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.

Primary Ventricular Fibrillation in the Primary Percutaneous Coronary Intervention ST-Segment Elevation Myocardial Infarction Era (from the "Codi IAM" Multicenter Registry).

Primary ventricular fibrillation (PVF) is a dreadful complication of ST segment elevation myocardial infarction (STEMI). Scarce data are available regarding PVF prognosis since primary percutaneous coronary intervention (PPCI) became routine practice in STEMI. Our aim was to compare 30-day and 1-year mortality for patients with and without PVF (including out-of-hospital and in-hospital PVF) within a regional registry of PPCI-treated STEMI patients. This prospective multicenter registry included all consecutive STEMI patients treated with PPCI from January 2010 to December 2014. Patients were classified as non-PVF or PVF, with further subdivision into out-of-hospital and in-hospital PVF. We analyzed 30-day and 1-year all-cause mortality in groups. The registry included 10,965 patients. PVF occurred in 949 patients (8.65%), including 74.2% out-of-hospital and 25.8% in-hospital PVF. Compared with the non-PVF group, PVF patients were younger; less commonly diabetic; more frequently had anterior wall STEMI, higher Killip-Kimball class, and left main disease; and showed significantly higher 24-hour (5.1% vs 1.1%), 30-day (18.5% vs 4.7%), and 1-year mortality (23.2% vs 7.9%) (all p <0.001). Mortality did not differ in out-of-hospital versus in-hospital PVF. After multivariable adjustment, PVF remained associated with all-cause 30-day (2.32, 95% CI: 1.91 to 2.82, p <0.001) and 1-year (HR: 1.59, 95% CI: 1.13 to 2.24, p = 0.008) mortality. In conclusion, we present the largest registry of PVF patients in the era of routine PPCI in STEMI. Although overall STEMI mortality has declined, PVF emerged as a predictor of both 30-day and 1-year mortality. These data warrant prospective validation and proper identification and protection of high-risk patients.

Early ST elevation myocardial infarction in non-capable percutaneous coronary intervention centres: in situ fibrinolysis vs. percutaneous coronary intervention transfer.

AIMS: The preferred reperfusion strategy for early ST elevation myocardial infarction (STEMI, defined as time from symptoms onset ≤120 min) in non-capable percutaneous coronary intervention (PCI) centres remains controversial. We sought to compare mortality of in situ fibrinolysis vs. PCI transfer in a real-life consecutive cohort of early STEMI. METHODS AND RESULTS: Prospective multicentre STEMI registry (Catalonia 'Codi IAM' network) of all-comers in a non-capable PCI centre with symptom onset to first medical contact (FMC) <120 min. Two groups were identified: in situ fibrinolysis and transfer to a PCI-capable centre. Primary endpoint was 30-day mortality. We included 2470 patients, of whom 2227 (90.2%) and 243 (9.8%) comprised the transfer and fibrinolysis groups, respectively. In the fibrinolysis group, diagnostic and system delays were shorter (24 vs. 31 min, P < 0.001; 45 vs. 119 min, P < 0.001, respectively). Thirty-day mortality was 7.7 and 5.1% in fibrinolysis and transfer groups, respectively (P = 0.09). However, patients in the transfer group whose time FMC-device was achieved within 140 min were associated with significantly lower mortality (2.0% for FMC-device <99 min, and 4.6% for FMC-device 99-140 min; P < 0.01 and P = 0.03, respectively vs. fibrinolysis). In multivariable logistic regression analysis, reperfusion with fibrinolysis was an independent 30-day mortality predictive factor (odds ratio: 1.91, 95% confidence interval: 1.01-3.50; P = 0.04), together with age and Killip-Kimball class (both P < 0.001). CONCLUSIONS: In early STEMI patients assisted in non-capable PCI centres, in situ fibrinolysis had worse prognosis than patient transfer. Transfer to a PCI-capable centre seems recommended in patients with FMC-device delay <140 min.

Cost-effectiveness of a European ST-segment elevation myocardial infarction network: results from the Catalan Codi Infart network.

OBJECTIVES: To evaluate the cost-effectiveness of the ST-segment elevation myocardial infarction (STEMI) network of Catalonia (Codi Infart). DESIGN: Cost-utility analysis. SETTING: The analysis was from the Catalonian Autonomous Community in Spain, with a population of about 7.5 million people. PARTICIPANTS: Patients with STEMI treated within the autonomous community of Catalonia (Spain) included in the IAM CAT II-IV and Codi Infart registries. OUTCOME MEASURES: Costs included hospitalisation, procedures and additional personnel and were obtained according to the reperfusion strategy. Clinical outcomes were defined as 30-day avoided mortality and quality-adjusted life-years (QALYs), before (N=356) and after network implementation (N=2140). RESULTS: A substitution effect and a technology effect were observed; aggregate costs increased by 2.6%. The substitution effect resulted from increased use of primary coronary angioplasty, a relatively expensive procedure and a decrease in fibrinolysis. Primary coronary angioplasty increased from 31% to 89% with the network, and fibrinolysis decreased from 37% to 3%. Rescue coronary angioplasty declined from 11% to 4%, and no reperfusion from 21% to 4%. The technological effect was related to improvements in the percutaneous coronary intervention procedure that increased efficiency, reducing the average length of the hospital stay. Mean costs per patient decreased from €8306 to €7874 for patients with primary coronary angioplasty. Clinical outcomes in patients treated with primary coronary angioplasty did not change significantly, although 30-day mortality decreased from 7.5% to 5.6%. The incremental cost-effectiveness ratio resulted in an extra cost of €4355 per life saved (30-day mortality) and €495 per QALY. Below a cost threshold of €30,000, results were sensitive to variations in costs and outcomes. CONCLUSIONS: The Catalan STEMI network (Codi Infart) is cost-efficient. Further studies are needed in geopolitical different scenarios.

The impact of new drug introduction on drug expenditure in primary health care in Catalunya, Spain.

BACKGROUND: Introduction of new drugs is a dynamic process with a high impact on consumption and expenditure. OBJECTIVE: To analyze the prescription of new drugs and the associated costs in public health care in Catalunya, Spain, in 2002. The analysis also attempts a perspective of consumption in relation to the grade of therapeutic innovation of the new drugs. METHODS: Prescription data on all 86 new drugs licensed for use during 1998-2002 were analyzed, using the prescription item as unit and the cost. RESULTS: Prescription for new drugs in 2002 represented 4% of overall items prescribed and 13% of the cost. The mean new drug item cost was 39, while that of overall drugs was 13. New drug item increase over the previous year was 18.6% compared with 5.2% of the overall drugs, and the proportional cost increased by 25.7% and 9.9%, respectively. Ten new drugs represented 55.1% of the expenditure of this group. Antiasthmatic drugs represented 20.7% of the expenditure on new drugs, angiotensin-receptor blockers represented 18.6%, antiaggregants 9.7%, and nonsteroidal antiinflammatory drugs 6.9%. New drugs providing significant or modest therapeutic improvement represented 25.6% of overall new drug items and 32.3% of their cost. CONCLUSIONS: New drugs have a mean cost growth rate greater than that of existing drugs, with only a quarter of them offering advantages over existing drugs. More detailed evaluations of new medications are warranted before they can be recommended for general use so that a better distribution of the limited resources available may be made when prescribing drugs that are newly available through prescription.

[Gender and ischemic heart disease]. / Género y cardiopatía isquémica.

Physiological and pathological processes differ in men and women, depending on factors such as sex and sociological and anthropological characteristics. However, many diseases are still approached from a masculine point of view. In this respect, ischemic heart disease is one of the diseases that most clearly reflects biological differences and social inequalities. In women, the disease presents at a more advanced age, and presentation is frequently atypical with a higher prevalence of comorbidities and greater severity. Consequently, treatment and outcome differ from those in men. Additionally, women differ in their knowledge, and beliefs regarding ischemic heart disease, as well as in their attitudes at symptom onset. Therefore, clinical practice should place significant emphasis on all these aspects in order to avoid inequalities between men and women in the correct diagnosis, treatment, prevention, and rehabilitation of ischemic heart disease.

Género y cardiopatía isquémica / Gender and ischemic heart disease

Tanto el sexo como los aspectos sociológicos y antropológicos relacionados con el género son factores que contribuyen a particularizar los procesos fisiológicos y patológicos de mujeres y hombres. Sin embargo, el abordaje integral de muchas enfermedades se realiza desde la perspectiva masculina. En este sentido, la cardiopatía isquémica (CI) es una de las enfermedades donde se pueden ejemplificar claramente las diferencias biológicas y las desigualdades sociales. Las mujeres presentan la enfermedad en edades más avanzadas que los hombres, la forma de aparición es más frecuentemente «atípica» y está asociada con una mayor comorbilidad y gravedad. Por tanto, el tratamiento y el pronóstico es diferente. Además, también se han observado diferencias en relación con el conocimiento y las creencias sobre la enfermedad, así como en las actitudes adoptadas cuando aparecen los primeros síntomas. Es preciso tener en cuenta todos estos aspectos biológicos y de género porque frecuentemente ocasionan desigualdades entre los hombres y las mujeres, tanto en relación con el diagnóstico certero de la CI como en el tratamiento, la prevención o la rehabilitación posterior (AU)

Physiological and pathological processes differ in men and women, depending on factors such as sex and sociological and anthropological characteristics. However, many diseases are still approached from a masculine point of view. In this respect, ischemic heart disease is one of the diseases that most clearly reflects biological differences and social inequalities. In women, the disease presents at a more advanced age, and presentation is frequently atypical with a higher prevalence of comorbidities and greater severity. Consequently, treatment and outcome differ from those in men. Additionally, women differ in their knowledge, and beliefs regarding ischemic heart disease, as well as in their attitudes at symptom onset. Therefore, clinical practice should place significant emphasis on all these aspects in order to avoid inequalities between men and women in the correct diagnosis, treatment, prevention, and rehabilitation of ischemic heart disease (AU)

[Comparison of population coronary heart disease risk estimated by the Framingham original and REGICOR calibrated functions]. / Comparación de la función de Framingham original y la calibrada del REGICOR en la predicción del riesgo coronario poblacional.

BACKGROUND AND OBJECTIVE: The therapeutic consequences of using the Framingham function calibrated by the REGICOR and Framingham investigators (Framingham-REGICOR) in the Spanish population are unknown. The objective of this study was to determine the differences in the classification of the population coronary risk when using the classical Framingham function (Framingham-Wilson) and that calibrated, and its consequences on the theoretical indication of lipid-lowering treatment. PATIENTS AND METHOD: The classification into the < 2%, 2-4,9%, 5-9,9%, 10-19,9%, 20-39,9%, and >= 40% risk categories observed by the two functions was compared in 3.270 individuals aged 35 to 74 years with no history of ischaemic heart disease or lipid-lowering drug treatment, recruited in two population samples representative of Girona between 1994 and 2001. The number of lipid-lowering treatment candidates was estimated applying the most recent guidelines for clinical practice, according to the risk level obtained with both functions. RESULTS: The proportion of patients excluded owing to the fact that they already were on lipid-lowering treatment was 6.2%. The Framingham-REGICOR assigned 54.2% of women and 67.9% of men to a lower level of risk as compared to the Framingham-Wilson function. In 0.2% of women and 21.2% of men the decrease was two categories of risk. The figures in diabetic participants were 75.7 and 18.5%, respectively. When the European recommendations published in 2003 were applied, lipid-lowering treatment would have been indicated in 14.5% and in 4.4% of non-diabetic participants by the Framingham-Wilson and the Framingham-REGICOR, respectively. CONCLUSIONS: The calibrated Framingham-REGICOR function assigns a lower coronary risk category in more than 50% of women and almost 90% of men than the uncalibrated Framingham function. The calibrated function is more suitable for risk estimation in primary prevention than the original function in Spain.

Comparación de la función de Framingham original y la calibrada del REGICOR en la predicción del riesgo coronario poblacional / Comparison of population coronary heart disease risk estimated by the Framingham original and REGICOR calibrated functions

FUNDAMENTO Y OBJETIVO: Se desconocen las implicaciones terapéuticas derivadas del uso de la función de riesgo coronario de Framingham calibrada por los investigadores de los estudios REGICOR y Framingham (Framingham-REGICOR) para la población española. El objetivo de este estudio fue determinar las diferencias en la clasificación del riesgo de la población de 35 a 74 años usando la función de Framingham clásica (Framingham-Wilson) y la calibrada y sus consecuencias en la indicación de tratamiento hipolipemiante con las guías de práctica clínica. PACIENTES Y MÉTODO: Se comparó la clasificación en las categorías de riesgo a 10 años de < 2 por ciento, 2-4,9 por ciento, 5-9,9 por ciento, 10-19,9 por ciento, 20-39,9 por ciento y 40 por ciento observada mediante ambas funciones en 3.270 individuos de entre 35 y 74 años sin antecedentes de cardiopatía isquémica ni tratamiento hipolipemiante, provenientes de 2 muestras poblacionales representativas de la provincia de Girona, reclutadas entre 1994 y 2001. Se calculó el número de candidatos a tratamiento hipolipemiante según las guías vigentes de práctica clínica y las 2 funciones. RESULTADOS: Un 5,9 por ciento del total de la muestra recibía tratamiento hipolipemiante en el momento del examen. La función Framingham-REGICOR asignó al 54,2 por ciento de las mujeres y al 67,9 por ciento de los varones no diabéticos a una categoría de riesgo inferior que la función Framingham-Wilson. El 0,2 por ciento de las mujeres y el 21,2 por ciento de los varones descendieron dos categorías. Un 75,7 por ciento de los participantes diabéticos descendió una categoría y el 18,5 por ciento descendió dos. Con las guías europeas de 2003 recibirían hipolipemiantes el 14,5 y el 4,4 por ciento de participantes no diabéticos usando las funciones de Framingham-Wilson y Framingham-REGICOR, respectivamente. CONCLUSIONES: La función calibrada de Framingham-REGICOR adjudica una categoría de riesgo coronario menor que la de Framingham original en más del 50 por ciento de mujeres y casi el 90 por ciento de varones. Es una herramienta más recomendable que ésta en la prevención primaria de la enfermedad coronaria en España (AU)