[Reduction in 28 days and 6 months of acute myocardial infarction mortality from 1995 to 2005. Data from PRIAMHO I, II and MASCARA registries]. / Reducción de la mortalidad precoz y a 6 meses en pacientes con IAM en el periodo 1995-2005. Datos de los registros PRIAMHO I, II y MASCARA.

INTRODUCTION AND OBJECTIVES: To determine whether mortality from acute myocardial infarction has reduced in Spain and the possibly related therapeutic factors. METHODS: Nine thousand, nine hundred and forty-nine patients with ST-segment elevation myocardial infarction admitted to the Coronary Care Unit were identified from PRIAMHO I, II and MASCARA registries performed in 1995, 2000 and 2005, with a 6 month follow-up. RESULTS: From 1995 to 2005 patients were increasingly more likely to have hypertension, hyperlipidemia and anterior infarction, but age of onset and the proportion of females did not increase. Twenty-eight-day mortality rates were 12.6%, 12.3% and 6% in 1995, 2000 and 2005 respectively, and 15.3%, 14.6% and 9.4% at 6 months (both P-trend <.001). Multivariate analysis was performed and the adjusted odds ratio for 28-day mortality for an infarction occuring in 2005 (compared with 1995) was 0.62 (95% confidence interval: 0.44-0.88) whereas the adjusted hazard ratio for mortality at 6 months was 0.40 (95% confidence interval: 0.24-0.67). Other variables independently associated with lower mortality at 28 days were: reperfusion therapy, and the use of anti-thrombotic treatment, beta-blockers and angiotensin-converting enzyme inhibitors. The 28-day-6-month period had an independent protective effect on the following therapies: coronary reperfusion, and prescription of antiplatelet agents, beta-blockers and lipid lowering drugs upon discharge. CONCLUSIONS: Twenty-eight-day and six-month mortality rates fell among patients with ST-elevation myocardial infarction in Spain from 1995 to 2005. The possibly related therapeutic factors were the following: more frequent reperfusion therapy and increased use of anti-thrombotic drugs, beta-blockers, angiotensin-converting enzyme inhibitors and lipid lowering drugs.

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.

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.

MASCARA (Manejo del Síndrome Coronario Agudo. Registro Actualizado) study. General findings.

INTRODUCTION AND OBJECTIVES: To investigate the clinical characteristics and treatment of acute coronary syndromes (ACS), and to determine the effects of an early invasive strategy (EIS) in non-ST-elevation ACS (NSTEACS) and of primary percutaneous coronary intervention (PCI) in ST-elevation ACS (STEACS). METHODS: Data were collected prospectively for 9 months during 2004-2005 from 50 hospitals, which were randomly selected according to the level of care provided. In addition, follow-up data on mortality and readmission for ACS were collected for 6 months. The adjusted effects of different reperfusion strategies were analyzed. RESULTS: After checking data quality, the analysis included data from 32 hospitals, which covered 7923 coronary events (4431 [56%] STEACS, 3034 [38%] NSTEACS and 458 [6%] unclassified ACS) in 7251 patients. Compared with previous studies, the use of primary PCI in STEACS had increased markedly (from 10.7% to 36.8% of patients undergoing reperfusion), as had the use of EIS in NSTEACS (from 11.1% to 19.6%). Overall in-hospital mortality was 5.7% (95% confidence interval [CI], 5.1%-6.2%); for STEACS it was 7.6% (95% CI, 6.7%-8.7%), for NSTEACS 3.9% (95% CI, 3.3%-4.6%), and for unclassified ACS 8.8% (95% CI, 6.2%-12.2%). In the population as a whole, there was no association between prognosis (i.e., 6-month mortality) and EIS in NSTEACS (hazard ratio [HR]=0.94; 95% CI, 0.66-1.3) or between prognosis and primary PCI in STEACS (HR=1; 95% CI, 0.7-1.5). Findings for mortality and rehospitalization for ACS at 6 months were similar. CONCLUSIONS: Data for 2004-2005 demonstrated a marked increase in the use of invasive procedures. However, the procedures employed were poorly matched to the patients' baseline risk.

Gender differences in management and outcome of patients with acute myocardial infarction.

BACKGROUND: The study objectives were to assess any gender differences in the application of diagnostic and therapeutic procedures and their impact on outcome in patients with acute myocardial infarction (AMI). METHODS: Prospective cohort study of patients in the PRIAMHO II registry. 58 randomly selected public hospitals in Spain included 6209 patients with AMI admitted to Coronary/Critical Care Unit from May 15 to December 15 2000 with 1-year follow-up. Data were gathered on use of coronary angiography and reperfusion procedures, on a combined outcome variable (including death, reinfarction, postinfarction angina, and stroke during hospital stay), and on 28-day and 1-year mortality rates. RESULTS: 4641 (74.75%) of the patients were male and 1568 (25.5%) female. No gender differences in coronary angiography or reperfusion therapy use were found. However, female sex alongside age, use of reperfusion therapy, diabetes mellitus, previous revascularization, previous AMI, and higher Killip class were predictors of the combined outcome variable, with an adjusted OR of 1.21 (CI 95% 1.02-1.42). CONCLUSIONS: No association was observed between the gender of patients with AMI and the application of diagnostic or therapeutic procedures. Nevertheless, female sex behaved as an independent adverse short-term prognostic factor.

[Effect of combined beta-blocker and angiotensin-converting enzyme inhibitor treatment on 1-year survival after acute myocardial infarction: findings of the PRIAMHO-II registry]. / Efecto de la asociación de bloqueadores beta e inhibidores de la enzima de conversión en la supervivencia al año tras un infarto agudo de miocardio. Resultados del registro PRIAMHO II.

INTRODUCTION AND OBJECTIVES: Clinical trials have shown that combining beta-blockers and angiotensin-converting enzyme (ACE) inhibitors has an additive effect in reducing mortality in patients with left ventricular dysfunction following acute myocardial infarction. Whether this additive effect also occurs in unselected post-myocardial infarction patients is unknown. METHODS: In total, 5397 patients who were discharged from hospital after suffering an acute myocardial infarction were followed for 1 year. The primary endpoint was all-cause mortality. The effects of the medications on 1-year survival were analyzed using a Cox regression model, which included propensity scores for beta-blocker and ACE inhibitor use to take account of any potential imbalance in drug prescription rates. RESULTS: At hospital discharge, 55.9% of patients were receiving beta-blockers and 45.1%, ACE inhibitors. The 1-year mortality rate was 5.5%. Overall, combination of the two medications significantly reduced the 1-year mortality rate (hazard ratio [HR]=0.51; 95% confidence interval [IC], 0.32-0.82); P<.005) to a greater extent than ACE inhibitors alone (HR=0.78; 95% CI, 0.54-1.12; P=.2) or beta-blockers alone (HR=0.67; 95% CI, 0.43-1.05; P=.08). The same trend was also observed in low-risk patients without acute heart failure who had an ejection fraction > or =40%. CONCLUSIONS: In unselected post-myocardial infarction patients, combined prescription of beta-blockers and ACE inhibitors had an additive effect on the 1-year survival rate.

[Management of myocardial infarction in Spain in the year 2000. The PRIAMHO II study]. / Tratamiento del infarto agudo miocardio en España en el año 2000. El estudio PRIAMHO II.

INTRODUCTION AND OBJECTIVES: Hospital registries are useful tools to measure the degree of implementation of new treatments and clinical practice guidelines. PATIENTS AND METHOD: The hospital registry described here was developed in the prospective PRIAMHO II study, which involved a random selection of Spanish hospitals with a coronary intensive care unit and external quality control. This study investigated patients admitted to the coronary care unit with acute myocardial infarction. Demographic and clinical characteristics were recorded, as well as the management, clinical course and survival after 28 days and one year. RESULTS: From May 15 to December 15 2000 we included in the registry 6,221 patients from the 58 hospitals that complied with the quality control requirements (71.6% of all participating hospitals). Acute mortality was 9.6%; 28-day and one-year mortality were 11.4% and 16.5%, respectively. Of the patients with ST elevation-myocardial infarction of less than 12 hours' duration, 71.6% were reperfused and 89.3% received fibrinolysis with a median door-to-needle time of 48 minutes. Ejection fraction was measured in 81% of the patients, and 43% were tested for inducible ischemia. About nine-tenths (91%) of the patients were discharged on least one antiplatelet drug, 56% on a beta blocker, 45% on an ACE inhibitor, and 45% on a lipid-lowering agent, with a coefficient of variation between hospitals greater than 25% for the last three drugs. CONCLUSIONS: The percentage of patients with ST elevation treated with reperfusion should increase, as it probably will thanks to the increasing use of primary angioplasty. The door-to-needle time was longer than the recommended interval. In-hospital risk stratification was good but nonsystematic for the evaluation of ejection fraction, and unsatisfactory for inducible ischemia testing. At discharge the percentages of patients receiving beta blockers, ACE inhibitors and statins were not optimal, and there were wide variations in prescribing practices between hospitals.