Summary
Background
The burden of cardiovascular diseases is anticipated to rise in developing countries. We sought to describe the epidemiology, management, and clinical outcomes of patients hospitalized with acute coronary syndromes (ACS) in three countries in western North Africa.
Methods
Adult patients hospitalized with a diagnosis of ACS were enrolled in the prospective ACute Coronary Events – a multinational Survey of current management Strategies (ACCESS) registry over a 13-month period (January 2007 to January 2008). We report on patients enrolled at sites in Algeria, Morocco and Tunisia. A standardized form was used to collect data on patient characteristics, treatments and outcomes.
Results
A total of 1687 patients with confirmed ACS were enrolled (median age 59 [interquartile range 52, 68] years; 76% men), 59% with ST-elevation myocardial infarction (STEMI) and 41% with non-ST-elevation ACS (NSTE-ACS). During hospitalization, most patients received aspirin (96%) and a statin (90%), 83% received a beta-blocker and 74% an angiotensin-converting enzyme inhibitor. Among eligible STEMI patients, 42% (419/989) did not receive fibrinolysis or undergo percutaneous coronary intervention. All-cause death at 12 months was 8.1% and did not differ significantly between patients with STEMI or NSTE-ACS (8.3% vs 7.7%, respectively; Log-rank test P = 0.82). Clinical factors associated with higher risk of death at 12 months included cardiac arrest, cardiogenic shock, bleeding episodes and diabetes, while percutaneous coronary intervention and male sex were associated with lower risk.
Conclusions
In this observational study of ACS patients from three Maghreb countries, the use of evidence-based pharmacological therapies for ACS was quite high; however, 42% of the patients with STEMI were not given any form of reperfusion therapy.
Résumé
Contexte
La fréquence des maladies cardiovasculaires est devenue inquiétante dans les pays en développement. Par ce travail, nous avons cherché à décrire l’épidémiologie, les modalités de prise en charge et le devenir clinique des patients hospitalisés pour un syndrome coronarien aigu (SCA) dans le Maghreb.
Méthodes
Des patients adultes hospitalisés pour SCA ont été enrôlés pour un suivi d’un an dans cette étude prospective multicentrique sur les stratégies actuelles de prise en charge des SCA (ACCESS). La période d’inclusion a duré environ 13 mois (début janvier 2007 à fin janvier 2008). Nous rapportons les données des patients inclus en Algérie, au Maroc et en Tunisie. Un formulaire identique dans les trois pays (registre ACCESS) a été utilisé pour recueillir des données cliniques et paracliniques des patients, les thérapeutiques instaurées et les résultats du suivi.
Résultats
Un total de 1687 patients, présentant un SCA confirmé, ont été inclus. L’âge moyen est 59 ans avec des extrêmes de 52 à 68 ans ; 76 % des patients étaient de sexe masculin, 59 % avaient un SCA ST+ (STEMI) et 41 % un SCA ST–. Pendant l’hospitalisation, la plupart des patients recevaient de l’aspirine (96 %) et une statine (90 %), 83 % ont reçu un bêta-bloquant et 74 % un inhibiteur de l’enzyme de conversion. Parmi les patients atteints de STEMI, 42 % (419/989) n’ont pas reçu un traitement thrombolytique ou une angioplastie coronarienne percutanée. La mortalité toute cause confondue à 12 mois était de 8,1 % et ne diffère pas significativement entre les patients atteints de STEMI ou non STEMI (8,3 % vs 7,7 %, p = 0,82). Les facteurs cliniques associés à un risque plus élevé de décès à 12 mois comprennent un arrêt cardiaque, un choc cardiogénique, des épisodes de saignement et un diabète, tandis que l’angioplastie coronaire percutanée et le sexe masculin ont été associés à un risque de mortalité plus faible.
Conclusions
Dans cette étude observationnelle de patients présentant un SCA dans trois pays du Maghreb, l’utilisation des thérapies pharmacologiques fondées sur des preuves était assez élevée, mais 42 % des patients atteints de STEMI n’ont reçu aucune forme de thérapie de reperfusion.
Introduction
In recent years, large multinational registries have provided novel insights into the characteristics, management and outcomes of the spectrum of patients with acute coronary syndromes (ACS) treated in everyday clinical practice. Several of these studies have reported decreased mortality rates associated with improved adherence to evidence-based ACS treatments . While observational studies offer new and valuable information that cannot be provided in the narrower confines of clinical trials, so far they have been limited largely to European and North American populations. Only limited data are available for ACS patients outside of these regions . Given the anticipated increase in burden of cardiovascular morbidity and mortality predicted for developing countries, it is now imperative to investigate how patients in such countries are being managed and how their outcomes compare with patients in developed countries. These studies have the potential to raise awareness of the disease and identify opportunities for improved treatment and patient outcomes.
The aim of the multinational observational ACute Coronary Events – a multinational Survey of current management Strategies (ACCESS) registry was to describe the characteristics, management and 1-year outcomes of patients hospitalized with non-ST-segment elevation ACS (NSTE-ACS) or ST-segment elevation myocardial infarction (STEMI) in countries in Africa, Latin America, and the Middle East . In this report, we describe the data for patients enrolled in three countries in western North Africa (“Maghreb”).
Methods
The rationale and methods for the ACCESS study have been described in detail elsewhere . ACCESS is a prospective, multinational, observational registry of patients hospitalized for an ACS. Patients were enrolled between January 2007 and January 2008 at 134 sites in 19 countries in western North Africa (“Maghreb”: Algeria, Morocco, Tunisia), South Africa, Latin America (Argentina, Brazil, Colombia, Dominican Republic, Ecuador, Guatemala, Mexico, Venezuela) and the Middle East (Egypt, Iran, Jordan, Kuwait, Lebanon, Saudi Arabia, United Arab Emirates).
The registry was conducted in accordance with the guidelines for Good Epidemiological Practice and under the leadership of a scientific advisory board. Participating countries were responsible for ensuring that the study was performed in accordance with local regulations. Local institutional review boards or independent ethics committees approved the study and all patients provided signed informed consent.
Study setting and site selection
A questionnaire was sent to all potential sites to collect data on the type of institution (public, private, teaching), its location, the number of ACS patients treated and the services offered. The affiliate in each country then provided a list of centres that represented their country as completely as possible. The final list of investigators (including cardiologists and internists) was then randomly generated by the trial manager. Physicians who declined to participate were replaced by the following physician in the list. The aim was to enroll approximately 25 patients per site, with at least 20 sites per country.
Study population
Eligible patients were those aged 21 years or above admitted to hospital for an ACS. Patients with symptoms precipitated by a comorbidity such as anaemia, heart failure or non-cardiac trauma, and patients participating in concomitant clinical trials, were excluded. Patients were recruited consecutively to avoid selection bias.
Patients had to present ischaemic symptoms of ACS within 24 hours of hospital presentation and have one or more of the following characteristics:
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electrocardiographic changes (transient ST-segment elevation ≥ 1 mm, ST-segment depression ≥ 1 mm, new T-wave inversion ≥ 1 mm, pseudonormalization of previously inverted T-waves, new Q waves [one-third the height of the R wave or > 0.04 seconds], new R wave > S wave in lead V1, or new left bundle branch block);
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documentation of coronary artery disease (history of myocardial infarction [MI], angina, congestive heart failure believed to be due to ischaemia or resuscitated sudden cardiac death, history of or new positive stress test with imaging, previous or new cardiac catheterization documenting coronary artery disease, prior or new percutaneous coronary intervention or coronary artery bypass graft [CABG] surgery);
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an increase in a cardiac biochemical marker of myocardial necrosis (troponin or CK-MB).
Evaluations and clinical outcomes
A standardized case report form (see Appendix B in Montalescot et al. ) was used to record data prospectively at hospital admission, at discharge, and at 6 ± 1 and 12 ± 1 month follow-up. Data were collected during follow-up visits or by telephone calls to the patient or a third party (e.g. relative/friend, family physician). The data collected at baseline, included demographics, medical history, risk factors, physical examination, cardiac biomarkers, ankle-brachial index, Killip class, chronic medical treatments and health insurance status. Data collected at discharge from hospital included discharge status and diagnosis, hospital management, cardiac biomarkers and hospital events. Follow-up data included clinical outcomes after discharge including those leading to rehospitalization, and treatments since discharge or previous follow-up.
Data quality control was performed by trained personnel at ≥ 10% of sites chosen at random in each country. All case report forms were monitored for source documentation and accuracy. Data-request forms were generated automatically in response to queries and resolved by the site investigators.
The primary endpoint was all-cause death at 1 year. Secondary endpoints (at 1 year) were cardiovascular death; non-fatal stroke; non-fatal MI; bleeding; and the combined endpoint of cardiovascular death, stroke or MI . All-cause death at 30 days was also recorded. Full definitions for selected evaluations and outcomes are given in the Appendix .
Statistical analysis
The study population comprised patients enrolled in the French-speaking Maghreb countries (Algeria, Morocco and Tunisia) participating in ACCESS.
Statistical analyses were performed at the 5% significance level, using two-sided tests or two-sided confidence intervals (CIs). Continuous data are given as mean ± standard deviation (SD) or median (interquartile range). A P value ≤ 0.05 was considered to be statistically significant. Categorical data are summarized using counts and percentages. Data were analysed with the SAS package, release 9.1.3 (SAS Institute, Cary, NC).
Results
A total of 1720 patients were recruited by 144 physicians at 21 sites in Algeria, 28 sites in Morocco and 15 sites in Tunisia between January 2007 and January 2008. Most of the participating physicians were non-interventional (57.6%) or interventional (34.7%) cardiologists, while 4.9% were hospital physicians and 2.8% were internists.
Study population
The patient flow chart is shown in Fig. 1 . Of the 1720 patients enrolled, 33 with “other cardiac”, “other” or missing diagnoses were excluded. A total of 1687 patients had a confirmed ACS diagnosis: 59% with STEMI and 41% with non-ST-elevation ACS (NSTE-ACS). Over the course of the study, 139 patients died, 95 were lost to follow-up, two withdrew consent, and 22 were excluded for another reason. Data were available for 1687 patients, 1429 of who had 1-year follow-up data (85% of the Maghreb population).
The baseline characteristics of the population are given in Table 1 . The overall population comprised 79% Caucasians and 20% Arabs. Patients with NSTE-ACS were slightly older than those with STEMI and had a more frequent medical history of angina, myocardial infarction, and congestive heart failure. Patients with STEMI were more commonly men, and were more likely to be tobacco smokers and to misuse alcohol. The mean (SD) GRACE risk score was 119.6 (36.9).
| All ACS ( n = 1687) | NSTE-ACS ( n = 698) | STEMI ( n = 989) | |
|---|---|---|---|
| Men | 76 | 68 | 82 |
| Age, years | 59 [52,68] | 60 [53,68] | 58 [52,67] |
| Ethnicity | |||
| Caucasian | 79 | 75 | 82 |
| Middle East (Arab) | 20 | 24 | 18 |
| Other | 0.8 | 1.1 | 0.6 |
| Presenting characteristics | |||
| Pulse, beats/min | 79 [68,90] | 76 [66,89] | 80 [70,92] |
| Systolic BP, mmHg | 124 [110,141] | 130 [115,147] | 119 [105,137] |
| Diastolic BP, mmHg | 73 [65,83] | 77 [67,84] | 71 [64,81] |
| Ankle-brachial index < 0.9 | 13 | 14 | 11 |
| LVEF, % | 55 [45,62] | 60 [52,66] | 50 [41,58] |
| Killip class II–IV | 17 | 13 | 20 |
| Medical history | |||
| Angina | 40 | 51 | 32 |
| Family history of CVD | 14 | 15 | 14 |
| Myocardial infarction | 12 | 14 | 11 |
| Congestive heart failure | 2.8 | 3.9 | 2.1 |
| Peripheral artery disease | 3.4 | 3.6 | 3.3 |
| TIA/stroke | 3.0 | 3.6 | 2.6 |
| Bleeding | 0.4 | 0.3 | 0.5 |
| PCI | 4.5 | 6.4 | 3.1 |
| CABG | 1.2 | 2.6 | 0.3 |
| Risk factors | |||
| Hypertension | 45 | 55 | 37 |
| Dyslipidemia | 22 | 29 | 17 |
| Diabetes | 37 | 40 | 34 |
| Overweight (BMI 25 – < 30 kg/m 2 ) | 42 | 40 | 43 |
| Obese (BMI ≥ 30 kg/m 2 ) | 19 | 22 | 17 |
| Abdominal obesity a | 67 | 71 | 64 |
| Current smoker b | 47 | 40 | 51 |
| Alcohol misuse c | 4.1 | 3.3 | 4.7 |
a Waist circumference: Caucasian, Black, Middle East (Arab): ≥ 94 cm for men; ≥ 80 cm for women. Native Latin American and Asian: ≥ 90 cm for men; ≥ 80 cm for women (according to International Diabetes Federation).
b ≥ 5 cigarettes for ≥ 6 months.
The median (Q1, Q3) delay from onset of symptoms to hospital admission was 7.0 (3.0, 23.7) hours, and was shorter among STEMI patients than NSTE-ACS patients (6.0 [2.8, 18.2] vs 10.4 [3.0, 33.6] hours).
Almost one-third ( n = 511, 31%) of patients had no medical insurance; the remaining patients had government insurance ( n = 1042, 62%), private insurance ( n = 107, 6.4%) or both ( n = 12, 0.7%).
Management in hospital and at discharge
Information on in-hospital management according to discharge diagnosis is given in Table 2 . Most ACS patients ( n = 1625, 96%) received aspirin, a statin ( n = 1510, 90%) and an angiotensin-converting enzyme inhibitor ( n = 1249, 74%) or angiotensin II receptor antagonist ( n = 111, 6.6%). A thienopyridine was used in 77% ( n = 1293) of patients, beta-blockers in 83% ( n = 1401) and intravenous glycoprotein IIb/IIIa inhibitor in 9.7% ( n = 164). Of the 989 patients with STEMI, 30% ( n = 298) received fibrinolytic therapy, most frequently with streptokinase (92%), followed by tenecteplase (6.4%) and alteplase (1.7%).
