODS: We studied 158 adult patients with repaired PVS (repair procedures performed from 1957 to 2010) receiving active follow-up in a tertiary referral center. RESULTS: A total of 95 patients (60%) received surgical treatment, and 63 patients (40%) received percutaneous pulmonary balloon valvuloplasty. At the end of follow-up (27 years, IQR, 20-33 years), most patients (n=134, 84.8%) were in New York Heart Association functional class I, but 61 patients (38.6%) required a reintervention, mainly pulmonary valve replacement (17.7%, n=28), and 19 patients (12%) had at least one cardiovascular complication: 13 (8.2%) supraventricular arrhythmias, 6 (3.8%) heart failure, 5 (3.2%) stroke, 1 (0.6%) death, 1 (0.6%) thromboembolism, and 1 (0.6%) ventricular arrhythmia. Multivariate analysis showed that age at PVS repair (HR, 1.08; 95%CI, 1.04-1.12; P <.001) and the presence of cyanosis before PVS repair (HR, 5.23; 95%CI, 1.99-13.78; P=.001) were independent predictors for cardiovascular complications. CONCLUSIONS: Good long-term outcome can be expected after PVS repair, but complications and the need for reintervention may appear. Older age and the presence of cyanosis at PVS repair emerged as predictors of cardiovascular complications and identified a population that may merit stricter control

Prevalence of pre-diabetes and undiagnosed diabetes in the Mollerussa prospective observational cohort study in a semi-rural area of Catalonia.

OBJECTIVES: To assess the prevalence of undiagnosed diabetes and pre-diabetes in the healthy population in the Mollerussa cohort. As a secondary objective, to identify the variables associated with these conditions and to describe the changes in glycaemic status after 1 year of follow-up in subjects with pre-diabetes. DESIGN: Prospective observational cohort study. SETTING: General population from a semi-rural area. PARTICIPANTS: The study included 583 participants without a diagnosis of diabetes recruited between March 2011 and July 2014. RESULTS: The prevalence of undiagnosed diabetes was 20, 3.4% (95% CI 2.6 to 4.2) and that of pre-diabetes was 229, 39.3% (37.3 to 41.3). Among those with pre-diabetes, 18.3% had isolated impaired fasting plasma glucose (FPG) (FPG: 100 to <126 mg/dL), 58.1% had isolated impaired glycated haemoglobin (HbA1c) (HbA1c 5.7 to <6.5) and 23.6% fulfilled both criteria. Follow-up data were available for 166 subjects; 41.6%(37.8 to 45.4) returned to normoglycaemia, 57.6% (57.8 to 61.4) persisted in pre-diabetes and 0.6% (0 to 1.2) progressed to diabetes. Individuals with pre-diabetes had worse cardiometabolic risk profiles and sociodemographic features than normoglycaemic subjects. In the logistic regression model, variables significantly associated with pre-diabetes were older age (OR; 95% CI) (1.033; 1.011 to 1.056), higher physical activity (0.546; 0.360 to 0.827), body mass index (1.121; 1.029 to 1.222) and a family history of diabetes (1.543; 1.025 to 2.323). The variables significantly associated with glycaemic normalisation were older age (0.948; 0.916 to 0.982) and body mass index (0.779; 0.651 to 0.931). CONCLUSIONS: Among adults in our region, the estimated prevalence of undiagnosed diabetes was 3.4% and that of pre-diabetes was 39.3%. After a 1-year follow-up, a small proportion of subjects (0.6%) with pre-diabetes progressed to diabetes, while a high proportion (41.6%) returned to normoglycaemia. Individuals with pre-diabetes who returned to normoglycaemia were younger and had a lower body mass index.

Determinants of long-term outcome of repaired pulmonary valve stenosis.

INTRODUCTION AND OBJECTIVES: Although pulmonary valve stenosis (PVS) is considered a low risk congenital heart disease, there have been reports of complications and the need for reintervention throughout follow-up. The aims of this study were to evaluate the long-term outcome of repaired PVS and to identify predictors of cardiovascular complications and reintervention. METHODS: We studied 158 adult patients with repaired PVS (repair procedures performed from 1957 to 2010) receiving active follow-up in a tertiary referral center. RESULTS: A total of 95 patients (60%) received surgical treatment, and 63 patients (40%) received percutaneous pulmonary balloon valvuloplasty. At the end of follow-up (27 years, IQR, 20-33 years), most patients (n=134, 84.8%) were in New York Heart Association functional class I, but 61 patients (38.6%) required a reintervention, mainly pulmonary valve replacement (17.7%, n=28), and 19 patients (12%) had at least one cardiovascular complication: 13 (8.2%) supraventricular arrhythmias, 6 (3.8%) heart failure, 5 (3.2%) stroke, 1 (0.6%) death, 1 (0.6%) thromboembolism, and 1 (0.6%) ventricular arrhythmia. Multivariate analysis showed that age at PVS repair (HR, 1.08; 95%CI, 1.04-1.12; P <.001) and the presence of cyanosis before PVS repair (HR, 5.23; 95%CI, 1.99-13.78; P=.001) were independent predictors for cardiovascular complications. CONCLUSIONS: Good long-term outcome can be expected after PVS repair, but complications and the need for reintervention may appear. Older age and the presence of cyanosis at PVS repair emerged as predictors of cardiovascular complications and identified a population that may merit stricter control.

Prevalencia y características de la enfermedad pulmonar obstructiva crónica en no fumadores / Prevalence and characteristics of chronic obstructive pulmonary disease in non-smokers

Objetivo: Conocer el perfil y las características de los enfermos diagnosticados de enfermedad pulmonar obstructiva crónica (EPOC) y que nunca han sido fumadores. Diseño: Estudio descriptivo transversal. Emplazamiento: Área Básica de Salud del Pla d’Urgell (Atención Primaria de Lleida, España). Participantes: Se incluyeron los 512 pacientes mayores de 40 años diagnosticados de EPOC del Área Básica de Salud con una espirometría compatible al inicio del estudio [cociente < 0,7 entre el volumen de espiración forzada en el primer segundo (FEV1) y la capacidad vital forzada (FVC)]. Mediciones principales: La variable dependiente fue la EPOC en no fumadores y las independientes fueron variables recogidas a partir de la información sobre la historia clínica respiratoria, los factores de riesgo del enfermo y sobre calidad vida. Se diseñó un modelo predictor de padecer EPOC en no fumadores en comparación con los fumadores. Resultados: El 33,2% de los pacientes EPOC nunca habían sido fumadores y de estos, el 59,4% eran mujeres. La media del FEV1 de los no fumadores fue de 70,5 (DE = 17,1), superior a los 62,6 (DE = 18,5) en los fumadores/exfumadores (p < 0,001). La cobertura de la vacunación antineumocócica 23V era mejor en los no fumadores (75,3%), p<0,001. Los EPOC en no fumadores (respecto a los fumadores/exfumadores) eran: mayormente mujeres (OR = 16,46), de mayor edad (OR = 1,1), con mejor FEV1 (OR = 1,1), mejor percepción de calidad de vida, EuroQoL-5D (OR = 0,8), con menor prevalencia de diabetes (OR = 0,5), menor nivel de estudios (OR = 0,2), y con menos hospitalizaciones previas (OR = 0,3). Conclusiones: El estudio evidencia una alta proporción de no fumadores en enfermos EPOC. Nuestro trabajo objetiva que las mujeres de mayor edad y con menor gravedad se asociarían a un mayor riesgo de EPOC en no fumadores. Parece indicar que la EPOC en no fumadores aparecería en edades más tardías y sería más leve que la EPOC relacionada con el tabaquismo

Objective: The objective of the study was to know the profile of patients diagnosed with chronic obstructive pulmonary disease (COPD) and who have never been smokers. Design: A transversal study. Location: Primary Care Centre of Pla d’Urgell (Primary care setting in Lleida, Spain). Participants: 512 patients older than 40 years with COPD from Primary Care Centre of Pla d’Urgell with a compatible spirometry [forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio < 0.7) to the beginning of the study. Main measurements: The dependent variable was de COPD in non-smokers and the independents were variables collected from the information on the respiratory clinical history, the risk factors of the patients and on quality of life. We designed a predictor model of COPD in non-smokers compared to smokers. Results: 33.2% of COPD patients had never been smokers, 59.4% of whom were women. The average FEV1 for non-smokers was 70.5 (SD = 17.1), higher than 62.6 (SD = 18.5) for smokers/former smokers (p < 0.001). The coverage of pneumococcal vaccination 23V was better in non-smokers (75.3%), p < 0.001. COPD in non-smokers (compared to smokers/former smokers) were: mostly women (OR = 16.46), older (OR = 1.1), with better FEV1 (OR = 1.1), better perception of quality, EuroQoL-5D (OR = 0.8), with lower prevalence of diabetes (OR = 0.5), lower level of studies (OR = 0.2), and with fewer previous hospitalizations (OR = 0.3). Conclusions: The study evidences a high proportion of non-smokers in COPD patients. Our study aims that older women with less severity would be associated with an increased risk of COPD in non-smokers. It seems to indicate that COPD in non-smokers would appear at later ages and would be milder than smoking-related COPD

Persistence with dual antiplatelet therapy after percutaneous coronary intervention for ST-segment elevation acute coronary syndrome: a population-based cohort study in Catalonia (Spain).

OBJECTIVES: Guidelines recommending 12-month dual antiplatelet therapy (DAPT) in patients with ST-elevation acute coronary syndrome (STEACS) undergoing percutaneous coronary intervention (PCI) were published in year 2012. We aimed to describe the influence of guideline implementation on the trend in 12-month persistence with DAPT between 2010 and 2015 and to evaluate its relationship with DAPT duration regimens recommended at discharge from PCI hospitals. DESIGN: Observational study based on region-wide registry data linked to pharmacy billing data for DAPT follow-up. SETTING: All PCI hospitals (10) belonging to the acute myocardial infarction (AMI) code network in Catalonia (Spain). PARTICIPANTS: 10 711 STEACS patients undergoing PCI between 2010 and 2015 were followed up. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome was 12-month persistence with DAPT. Calendar year quarter, publication of guidelines, DAPT duration regimen recommended in the hospital discharge report, baseline patient characteristics and significant interactions were included in mixed-effects logistic regression based interrupted time-series models. RESULTS: The proportion of patients on-DAPT at 12 months increased from 58% (56-60) in 2010 to 73% (71-75) in 2015. The rate of 12-month persistence with DAPT significantly increased after the publication of clinical guidelines with a time lag of 1 year (OR=1.20; 95% CI 1.11 to 1.30). A higher risk profile, more extensive and complex coronary disease, use of drug-eluting stents (OR=1.90; 95% CI 1.50 to 2.40) and a 12-month DAPT regimen recommendation at discharge from the PCI hospital (OR=5.76; 95% CI 3.26 to 10.2) were associated with 12-month persistence. CONCLUSION: Persistence with 12-month DAPT has increased since publication of clinical guidelines. Even though most patients were discharged on DAPT, only 73% with potential indication were on-DAPT 12 months after PCI. A guideline-based recommendation at PCI hospital discharge was highly associated with full persistence with DAPT. Establishing evidence-based, common prescribing criteria across hospitals in the AMI-network would favour adherence and reduce variability.

[Prevalence and characteristics of chronic obstructive pulmonary disease in non-smokers]. / Prevalencia y características de la enfermedad pulmonar obstructiva crónica en no fumadores.

OBJECTIVE: The objective of the study was to know the profile of patients diagnosed with chronic obstructive pulmonary disease (COPD) and who have never been smokers. DESIGN: A transversal study. LOCATION: Primary Care Centre of Pla d'Urgell (Primary care setting in Lleida, Spain). PARTICIPANTS: 512 patients older than 40 years with COPD from Primary Care Centre of Pla d'Urgell with a compatible spirometry [forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio <0.7) to the beginning of the study. MAIN MEASUREMENTS: The dependent variable was de COPD in non-smokers and the independents were variables collected from the information on the respiratory clinical history, the risk factors of the patients and on quality of life. We designed a predictor model of COPD in non-smokers compared to smokers. RESULTS: 33.2% of COPD patients had never been smokers, 59.4% of whom were women. The average FEV1 for non-smokers was 70.5 (SD=17.1), higher than 62.6 (SD=18.5) for smokers/former smokers (p<0.001). The coverage of pneumococcal vaccination 23V was better in non-smokers (75.3%), p<0.001. COPD in non-smokers (compared to smokers/former smokers) were: mostly women (OR=16.46), older (OR=1.1), with better FEV1 (OR=1.1), better perception of quality, EuroQoL-5D (OR=0.8), with lower prevalence of diabetes (OR=0.5), lower level of studies (OR=0.2), and with fewer previous hospitalizations (OR=0.3). CONCLUSIONS: The study evidences a high proportion of non-smokers in COPD patients. Our study aims that older women with less severity would be associated with an increased risk of COPD in non-smokers. It seems to indicate that COPD in non-smokers would appear at later ages and would be milder than smoking-related COPD.

Bin-CE: A comprehensive web application to decide upon the best set of outcomes to be combined in a binary composite endpoint.

The estimation of the Sample Size Requirement (SSR) when using a binary composite endpoint (i.e. two or more outcomes combined in a unique primary endpoint) is not trivial. Besides information about the rate of events for each outcome, information about the strength of association between the outcomes is crucial, since it can determine an increase or decrease of the SSR. Specifically, the greater the strength of association between outcomes the higher the SSR. We present Bin-CE, a free tool to assist clinicians for computing the SSR for binary composite endpoints. In a first step, the user enters a set of candidate outcomes, the assumed rate of events for each outcome and the assumed effect of therapy on each outcome. Since the strength of the association between outcomes is usually unknown, a semi-parametric approach linking the a priori clinical knowledge of the potential degree of association between outcomes with the exact values of these parameters was programmed with Bin-CE. Bin-CE works with a recursive algorithm to choose the best combination of outcomes that minimizes the SSR. In addition, Bin-CE computes the sample size using different algorithms and shows different figures plotting the magnitude of the sample size reduction, and the effect of different combinations of outcomes on the rate of the primary endpoint. Finally, Bin-CE is programmed to perform sensitivity analyses. This manuscript presents the mathematic bases and introduces the reader to the use of Bin-CE using a real example.

Prevalencia de enfermedad pulmonar obstructiva crónica no diagnosticada en una población con factores de riesgo cardiovascular / Prevalence of chronic obstructive pulmonary disease (COPD) not diagnosed in a population with cardiovascular risk factors

Antecedentes y objetivo: Se desconoce cuál es la magnitud de la enfermedad pulmonar obstructiva crónica (EPOC) no diagnosticada en nuestro medio en población con factores de riesgo cardiovascular (FRCV). El objetivo fue estimar la prevalencia de EPOC no diagnosticada y sus características en una población con FRCV. Materiales y métodos: Estudio de prevalencia de EPOC en una población con FRCV seleccionada de forma aleatoria. Se les practicó una espirometría entre el 01/01/2015 y el 31/12/2016 y se determinó el porcentaje de pacientes con EPOC que no estaban diagnosticados previamente. Para cada paciente se registraron variables de interés y, en los enfermos con espirometría compatible con EPOC, si tenían o no registrado el diagnóstico en su historia clínica informatizada. La asociación de la EPOC no diagnosticada con las diferentes variables independientes se determinó con las odds ratio ajustadas (ORa) mediante modelos de regresión logística. Resultados: Se estudiaron 2.295 pacientes con FRCV. La prevalencia global de EPOC fue del 14,5%. Se objetivó un infradiagnóstico del 73,3%. Los nuevos diagnosticados de EPOC respecto a los ya diagnosticados con anterioridad presentaron un mayor porcentaje de mujeres (74,1% vs. 36,0%; p=0,081), de nunca fumadores (21,3% vs. 12,4%; p=0,577), de casos leves (GOLD1) (42,6% vs. 32,4%, p=0,008) y con una media inferior de HbA1c (5,5% vs. 5,6%; p=0,008) y de ácido úrico (5,1mg/dl vs. 5,6mg/dl; p=0,011). Las variables asociadas a la EPOC no diagnosticada fueron: el sexo femenino (ORa=1,27; IC95%: 0,74-2,17; p=0,383); la edad (ORa=0,94; IC95%: 0,87-0,99; p=0,018); el tabaquismo (fumador/exfumador) (ORa=0,47; IC95%: 0,22-1,01; p=0,054) y HbA1c (%) (ORa=0,45; IC95%: 0,23-0,88; p=0,019). Conclusiones: El infradiagnóstico de EPOC es muy elevado. Se tendría que valorar el contacto con el sistema sanitario de los enfermos entre 50 y 65 años y con algún FRCV para solicitarles una espirometría

Background and objective: The magnitude of undiagnosed COPD in our population with cardiovascular risk factors (CVRF) is unknown. The objective of this study was to estimate the prevalence of undiagnosed COPD and its specific characteristics in a population with CVRF. Materials and methods: Study the prevalence of COPD in patients with CVRF. Spirometry was performed between 01/01/2015 and 12/31/2016 and the percentage of patients with COPD, who had not previously been diagnosed, was determined. Each patient's variables of interest were recorded; the records of patients who had spirometry showing COPD were checked to confirm whether a diagnosis had been recorded or not. The association of undiagnosed COPD with different independent variables was determined with adjusted odds ratio (aOR) by non conditional logistic regression models. Results: 2,295 patients with CVRF were studied. The overall prevalence of COPD was 14.5%. An underdiagnosis of 73.3% was observed. Newly diagnosed COPD vs. undiagnosed COPD showed to be higher in women (74.1% vs. 36.0%; P=.081), non-smokers (21.3% vs. 12.4%; P=.577), mild cases (GOLD1) (42.6% vs. 32.4%, P=.008) and cases with lower than average HbA1c (5.5% vs. 5.6%; P=.008) and uric acid (5.1mg/dL vs. 5.6mg/dL; P=.011). The variables associated with undiagnosed COPD were: women (aOR=1.27; 95%CI: 0.74-2.17; P=.383); age (aOR=0.94; 95%CI: 0.87-0.99; P=.018); smokers (smoker/non-smoker) (aOR=0.47; 95%CI: 0.22-1.01; P=.054) and HbA1c (%) (aOR=0.45; 95%CI: 0.23-0.88; P=.019). Conclusions: The under-diagnosis of COPD is very high. The contact patients aged between 50 and 65 years-old who have CVRF with their health system should be reassessed, and they need to ask for a spirometry

Meta-Analysis Comparing Single Versus Dual Antiplatelet Therapy Following Transcatheter Aortic Valve Implantation.

To compare dual antiplatelet therapy (DAPT) versus single antiplatelet therapy (SAPT) as antithrombotic treatment after transcatheter aortic valve implantation (TAVI) for the prevention of ischemic events, vascular and bleeding events, and death. Data from the 3 randomized trials comparing DAPT versus SAPT post-TAVI were pooled and analyzed in a patient-level meta-analysis. The primary end point was the occurrence of death, major or life-threatening bleedings, and major vascular complications at 30-day follow-up. Events were adjudicated according to the Valve Academic Research Consortium 2 definitions. A total of 421 patients randomized to DAPT (210 patients) or SAPT (211 patients) post-TAVI were analyzed. There were no differences between groups in baseline clinical and procedural characteristics. The occurrence of the 30-day combined primary end point was higher in the DAPT group (17.6% vs 10.9%, odds ratio 1.73, 95% confidence interval 1.00 to 2.98, p = 0.050), with an increased rate of major or life-threatening bleeding events in the DAPT group (11.4% vs 5.2%, odds ratio 2.24, 95% confidence interval 1.12 to 4.46, p = 0.022). There were no differences between DAPT and SAPT groups in the incidence of death (5.2% vs 3.8%, p = 0.477), global ischemic events (3.8% vs 3.8%, p = 0.999), or stroke (2.4% vs 2.4%, p = 0.996). DAPT (vs SAPT) was associated with a higher rate of major adverse events after TAVI, mainly driven by an increased risk of major or life-threatening bleeding complications along with a lack of beneficial effect on ischemic events. These results do not support the current recommendation of DAPT as antithrombotic therapy after TAVI.