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European Heart Journal Advance Access published online on April 5, 2007
European Heart Journal, doi:10.1093/eurheartj/ehm031
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© The European Society of Cardiology 2007. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

STEMI and NSTEMI: are they so different? 1 year outcomes in acute myocardial infarction as defined by the ESC/ACC definition (the OPERA registry){dagger}

Gilles Montalescot1,*, Jean Dallongeville2, Eric Van Belle3, Stephanie Rouanet4, Cathrine Baulac5, Alexia Degrandsart5 and Eric Vicaut for the OPERA Investigators6

1 Institut de Cardiologie and INSERM U856, Pitié-Salpétrière University Hospital, AP-HP, 47 Boulevard de l'Hôpital, Paris 75013, France
2 Institut Pasteur and INSERM U508, Lille, France
3 University Hospital and INSERM ERI9, Lille, France
4 THERAPHARM Recherches, Boulogne-Billancourt, France
5 Pfizer, Paris, France
6 Clinical Research Unit, Fernand Vidal Hospital, Paris, France

Received 3 October 2006; revised 15 February 2007; accepted 23 February 2007.

* Corresponding author. Tel: +33 1 42 16 30 06; fax: +33 1 42 16 29 31; E-mail address: gilles.montalescot{at}psl.aphp.fr


   Abstract
Top
 Abstract
Introduction
 Methods
 Results
 Discussion
 Conclusions
 Acknowledgements
 References
 
Aims: The ESC/ACC redefined myocardial infarction as any amount of necrosis caused by ischaemia. The aim of this study was to describe the management and outcomes using ‘real-world’ data taking the new definition of acute myocardial infarction into account.

Methods and results: A total of 2151 consecutive patients (76.0% men) with a myocardial infarction were enrolled at 56 centres in France. The median delay to presentation was shorter in patients with ST-segment elevation myocardial infarction (STEMI) vs. non-STEMI (NSTEMI) (4 vs. 7 h, P < 0.0001). STEMI patients were more likely to receive fibrinolysis (28.9 vs. 0.7%, P < 0.0001) or undergo PCI (71.0 vs. 51.6%, P < 0.0001) but less likely to have bypass surgery (3.1 vs. 4.9%, P < 0.05). At discharge, patients with STEMI received more aggressive secondary prevention therapies than those with NSTEMI, which was not supported by differences in disease severity. A total of 1878 patients were followed-up for 1 year: 36.7% of STEMI and 41.5% of NSTEMI patients were rehospitalized (P = 0.05); 16% in both groups were revascularized. In-hospital mortality was similar (4.6 vs. 4.3%), and 1-year mortality was 9.0% in STEMI patients and 11.6% in NSTEMI patients (Log-Rank P = 0.09). Independent correlates of in-hospital mortality were untreated dyslipidaemia, advanced age, diabetes, and low blood pressure. The strongest predictors of 1-year mortality were heart failure and age. Similar predictors were found in STEMI and NSTEMI subgroups.

Conclusions: Despite different management, patients with STEMI and NSTEMI have similar prognoses and independent correlates of outcome. These findings support the new definition of myocardial infarction.

Key Words: Myocardial infarction • Death • Predictors


   Introduction
Top
 Abstract
 Introduction
Methods
 Results
 Discussion
 Conclusions
 Acknowledgements
 References
 
Despite advances in our understanding of the pathophysiology of coronary disease and improvements in its management and prevention, acute coronary syndromes remain a major cause of mortality and morbidity in industrialized countries1–5 and are becoming an increasingly important problem in developing countries.6

In 2000, The Joint European Society of Cardiology/American College of Cardiology (ESC/ACC) Committee for the redefinition of myocardial infarction7 suggested that any amount of necrosis resulting from ischaemia should be diagnosed as a myocardial infarction. As a consequence of this new definition, patients who would previously have been considered to have unstable angina are being diagnosed with a myocardial infarction.8 Since then, higher levels of troponin have also been associated with more severe prognosis.8–14

Recent guidelines for the management of patients with myocardial infarction15–18 have been published in response to improvements in clinical outcomes reported in major randomized clinical trials of new pharmacological or interventional treatments. Few studies have, however, reported on how these guidelines are being implemented in clinical practice, both in hospital and over the longer term, from a ‘real-world’ perspective. Most observational studies are limited to a follow-up of 6 months following discharge from hospital. In addition, the most recent registry data on acute myocardial infarction have enrolled patients with ST-segment elevation myocardial infarction (STEMI), whereas data from patients with non-STEMI (NSTEMI) are analysed separately with unstable angina patients.19

The primary objective of the nationwide OPERA (Observatoire sur la Prise en charge hospitalière, l'Evolution à un an et les caRactéristiques de patients présentant un infArctus du myocarde avec ou sans onde Q) study was to describe the in-hospital management and cardiovascular outcomes at 1 year of patients with a myocardial infarction, using the new definition. The secondary objectives were to describe the management of patients in the year following the index admission, including smoking status and level of physical activity in patients with STEMI and NSTEMI. The aim of the present study was to describe patients' in-hospital and long-term management and their clinical outcomes and to identify independent predictors of death.


   Methods
Top
 Abstract
 Introduction
 Methods
Results
 Discussion
 Conclusions
 Acknowledgements
 References
 
The OPERA registry was a nationwide, prospective, longitudinal cohort study. Approximately 100 centres, representative of different types of hospitals (e.g. public or private, academic or non-academic, with or without catheterization facilities, low or high volume) located throughout France, volunteered to participate. Physicians were to include consecutive patients who fulfilled the inclusion criteria with a suspected myocardial infarction according to the new definition over the enrolment period.

To be eligible for inclusion, patients had to be aged 18 years or older, hospitalized for a myocardial infarction [defined as a rise in cardiac enzyme concentrations (troponin I and/or T, and/or creatine phosphokinase-MB) according to the local hospital's standard in the first 24 h], and to have the diagnosis of myocardial infarction confirmed at discharge from hospital. Patients who had been previously enrolled in the OPERA study were not eligible for re-enrolment.

The study protocol was reviewed by the Institutional Review Board (CCPPRB) of Hôpital La Pitié-Salpêtrière on 27 March 2002, using the French centralized nationwide Institutional Review Board approval procedure, and was performed in accordance with French law and the Declaration of Helsinki. All patients provided informed consent before participating in the study.

Treatment and follow-up methods were left to the discretion of the treating physician during the follow-up period. Investigating physicians completed standardized case report forms to collect information about patients' demographics, family or personal history of cardiovascular disease, cardiovascular risk factors, presenting characteristics, cardiovascular treatments during hospitalization and post-discharge, and in-hospital and post-discharge clinical outcomes. Completed case report forms were sent to the coordinating centre and measures were carried out to check the validity and consistency of the data.

Statistical analyses
Analyses were conducted using SAS (version 9.13, SAS Institute, Cary, NC, USA) and S+ software. Data are summarized as frequencies and percentages for categorical data and were tested using the {chi}2 test or, if not applicable, Fisher's exact test. Continuous variables are presented as means and standard deviations and were tested using Student's t-test or as medians and 25th and 75th percentiles, and were tested using the Mann–Whitney U test.

Univariable analyses were carried out using the {chi}2 test for qualitative variables and Student's t-test for quantitative variables. Variables with a P-value <0.10 in the univariable analysis were included in the stepwise multivariable model.

Multivariable stepwise logistic regression, adjusting for patients' demographics, cardiovascular risk factors, medical history, and presenting characteristics, was performed to identify independent predictors of all-cause death both in hospital and at 1 year (P-values for inclusion and removal from the model were 0.05 and 0.1, respectively). ACS type (STEMI vs. NSTEMI) was not included in the analysis. Instead, multivariable analysis was done in the overall population and in both ACS subgroups to compare predictors in these two different clinical situations. Several aspects were taken into account when building the multivariable logistic models. A multicollinearity diagnosis was made and collinear variables that are known to frequently induce estimation problems or unstable models were not taken into account. All models were evaluated for their predictive performance, using the area under the receiver operating characteristic (ROC) curve, calibration slope (well-calibrated models have a slope equal or close to 1), and Brier score [model scores range from 0 (perfect) to 0.25 (worthless)]. A well-known problem of predictive multivariable models is that their performance is frequently overestimated because they are evaluated on the sample used for their construction. Such a phenomenon, known as ‘optimism’, is important for appropriate choice and validation of the multivariable models. For validation, we used a 10-fold cross-validation and bootstrapping procedure (n = 1000 bootstrap samples) that allowed us to evaluate the optimism of the models' performances.20 All tests were two-sided and considered statistically significant at {alpha} < 0.05. Odds ratios are reported with 95% confidence intervals.


   Results
Top
 Abstract
 Introduction
 Methods
 Results
Discussion
 Conclusions
 Acknowledgements
 References
 
Study population
Fifty-six centres in France enrolled consecutive patients into the OPERA study between October 2002 and September 2003. The spectrum of clinic types was represented in this nationwide study: 24 (42.9%) general hospitals, 17 (30.4%) university hospitals, 2 (3.6%) regional hospitals, and 10 (17.9%) private clinics.

A total of 2176 patients were diagnosed with myocardial infarction according to the new definition.7 Of these, 2151 patients had the diagnosis of myocardial infarction confirmed at hospital discharge, and 2090 were enrolled in the study after they received appropriate information regarding the protocol (Figure 1).


Figure 1
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  		Figure 1 Patient flow chart.

 
Three-quarters of the population were men (76.0%), the mean body mass index was 26.7 ± 4.4 kg/m2 (Table 1), and the mean weight was 76.4 ± 14.8 kg. The mean age of the population was 64 ± 14 years, and women tended to be older than men (72 vs. 61 years, P < 0.0001; Table 1). In 61.3% of the population, the index event was the first cardiac manifestation, whereas the other patients had a history of myocardial infarction (14.2%), unstable (12.3%) or stable angina (14.8%), or atrial fibrillation (5.8%). A high proportion of patients had cardiovascular risk factors, including dyslipidaemia (49.7%), hypertension (47.1%), smoking (36.6%), and diabetes mellitus (15.6% type 2 and 3.3% type 1).


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  		Table 1 Patients' baseline characteristics

 
The majority of patients presented with STEMI (70.8%), whereas the remaining patients were diagnosed with NSTEMI (Table 1). Almost half (48.1%) of the patients were diagnosed with a new or old Q-wave myocardial infarction. One-fifth of the patients (19.8%) also presented with left-ventricular dysfunction (left-ventricular ejection fraction ≤40%).

The median time between symptom onset and arrival at hospital was 6 h and was shorter in patients with STEMI vs. those with NSTEMI (4 vs. 7 h, P < 0.0001). The mean length of hospitalization was 9.0 ± 7.7 days.

In-hospital treatments
The use of in-hospital treatments and interventions is shown in Table 2. At admission, aspirin was administered to 86.8% of patients and statins to 46.5%. Beta-blockers were given to 62.4% of patients and 28.7% received an ACE-inhibitor. Fibrinolytic drugs were administered almost exclusively to patients with STEMI (28.9 vs. 0.7% in NSTEMI). Over half of the patients (58.4%) were given thienopyridine. Overall, unfractionated heparin was used more frequently than low-molecular-weight heparin (50.9 vs. 44.9%), but low-molecular-weight heparin was used more frequently in patients with NSTEMI.


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  		Table 2 Pharmacological therapies at admission and at discharge, and invasive procedures during hospitalization

 
Two-thirds of patients underwent PCI during hospitalization, which was performed in 71.0% of patients with STEMI and in 51.6% of those with NSTEMI (P < 0.0001). Bypass surgery was more frequently performed in patients with NSTEMI (4.9 vs. 3.1%, P < 0.05) (Table 2).

At discharge from hospital, the rate of the use of ACE-inhibitors, aspirin, beta-blockers, statins, and thienopyridines increased relative to their use at admission in both STEMI and NSTEMI populations (Table 2).

Treatments at 12 months following discharge
Pharmacological medications being taken at 1 year follow-up are shown in Table 3. Compared with medication usage at discharge, the overall rate of the use of ACE-inhibitors, aspirin, beta-blockers, calcium inhibitors, nitrates, thienopyridines, and heparins fell over the 1 year follow-up period, whereas that of angiotensin II antagonists, statins, and vitamin-K antagonists increased.


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  		Table 3 Pharmacological medications being taken at 1 year after discharge (n = 1878)

 
When analysed according to the type of ACS, patients with STEMI were significantly more likely to be taking ACE-inhibitors, aspirin, beta-blockers, and statins than patients with NSTEMI. Conversely, patients with NSTEMI were more likely to be taking calcium inhibitors, diuretics, oral antidiabetic drugs, nitrates, and vitamin-K antagonists (Table 3).

In-hospital and post-discharge outcomes
Overall, 97 of 2151 (4.5%) patients with a confirmed diagnosis of myocardial infarction died in hospital (31 died before receiving information regarding the study protocol). Of the 2090 patients who were enrolled in the study, 66 (3.2%) died while in hospital. The in-hospital mortality rate did not differ between patients with STEMI or NSTEMI (Table 4). Sixty-nine patients (3.3%) had recurrent ischaemia or extension to a Q-wave myocardial infarction and 1.0% had a stroke (Table 4).


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  		Table 4 Clinical outcomes in hospital and at 1 year post-discharge

 
Follow-up data were available for 92.8% (1878 of 2024) of the patients who survived to hospital discharge (Table 4). The cumulative in-hospital (total population) and post-discharge (enrolled patients) death rate at 1 year was 11.6% in patients with NSTEMI vs. 9.0% in STEMI [P = 0.06 ({chi}2)] (Table 4). The long-term survival rate was similar between the two populations (Figure 2). The cumulative 1 year mortality rate was much higher in patients with a left-ventricular ejection fraction ≤40 vs. >40% (22.7 vs. 4.6%), with similar differences in patients with STEMI and NSTEMI (Table 4, P = 0.09, log-rank test). Following discharge from hospital, 36.7% of patients with STEMI and 41.5% with NSTEMI were rehospitalized, and approximately 16% of patients in either group had a new revascularization (PCI or CABG).


Figure 2
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  		Figure 2 One year Kaplan–Meier survival curves in the global population according to type of infarct at presentation (STEMI vs. NSTEMI).

 
Lifestyle modification at 1 year
Over the 1 year follow-up period, 61.5% of smokers stopped smoking, 8.3% exercised more frequently than before the index event, and 13.2% reported that they exercised less frequently. At 1 year, the patients' mean weight was 76.3 ± 14.4 kg. Overall, 13.1% of patients increased in weight by at least 5 kg, 43.3% lost weight, and 16.6% remained the same.

Multivariable analysis
After logistic regression analysis, independent predictors of in-hospital mortality were untreated dyslipidaemia, advancing age, diabetes, and low blood pressure on admission; treatment with a statin was associated with a lower risk (Figure 3). Area under the ROC curve, calibration slope, and Brier score were 90%, 1, and 0.025, respectively. Degrees of optimism were found very moderate (0.3% for area under the ROC curve, 0.048 for calibration slope, and 0.0007 for the Brier score), demonstrating the validity of the multivariable models.


Figure 3
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  		Figure 3 Independent predictors of in-hospital mortality. For continuous variables, the odds ratio was calculated for the interval of change indicated in brackets.

 
Independent correlates of 1 year mortality were history of heart failure, advancing age, untreated dyslipidaemia, diabetes, high heart rate on admission, and low blood pressure on admission, whereas treatment with a statin was associated with a lower risk (Table 5). The predictors of 1 year mortality in patients with STEMI were similar to the overall population (Table 5).


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  		Table 5 Independent predictors of 1 year post-discharge mortalitya

 
History of heart failure, advancing age, low blood pressure on admission, and high heart rate on admission were also significant predictors of 1 year mortality, with similar odd ratios, in the smaller group of patients with NSTEMI (Table 5). Among patients with STEMI or NSTEMI, the strongest predictors of 1 year mortality were heart failure and advanced age. All calculated parameters indicated good performance of the multivariable logistic models. Area under the ROC curve, calibration slope, and Brier score were, respectively, 85%, 1, and 0.06 for the total population, 86%, 1, and 0.06 for the STEMI group, and 84%, 1, and 0.08 for the NSTEMI group. With regard to the validation of the models, all variables selected were found to be stable in 10-fold cross-validation. The degree of optimism was very moderate for all models (<0.6% for area under the ROC curve, <0.04 for calibration slope, and <0.003 for Brier score), demonstrating the validity of the proposed multivariable models.


   Discussion
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
Conclusions
 Acknowledgements
 References
 
In contrast to recent observational studies,21–24 which usually separate STEMI and NSTEMI and are limited to in-hospital or 6 month outcomes, this registry provides insights into the characteristics and in-hospital management of patients with an acute myocardial infarction according to the new ESC/ACC definition and their clinical outcomes at 1 year. The results of our study demonstrate that patients with STEMI, who benefit most from reperfusion therapy (with either a fibrinolytic drug or primary PCI) soon after the onset of symptoms,15 still delay presentation to hospital by 4 h. Furthermore, there appears to be underutilization of evidence-based therapies for acute myocardial infarction. Alongside appropriate reperfusion therapy, evidence-based guidelines recommend prompt treatment with aspirin in patients without contraindications.15 The rates of the use of aspirin at admission in this contemporary study were lower (87 vs. 91%) than those reported in the Global Registry of Acute Coronary Events (GRACE),25 but had increased to 91% for STEMI and 86% for NSTEMI by the time of discharge. The efficacy of statins has been demonstrated in large randomized trials,26–31 and there is increasing emphasis on their use during the acute phase to reduce both the incidence of ischaemic events and the time-to-benefit and to improve patient compliance with long-term administration.32–35 In this study, less than half of the patients were given a statin at admission, whereas 80% were prescribed one at hospital discharge, and 83% were taking a statin at 1 year follow-up.

After multivariable regression analysis, the strongest predictor of in-hospital death was untreated dyslipidaemia. In addition, advanced age, diabetes, and low blood pressure on admission were independent predictors of in-hospital death. Similarly, the strongest independent predictor of 1 year mortality was history of heart failure, followed by advanced age, untreated dyslipidaemia, diabetes, increased heart rate, and low blood pressure on admission. Treatment with a statin was associated with a lower risk of in-hospital and 1 year death compared with patients with no dyslipidaemia; this trend was also observed for the subgroup of patients with STEMI. These findings lend further support to early and continuing treatment with a statin.

Overall in this study, one in 10 patients with an acute myocardial infarction died within 1 year of discharge from hospital. The question remains: are patients with STEMI very different from those with NSTEMI? Both conditions stem from the same pathophysiological process36–38 and the same treatments are prescribed to prevent plaque rupture. Although the presence of ST-elevation drives the decision to proceed to rapid reperfusion therapy, in this study, prescription at discharge of other cardiac medications also favoured patients with STEMI. The baseline characteristics of the two subgroups differed, with NSTEMI patients being older and at higher risk of recurrent ischaemic events. They were also at greater risk of death following discharge. However, the cumulative in-hospital to 1 year post-discharge mortality did not differ between the two groups. The annual rates of angioplasty and revascularization were also similar between STEMI and NSTEMI subgroups and the strongest predictors of death were the same. Taken together, these findings suggest that the common definition of myocardial infarction, combining STEMI with NSTEMI, as defined by the Joint ESC/ACC Committee, is appropriate.

Guidelines emphasize the importance of lifestyle advice for patients after a cardiac ischaemic event, which includes following a healthy diet, weight control, stopping smoking, and taking regular exercise.15 In this study, 62% of patients had stopped smoking in the year after hospitalization, whereas only 8% had increased their levels of physical activity. Of concern was that 13% of patients reported less physical activity after their index event compared with before, and 13% had increased in weight. These findings suggest that progress has been made in terms of prescribing effective cardiac medications but further attention is needed to help patients make important lifestyle changes.

The observations in this study highlight the need to improve adherence to treatment guidelines in an effort to increase the prescription of evidence-based treatments for the secondary prevention of ischaemic events in patients with a myocardial infarction. They also demonstrate that improvements need to be made to encourage patients to commit to beneficial lifestyle changes.

Limitations
The OPERA study is a non-randomized, observational study and is subject to a number of limitations associated with this type of investigation. Both low-volume and high-volume centres with all types of facilities enrolled patients into the study. Participation in the study was voluntary; therefore, the findings may not be representative of clinical practice throughout France. Patients had to receive appropriate information regarding the protocol to participate in the OPERA study. Thus, patients who experienced major clinical complications upon hospital arrival may be under-represented. However, patients admitted for acute myocardial infarction who died before receiving information about the study were included in the in-hospital mortality calculation. We did not record all of the reasons for non-prescription of certain therapies, and details about medication doses or the use of specific medications were not collected. Although a multivariable analysis was carried out, we may not have included all potential confounders.


   Conclusions
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Conclusions
Acknowledgements
 References
 
The results of this nationwide observational study show that patients with NSTEMI and STEMI have comparable in-hospital and long-term prognoses. They also have similar independent correlates of adverse outcome. These findings therefore support the new ESC/ACC definition of myocardial infarction, which combines STEMI with NSTE-ACS and elevated troponin. STEMI and NSTEMI patients are treated differently in terms of coronary reperfusion but more surprisingly also in terms of secondary prevention. Compared with those with STEMI, patients with NSTEMI appear to be undertreated after discharge from hospital despite having a higher risk profile. The common definition and similar prognosis of patients with STEMI or NSTEMI should lead to more similar secondary prevention therapies to avoid recurrent ischaemic events.


   Acknowledgements
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Conclusions
 Acknowledgements
References
 
We thank the physicians and nurses participating in the OPERA study. The OPERA study is funded by an unrestricted educational grant from Pfizer, Paris, France. Sophie Rushton-Smith, PhD, provided editorial assistance and was funded by Pfizer.

Conflict of interest: Pfizer had no involvement in the collection, analysis, and interpretation of data; in the writing of the manuscript; or in the decision to submit the paper for publication.


   Footnotes
 
{dagger} These data were presented at the European society of cardiology/world congress of cardiology in Barcelona, Spain, on 4 September 2006. Back


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 Introduction
 Methods
 Results
 Discussion
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