Josep R. Marsal

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.

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.

Predicting In-Hospital Mortality With Coronary Bypass Surgery Using Hospital Discharge Data: Comparison With a Prospective Observational Study

INTRODUCTION AND OBJECTIVES The aim was to determine the usefulness of the hospital discharge Minimum Basic Data Set (MBDS) for predicting in-hospital mortality with coronary bypass surgery by using data from a prospective observational study as a reference. METHODS The observational study involved collecting data on all patients undergoing first coronary bypass surgery at five hospitals in Catalonia, Spain between November 2001 and November 2003. In addition, data covering the same period and hospitals were obtained from the MBDS for procedure code 36.1. We investigated the concordance between the information from the two data sources and logistic regression was used to derive predictive models for in-hospital mortality. The model derived using MBDS data was validated using data from the prospective observational study and MBDS data for the years 2004-2006. Model validity was evaluated using discrimination and calibration indices. RESULTS Some 4.1% of cases in the observational study could not be found in the MBDS. The concordance between the two data sources was highly variable and generally low (kappa values ranged from 0.16 to 0.79). The discriminative ability of the MBDS model was equivalent to that of the observational study model (c=0.80 vs. c=0.79), but when the validity of the former was tested using prospective data and MBDS data for 2004-2006, the discrimination c-index decreased to 0.76 and 0.65, respectively, and the calibration worsened significantly (P< .001). CONCLUSIONS The risk of in-hospital mortality following coronary surgery cannot be accurately evaluated using MBDS data. However, our results indicate that their use as a predictive tool could be improved.

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 (GRACE<or=140) and 1,240 had high risk (GRACE>140). 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.

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.

Supervivencia, estado clínico y calidad de vida a los cinco años de la cirugía coronaria. Estudio ARCA

Introduccion y objetivos El resultado tardio de la cirugia coronaria y sus determinantes son poco conocidos en Espana. Este estudio evalua la evolucion clinica, la calidad de vida y la supervivencia de una cohorte de pacientes, transcurridos 5 anos de un primer injerto aortocoronario sin otros procedimientos asociados. Metodos Seguimiento telefonico a los 5 anos a los supervivientes de la operacion, de los que se habia recogido prospectivamente los datos preoperatorios y postoperatorios. Resultados De los 1.525 pacientes dados de alta vivos, a los 5 anos se obtuvo informacion de 1.300 (85,2%), de los que el 13,6% habia fallecido y el 24% habia fallecido o habia sido revascularizado o ingresado por causa cardiaca. La supervivencia acumulada (excluyendo la fase hospitalaria) fue de 0,87 (intervalo de confianza [IC] del 95%, 0,85-0,89). La tasa de mortalidad fue distinta segun el riesgo preoperatorio (EuroSCORE); la del grupo con bajo riesgo fue equivalente a la de la poblacion general de referencia. Conclusiones De cada 4 supervivientes al alta 3 estan libres de eventos mayores a los 5 anos, con buenas capacidad funcional y calidad de vida. La supervivencia despues del postoperatorio inmediato varia en funcion de las caracteristicas prequirurgicas de riesgo y en el grupo con bajo riesgo es equivalente a la de la poblacion general de referencia.

Prognostic Value of an Abnormal Ankle–Brachial Index in Patients Receiving Drug-Eluting Stents

Advanced atherosclerotic disease increases the risk of stent thrombosis after drug-eluting stent (DES) implantation. We aimed to determine if an abnormal ankle-brachial index (ABI) value as a surrogate of atherosclerotic disease and vascular inflammation provides information on 1-year risk of cardiovascular events after DES implantation. A prospective cohort of 1,437 consecutive patients undergoing DES implantation from January through April 2008 in 26 Spanish hospitals was examined. ABI was calculated by Doppler in a standardized manner. Patients were followed to 12 months after the percutaneous coronary intervention to determine total and cardiovascular mortality, stroke, nonfatal acute coronary syndrome (ACS), and new revascularizations. Association of an abnormal ABI value (i.e., ≤ 0.9 or ≥ 1.4) with outcomes was assessed by conventional logistic regression and by propensity-score analysis. Patients with abnormal ABI values (n = 582, 40.5%) in general had higher global cardiovascular risk, the reason for DES implantation was more often ACS, and had a higher rate of complications during admission (heart failure or stroke or major hemorrhage 11.3% vs 5.3%, p <0.001). An abnormal ABI value was independently associated with 1-year total mortality (odds ratio 2.23, 95% confidence interval 1.13 to 4.4) and cardiovascular mortality (odds ratio 2.06, 95% confidence interval 1.04 to 4.22). No independent association was found between an abnormal ABI value and 1-year nonfatal ACS, stroke, and new revascularizations. In conclusion, although an abnormal ABI value was associated with fatal outcomes in patients receiving DESs, no association was found with nonfatal ACS and new revascularizations. A clear relation between abnormal ABI and surrogates of DES thrombosis could not be established.

Survival, Clinical Status, and Quality of Life Five Years After Coronary Surgery. The ARCA Study

INTRODUCTION AND OBJECTIVES Little is known about the long-term outcomes of coronary surgery and their determinants in Spain. The objectives of this study were to evaluate clinical outcomes, quality of life and survival in a cohort of patients 5 years after undergoing a first aortocoronary bypass operation without any other associated procedure. METHODS Patients who survived the operation and whose pre- and postoperative data had been collected prospectively were followed up by telephone interview after 5 years. RESULTS Information was available after 5 years on 1,300 (85.2%) of the 1,525 patients who survived until hospital discharge. Of these, 13.6% had died, while 24% had either died, undergone revascularization or were readmitted because of a cardiac complaint. The cumulative survival rate (excluding the period of hospitalization) was 0.87 (95% confidence interval, 0.85-0.89). Mortality varied significantly with the level of preoperative risk (i.e. the EuroSCORE), to the extent that mortality in the low-risk group was equivalent to that in the general reference population. CONCLUSIONS Three-quarters of patients who survived until hospital discharge after coronary surgery did not experience a major cardiac event within 5 years and their level of functioning and quality of life were good. The survival rate after the immediate postoperative period varied according to the patients preoperative risk profile and, in low-risk patients, was equivalent to that in the general reference population.

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.

Short-term exposure to air pollutants increases the risk of ST elevation myocardial infarction and of infarct-related ventricular arrhythmias and mortality

BACKGROUND The relation between STEMI and air pollution (AP) is scant. We aimed to investigate the short term association between AP and the incidence of STEMI, and STEMI-related ventricular arrhythmias (VA) and mortality. METHODS The study was carried out in the area of Barcelona from January 2010 to December 2011. Daily STEMI rates and incidence of STEMI-related VA and mortality were obtained prospectively. The corresponding daily levels of the main pollutants were recorded as well as the atmospheric variables. Three cohorts were defined in order to minimize exposure bias. The magnitude of association was estimated using a time-series design and was adjusted according to atmospheric variables. RESULTS The daily rate of hospital admissions for STEMI was associated with increases in PM 2.5, PM 10, lead and NO2 concentrations. VA incidence and mortality were associated with increases in PM 2.5 and PM 10 concentrations. In the most specific cohort, BCN (Barcelona) Attended & Resident, STEMI incidence was associated with increases in PM 2.5 (1.009% per 10μg/m3) and PM 10 concentrations (1.005% per 10μg/m3). VA was associated with increases in PM 2.5 (1.021%) and PM 10 (1.015%) and mortality was associated with increases in PM 2.5 (1.083%) and PM 10 (1.045%). CONCLUSIONS Short-term exposure to high levels of PM 2.5 and PM 10 is associated with increased daily STEMI admissions and STEMI-related VA and mortality. Exposure to high levels of lead and NO2 is associated with increased daily STEMI admissions, and NO2 with higher mortality in STEMI patients.