Effect of COMBinAtion therapy with remote ischemic conditioning and exenatide on the Myocardial Infarct size: a two-by-two factorial randomized trial (COMBAT-MI).

Remote ischemic conditioning (RIC) and the GLP-1 analog exenatide activate different cardioprotective pathways and may have additive effects on infarct size (IS). Here, we aimed to assess the efficacy of RIC as compared with sham procedure, and of exenatide, as compared with placebo, and the interaction between both, to reduce IS in humans. We designed a two-by-two factorial, randomized controlled, blinded, multicenter, clinical trial. Patients with ST-segment elevation myocardial infarction receiving primary percutaneous coronary intervention (PPCI) within 6 h of symptoms were randomized to RIC or sham procedure and exenatide or matching placebo. The primary outcome was IS measured by late gadolinium enhancement in cardiac magnetic resonance performed 3-7 days after PPCI. The secondary outcomes were myocardial salvage index, transmurality index, left ventricular ejection fraction and relative microvascular obstruction volume. A total of 378 patients were randomly allocated, and after applying exclusion criteria, 222 patients were available for analysis. There were no significant interactions between the two randomization factors on the primary or secondary outcomes. IS was similar between groups for the RIC (24 ± 11.8% in the RIC group vs 23.7 ± 10.9% in the sham group, P = 0.827) and the exenatide hypotheses (25.1 ± 11.5% in the exenatide group vs 22.5 ± 10.9% in the placebo group, P = 0.092). There were no effects with either RIC or exenatide on the secondary outcomes. Unexpected adverse events or side effects of RIC and exenatide were not observed. In conclusion, neither RIC nor exenatide, or its combination, were able to reduce IS in STEMI patients when administered as an adjunct to PPCI.

Compliance with the guidelines on recommended immunization schedule in patients with inflammatory bowel disease: implications on public health policies.

BACKGROUND: Patients with inflammatory bowel disease (IBD) have a higher risk of developing opportunistic infections due to either the disease itself or to treatment with immunosuppressants. This risk can be reduced through vaccination. The aim of this study was to determine the prevalence of compliance with the guidelines on recommended immunization schedule in patients with IBD in the health district of Lleida, Spain. METHODS: Descriptive, cross-sectional, retrospective study of data at December 31, 2016. The reference population was formed by adults with a clinical diagnosis of IBD. The dependent variable was "compliance with the guidelines on recommended immunization schedule". Variables were sex, age, residence, diagnosis, vaccination against measles, mumps, rubella, varicella, tetanus-diphtheria, influenza, pneumococcus, meningococcus C, hepatitis B, and hepatitis A. Data were obtained from electronic medical records. For the data analysis, mean (standard deviation), prevalence with 95% confidence intervals, χ2 test and Mann-Whitney test were used. RESULTS: Compliance did not exceed 65% for any of vaccines analysed in the 1722 studied patients with ulcerative colitis or Crohn's disease. Significant differences across age groups were found in compliance for measles, mumps, rubella, varicella, tetanus, diphtheria and influenza in both ulcerative colitis and Crohn's disease and for meningococcus C and hepatitis A exclusively in ulcerative colitis. CONCLUSIONS: Compliance in patients with IBD is low. Thus, prevention of immunopreventable diseases or their complications is not maximized in this kind of patients. Greater awareness of how vaccines can reduce the risk of vaccine-preventable infections is needed among both patients and healthcare professionals.

Diabetes as a risk factor for severe exacerbation and death in patients with COPD: a prospective cohort study.

BACKGROUND: Type 2 diabetes comorbidity is common in patients with COPD. One of the most frequent causes of hospital admission in patients with COPD are exacerbations. METHODS: Prospective cohort study, which included 512 patients with COPD recruited in a primary care centre in Mollerussa (Lleida, Spain). Inclusion criteria were: patients >40 years of age with COPD according to the Global Initiative for Chronic Obstructive Lung Disease. Variables collected were as follows: age, gender, civil status, education level, smoking habit, severity (Global Initiative for Chronic Obstructive Lung Disease), comorbidities (Charlson), history of severe exacerbations, dyspnoea (mMRC), BODEx, EuroQol 5 D and depression (HAD). Logistic regression was used to determine the association of diabetes with risk of hospital admission and death. RESULTS: Prevalence of diabetes was 25.8%. During the second year of follow up, 18.2% of patients with COPD and diabetes were admitted for exacerbation, in comparison with 8.9% non-diabetic COPD patients. The variables associated with hospital admission were diabetes (ORa=1.54); gender (men, ORa=1.93); age (ORa=1.02); number of hospital admissions during the previous year: 1 (ORa=2.83) or more than one admission (ORa=4.08); EuroQol 5 D (ORa=0.76) and BODEx (ORa=1.24). With the exclusion of BODEx, all these variables were associated with a higher risk of death. CONCLUSION: Prevalence of diabetes is high in patients suffering from COPD. COPD patients with diabetes are at higher risk of severe exacerbation and death. The suggested predictive model could identify patients at higher risk so that adequate preventive and therapeutic measures can be implemented.

Efficacy and safety of topical application of 15% and 10% potassium hydroxide for the treatment of Molluscum contagiosum.

BACKGROUND/OBJECTIVES: Molluscum contagiosum is the most common skin infection in children. One topical treatment used for Molluscum contagiosum is potassium hydroxide. The objective of this study was to compare the efficacy of potassium hydroxide topical treatment at different concentrations with that of placebo in terms of complete clearing of Molluscum contagiosum lesions and to assess the safety and tolerance of potassium hydroxide topical treatment. METHODS: This was a double-blind randomized clinical trial of three treatments (potassium hydroxide 10%, potassium hydroxide 15%, placebo) applied once daily up to complete clearing of lesions (maximum duration 60 days) in 53 children aged 2-6 years in primary health care pediatric offices in Catalonia, Spain. RESULTS: In the intention-to-treat analysis, potassium hydroxide 10% (58.8%, P = .03) and potassium hydroxide 15% (64.3%, P = .02) had efficacy superior to that of placebo (18.8%). The number of Molluscum contagiosum lesions was significantly reduced with potassium hydroxide 10% and 15%. The main efficacy outcome was achieved in 58.8% of children in the potassium hydroxide 10% group (P = .03 vs placebo) and in 64.3% of children in the potassium hydroxide 15% group (P = .02 vs placebo). Potassium hydroxide 10% and 15% were not significantly different in efficacy from each other. Potassium hydroxide 10% and placebo were better tolerated than potassium hydroxide 15%. No adverse events were reported during the study period. CONCLUSIONS: Potassium hydroxide 10% and 15% demonstrated high rates of efficacy in clearing Molluscum contagiosum lesions, with potassium hydroxide 10% being better tolerated.

Latent autoimmune diabetes in adults is perched between type 1 and type 2: evidence from adults in one region of Spain.

BACKGROUND: The aim of this study was to characterize the clinical characteristics and insulin secretion in adults with latent autoimmune diabetes in adults (LADA). We also compared these characteristics in subjects with antibody-negative type 2 diabetes (T2DM) or adult-onset type 1 diabetes (T1DM) to subjects with LADA. METHODS: In this cross-sectional study, 82 patients with LADA, 78 with T1DM and 485 with T2DM were studied. Clinical and metabolic data, in particular those that related to metabolic syndrome, fasting C-peptide and islet-cell autoantibodies [glutamic acid decarboxylase (GADAb) and IA2 (IA2Ab)] were measured. RESULTS: The frequency of metabolic syndrome in patients with LADA (37.3%) was higher than in those with T1DM (15.5%; p = 0.005) and lower than in patients with T2DM (67.2%; p < 0.001). During the first 36 months of the disease, the C-peptide concentration in LADA patients was higher than in subjects with T1DM but was lower than in T2DM patients (p < 0.01 for comparisons). Glycemic control in LADA patients (HbA1c 8.1%) was worse than in patients with T2DM (HbA1c 7.6%; p =0.007). An inverse association between GADAb titers and C-peptide concentrations was found in subjects with LADA (p < 0.001). Finally, LADA patients rapidly progressed to insulin treatment. CONCLUSIONS: As in other European populations, patients with LADA in Spain have a distinct metabolic profile compared with patients with T1DM or T2DM. LADA is also associated with higher impairment of beta-cell function and has worse glycemic control than in T2DM. Beta cell function is related to GADAb titers in patients with LADA.

Association of renin-angiotensin system blockers with COVID-19 diagnosis and prognosis in patients with hypertension: a population-based study.

BACKGROUND: The effect of renin-angiotensin system (RAS) blockade either by angiotensin-converting enzyme inhibitors (ACEis) or angiotensin-receptor blockers (ARBs) on coronavirus disease 2019 (COVID-19) susceptibility, mortality and severity is inadequately described. We examined the association between RAS blockade and COVID-19 diagnosis and prognosis in a large population-based cohort of patients with hypertension (HTN). METHODS: This is a cohort study using regional health records. We identified all individuals aged 18-95 years from 87 healthcare reference areas of the main health provider in Catalonia (Spain), with a history of HTN from primary care records. Data were linked to COVID-19 test results, hospital, pharmacy and mortality records from 1 March 2020 to 14 August 2020. We defined exposure to RAS blockers as the dispensation of ACEi/ARBs during the 3 months before COVID-19 diagnosis or 1 March 2020. Primary outcomes were: COVID-19 infection and severe progression in hospitalized patients with COVID-19 (the composite of need for invasive respiratory support or death). For both outcomes and for each exposure of interest (RAS blockade, ACEi or ARB) we estimated associations in age-, sex-, healthcare area- and propensity score-matched samples. RESULTS: From a cohort of 1 365 215 inhabitants we identified 305 972 patients with HTN history. Recent use of ACEi/ARBs in patients with HTN was associated with a lower 6-month cumulative incidence of COVID-19 diagnosis {3.78% [95% confidence interval (CI) 3.69-3.86%] versus 4.53% (95% CI 4.40-4.65%); P < 0.001}. In the 12 344 patients with COVID-19 infection, the use of ACEi/ARBs was not associated with a higher risk of hospitalization with need for invasive respiratory support or death [OR = 0.91 (0.71-1.15); P = 0.426]. CONCLUSIONS: RAS blockade in patients with HTN is not associated with higher risk of COVID-19 infection or with a worse progression of the disease.

Revascularized ST-segment elevation myocardial infarction. Temporal trends in contemporary therapies and impact on outcomes.

INTRODUCTION AND OBJECTIVES: To assess, in patients with ST-segment elevation myocardial infarction (STEMI) who underwent primary percutaneous intervention, the pace of introduction in clinical practice (2010-2017) of drug-eluting stents (DES), ticagrelor, prasugrel, and prolonged dual antiplatelet therapy (DAPT) duration, and their potential impact on the risk of 2-year outcomes. METHODS: Prospective and exhaustive community-wide cohort of 14 841 STEMI patients undergoing primary percutaneous intervention between 2010 and 2017. Index episodes were obtained from the Catalan Codi IAM Registry, events during follow-up from the Minimum Data Set and DAPT were defined by pharmacy dispensation. Follow-up was 24 months. The temporal trend for exposures and outcomes was assessed using regression models. RESULTS: Age> 65 years, diabetes, renal failure, previous heart failure, and need for anticoagulation at discharge were more frequent in later periods (P <.001). From 2010 to 2017, the use of DES increased from 31.1% to 69.8%, ticagrelor from 0.1% to 28.6%, prasugrel from 1.5% to 23.8%, and the median consecutive months on DAPT from 2 to 10 (P <.001 for all). Adjusted analysis showed a temporal trend to a lower risk of the main outcome over time: the composite of death, acute myocardial infarction, stroke and repeat revascularization (absolute odds reduction 0.005% each quarter; OR, 0.995; 95%CI, 0.99-0.999; P=.028). The odds of all individual components except stroke were reduced, although significance was only reached for revascularization. CONCLUSIONS: Despite a strong increase between 2010 and 2017 in the use and duration of DAPT and the use of ticagrelor, prasugrel and DES, there was no substantial reduction in major cardiovascular outcomes.

Background, incidence, and predictors of antiplatelet therapy discontinuation during the first year after drug-eluting stent implantation.

BACKGROUND: Predictors of antiplatelet therapy discontinuation (ATD) during the first year after drug-eluting stent implantation are poorly known. METHODS AND RESULTS: This was a prospective study with 3-, 6-, 9-, and 12-month follow-up of patients receiving at least 1 drug-eluting stent between January and April 2008 in 29 hospitals. Individual- and hospital-level predictors of ATD were assessed by hierarchical-multinomial regression analysis. ATD could be assessed in 1622 candidates for follow-up (82.5%). A total of 234 patients (14.4%) interrupted at least 1 antiplatelet therapy drug, predominantly clopidogrel (n=182, 11.8%). Bleeding events or invasive procedures led to ATD in 109 patients. This was predicted by renal impairment (odds ratio [OR] 2.81, 95% confidence interval [CI] 1.48 to 5.34), prior major hemorrhage (OR 3.77, 95% CI 1.41 to 10.03), and peripheral arterial disease (OR 1.78, 95% CI 1.01 to 3.15). Medical decisions led to ATD in 70 patients; this was predicted by long-term use of anticoagulant therapy (OR 3.88, 95% CI 1.26 to 11.98), undergoing the procedure in a private hospital (OR 13.3, 95% CI 1.69 to 105), and not receiving instructions about medication (OR 2.8, 95% CI 1.23 to 6.36). Thirty-nine patients interrupted ATD on their own initiative, mainly immigrants (OR 3.78, 95% CI 1.2 to 11.98) and consumers of psychotropic drugs (OR 2.58, 95% CI 1.3 to 5.12). CONCLUSIONS: ATD during the first year after drug-eluting stent implantation is based mainly on patient decision or a medical decision not associated with major bleeding events or major surgical procedures. Individual- and hospital-level variables are important to predict ATD.

Efficacy and tolerance of the topical application of potassium hydroxide (10% and 15%) in the treatment of molluscum contagiosum: randomized clinical trial: research protocol.

BACKGROUND: Molluscum contagiosum is a non-severe pediatric viral infection. Because it is highly contagious and current treatments have negative aesthetic and psychological effects, we want to test an alternative treatment in the primary care setting, consisting of two different concentrations of potassium hydroxide solution. METHODS/DESIGN: The study design is a double-blind, randomized clinical trial, using three types of topical treatment. The treatment consist of daily applications of potassium hydroxide (KOH) in aqueous solution at 10% and 15% concentration, and a placebo administered in the control group. Four follow-up visits (at 15, 30, 45 and 60 days) are planned to evaluate treatment effectiveness and patient tolerance. The main outcome measure of the trial will be the healing rate, defined as lesion disappearance in the affected zones after the topic application of the experimental treatment. Secondary measures will be the principal characteristics and evolution of the affected zone (surface area, number of lesions, size and density of lesions), treatment tolerance (hyperpigmentation, itching, burning, pain), recurrence rate and the natural evolution of lesions in the control group. DISCUSSION: KOH can potentially be an effective and safe treatment for MC in primary care, and can also reduce referrals to dermatologists and hospital pediatric departments. In addition, KOH may be a valid and less expensive alternative to current invasive treatments (surgical excision).

[Factors determining antibiotic prescription in primary care]. / Determinantes de la prescripción de antibióticos en atención primaria.

INTRODUCTION: To determine patient and physician-related factors associated with variability in antibiotic prescription. MATERIAL AND METHODS: Observational study of the prevalence of antibacterial medication prescription >14 years old. DATA SOURCE: official prescriptions, clinical histories and individual health cards. Patient-related variables were: age, sex, number of medical visits-year, comorbidity, antibacterials dispensed with prescription. Physician-related variables were age, sex, number of patients assigned, place of work and rurality. Variables associated with prescription were studied by estimating the odds ratio (OR) from the fit of the multilevel logistic regression models. RESULTS: The rate of antibiotic prescription-year in the population was 31.4%. Factors associated with prescription were high rate of visits (users with more than 5 annual visits multiply the probability of receiving antibiotics, compared to those who madeno visits: OR=10.8), age (non-linearly, with a greater likelihood in the young and the elderly) and sex, with a higher rate in women (OR=1.5). No association was found between prescription and age and sex of the physician, but an association was found with workload: the higher the physician's workload, the higher the likelihood of antibiotic prescription. CONCLUSIONS: The most important factor associated with the increase in prescription rate was the frequency of visits. In addition, women, the young and the elderly receive more antibiotics. A multi-factor intervention focusing on demand, patients, and physicians should be carried out to reduce prescription rates.

"Do GRACE (Global Registry of Acute Coronary events) risk scores still maintain their performance for predicting mortality in the era of contemporary management of acute coronary syndromes?".

BACKGROUND: Although the GRACE risk scores (RS) are the preferred scoring system for risk stratification in acute coronary syndromes (ACS), little is known whether these RS still maintain their performance in the current era. We aimed to investigate this issue in a contemporary population with ACS. METHODS: The study population composed of patients enrolled in the MASCARA national registry. The GRACE RS were calculated for each patient. Discrimination and calibration were evaluated with the C statistic and the Hosmer-Lemeshow test, in the whole population and according to the type of ACS, risk strata, and whether the patient had a history of diabetes and/or chronic renal failure. We determined if left ventricular ejection fraction (LVEF) provides incremental prognostic information above that established by the RS and whether percutaneous coronary intervention (PCI) during admission affects the performance of the score for predicting 6-month mortality. RESULTS: The 5,985 patients constituted the validation cohort for the in-hospital mortality RS and 5,635 the validation cohort for the 6-month mortality RS. Overall, both GRACE RS demonstrated excellent discrimination (C > 0.80) and calibration (all P values in Hosmer-Lemeshow >.1). Although similar results were seen in all subgroups, the 6-month mortality RS performed significantly less well in patients undergoing PCI compared to those patients who did not (C = 0.73 vs 0.76, P < .004). Adding LVEF to the RS did not convey significant prognostic information. CONCLUSIONS: The GRACE RS for predicting in-hospital and 6-month mortality still maintain their excellent performance in a contemporary cohort of patients with ACS. Further studies are needed to investigate the performance of the 6-month mortality GRACE score in patients undergoing in-hospital PCI. Left ventricular ejection fraction did not convey significant information over that provided by the RS.

Randomized placebo-controlled clinical trial on efficacy and safety of topical 10% Potassium hydroxide for molluscum contagiosum treatment in children.

Introduction: Our objective was to assess efficacy, safety and tolerance of topical potassium hydroxide (KOH) 10% for treating Molluscum contagiosum (MC) in children. Material and methods: Randomized, double-blind, placebo-controlled clinical trial including all children 2-16 years with MC infection attending pediatrician primary healthcare visits. The treatment was KOH 10% gel applied once daily up to clearing (maximum 30 days). Results: KOH 10% showed superior efficacy to placebo (55.3% vs 16.3%, p < .001). Time until clearing was inferior with KOH 10% (p = .001). MC lesions were reduced with KOH 10%, which also showed higher efficacy when the instructions of use of the device were modified. KOH 10% patients presented more adverse events (AE) than placebo patients (72.3% vs 31.8%, p < .001). Most patients (91.5%) completely recovered. There were no differences in frequency of AE before and after the change of instructions, intolerance was more frequently reported by parents with new instructions. Conclusions: KOH 10% was superior to placebo in the main efficacy outcome and most secondary efficacy outcomes. KOH 10% patients had more AE and intolerance symptoms than placebo, although there were no severe AE and most patients recovered. KOH 10% is an effective and safe topical treatment for MC infection in children.

Patterns of use and effectiveness of early invasive strategy in non-ST-segment elevation acute coronary syndromes: an assessment by propensity score.

BACKGROUND: The patterns of use and the benefit of an early invasive strategy (EIS) in patients with non-ST-segment elevation acute coronary syndrome in a real-life population are not well established. METHODS: All consecutive patients hospitalized because of non-ST-segment elevation acute coronary syndrome between November 2004 and June 2005 in 32 randomly selected hospitals were prospectively included. Patients were stratified by their baseline risk profile using the Global Registry of Acute Coronary Events (GRACE) risk score in 2 groups. Inhospital mortality and 1- and 6-month mortality or rehospitalization for acute coronary syndromes were analyzed. To ensure optimal adjustment propensity score, conventional logistic regression and Cox regression were used. RESULTS: Of 2,856 patients analyzed, 1,616 (56%) had low/intermediate risk (GRACE140). Patients who underwent EIS had lower risk than those who did not (GRACE score 128.2+/-41 vs 138.5+/-43, P<.001). Coronary angiography facility emerged as the strongest predictor of EIS (odds ratio [OR] 13.7 [95% CI 7.1-25]). Patients who underwent EIS had lower rate of the 6-month outcome in both the whole population (9% [95% CI 6.6-11.9] vs 14% [95% CI 12.5-15.6], P=.003) and in high-risk patients (16.5% [95% CI 11-23] vs 23.6% [95% CI 20.8-26.5], P=.04). However, this benefit of EIS was not apparent after statistical adjustment in the whole population (OR 0.8, CI 0.55-1.1, P=.17) or in high-risk patients (OR 0.7, CI 0.46-1.1, P=.16). CONCLUSIONS: In a real-life population, EIS was mainly performed in patients of low/intermediate risk. An obvious benefit of this strategy could not be found.

Cross-sectional study of the association between healthcare professionals' empathy and burnout and the number of annual primary care visits per patient under their care in Spain.

OBJECTIVE: The aim of this study was to evaluate the association between physician and nurse self-reported empathy and burnout and the number of annual primary care visits per patient under their care. METHODS: Design: A cross-sectional survey study was conducted from January 2013 to July 2014. Site: The 22 primary care centres of the Lleida Health Region in Spain. MAIN OUTCOME MEASURES: The Jefferson Scale of Physician Empathy and the Maslach Burnout Inventory were used to measure empathy and burnout, respectively. The number of visits and the number of diagnoses coded per visit were obtained through the Region's electronic health record. RESULTS: Two hundred and sixty-seven healthcare professionals (physicians and nurses, 52.6% participation of the total in the region) with 301 657 patients under their care. Healthcare professionals' degree of burnout and empathy was associated with the number of annual visits per patient under their care. Burned out nurses and physicians received fewer visits (4.5vs3.7 in nurses and 18.1vs18.9 in physicians), whereas more empathic physicians received more visits per patient (19.4vs17.2, p<0.05) and documented more diagnoses per visit (10.2vs9.7, p=0.001). Less burned out and less empathic nurses documented more diagnoses per visit (10.2vs10.0 and 8.2vs9.9, p<0.05). CONCLUSIONS: The number of annual primary care visits per patient that healthcare professionals receive is closely associated with healthcare professionals' empathy and burnout. These results should serve to promote empathic skills and establish organisational changes that promote efficiency in the practice and, in turn, reduce the degree of burnout of healthcare professionals.

Neurological damage after transcatheter aortic valve implantation compared with surgical aortic valve replacement in intermediate risk patients.

BACKGROUND AND PURPOSE: The risk of neurological damage following transcatheter aortic valve implantation (TAVI) vs. surgical aortic valve replacement (SAVR) in severe aortic stenosis patients deemed to be at intermediate surgical risk is unknown. In this target population, the degree of neurological damage was compared using brain diffusion-weighted magnetic resonance imaging (DW-MRI) and cognitive testing. METHODS: Forty-six consecutive patients undergoing TAVI (78.0 ± 8.3 years; STS score 4.4 ± 1.7) and 37 patients undergoing SAVR (78.9 ± 6.2 years, STS score 4.7 ± 1.7) were compared. DW-MRI was performed in 67 patients (40 in TAVI vs. 27 in SAVR group) within the first 15 days post-procedure. A cognitive assessment was performed at baseline and at 3 months follow-up. The occurrence of potential cognitive impairment post-intervention was determined using the reliable change index (RCI). RESULTS: Baseline characteristics were comparable in TAVI and SAVR groups except for the presence of severe calcified aorta, which occurred more frequently in the TAVI group [17 (37 %) vs. 0 (0 %), p < 0.001]. Three patients presented a clinical stroke: 1 (2.2 %) in TAVI group vs. 2 (5.4 %) in SAVR group, (p = 0.58). No differences were observed in the rate of acute ischemic cerebral lesions detected by DWI in patients undergoing TAVI vs. SAVR [18 (45 %) in TAVI vs. 11 (40.7 %) in SAVR, adjusted OR 0.95; 95 % CI 0.25-3.65; p = 0.94]. TAVI was associated with a lower number of DWI lesions (adjusted OR 0.54; 95 % IC 0.37-0.79; p = 0.02). An older age was a predictor of the occurrence of acute lesions (OR 1.13; 95 % CI 1.03-1.23; p = 0.01), and the use of vitamin-K antagonist therapy had a protective effect (OR 0.25; 95 % CI 0.07-0.92; p = 0.037) regardless the type of intervention. Overall no significant changes were observed in global cognitive scores post-intervention (p = 0.23). The RCI showed mild cognitive decline in nine patients undergoing TAVI (26.4 %) and in six patients in the SAVR group (30.0 %) (p = 0.96). There was no association between the number and total volume of lesions and the occurrence of cognitive decline (CC Spearman 0.031, p = 0.85 and -0.011, p = 0.97, respectively). CONCLUSIONS: TAVI and SAVR were associated with a similar rate of acute silent ischemic cerebral lesions in intermediate risk patients. Although acute lesions occurred very frequently in both strategies, their cognitive impact was not clinically relevant.

Prevalence of calcific aortic valve disease in the elderly and associated risk factors: a population-based study in a Mediterranean area.

AIMS: To determine the prevalence of aortic valve sclerosis (ASC) and stenosis (AS) in the elderly in a Mediterranean area and to identify associated clinical factors. METHODS AND RESULTS: Population cross-sectional study in a random sample of 1068 people ≥65 years in a Mediterranean area. ASC was categorized as absent, mild-to-moderate, or moderate-to-severe depending on the severity of thickening and calcification. The relation between the severity of ASC and potential risk factors was assessed by multinomial logistic regression analysis. Some degree of thickening and/or calcification was present in 45.4%, of the sample, 73.5% in >85 years. AS prevalence was 3% for the total cohort and 7.4% in >85 years. Adjusting for gender it was found that age, smoking habit, hypertension, waist circumference, and ankle-brachial index <0.9 were associated with degrees of ASC. Except for waist circumference, there was a gradient between the magnitude of association and the severity of ASC. The OR for age was 1.56 (95% CI 1.39-1.76) for mild-to-moderate ASC and 2.03 (95% CI 1.72-2.4) for moderate-to-severe ASC, and for smoking habit 1.59 (95% CI 1.08-2.34) for mild-to-moderate ASC and 2.13 (95% CI 1.19-3.78) for moderate-to-severe ASC. Diabetes and renal impairment were associated with advanced but not with early stages of ASC. CONCLUSIONS: The prevalence of ASC and AS in people ≥65 years is similar to that reported in other regions. The gradient in the association of cardiovascular risk factors with the severity of ASC suggests that they may be causally implied in the pathogenesis of the disease.

Eplerenone in systemic right ventricle: double blind randomized clinical trial. The evedes study.

BACKGROUND: There is no proven pharmacological strategy for the treatment of the failing systemic right ventricle (SRV) but myocardial fibrosis may play a role in its pathophysiology. METHODS: We designed a double-blind, placebo-controlled clinical trial to assess the effects of eplerenone 50mg during 12 months on cardiac magnetic resonance parameters (SRV mass and ejection fraction) and neurohormonal and collagen turnover biomarker (CTB) levels. RESULTS: Twenty six patients with atrial switch repair for transposition of the great arteries were randomized to eplerenone (n=14) or placebo (n=12) and 14 healthy volunteers served as controls for comparison of baseline neurohormones and CTB levels. The study population showed a good baseline profile in terms of SRV mass (57.4 ± 17 g/m(2)) and ejection fraction (54.9 ± 7.5%). However, levels of N-terminal pro-brain natriuretic peptide (NT-proBNP), C terminal propeptide of type I procollagen (CICP) and C-terminal Telopeptide of type I Collagen (ICTP) were significantly elevated when compared to healthy controls. After one year of treatment, a trend toward reduction of CICP, N-terminal pro-Matrix Metalloproteinase 1 (NT-proMMP1), Tissue Inhibitor of Metalloproteinases 1 (TIMP1) and galectin 3 levels and a lower increase in ICTP in patients under eplerenone was observed. The reduction of SRV mass and the improvement of SRV function with eplerenone were not conclusive. CONCLUSIONS: Patients with SRV treated with eplerenone showed an improvement of an altered baseline CTB profile suggesting that reduction of myocardial fibrosis might be a therapeutic target in these patients.

Drug-eluting stents for off-label indications in real clinical world: evidence based or 'intuition' based clinical practice?

BACKGROUND: The use of drug-eluting stents (DES) is an example of the disparity between recommendations given by regulatory agencies and the real clinical world. Such disparity might lead cardiologists to adopt different routines in the use of DES. We aimed to assess variability of off-label DES use between hospitals and to what extent it can be explained by differences in patient or hospital characteristics. METHODS: Characteristics of consecutive patients receiving DES in 29 hospitals were recorded. Individual and hospital determinants of receiving DES for off-label indications were assessed by multilevel logistic regression. RESULTS: 1903 patients were recruited and 1188 (62.4%) received DES for off-label indications. Individual variables associated with off-label use were age (OR 1.01 (1-1.02)), previous percutaneous (OR 2.24 (1.68-2.97)) or surgical (2.41 (1.52-3.84)) revascularization, repeated procedure at the same admission (OR 4.66 (2.7-8.05)), receiving two (OR 4.17 (3.24-5.37)) or three or more DES (OR 14.12 (9.08-21.96)) vs one. Adjusting for individual variables, the Odds of receiving DES for off-label indication was higher in public funding hospitals with surgery availability vs private hospitals: 1.49 (0.86-2.6), and in public hospitals without surgery vs public with surgery availability: OR 1.76 (1.02-3.03). Interhospital variability reminded significant after adjustment for individual and contextual variables. CONCLUSION: Off-label DES use is highly variable between centers. Although this variability is partially determined by hospital type of funding and cardiac surgery availability, the substantial interhospital variability after multilevel adjustment suggests heterogeneity in the process of care.

Usefulness of exercise test and myocardial perfusion-gated single photon emission computed tomography to improve the prediction of major events.

BACKGROUND: The incremental prognostic value of myocardial perfusion-gated single photon emission computed tomography (MPGS) compared with exercise test has not yet been properly evaluated. METHODS AND RESULTS: Five thousand six hundred seventy-two consecutive patients with known or suspected coronary disease undergoing exercise MPGS between 1997 and 2007 were included. Three-year predictive models for total death and death from cardiovascular causes or acute myocardial infarction (ie, major cardiovascular events [MCE]) were built using Cox-regression modeling, including only the clinical information. Then the exercise and MPGS information was sequentially added. The added discriminative ability of exercise test information and MPGS was assessed by net reclassification improvement and integrated discrimination improvement. The increase in predictive ability of exercise information for death and MCE was high as assessed by net reclassification improvement (0.199 and 0.263) and integrated discrimination improvement (0.042 and 0.021). The only variable of MPGS associated with total death was ejection fraction (hazard ratio, 0.84; 95% confidence interval, 0.79-0.89; P<0.001). Global stress ischemic score emerged as an additional variable associated with MCE (hazard ratio, 1.07; 95% confidence interval, 1.02-1.12; P=0.007). Adding MPGS information barely improved the prognostic value for total death (net reclassification improvement, 0.017; integrated discrimination improvement, 0.013), but it increased for MCE (net reclassification improvement, 0.122; integrated discrimination improvement, 0.033). CONCLUSIONS: Adding MPGS information to exercise information does not improve prediction of total death, although it allows a more accurate prediction of MCE.

Double antiplatelet therapy after drug-eluting stent implantation: risk associated with discontinuation within the first year.

OBJECTIVES: The goal of this study was to assess the risk associated with double antiplatelet therapy (DAT) discontinuation, and specifically, temporary discontinuation, during the first year after drug-eluting stent (DES) implantation. BACKGROUND: Doubts remain about the risk of temporary DAT discontinuation within 1 year after DES implantation. METHODS: A total of 1,622 consecutive patients undergoing DES implantation at 29 hospitals were followed up at 3, 6, 9, and 12 months to record the 1-year antiplatelet therapy discontinuation (ATD) rate, the number of days without DAT, and the rate of 1-year major cardiac events. Cox regression was used to analyze the association between ATD considered as a time-dependent covariate and 1-year cardiac events. RESULTS: One hundred seventy-two (10.6%) patients interrupted at least 1 antiplatelet drug during the first year after DES implantation, although only 1 during the first month. Most (n=111, 64.5%) interrupted DAT temporarily (median: 7 days; range: 5 to 8.5): 79 clopidogrel (31 temporarily), 38 aspirin (27 temporarily), and 55 both drugs (53 temporarily). Discontinuation was followed by acute coronary syndrome in 7 (4.1%; 95% confidence interval [CI]: 1.7 to 8.2), a similar rate of major cardiac events to that in patients without ATD (n=80; 5.5%; 95% CI: 4.4 to 6.8; p=0.23). ATD was not independently associated with 1-year major cardiac events (hazard ratio: 1.32 [95% CI: 0.56 to 3.12]). CONCLUSIONS: ATD within the first year and beyond the first month after DES is not exceptional, is usually temporary, and does not appear to have a large impact on risk.