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.

"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.

[Evaluation of risk-adjusted hospital mortality after coronary artery bypass graft surgery in the Catalan public healthcare system. Influence of hospital management type (ARCA Study)]. / Evaluación de la mortalidad hospitalaria ajustada al riesgo de la cirugía coronaria en la sanidad pública catalana. Influencia del tipo de gestión del centro (estudio ARCA).

INTRODUCTION AND OBJECTIVES: Previous studies suggest that the effectiveness of coronary surgery is influenced by the type of management at the healthcare centre where the intervention is performed. The present study assessed the risk-adjusted hospital mortality of coronary surgery in the Catalan healthcare system in hospitals under either private or public management. METHODS: We carried out a prospective study of all consecutive patients receiving a first coronary artery bypass graft, with public financial support, in a period of 2 years at 5 hospitals under either public or private management. Preoperative risk was assessed using the EuroSCORE and Catalan Agency for Health Technology Assessment (CAHTA) predictive models. RESULTS: Overall, 1605 patients underwent interventions, 21% of which were at private hospitals. The percentage of patients undergoing non-elective surgery was higher at private hospitals (64% vs 50%), as was the percentage needing intravenous nitrates (17% vs 11%) and the percentage in functional class IV (20% vs 11%). The odds ratio for in-hospital mortality in private compared with public hospitals was 0.56 (95% CI, 0.29-1.06) when adjusted for EuroSCORE, 0.56 (95% CI, 0.29-1.07) when adjusted for CAHTA score, and 0.43 (95% CI, 0.21-0.87) when adjusted for patient characteristics. The mortality observed, 4.8% (95% CI 3.8-5.6), was not significantly higher than that predicted. CONCLUSIONS: a) Hospital mortality was equivalent to or lower than that expected after adjustment for the 2 risk scores; b) after adjustment for baseline patient characteristics, the results favored privately managed centers; and c) comparison with previous results suggests that coronary surgery effectiveness has improved in recent years.

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.

[Methods of reporting research-results and their influence on decision-making by cardiologists prescribing drugs for primary and secondary prevention]. / La influencia de los métodos de presentación de los resultados en ensayos clínicos sobre la eficacia de una intervención y la intención de prescribir fármacos para la prevención cardiovascular.

OBJECTIVES: To assess the influence of the form of presentation of the results of clinical trials on the quantitative perceptions of cardiologists regarding the efficacy of drugs for the primary and secondary prevention of coronary heart disease and their likelihood of prescribing them. METHOD: We conducted a survey of 1,408 cardiologists in Spain who were randomly allocated of three questionnaires that used different measurements to evaluate the impact of published clinical trials. RESULTS: Five-hundred and fifty-nine questionnaires (40%) were suitable for analysis. On a scale of 0 to 10, the following mean efficacy estimates were obtained from questionnaire items that focused, respectively, on the results of clinical trials in terms of relative risk reduction, absolute risk reduction, and number needed to treat: primary prevention with statins: 6.79, 6.38 and 5.43; primary prevention with aspirin: 6.84, 5.06 and 4.25; secondary prevention with statins: 8.16, 7.76 and 7.54; secondary prevention with ACE inhibitors: 7.11, 7.81 and 7.19, and secondary prevention with beta-blockers: 7.22, 7.43 and 6.98. The likelihood that a drug treatment would be prescribed was not influenced very much by the form of presentation of the trial results. CONCLUSIONS: Presenting the results of clinical trials in the form of relative risk reduction, as compared with presenting results in terms of absolute risk reduction or number needed to treat, led to overestimation of the efficacy of interventions without influencing the likelihood of prescribing a given drug therapy.

[Usefulness of coronary risk assessment using the equation of the Framingham study: a case control study]. / Utilidad de la medición del riesgo coronario a partir de la ecuación del estudio de Framingham: estudio de casos y controles.

BACKGROUND AND OBJECTIVE: During the last decade, recommendations for coronary heart disease prevention have emphasized the need of an assessment of coronary risk. The objective of this study was to assess the usefulness of the Framingham risk function for the estimation of coronary risk in our population, assessing the accuracy of the coronary risk as a diagnostic test (assuming that a coronary risk >20% is a positive diagnosis test of coronary disease). PATIENTS AND METHOD: Prospective case-control study, carried out in a public tertiary hospital. RESULTS: 138 cases were identified and matched, according to age and sex, with 223 controls. The level of risk > or =20% was the one which better classified the patients (70% of patients correctly classified as cases and controls) with an area under the ROC curve of 73.5% (moderate accuracy). Patients with a coronary risk >20% had a six times higher probability of being a case than a control (OR=6.09; 95% CI, 3.30-11.22). CONCLUSIONS: The utilization of the Framingham function for the prediction of coronary disease is a useful method to identify high risk patients. It is recommended to use it in clinical practice until we have our own model derived from populations with a baseline risk similar to ours allowing to predict the risk with higher accuracy.

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.

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.

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.

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.

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.

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.

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 patient's preoperative risk profile and, in low-risk patients, was equivalent to that in the general reference population.

Outcomes in off-pump vs. on-pump coronary artery bypass grafting stratified by pre-operative risk profile: an assessment using propensity score.

AIMS: To assess the benefit of off-pump coronary surgery stratified by the pre-operative risk profile. METHODS AND RESULTS: Prospective and multicentric cohort study. All consecutive patients undergoing a first coronary bypass procedure between November 2001 and November 2003 were potentially eligible. Pre-operative EuroSCORE and in-hospital outcomes were prospectively collected using strictly standardized criteria. To ensure optimal adjustment, a propensity score was constructed using clinically relevant variables and incorporating individual centres. Of 1602 patients who underwent a first coronary bypass, EuroSCORE could be calculated in 1585: 787 were of moderate/high pre-operative risk profile (EuroSCORE > 3), of which 347 underwent off-pump procedures, and 798 were of low pre-operative risk profile (EuroSCORE < or = 3), of which 349 underwent off-pump procedures. After risk adjusting for propensity score, off-pump patients had less major events (post-operative death, myocardial infarction, and need for reoperation). This benefit was higher in the low-risk stratum (OR ranged between 0.27 and 0.4; P = 0.02-0.07) than in the high-risk stratum (OR between 0.4 and 0.7; P, not significant). CONCLUSION: In real-life conditions, off-pump coronary surgery may be more effective than on-pump surgery. In contrast with previous reports, our results suggest that this benefit may be higher in patients with low pre-operative risk.

Prophylactic treatment after myocardial infarction in primary care: how far can we go?

BACKGROUND: Despite best practice, it may not be achievable in some patients to reach the optimal goals of secondary prevention recommendations for various reasons, such as co-morbidity, contraindications for some drugs or side effects. OBJECTIVE: Our aim was to estimate the achievable standards for audit purposes in primary care for prophylactic treatment of secondary prevention of myocardial infarction. METHODS: We conducted a survey of consecutive patients with a hospital diagnosis of first acute myocardial infarction during 1997 who were identified from discharge books from four hospitals and interviewed at their primary health centre 2 years after admission. The achievable standard for a prophylactic drug was then defined as the proportion of patients that could benefit from the treatment excluding those that for one justified reason or another were off medication. RESULTS: Three hundred and sixty-nine patients were interviewed in the follow-up. Aspirin or another antiplatelet regimen was prescribed in 86.9 patients, beta-blockers in 50.2%, angiotensin-converting enzyme (ACE) inhibitors in 32.5% and lipid-lowering drugs in 52%. The estimated achievable standards for those prescribed drugs were 94.5, 71,8, 50.5 and 69.8%, respectively. CONCLUSIONS: There is an underuse of prophylactic drug therapies after myocardial infarction. The standards established in this study for secondary preventive drug treatment might be achieved through a reasonable effort by GPs working in primary care committed to improving the quality of care.