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.

Pronóstico y manejo de los pacientes con síndrome coronario agudo y enfermedad polivascular / Prognosis and management of patients with acute coronary syndrome and polyvascular disease

Introducción y objetivos. Valorar el pronóstico y los patrones de manejo de pacientes con síndrome coronario agudo y arteriopatía periférica, enfermedad cerebrovascular o ambos (enfermedad polivascular) en condiciones de práctica clínica real. Métodos. Se utilizaron los datos del registro MASCARA de síndrome coronario agudo entre 2004 y 2005. Se estratificó a los pacientes según presentaran arteriopatía periférica, enfermedad cerebrovascular, ambas o ninguna. Se analizaron el manejo intrahospitalario, el tratamiento al alta y los resultados clínicos a 6 meses. Resultados. De 6.745 pacientes, 597 (8,85%) tenían arteriopatía periférica; 392 (5,8%), enfermedad cerebrovascular; 131 (1,94%), ambas y 5.625 (83,4%), ninguna. Los pacientes con enfermedad polivascular tenían enfermedad coronaria más extensa, pero recibieron menos tratamientos habitualmente recomendados (por ejemplo, recibieron aspirina al alta el 75% de los pacientes con arteriopatía periférica y el 84% de los libres de ella). La mortalidad hospitalaria y a 6 meses fue más alta en pacientes con arteriopatía periférica (el 9,1 y el 24,5%, respectivamente), enfermedad cerebrovascular (el 9,2 y el 22,4%) y especialmente con ambas (el 16 y el 29,8%) que en los libres de estas afecciones (el 4,8 y el 10,8%) (p < 0,001). Tanto la arteriopatía periférica y la enfermedad cerebrovascular como su combinación se asociaron independientemente a la mortalidad intrahospitalaria y a los 6 meses: odds ratio (intervalo de confianza del 95%) a 6 meses, 1,45 (1,1-2,02) en enfermedad cerebrovascular, 1,88 (1,45-2,4) en arteriopatía periférica y 1,88 (1,17-3) en la combinación de ambas. Conclusiones. Los pacientes con síndrome coronario agudo y arteriopatía concomitante tienen enfermedad coronaria más extensa y peores resultados clínicos intrahospitalarios y a los 6 meses, pero habitualmente reciben menos tratamientos regularmente recomendados (AU)

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 (ie, 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 (ie, 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 (AU)

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.

Estudio MASCARA (Manejo del Síndrome Coronario Agudo. Registro Actualizado). Resultados globales / MASCARA (Manejo del Síndrome Coronario Agudo. Registro Actualizado) Study. General Findings

Introducción y objetivos. Determinar el perfil clínico,el manejo del síndrome coronario agudo (SCA) y el efectode la estrategia intervencionista precoz (EIP) en elSCA sin elevación del ST (SCASEST) y del intervencionismocoronario percutáneo (ICP) primario en el SCA conelevación del ST (SCACEST).Métodos. Inclusión prospectiva en 50 hospitales seleccionados aleatoriamente según nivel asistencial, durante 9 meses entre 2004 y 2005, y seguimiento a 6 meses de la mortalidad o el reingreso por SCA. Se analizó el efecto ajustado de las estrategias de reperfusión.Resultados. Tras control de calidad, se analizaron losdatos de 32 hospitales, correspondientes a 7.923 acontecimientos coronarios (4.431 SCASEST [56%], 3.034SCACEST [38%] y 458 SCA inclasificable [6%]) de 7.251pacientes. Respecto a registros anteriores, destaca un incremento del ICP primario en el SCACEST (del 10,7 al36,8% de los reperfundidos) y la EIP en el SCASEST (del11,1 al 19,6%). La mortalidad hospitalaria total fue del5,7% (intervalo de confianza [IC] del 95%, 5,1%-6,2%);del SCACEST, el 7,6% (IC del 95%, 6,7%-8,7%); delSCASEST, el 3,9% (IC del 95%, 3,3%-4,6%), y del indeterminado, el 8,8% (IC del 95%, 6,2%-12,2%). No se observó, en el total de la población, relación con el pronóstico (mortalidad a 6 meses) de la EIP en el SCASEST (hazard ratio [HR] = 0,94; IC del 95%, 0,66-1,3) ni del ICP primario en el SCACEST (HR = 1; IC del 95%, 0,7-1,5). Se observaron resultados similares con la variable muerte o reingreso por SCA a 6 meses.Conclusiones. En 2004-2005 se registró en Españaun aumento de estrategias invasivas. Se observó una insuficiente adecuación de éstas al riesgo basal de los pacientes

Introduction and objectives. To investigate theclinical characteristics and treatment of acute coronarysyndromes (ACS), and to determine the effects of anearly invasive strategy (EIS) in non-ST-elevation ACS(NSTEACS) and of primary percutaneous coronaryintervention (PCI) in ST-elevation ACS (STEACS).Methods. Data were collected prospectively for 9months during 2004-2005 from 50 hospitals, which wererandomly 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 analysisincluded data from 32 hospitals, which covered 7923coronary events (4431 [56%] STEACS, 3034 [38%]NSTEACS and 458 [6%] unclassified ACS) in 7251patients. Compared with previous studies, the use ofprimary PCI in STEACS had increased markedly (from10.7% to 36.8% of patients undergoing reperfusion), ashad the use of EIS in NSTEACS (from 11.1% to 19.6%).Overall in-hospital mortality was 5.7% (95% confidenceinterval [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 noassociation 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 inSTEACS (HR=1; 95% CI, 0.7-1.5). Findings for mortalityand rehospitalization for ACS at 6 months were similar.Conclusions. Data for 2004-2005 demonstrated amarked increase in the use of invasive procedures.However, the procedures employed were poorly matchedto the patients’ baseline risk