Josep Ramon Marsal

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.

Patient Registries of Acute Coronary Syndrome Assessing or Biasing the Clinical Real World Data

Background—The risk of selection bias in registries and its consequences are relatively unexplored. We sought to assess selection bias in a recent registry about acute coronary syndrome and to explore the way of conducting and reporting patient registries of acute coronary syndrome. Methods and Results—We analyzed data from patients of a national acute coronary syndrome registry undergoing an audit about the comprehensiveness of the recruitment/inclusion. Patients initially included by hospital investigators (n=3265) were compared to eligible nonincluded (missed) patients (n=1439). We assessed, for 25 exposure variables, the deviation of the in-hospital mortality relative risks calculated in the initial sample from the actual relative risks. Missed patients were of higher risk and received less recommended therapies than the included patients. In-hospital mortality was almost 3 times higher in the missed population (9.34% [95% CI, 7.84 to 10.85] versus 3.9% [95% CI, 2.89 to 4.92]). Initial relative risks diverged from the actual relative risks more than expected by chance (P<0.05) in 21 variables, being higher than 10% in 17 variables. This deviation persisted on a smaller degree on multivariable analysis. Additionally, we reviewed a sample of 129 patient registries focused on acute coronary syndrome published in thirteen journals, collecting information on good registry performance items. Only in 38 (29.4%) and 48 (37.2%) registries was any audit of recruitment/inclusion and data abstraction, respectively, mentioned. Only 4 (3.1%) authors acknowledged potential selection bias because of incomplete recruitment. Conclusions—Irregular inclusion can introduce substantial systematic bias in registries. This problem has not been explicitly addressed in a substantial number of them.

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

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.

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.

Association between low empathy and high burnout among primary care physicians and nurses in Lleida, Spain

Abstract Background: Burnout is a growing problem among healthcare professionals and may be mitigated and even prevented by measures designed to promote empathy and resilience. Objectives: We studied the association between burnout and empathy in primary care practitioners in Lleida, Spain and investigated possible differences according to age, sex, profession, and place of practice (urban versus rural). Methods: All general practitioners (GPs) and family nurses in the health district of Lleida (population 366 000) were asked by email to anonymously complete the Maslach Burnout Inventory (MBI) and the Jefferson Scale of Physician Empathy (JSPE) between May and July 2014. Tool consistency was evaluated by Cronbach’s α, the association between empathy and burnout by Spearman’s correlation coefficient, and the association between burnout and empathy and sociodemographic variables by the χ2 test. Results: One hundred and thirty-six GPs and 131 nurses (52.7% response rate) from six urban and 16 rural practices participated (78.3% women); 33.3% of respondents had low empathy, while 3.7% had high burnout. The MBI and JSPE were correlated (P < .001) and low burnout was associated with high empathy (P < .05). Age and sex had no influence on burnout or empathy. Conclusion: Although burnout was relatively uncommon in our sample, it was associated with low levels of empathy. This finding and our observation of lower empathy levels in rural settings require further investigation. KEY MESSAGES More empathic primary care practitioners have lower burnout scores. Practitioners working in rural areas have significantly lower levels of empathy than their urban counterparts have. Interventions designed to foster attributes and skills such as empathy, resilience, and doctor–patient communication may help to reduce and prevent burnout.

Effect of Clopidogrel and Aspirin vs Aspirin Alone on Migraine Headaches After Transcatheter Atrial Septal Defect Closure: The CANOA Randomized Clinical Trial

IMPORTANCE The occurrence of new-onset migraine attacks is a complication of transcatheter atrial septal defect (ASD) closure. It has been suggested that clopidogrel may reduce migraine attacks after ASD closure. OBJECTIVE To assess the efficacy of clopidogrel, used in addition to taking aspirin, for the prevention of migraine attacks following ASD closure. DESIGN, SETTING, AND PARTICIPANTS Randomized, double-blind clinical trial performed in 6 university hospitals in Canada. Participants were 171 patients with an indication for ASD closure and no history of migraine. INTERVENTIONS Patients were randomized (1:1) to receive dual antiplatelet therapy (aspirin + clopidogrel [the clopidogrel group], n = 84) vs single antiplatelet therapy (aspirin + placebo [the placebo group], n = 87) for 3 months following transcatheter ASD closure. The first patient was enrolled in December 2008, and the last follow-up was completed in February 2015. MAIN OUTCOMES AND MEASURES The primary efficacy outcome was the monthly number of migraine days within the 3 months following ASD closure in the entire study population. The incidence and severity of new-onset migraine attacks, as evaluated by the Migraine Disability Assessment questionnaire, were prespecified secondary end points. A zero-inflated Poisson regression model was used for data analysis. RESULTS The mean (SD) age of the participants was 49 (15) years and 62% (106) were women. Patients in the clopidogrel group had a reduced mean (SD) number of monthly migraine days within the 3 months following the procedure (0.4 [95% CI, 0.07 to 0.69] days) vs the placebo group (1.4 [95% CI, 0.54 to 2.26] days; difference, -1.02 days [95% CI, -1.94 to -0.10 days]; incident risk ratio [IRR], 0.61 [95% CI, 0.41 to 0.91]; P = .04) and a lower incidence of migraine attacks following ASD closure (9.5% for the clopidogrel group vs 21.8% for the placebo group; difference, -12.3% [95% CI, -23% to -1.6%]; odds ratio [OR], 0.38 [95% CI, 0.15 to 0.89]; P = .03). Among patients with migraines, those in the clopidogrel group had less-severe migraine attacks (zero patients with moderately or severely disabling migraine attacks vs 37% [7 patients] in the placebo group; difference, -36.8% [95% CI, -58.5% to -15.2%]; P = .046). There were no between-group differences in the rate of patients with at least 1 adverse event (16.7% [14 patients] in the clopidogrel group vs 21.8% [19 patients] in the placebo group; difference, -5.2% [95% CI, -17% to 6.6%]; P = .44). CONCLUSIONS AND RELEVANCE Among patients who underwent transcatheter ASD closure, the use of clopidogrel and aspirin, compared with aspirin alone, resulted in a lower monthly frequency of migraine attacks over 3 months. Further studies are needed to assess generalizability and durability of this effect. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00799045.

Evolución de la calidad de vida relacionada con la salud en pacientes ingresados por insuficiencia cardiaca. Estudio IC-QoL

Introduccion y objetivos. La insuficiencia cardiaca conlleva un mal pronostico tanto en la supervivencia como en el estado sintomatico. El objetivo de este estudio es evaluar en una poblacion heterogenea de pacientes con insuficiencia cardiaca los patrones de evolucion de la calidad de vida relacionada con la salud (CVRS), especialmente en subgrupos de interes clinico, asi como los determinantes de la mortalidad. Metodos. Estudio prospectivo de 1 ano de seguimiento con seis evaluaciones de la CVRS mediante un cuestionario generico (SF-36) y un cuestionario especifico (MLHFQ) a 883 pacientes dados de alta del hospital por insuficiencia cardiaca de 50 hospitales del territorio espanol. Resultados. Se observo una importante alteracion inicial de todas las dimensiones y de los componentes sumario fisico (CSF) (media, 34,1) y mental (CSM) (media, 40,1), del SF-36 y del MLHFQ (media, 37,5), y una clara mejora en el primer mes, que se mantuvo estable posteriormente, excepto en los menores de 40 anos, que mostraron una mejora progresiva de la CVRS. Se identificaron como predictores de mortalidad la edad, el grado funcional, la comorbilidad y los valores iniciales de CVRS. Conclusiones. La evolucion de la CVRS de los pacientes con insuficiencia cardiaca mejora durante el primer mes tras el alta hospitalaria, pero despues se mantiene estable, excepto en los pacientes mas jovenes, en los que se observa una mejora persistente

Prognosis and Management of Patients With Acute Coronary Syndrome and Polyvascular Disease

INTRODUCTION AND OBJECTIVES To assess prognosis and patterns of care in patients with acute coronary syndrome and peripheral arterial disease (PAD), cerebrovascular disease or both (i.e., polyvascular disease) in everyday clinical practice. METHODS We used data from the MASCARA acute coronary syndrome registry for 2004 and 2005. Patients were stratified according to the presence of PAD, cerebrovascular disease, neither, or both. In-hospital management, treatment at discharge and outcomes at 6 months were recorded. RESULTS Of 6745 patients, 597 (8.85%) had PAD, 392 (5.8%) had cerebrovascular disease, 131 (1.94%) had both and 5625 (83.4%) had neither. Patients with polyvascular disease had more extensive coronary disease, but less often received regularly recommended treatment (e.g., 75% with PAD received aspirin at discharge versus 84% of those without). In-hospital and 6-month mortality were significantly higher (P< .001) in patients with PAD (9.1% and 24.5%, respectively) or cerebrovascular disease (9.2% and 22.4%, respectively) or, especially, both (16.0% and 29.8%, respectively) than in those free from these conditions (4.8% and 10.8%, respectively). Cerebrovascular disease, PAD and their combination were all independently associated with in-hospital and 6-month mortality: for cerebrovascular disease, the odds ratio (OR) for mortality at 6 months was 1.45 (95% confidence interval [CI], 1.10-2.02); for PAD, it was 1.88 (95% CI, 1.45-2.40); and for both combined, 1.88 (95% CI, 1.17-3.00). CONCLUSIONS Patients with acute coronary syndrome and concomitant arterial disease had more extensive coronary artery disease and poorer outcomes, both inhospital and at 6 months, but frequently did not receive regularly recommended treatment.

Predictors and Association With Clinical Outcomes of the Changes in Exercise Capacity After Transcatheter Aortic Valve Replacement

Background: At present, there are no objective data specifically examining the clinical impact of variations in exercise capacity post–transcatheter aortic valve replacement (TAVR). We describe the changes in exercise capacity between baseline and 6 months post-TAVR, and ascertain factors associated with and clinical implications of a lack of improvement in exercise capacity post-TAVR. Methods: A total of 305 patients (mean age, 79±9 years; 44% men; Society of Thoracic Surgeons predicted risk mortality score, 6.7±4.2%) undergoing TAVR completed both baseline and follow-up exercise capacity assessments at 6 months post-TAVR. Exercise capacity was evaluated by the 6-minute walk test (6MWT). Clinical outcomes were compared between patients displaying greater than (n=152; improving group) versus less than (n=153; nonimproving group) the median percentage change in distance walked between baseline and 6-month follow-up examinations. The primary outcome measure was clinical event rates, measured from the 6-month post-TAVR period onward. Further dichotomization according to baseline 6MWT distance (less than versus more than median walking distance, or slow walker versus fast walker) was also assessed. Results: The mean overall distances walked pre- and post-TAVR (6 months post-TAVR) were 204±119 and 263±116 m, respectively (&Dgr;6MWT=60±106 m), with 219 (72%) patients demonstrating an increase in their walking distance (median percentage increase of the entire population was 20% [interquartile range, 0%–80%]). Factors independently correlated with reduced exercise capacity improvement included a range of baseline clinical characteristics (older age, female sex, chronic obstructive pulmonary disease; P<0.05 for all), periprocedural major or life-threatening bleeding (P=0.009) and new-onset anemia at 6 months post-TAVR (P=0.009). Failure to improve the 6MWT distance by at least 20% was independently associated with all-cause mortality (P=0.002) and cardiovascular death or rehospitalization for cardiovascular causes (P=0.001). Baseline slow walkers who were able to improve the 6MWT distance presented with significantly better outcomes than nonimprovers (P=0.01 for all-cause mortality; P=0.001 for cardiovascular end point). Conclusions: Approximately one-third of patients undergoing TAVR did not improve their exercise capacity postprocedure. The lack of functional improvement post-TAVR was predicted by a mix of baseline and periprocedural factors translating into poorer clinical outcomes. These results suggest that systematically implementing exercise capacity assessment pre- and post-TAVR may help to improve patient risk stratification.

Prevalencia y factores asociados al consumo de tabaco en alumnos de enseñanza secundaria de Cataluña

Resumen Objetivos Analizar aquellos factores asociados al consumo de tabaco en adolescentes para plantear futuras intervenciones de promoción de la salud desarrolladas por las escuelas y centros de atención primaria. Diseño Estudio transversal, muestreo por conglomerados bietápico. Emplazamiento Se incluyeron 97 centros escolares de Cataluña, 2005-2006. Participantes Se obtuvieron 9.340 cuestionarios completos de estudiantes entre 14-16 años. Mediciones principales Encuesta autoadministrada que recogía variables sociodemográficas, académicas, estado de salud, familiares, relaciones sexuales, sustancias adictivas, estados de ánimo y variables de opinión sobre el consumo. Se analizó la asociación de estas variables con la variable dependiente fumador/no fumador y también fueron analizadas como factores que aumentaban la probabilidad de ser fumador mediante modelos multinivel. Resultados Se incluyeron 4.653 chicos y 4.687 chicas, con una edad media de 15,2 años. El 71,1% de los estudiantes eran no fumadores, el 75% de los chicos y el 67,3% de las chicas. Aumentaban la probabilidad de ser fumador (OR e IC 95%): ser chica 0,60 (0,53-0,68), cursar 4.o ESO 1,27 (1,12-1,43), tener un rendimiento escolar bajo 3,38 (2,74-4,17), tener una autopercepción de salud regular/mala 2,81 (2,21-3,58), tener padres fumadores 1,68 (1,45-1,95), consumir alcohol 5,05 (4,35-5,86), tener 3 o más problemas de estado de ánimo 1,22 (1,05-1,41), vivir sin ningún progenitor 1,59 (1,07-2,38), estar de acuerdo en que exista publicidad sobre tabaco 1,64 (1,45-1,85), y opinar que el tabaco ayuda a relajarse 3,57 (3,23-4,17). Conclusiones Aunque la mayoría de los estudiantes eran no fumadores, el consumo de tabaco era más prevalente en las chicas. Factores sociodemográficos, socioculturales, del entorno y opinión se asociaban con el consumo de tabaco entre los jóvenes.