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Archives of cardiovascular diseases
Volume 105, n° 11
pages 566-577 (novembre 2012)
Doi : 10.1016/j.acvd.2012.07.002
Received : 5 Mars 2012 ;  accepted : 3 July 2012
Management of acute coronary syndromes in Maghreb countries: The ACCESS (ACute Coronary Events – a multinational Survey of current management Strategies) registry
Prise en charge des syndromes coronaires aigus au Maghreb : sous-analyse du registre ACCESS
 

Abdelhamid Moustaghfir a, , 1 , Mohand Haddak b, 1, Rachid Mechmeche c, 1
a Service des soins intensifs et rythmologie, faculté de médecine de Rabat, hôpital militaire d’instruction Mohammed V, Rabat, Morocco 
b Service de cardiologie, hôpital Central de l’Armée, Alger, Algeria 
c Service de cardiologie, CHU La Rabta, Tunis, Tunisia 

Corresponding author. Fax: +212 3771 6044.
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.

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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 59ans avec des extrêmes de 52 à 68ans ; 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.

The full text of this article is available in PDF format.

Keywords : Acute coronary syndrome, Evidence-based therapy, Guidelines, Maghreb, Reperfusion

Mots clés : Maghreb, Médecine basée sur les preuves, Reperfusion, Syndrome coronarien aigu

Abbreviations : ACCESS, ACS, CI, HR, MI, NSTE-ACS, PCI, STEMI


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 [1, 2, 3]. 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 [4, 5, 6, 7, 8, 9]. 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 [10]. 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 [10]. 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 24hours of hospital presentation and have one or more of the following characteristics:

electrocardiographic changes (transient ST-segment elevation1mm, ST-segment depression1mm, new T-wave inversion1mm, pseudonormalization of previously inverted T-waves, new Q waves [one-third the height of the R wave or>0.04seconds], new R wave>S wave in lead V1, or new left bundle branch block);
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);
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. [10]) 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 at10% 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 [11]. 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 value0.05 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).

Funding

The ACCESS registry was sponsored by Sanofi-Aventis, Paris, France.

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 Figure 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).



Figure 1


Figure 1. 

Study flowchart: Maghreb population.

Zoom

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 [12] was 119.6 (36.9).

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%).

During the initial hospitalization, coronary angiography was done in less than half of the patients (n =757, 45%). Percutaneous coronary intervention (PCI) was performed in 22% of patients with NSTE-ACS and in 27% with STEMI, 97% of whom received a stent (Table 2). Forty-two per cent (n =419) of eligible STEMI patients received no form of acute reperfusion therapy (i.e. PCI or fibrinolytic therapy within 24hours of admission to hospital).

Selected treatments at discharge from hospital are shown in Table 3. A large proportion of patients were treated with aspirin (94%), statins (84%), beta-blockers (82%) and thienopyridines (73%).

Country comparisons

Both in-hospital and at discharge, the highest rates of use of angiotensin-converting enzyme/angiotensin II receptor antagonist, beta-blockers and statins were in Algeria; aspirin was less frequently used in Tunisia (Table 4). Fibrinolytic therapy for treatment of STEMI was infrequent in Morocco (8.6%, 39/452). Early PCI for patients with STEMI was 2.5% in Algeria and 22% in both Tunisia and Morocco. The rate of no reperfusion was highest in Tunisia (60%), intermediate in Algeria (50%) and lowest in Morocco (30%).

Clinical outcomes

The rate of 30-day all-cause death was 4.1% rising to 8.1% by 12 months, and did not differ between ACS subgroups (Table 5; P =not significant). Kaplan–Meier survival curves show an early risk of death up to approximately 50 days, which was similar in both ACS subgroups (Figure 2; P =not significant).



Figure 2


Figure 2. 

Survival curves up to 1 year for patients with STEMI and NSTE-ACS: Maghreb population. Log-rank test P =0.83.

Zoom

The 12-month event rates for the other outcomes are shown in Table 5. The rate of cardiovascular death was 6.2% overall, and was slightly but not statistically significantly lower among patients with NSTE-ACS versus STEMI. Non-fatal stroke occurred in 2.3% of ACS patients, non-fatal myocardial infarction in 4.4% and bleeding in 4.1%. The composite of non-fatal outcomes plus cardiovascular death was 12%, and was consistent across ACS subgroups.

Among the 136 patients who died within 12 months of presentation for an ACS, the most common reasons were “other” cardiovascular death (including sudden death of unknown cause; 38%) and myocardial infarction (32%). Deaths were due to strokes in 5.9% of patients and for non-cardiovascular reasons in 5.1%. The remaining deaths (18%) were of unknown cause.

When analysed by country, the rates of all-cause death (both overall and in the NSTE-ACS subgroup) were lowest in Tunisia, intermediate in Morocco and highest in Algeria (Figure 3).



Figure 3


Figure 3. 

All-cause mortality by country.

Zoom

According to a Cox proportional hazards model, factors associated with a higher risk of death at 12 months were cardiac arrest during initial hospitalization (hazard ratio [HR] 13.41, P <0.0001), cardiogenic shock during hospitalization (HR 4.66, P <0.0001), bleeding during hospitalization (HR 2.78, P =0.0055), age (HR 1.67, P =0.0083) and history of diabetes (HR 1.44, P =0.055). Factors associated with a lower risk were male sex (HR 0.63, P =0.014) and PCI (HR 0.25, P <0.001).

Discussion

The present study reports on the contemporary management and outcomes for 1687 patients hospitalized for an ACS in three countries in western North Africa – Algeria, Morocco and Tunisia. Fifty-nine per cent of the patients were given a discharge diagnosis of STEMI and the remaining 41% a diagnosis of NSTE-ACS. Patients with STEMI were slightly younger than those with NSTE-ACS, were more likely to be male, have a less frequent history of cardiac disease, fewer risk factors and a lower systolic arterial blood pressure; they did, however, have a higher heart rate and were more often tobacco smokers and heavy drinkers. The all-cause mortality rate rose from 4.1% at 30 days to 8.1% at 1 year and did not differ between ACS subgroups.

Maghreb population vs other observational data

The patients enrolled in the Maghreb countries differed from those in the overall ACCESS population, which involved 11,731 patients with an ACS [10], and in which 54% were diagnosed with NSTE-ACS versus only 41% in Maghreb. The proportion of NSTE-ACS patients in the Maghreb population is much lower than that reported in predominantly “Western” ACS populations such as the Global Registry of Acute Coronary Events (GRACE) (66%) [13] and the second Euro Heart Survey (EHS-ACS-II) (48%) [3], but also in Arab populations as shown in the Gulf RACE study (61%) [13]. In the Indian CREATE registry, however, which involved over 20,000 ACS patients (mean age 58±12 years), 39% were diagnosed with NSTE-ACS.

The Maghreb ACCESS ACS population appears intermediate between the GRACE registry and the Gulf RACE registry in terms of mean age at presentation (60 years vs 66 years in GRACE and 56 years in Gulf RACE), proportion of men (76% vs 69% and 76%) and rate of hypertension (45% vs 66% and 50%). In the STEMI population, however, the proportion of patients with diabetes mellitus was highest in the Maghreb patients (34% vs 22% in GRACE and 32% in Gulf RACE).

When compared with the overall ACCESS data [10], patients in Maghreb had lower rates of cardiac risk factors, medical histories of angina, cardiac disease and bleeding, and family histories of cardiovascular disease. In contrast, a greater percentage of Maghreb patients were tobacco smokers. The rate of smoking was also higher than reported in other observational studies (40% vs 28% in GRACE and 37% in Gulf RACE [13]), was the same as in the CREATE registry (40%) [7], but was lower than in a Tunisian study of patients with myocardial infarction (63%) [8].

These differences suggest that patients in the Maghreb region, similar to those in the Indian CREATE registry, tend to present at a younger age. They also suggest insufficient public awareness of the negative impact of smoking on cardiovascular disease, and provide an incentive to encourage the adoption of anti-smoking campaigns and smoking bans in public areas.

Variations in management

When compared with the overall ACCESS population [10], the use of beta-blockers (83% vs 78% overall) and aspirin (96% vs 93% overall) was slightly higher in the Maghreb countries, and was in line with the results reported for other studies (≥95%) [1, 3]. Similarly, Maghreb physicians showed a preference to use the low-molecular-weight heparin enoxaparin (76% in Maghreb vs 57% in overall ACCESS) over unfractionated heparin (24% vs 37%) in patients with NSTE-ACS. In line with the overall data, other, newer anticoagulants such as fondaparinux or bivalirudin were almost never used.

Coronary angiography (45% in Maghreb vs 58% overall ACCESS) and PCI (25% vs 35% overall) were performed much less frequently in Maghreb when compared with the overall ACCESS population [10] and other registry studies such as GRACE and EHS-ACS-II [1, 3], but were used substantially more frequently than in the Gulf RACE study (21% for coronary angiography and 7% for PCI) [6] or the Indian CREATE registry (23% and 7.5%, respectively) [7]. Among patients with STEMI or left bundle branch block, the Gulf RACE data showed a very high rate of use of thrombolysis (93%; 65% overall rate of reperfusion), compared with only 30% (58% overall rate of reperfusion) in STEMI patients in Maghreb. Similarly, the CREATE registry reported a higher rate of reperfusion with fibrinolytic therapy for patients with STEMI (59%) but a very low rate of in-hospital PCI (8.0%) [7].

At discharge from hospital, the use of evidence-based ACS medications including aspirin, ACE inhibitors/angiotensin-converting enzyme receptor blockers, beta-blockers and statins was reassuringly high, and was greater than in the overall ACCESS registry [10].

Clinical outcomes

The rate of all-cause 30-day mortality in the Maghreb ACCESS population was higher than that in the overall ACCESS population (4.1% vs 3.6%) [10], driven by a higher rate of death among patients with NSTE-ACS (4.0% vs 2.4%) and despite the lower rate among STEMI patients (4.2% vs 5.0%). This difference was maintained at 12 months for both all-cause and cardiovascular deaths.

While the Maghreb population shares some similarities with the Indian CREATE registry [7], the rate of death at 30 days in STEMI patients was 50% lower (4.2% vs 8.6%), perhaps reflecting the very low rate of the primary PCI in the Indian population. In comparison, the rate of 30-day death among patients with NSTE-ACS was marginally higher in ACCESS (4.0% vs 3.7%). These differences in outcome may be due to variations in clinical management, but also to socioeconomic divisions such as disparity in treatments, type of hospital, and delays to presentation and treatment [7]. The low rates of 30-day death in ACCESS may also reflect the GRACE risk score (mean of 119.6 [36.9]), which corresponds to an intermediate risk of death in patients with NSTE-ACS and a low risk among those with STEMI [12].

The 12-month rates of non-fatal stroke, non-fatal myocardial infarction and the composite of cardiovascular death, non-fatal stroke and non-fatal myocardial infarction were also slightly higher in the Maghreb subgroup compared with the overall ACCESS population [10], whereas the rates of bleeding were lower, perhaps reflecting differences in the use of pharmacological therapies with potential bleeding complications.

The rate of death in the STEMI population was highest in Morocco and lowest in Tunisia. These findings are unexpected, taking into account the greater use of reperfusion in Morocco, and suggest the presence of unmeasured factors such as, for example, differences in extent of disease and delayed thrombolysis or PCI.

Limitations

This observational study is subject to limitations and biases, including the collection of non-randomized data, incomplete information (including loss to follow-up), potential confounding by drug indication, dosage, or other unmeasured covariates, and potential bias in site selection. The patients may not be wholly representative of their countries and may not reflect trends in other countries in Africa.

Conclusions

These observational data, from three countries in western North Africa, provide insights into the clinical characteristics, risk factors, management and outcomes for patients hospitalized for an ACS. These findings demonstrate the need for strategies aimed at cardiovascular disease prevention, as evidenced by the high rates of diabetes mellitus, smoking and alcohol misuse. Greater adherence to evidence-based strategies of cardiovascular disease treatment, including more extensive use of reperfusion therapy, especially primary PCI, alongside reduction in risk factors, may in time lead to reductions in the rates of death due to cardiovascular diseases.

Disclosure of interest

Abdelhamid Moustaghfir is a Consultant for Saint Jude Medical France and for Servier Morocco.

Access steering committee

Gilles Montalescot (Principal Investigator) (France), Norka Antepara (Venezuela), Alvaro Escobar (Colombia), Samir Alam (Lebanon), Alain Leizorovicz (France), Carlos Martinez (Mexico), José Nicolau (Brazil), Mohamed Sobhy (Egypt).

Access investigators: North Africa
Algeria

Mohand Haddak (National Coordinator), Nabil Bendaoud, Mourad Saidane, Samia Latreche, Yazid Aoudia, Hocine Ramdani, Samir Ahnia, Sofiane Ghemri, Mourad Chabane Chaouche, Saliha Lehachi, Aldjia Kachnoura, Krim Messaad, Karima Hammidouche, Abdelghani Bachir Cherif, Aziz Rahli, Mohamed Fayçal Beddai, Lila Manamani, Tarek Meziane, Zakia Mostefa Kara, Nassima Benyoucef, Daim Ellah.

Morocco

Abdelhamid Moustaghfir (National Coordinator), Abdellatif Darif, Abdou Louali, Mohamed Allaoui, Ahmed Bennis, Laila Azzouzi, Mohamed Saadaoui, Rachida Habbal, Cherif Abdelkhirane, Oussama Fassi Fihri, Youssef Allali, Abdessamad Dahreddine, Ahmed Hamani, Samir Ztot, Assad Chaara, Saadia Bahosse, Ali Khatouri, Ridwane Faik, Samira El Fath, Faycal Bel Aouchi, Naima Riad, Saïd Oudghiri, M’Barek Nazzi, Hafid Akoudad, Rachid Tarhbalouti, Mohamed Chbil, Kenza Boubel, Said Elkhatib.

Tunisia

Rachid Mechmech (National Coordinator), Boujnah Rachid, Farhati Abdeljlil, Boughzela Essia, Addad Faouzi, Ben Khalfallah Ali, Ben Farhat Mohamed, Kachboura Salem, Kammoun Samir, Gouider Jeridi, Chahbani Iheb, Karaborni Traki, Marsit Nabil, Hilmi Kammoun, Ridha Hassine.


Acknowledgements

Sophie Rushton-Smith, PhD, provided medical writing assistance in the preparation of this report and was funded by Sanofi-Aventis.


Appendix. Study definitions used in ACCESS



Event Definition 
Cardiovascular death Any death with a clear cardiac or vascular cause (including hemorrhagic death of any origin and fatal pulmonary embolism) or unknown cause (including sudden death, unobserved and unexpected death, and other death not definitely attributed to a non-vascular cause) 
 
Myocardial infarction [14Patients who did not undergo a cardiac intervention within the previous 24hours. At least one of the following must be present: 
a) CK-MB elevation (>2×ULN in one sample or>ULN in two samples); 
b) Troponin elevation (>ULN in one sample); 
c) Creatinine kinase elevation (in the absence of a or b), CK>2×ULN) 
AND at least one of the following: 
• ischemic symptoms within the past 24hours 
• ST depression of0.1mV or T-wave inversion 
• Left bundle branch block (new or old) or paced rhythm that obscures assessment of ST 
• ST-elevation (new ST-elevation in2 contiguous leads0.2mV in V1, V2, or V3 or0.1mV in other leads) 
• New tall R wave with R/S1 in V1 and R/S1.5 in V2 
• New Q waves40 ms in two contiguous leads 
Patients who underwent recent PCI or CABG within the previous 24hours: 
a) PCI: CK-MB3×ULN (no electrocardiographic changes or symptoms required) 
b) CABG: either CK-MB5×ULN and new Q waves, or CK-MB10×ULN (with or without Q wave) 
 
Bleeding (GUSTO [11]) Grade I: severe bleeding: documented intracranial hemorrhage or bleeding that causes hemodynamic compromise requiring blood or fluid replacement, inotropic support, ventricular assist devices, surgical intervention (other than vascular site repair), or CPR to maintain a sufficient cardiac output 
Grade II: moderate bleeding: bleeding that requires transfusion of blood but does not lead to hemodynamic compromise requiring intervention 
Grade III: mild bleeding: bleeding not requiring transfusion and not causing hemodynamic compromise, including subcutaneous bleeding, mild hematomas, oozing from puncture sites, etc. 
 
Ischemic stroke An acute brain or retinal ischemic event with focal signs either lasting>24hours or accompanied by neuroimaging evidence of new brain infarction. If a previous deficit has worsened, the worsening must persist for>24hours and should be accompanied by new ischemic changes on brain or CT 

ULN: upper limit of normal; PCI: percutaneous coronary intervention; CABG: coronary artery bypass graft; CPR: cardiopulmonary resuscitation; MRI: magnetic resonance imaging; CT: computed tomography.

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1  For the ACCESS Investigators.


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