Summary
Background
Multicentre registries of myocardial infarction management show a steady improvement in prognosis and greater access to myocardial revascularization in a more timely manner. While French registries are the standard references, the question arises: are data stemming solely from the activity of French cardiac intensive care units (ICUs) a true reflection of the entire French population with ST-segment elevation myocardial infarction (STEMI)?
Aim
To compare data on patients hospitalized for STEMI from two French registries: the French registry of acute ST-elevation or non-ST-elevation myocardial infarction (FAST-MI) and the Échantillon généraliste des bénéficiaires (EGB) database.
Methods
We compared patients treated for STEMI listed in the FAST-MI 2010 registry ( n = 1716) with those listed in the EGB database, which comprises a sample of 1/97th of the French population, also from 2010 ( n = 403).
Results
Compared with the FAST-MI 2010 registry, the EGB database population were older (67.2 ± 15.3 vs 63.3 ± 14.5 years; P < 0.001), had a higher percentage of women (36.0% vs 24.7%; P < 0.001), were less likely to undergo emergency coronary angiography (75.2% vs 96.3%; P < 0.001) and were less often treated in university hospitals (27.1% vs 37.0%; P = 0.001). There were no significant differences between the two registries in terms of cardiovascular risk factors, comorbidities and drug treatment at admission. Thirty-day mortality was higher in the EGB database (10.2% vs 4.4%; P < 0.001).
Conclusions
Registries such as FAST-MI are indispensable, not only for assessing epidemiological changes over time, but also for evaluating the prognostic effect of modern STEMI management. Meanwhile, exploitation of data from general databases, such as EGB, provides additional relevant information, as they include a broader population not routinely admitted to cardiac ICUs.
Résumé
Contexte
Les registres multicentriques de prise en charge de l’infarctus du myocarde (MI) mettent en évidence une constante amélioration du pronostic ainsi qu’un plus large accès à la revascularisation myocardique dans des délais plus courts. Les registres français (USIK, FAST-MI) font référence, mais les données uniquement issues de l’activité des USIC français sont-elles le reflet de l’ensemble de la population française souffrant d’un syndrome coronarien aigü avec élévation du segment ST (STEMI) ?
Objectif
Comparaison du registre « French registry of acute ST-elevation or non-ST-elevation myocardial infarction 2010 » (FAST-MI 2010) à ceux repertoriés dans l’Échantillon généraliste des bénéficiaires (EGB).
Méthodes
Nous comparons, dans ce travail, les patients pris en charge pour STEMI répertoriés dans le registre « French registry of acute ST-elevation or non-ST-elevation myocardial infarction 2010 » (FAST-MI 2010) ( n = 1716) à ceux répertoriés dans l’Échantillon généraliste des bénéficiaires (EGB), échantillon de 1/97 e de la population française sur la même période ( n = 403).
Résultats
La population EGB comparée au registre FAST-MI 2010 est plus âgée (67,2 ± 15,3 vs 63,3 ± 14,5 ans ; p < 0,001), plus féminine (36,0 % vs 24,7 % ; p < 0,001) et bénéficie de moins d’angiographies coronaires en urgence (75,2 % vs 96,3 % ; p < 0,001). Elle est également moins souvent hospitalisée dans les centres hospitaliers universitaires (27,1 % vs 37,0 % ; p = 0,001). Aucune différence significative n’est observée dans les deux registres en termes de facteurs de risques cardiovasculaires, de comorbidités (exceptés diabète [ p = 0,008] et insuffisance rénale chronique [ p < 0,001] plus présents dans l’EGB) et de traitement médicamenteux à l’admission. Enfin, la mortalité à 30 jours est plus importante dans l’EGB (10,2 % vs 4,4 % ; p < 0,001).
Conclusions
Les registres comme FAST-MI sont indispensables pour apprécier au fil du temps les changements épidémiologiques, mais aussi l’impact pronostic de la prise en charge moderne du STEMI. L’exploitation de datas issues d’une base de données généralistes apporte un complément d’information pertinent puisqu’incluant une population plus large non systématiquement admise en USIC.
Background
Over the past 20 years, acute coronary syndrome with ST-segment elevation (ST-segment elevation myocardial infarction [STEMI]) has seen a remarkable transformation in its prognosis. A net decrease in the mortality of patients with STEMI has been observed in French registries conducted every 5 years, namely USIK in 1995 and USIC in 2000 , followed by the French registry of acute ST-elevation or non-ST-elevation myocardial infarction (FAST-MI) in 2005 and 2010 . Accordingly, the 30-day mortality has decreased drastically from 13.7% in 1995 to 4.4% in 2010 .
Such a reduction in mortality is correlated with better management of STEMI not only as a result of greater access to coronary angioplasty, drug optimization and enhancements in both technology and angioplasty equipment, but also as a result of patient population characteristics (younger, more likely to be women) . These results are extremely encouraging for the acute management of STEMI. However, clinical studies, as well as other American and European registries, report more subtle results . This difference is possibly explained by the fact that the patients enrolled in FAST-MI are those hospitalized exclusively in cardiac intensive care units (CICUs). It would thus appear both useful and important to compare these selected data with a population obtained from the Échantillon généraliste des bénéficiaires (EGB; general sample of beneficiaries). Indeed, this database, the validity of which we have shown previously in the field of heart failure, allows for a more tailored approach to daily clinical practice (indexing of all managed STEMI patients even if not hospitalized in CICUs).
The objective of this study was to compare data on patients hospitalized for STEMI obtained from these two French registries (FAST-MI and EGB).
Methods
FAST-MI 2010 registry
The FAST-MI 2010 registry encompassed 213/279 (76.3%) CICUs distributed in 149 public hospitals (including 38 university hospital centres [17.8%]), 62 private centres and two military centres.
Inclusion criteria for the FAST-MI 2010 registry were as follows: patients aged ≥ 18 years who agreed to participate in the study and were admitted to the CICU for acute coronary syndrome within 48 hours after the onset of symptoms over a period of 1 month (October 2010). Exclusion criteria were: any symptoms lasting > 48 hours after the first call; and iatrogenic infarctions.
EGB database
Data were extracted from the EGB database, which comprises a representative 1/97th random sample of the population covered by the French national health insurance system (approximately 80% of the French population) . The EGB database currently includes more than 600,000 beneficiaries, and has been used widely for public health and pharmacoepidemiological purposes for more than 5 years .
Since 2005, the EGB database has included basic demographic data and has prospectively collected all claims for visits to physicians and exhaustive claims for all reimbursed drugs dispensed in retail pharmacies (including dates of prescription and dispensing, and quantities delivered). Medications are identified by their Anatomical therapeutic chemical class codes, which are included in the EGB database. The EGB database also contains data collected by the Programme de médicalisation des systèmes d’information (PMSI; programme for medicalization of information systems) in healthcare institutions (medical and surgical departments); thus, during the patient’s stay, principal diagnoses and associated diagnoses are available, coded according to the International classification of diseases 10th edition (ICD-10). Associated diagnoses represent a proxy for comorbidity assessment and identification of triggering factors. All medical procedures performed during each stay are identified with their specific codes from the Common classification of medical procedures. The EGB database also includes registration of the date of death, recorded automatically from the Institut national de la statistique et des études économiques (INSEE; National institute for statistics and economic studies), independent of the use or not of health care resources.
Only hospitalized patients with an ICD-10 code of STEMI are included (codes I21.0× to I21.9×, except for code I21.4, which is defined as subendocardial infarction).
Patient inclusion in the present study
Only those patients treated for STEMI stemming from the initial publication of FAST-MI 2010 were included in the present study. Patients included from the EGB database were hospitalized patients, with a discharge date during the year 2010 and at least one ICD-10 code of STEMI as principal diagnosis.
Patients with a non-STEMI in the EGB database or the FAST-MI 2010 registry, as well as those who died before hospital admission, were not included. Information regarding death was directly accessible, whether indicated in the INSEE or via the PMSI and recorded by the French public administration. Treatment data included drugs dispensed in pharmacies, within 60 days after hospitalization for STEMI, that had been the subject of a reimbursement claim.
Statistical analysis
All analyses were performed using Stata software, version 12 (StataCorp, College Station, TX, USA). All analyses were done for a two-sided type I error of α = 5%. Population data are described as frequencies and associated percentages for categorical variables and as means ± standard deviations for quantitative variables (age). Quantitative data were compared between groups (EGB 2010 and FAST-MI 2010) using Student’s t -test, according to their assumptions (normality studied by the Shapiro-Wilk test and homoscedasticity by the Fisher-Snedecor test). Comparisons concerning categorical data were performed using the χ 2 test or, when appropriate, Fisher’s exact test. Then, a univariate analysis of 30-day mortality was performed using logistic regression, followed by a multivariable logistic regression model to determine predictive factors of 30-day mortality, by backward and forward stepwise selection of factors considered significant in the univariate analysis and according to clinical relevance variables . Results are presented as odds ratios (ORs; for univariate analysis) and adjusted ORs (for multivariable analysis) with associated 95% confidence intervals (CIs).
Results
Baseline characteristics
During the year 2010, 403 patients with a diagnosis of STEMI were listed in the EGB database. In the FAST-MI 2010 registry, 56% of patients ( n = 1716/3079) were included with the same diagnosis. Patients in the EGB database were older (67.2 ± 15.3 vs 63.3 ± 14.5 years; P < 0.001), were more often women (36.0% vs 24.7%; P < 0.001) and were less frequently treated in university hospital centres (27.1% vs 37.0%; P = 0.001) ( Table 1 ).
| EGB 2010 ( n = 403) | FAST-MI 2010 ( n = 1716) | P | |
|---|---|---|---|
| Age (years) | 67.2 ± 15.3 | 63.3 ± 14.5 | < 0.001 |
| < 60 years | 133 (33.0) | 742 (43.3) | |
| 60–74 years | 111 (27.5) | 537 (31.3) | |
| ≥ 75 years | 146 (39.5) | 437 (25.4) | |
| Women | 145 (36.0) | 423 (24.7) | < 0.001 |
| Centre | |||
| University medical centre | 105 (27.1) | 634 (37.0) | 0.001 |
| Community/military | 201 (51.8) | 755 (44.0) | |
| Private, for profit | 82 (21.1) | 327 (19.0) | |
| Cardiovascular risk factors | |||
| Hypertension | 193 (47.9) | 806 (47.0) | 0.74 |
| Dyslipidaemia | 167 (41.4) | 675 (39.3) | 0.44 |
| Diabetes mellitus | 89 (22.1) | 283 (16.5) | 0.008 |
| Tobacco use | 102 (25.3) | 701 (40.9) | < 0.001 |
| Obesity (BMI > 30 kg/m 2 ) | 53 (13.2) | 324 (20.1) | 0.007 |
| Coronary heredity | 23 (5.7) | 450 (25.0) | < 0.001 |
| Cardiovascular history | |||
| Myocardial infarction | 55 (13.6) | 187 (10.9) | 0.12 |
| Stroke/TIA | 18 (4.5) | 68 (4.0) | 0.64 |
| Heart failure | 12 (3.0) | 41 (2.4) | 0.50 |
| PAD/peripheral vasculopathies | 38 (9.4) | 83 (4.8) | < 0.001 |
| CABG | 10 (2.5) | 95 (5.6) | 0.01 |
| Stenting/dilatation (PCI) | 63 (15.6) | 175 (10.2) | 0.002 |
| Comorbidities | |||
| Atrial fibrillation | 50 (12.4) | 100 (5.6) | < 0.001 |
| Chronic respiratory failure | 23 (5.7) | 85 (5.0) | 0.54 |
| Chronic renal failure | 26 (6.4) | 42 (2.1) | < 0.001 |
| Neoplasia | 43 (10.7) | 147 (8.6) | 0.18 |
| Complications | |||
| Cardiogenic shock | 26 (6.5) | 87 (4.9) | 0.19 |
| Complete AV block | 31 (7.7) | 46 (2.6) | < 0.001 |
| Ventricular fibrillation/CPA | 8 (2.0) | 49 (2.8) | 0.37 |
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