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Archives of cardiovascular diseases
Volume 102, n° 1
pages 51-58 (janvier 2009)
Doi : 10.1016/j.acvd.2008.09.014
Received : 22 January 2008 ;  accepted : 1 September 2008
Efficacy over time of a short overall atherosclerosis management programme on the reduction of cardiovascular risk in patients after an acute coronary syndrome
Efficacité d’un programme court de prise en charge globale de l’athérosclérose sur la réduction du risque cardiovasculaire des patients à distance d’un syndrome coronarien aigu
 

Marianne Lafitte a, Vincent Pradeau a, Lionel Leroux a, c, Vincent Richeboeuf a, Sandrine Tastet a, Carine Boulon a, Bertrand Paviot a, Jacques Bonnet a, b, c, Thierry Couffinhal a, b, c,
a Centre d’exploration, de prévention et de traitement de l’athérosclérose (Cepta), hôpital cardiologique du Haut-Levêque, avenue de Magellan, 33604 Pessac cedex, France 
b Université Victor-Ségalen-Bordeaux-2, Bordeaux, France 
c Inserm unité 828, Pessac, France 

Corresponding author. Fax: +05 57 65 62 71.
Summary
Introduction

The prognostic significance of monitoring risk factors and adjusting treatments in patients after an acute coronary syndrome (ACS) is well documented. However, studies over the last few years show that secondary prevention objectives are rarely met. Prevention programmes are effective but their benefit is only partially maintained in long-term follow-up.

Aim of the study

To evaluate the efficacy of a global management programme for atherosclerosis (the CEPTA programme) on the long-term monitoring of cardiovascular risk factors, on adherence to treatment, and to compare the data of clinical events post-ACS with that contained in the scientific literature.

Patients and methods

Six hundred and sixty consecutive patients were hospitalised three months after the occurrence of an ACS to evaluate residual risk factors, the atherosclerosis burden, and to undergo a treatment adjustment and a therapeutic and dietary education programme. We evaluated the impact of this long-term programme on the balance of risk factors, treatment maintenance and clinical events. At the end of an average follow-up of 20 months, 96.3% of patients were on antiaggregates, 86.0% were on β-blockers or Verapamil®, 62.4% were on angiotensin-converting enzyme inhibitors or angiotensin to receptor antagonists, 88.4% were on cholesterol-lowering medication and 75.5% were receiving a combination of β-blocker antiaggregates and cholesterol-lowering drugs. Monitoring of LDL cholesterol and blood pressure was done in over 81 and 71% of patients, respectively. At 20 months of follow-up, total mortality was 3.6% and one cardiovascular event occurred in 12% of patients. In conclusion, this short programme following ACS is beneficial for the long-term management of cardiovascular risk factors and the sustainability of drug treatments.

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Résumé
Introduction

L’importance pronostique du contrôle des facteurs de risque et de l’adaptation thérapeutique chez les patients après un syndrome coronarien aigu (SCA) est bien établie. Pourtant, les études montrent que les objectifs de prévention secondaire sont rarement atteints. Les programmes de prévention sont efficaces mais leur bénéfice n’est que partiellement maintenu dans le suivi à long terme.

But de l’étude

Évaluer l’efficacité d’un programme de prise en charge globale de l’athérosclérose (programme Cepta) sur le contrôle à long terme des facteurs de risques cardiovasculaires, sur l’adhésion au traitement et comparer les données sur les événements cliniques après un SCA à celles de la littérature.

Patients et méthodes

Six cent soixante patients consécutifs ont été hospitalisés, trois mois après la survenue d’un SCA, pour évaluation des facteurs de risques résiduels, de la charge en athérome ainsi que pour bénéficier d’une adaptation thérapeutique et d’un programme d’éducation thérapeutique et diététique. Nous avons évalué l’impact de ce programme à long terme sur l’équilibre des facteurs de risque, le maintien du traitement et les événements cliniques. Au terme d’un suivi médian de 20 mois, 96,3 % des patients étaient sous antiagrégant, 86,0 % étaient sous bêtabloqueur ou Verapamil, 62,4 % sous inhibiteur de l’enzyme de conversion ou antagoniste des récepteurs à l’angiotensine II, 88,4 % étaient sous un médicament hypocholestérolémiant et 75,5 % bénéficiaient d’une combinaison antiagrégant bêtabloqueur et hypocholestérolémiant. Le contrôle du LDL cholestérol et de la tension artérielle était obtenu chez plus de 81 et 71 % des patients respectivement. À 20 mois de suivi, la mortalité totale était de 3,6 % et un événement cardiovasculaire est intervenu chez 12 % des patients. En conclusion, ce programme court à distance du SCA est bénéfique sur la prise en charge à long terme des facteurs de risques cardiovasculaires et sur la pérennité du traitement médicamenteux.

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Keywords : Atherosclerosis, Acute coronary syndrome, Secondary prevention, Therapeutic education, Compliance, Risk factors

Mots clés : Athérosclérose, Syndromme coronarien aigu, Prévention secondaire, Éducation thérapeutique, Observance


Introduction

The majority of intervention studies have established the prognostic significance of long-term monitoring of risk factors in patients having presented with an acute coronary syndrome (ACS) [1, 2]. And yet national and international studies show that these guidelines are only partially applied in daily clinical practice [3, 4, 5]. Among these are the Euroaspire II and III studies, which show the persistently high prevalence of changeable risk factors and lifestyles unsuitable for patients with a proven coronary disease [5, 6]. These studies highlight the insufficient use of drugs recommended in the secondary prevention of coronary heart disease. They also emphasise the efforts required to meet the standards of preventive cardiology by improving lifestyle changes, the monitoring of risk factors and the optimal use of prophylactic drugs so as to reduce cardiovascular morbidity and mortality.

In response to the difficulties of optimising secondary prevention, optimised management programmes of atherosclerosis have been developed, which rely on the national and European guidelines on cardiovascular disease prevention [7, 8]. While considering the efficacy or failure of some previously reported prevention actions, the Centre d’exploration, de prévention et de traitement de l’athérosclérose (CEPTA) was created at the CHU de Bordeaux for post-ACS patients, the aim of which is to significantly improve secondary prevention measures in the long-term. This programme includes the initiation of these measures during hospitalisation for an ACS, and a 48 h stay during the third month after the ACS. The programme is focused on the overall management of the coronary patient through complete evaluation of the extension of their atheroma, myocardial function and risk factors, combined with a therapeutic and dietary education. At the end of the 3-month review, particular attention is paid to adjusting the drug prescription according to the guidelines and the patient’s risk profile. Our hypothesis is that these different management stages of the coronary patient could be an effective means of improving the secondary prevention measures.

The main objective of this prospective study is to analyse the effects of the secondary prevention objectives at the end of the follow-up. The secondary objective is to report the morbidity and mortality of this cohort of patients so as to compare them with the data from the literature.

In this study we report the results demonstrating the impact of this overall programme post-ACS over time, on the monitoring of risk factors, the persistence and adherence to treatment, and the clinical events.

Patients and methods
Study population

We studied a monocentric cohort of patients recruited consecutively during hospitalisation for ACS. The inclusion criteria (nine) was the onset of an ACS according to the criteria of the ESC [9]. The diagnosis was established if two serum values of troponin T appeared to be over 0.05g/L or if the CPK-MB were over 10μg/L with the typical symptoms (chest pain lasting more than 15min, pulmonary edema without significant valvulopathy, cardiogenic shock and ventricular arrhythmia), all with new Q-waves in at least 2 of the standard 12 electrocardiography leads or electrocardiography changes indicating acute ischaemia (ST-segment elevation, ST-segment depression or T-wave inversion). There were no exclusion criteria.

Acute phase of ACS

Each patient underwent a coronary angiography at the USIC and received medical treatment during the acute phase that was the most adapted in relation to the most recent guidelines. The ACS characteristics included initial electrocardiographic modifications, the affected coronary artery, increased enzyme levels, initial treatment (angioplasty with or without stenting and coronary artery bypasses) and acute complications.

Between two and four days after ACS, the patients were transferred to CEPTA where they received advice necessary for their change in lifestyle, diet and not smoking. An optimal treatment was prescribed in the discharge prescription depending on the cardiovascular condition and risk factors according to guidelines [7, 8].

Intervention at 3 months

Three months after the ACS, the patients were systematically invited for an appointment to assess their atheromatous disease and its consequences, and to participate in the secondary prevention programme described as follows:

screening for risk factors: each patient underwent an assessment of their tobacco consumption, dietary habits and physical activity. Weight and height were recorded to calculate the body mass index (BMI). Blood pressure was monitored for an hour while lying down and an average of at least five measurements was used for data analysis. Fasting blood samples were taken to measure the concentration of total cholesterol, LDL and HDL cholesterol, triglycerides, blood glucose, glycated haemoglobin and fibrinogen;
personalised dietary advice aiming the nutritional balance was given to them by the ward’s dietician. Before this consultation, patients had already answered a questionnaire concerning their nutritional habits (a one page per week diary). The aim of this intervention was to correct the major nutritional mistakes and to set the daily fat intake to less than 30% of the energy ration and the saturated fatty acid intake to less than 10% of this ration. Consumption of cereals, fibres and fruits was recommended;
active smoking patients underwent a consultation with a smoking cessation specialist;
an educational session focusing on cardiovascular risk factors and on lifestyle habits was conducted by the nurses and cardiologists of the ward and the nutritional session was conducted by the dieticians. Comprehensive education was given on all aspects of coronary disease, including changes in lifestyle habits, blood pressure, smoking, and management of diabetes and cholesterol;
discharge medication was scrupulously adapted to the cardiac condition, risk factors and specific objectives to be met in accordance with guidelines. This treatment included β-blockers (if contraindication, Verapamil® was prescribed), ACE inhibitors or AT2 receptor agonist, and patients who still had high blood pressure could receive one or several additional antihypertensive drugs. Antiaggregates (aspirin and clopidogrel) and hypolipidaemic medication (statins or fibrates) were also used in combination. Diabetic patients received oral antidiabetic agents and/or an insulin treatment after discussion with the diabetes specialist;
assessment of the left ventricle ejection fraction via echocardiography and isotopic ventriculography and screening for residual myocardial ischaemia via 99mTc-MIBI myocardial perfusion scintigraphy;
assessment of the atherosclerosis burden:
coronary atheroma: coronary stenoses were quantified on digital angiography measurements of the coronary angiographies performed during the acute phase. Stenoses estimated as at least 50% were retained as significant so as to quantify the single-, two- or three-vessel disease of the patient,
carotid atheroma: carotid stenoses were quantified during a cervical ultrasonography examination. The stenoses were expressed in reduction percentage of diameter according to the NASCET criteria. The criterion retained for this study was the presence of a stenosis of at least 20%;

arteriopathy of the lower limbs: the arteriography diagnosis was established with an abnormal measurement (< 0.9 or > 1.4) of the Ankle Brachial Index (ABI). Thus, systolic pressure measurements were recorded from the posterior tibial arteries, the dorsalis pedis arteries, and the two brachial arteries on a patient lying in the dorsal decubitus position at rest for at least 5min by using a handheld continuous wave Doppler unit at 8MHz and an adjustable cuff. For each ankle, the ABI measurement was obtained by calculating the ratio between the highest pressure of each ankle and the highest brachial artery pressure. The lowest ABI on the right or the left was retained for the continuation of the analysis, corresponding to the global ABI of the patient [10].

Follow-up

Patients were monitored by their usual doctor or their cardiologist and were not contacted by the CEPTA until final follow-up. Follow-up was obtained via a standardised questionnaire sent to each patient and each doctor approximately 18 months after the patient’s last visit. This easy-to-understand questionnaire enabled us to gauge symptoms, the onset of an event (recurrence of infarction, stroke, arteriopathy of lower limbs or an angioplasty-type intervention, bypass and endarterectomy), lifestyle habits (smoking and physical activity), weight and ongoing treatment. The usual doctor measured blood pressure. A blood sample was taken (identification of lipid abnormality, blood glucose and glycated haemoglobin) to evaluate the risk factors. When events occurred during follow-up, we resorted to the hospitalisation reports. The events were classified as major (cardiovascular death, ACS, stroke) and minor (heart failure, coronary or peripheral revascularisation).

Assessment criteria and definitions

Patients included in the study were those who completed the 3-month analysis. Data concerning deceased or nonhospitalised patients between the time of the ACS and hospitalisation at 3 months were reported. All patients seen at 3 months were monitored for 2 years.

The primary objective of this prospective study is to evaluate the effect of this prospective programme on meeting the secondary prevention objectives at 2 years after ACS. The secondary objective is to evaluate the morbidity and mortality in this group. In the absence of a control group, a comparison with data in the literature will be done. However the primary objective enables us to conclude on the impact of this effect, insofar as these objectives are defined by the scientific community. The set objectives are defined according to the following criteria: LDL cholesterol below 3.35mmol/L (current criteria during the patient inclusion period), HDL cholesterol above 1.03mmol/L, triglycerides below 1.69mmol/L, blood pressure below 140/90mmHg, HbA1c below 7%, waistline below 102cm for men and 98cm for women.

Definitions for statistical analysis

The initial protocol was validated by the team of methodologists at the CHU.

The data were analysed through descriptive and analytical statistics. The category variables, the descriptive statistics were reported as numbers and percentages. The difference in distribution of certain category variables was examined by using a Chi-square test. A paired t -test was used to compare continuous variables. Analyses were performed using the Statview 5.0.1 software and verifying using STATA. A value of p <0.05 was considered significant.

Results
Initial characteristics of the ACS and extension of the atheroma

From January 2001 to July 2004, 685 consecutive men and women were hospitalised for a coronary syndrome. Six hundred and sixty patients were hospitalised again at 3 months, while 20 patients refused hospitalisation and five patients deceased over the same period. The cardiac and vascular demographic data and the characteristics of the treatment for these patients are shown in Table 1.

Over 40% of patients had a significant coronary stenosis in two or three vessels and one third of patients had carotid atheromatous plaques, while over 20% presented with an arterial disease of the lower limbs diagnosed through an ABI below 0.9 or above 1.4 with or without intermittent claudication.

Following hospital discharge after the coronary syndrome, 97.9% of patients received a β-blocker or a calcium antagonist, 94.3% took cholesterol-lowering medication, 100% were treated with an antiaggregate, 82% received an angiotensin converting enzyme inhibitor or an angiotensin II receptor antagonist (Table 2).

Cardiovascular risk factors at 3 months and follow-up

The average follow-up time was 621 days (interquartile 492–730) from the initial episode of the ACS. Two patients were lost to follow-up (0.4%). The rate of available information concerning lifestyle, risk factors, laboratory parameters and treatments collected at the time of follow-up was over 95%.

The medicinal treatments at the time of follow-up were the following: 96.3% of patients were on antiaggregates, 86.0% were on β-blockers or Verapamil®, 62.4% were on ACE inhibitors or AT2 receptor agonist, and 88.4% were on cholesterol-lowering medication. Moreover, 75.5% of patients took an antiaggregate, a β-blocker or Verapamil® and a cholesterol-lowering medication simultaneously (Table 2). Besides, 3.7% of patients did not take an antiaggregate, of which half were due to gastric intolerance or the need for an oral anticoagulant treatment and the other half for no known reason.

The prevalence and distribution of risk factors at 3 months and at follow-up are included in Table 3. Therapeutic control of LDL cholesterol levels was achieved in 81.5% of patients (with a recommended LDL target level below 3.35mmol/L at the time of the study). Among the patients with an LDL cholesterol level above 3.35mmol/L, 30% had stopped their statin medication, of which half were due to muscular or hepatic intolerances. A third of them were on a low-strength statin.

Therapeutic control of blood pressures was achieved in 71.1% of patients. In patients with ongoing hypertension, only 16% had a systolic pressure above 160mmHg. The 3-month evaluation of the whole population revealed that 6.7% presented electrical left ventricular hypertrophy and 23.6% presented echocardiographic left ventricular hypertrophy.

The glycaemic parameters were correctly controlled with stable values in the follow-up period.

Tobacco control was improved with the intervention of a smoking cessation specialist in resistant smokers who had not quit during the first 3 months after ACS. After intervention by the specialist, 18% of smokers quit during the follow-up. Surprisingly, some former smokers (patients who no longer smoked at the time of ACS) resumed their tobacco use during the follow-up. In total, 18.6% of patients smoked at follow-up after the ACS compared with 16.8% at 3 months.

We noticed a significant decrease in the triglyceride levels, stable BMI and improvement in physical activity (Table 4).

Clinical events

During the 20 months of follow-up after hospital discharge for ACS, the total mortality rate was 4.3%. During the 17 months of follow-up after the intervention at 3 months, 3.6% of patients were deceased: 2.4% died of cardiovascular diseases (fatal myocardial infarction and sudden death) and 1.2% from cancer (seven patients) or pulmonary embolism (one patient). We recorded a total of 12% cardiovascular events including 6.5% major events (cardiovascular death, ACS or cerebrovascular accident). Details of the clinical events are listed in Table 4.

We demonstrate that there is no significant difference in the rates of cardiovascular events at 20 months in the less than 65 years and more than 65 years groups.

Discussion

The programme proposed by the CEPTA focuses on optimising secondary prevention management by combining coronary patient information and education, clinical and paraclinical evaluations of their ischaemic cardiomyopathy and cardiovascular risk, and drug and dietary interventions. This study demonstrates the need for the long-term evaluation of the acute episode due to the persistent number of risk factors at 3 months. It also demonstrates the feasibility and efficacy of this short programme, staggered in time compared with the acute event, and the overall impact of management of atherosclerosis in patients after an ACS on their treatment compliance and reduction of their cardiovascular risk.

Previous studies have reported the impact of programmes intended to improve risk factors in coronary patients or to improve their level of treatment, specifically in lipid-lowering specialised centres or in cardiac rehabilitation programmes [11, 12, 13, 14, 15, 16]. We were inspired by this already validated type of system to develop a more global approach to atherosclerotic disease. We noticed how long-term control of risk factors failed in several studies, especially in patients after cardiac rehabilitation. It is whilst considering this time restriction that we developed a programme at 3 months after the onset of ACS, a time when patient motivation decreases and when risk factors reappear. On the other hand, this visit after 3 months enables a reliable evaluation of the persistent or recurrent myocardial ischaemia, the myocardial function, and the risk factors at the same time. The main points of the programme that we developed are summarised as followed:

the programme is conducted by cardiologists because it has been shown that they more readily use recommended therapeutic strategies to improve the coronary condition of patients [15, 17];
the group made up of cardiologists, specialist nurses and a psychologist developed a tailor-made programme to manage the coronary disease of each patient (with a combination of patient information on the main practical rules, patient education, appropriate consultations and adapted quality care offered [18, 19, 20]. This type of intervention proved to be effective in improving coronary risk factors, reducing hospital admissions and improving the quality of life or functional abilities of coronary patients;
the programme included implementing secondary prevention measures immediately after ACS before hospital discharge. This early start proved to be effective in improving therapeutic dosage, long-term compliance of the patient and clinical events [12, 21];
special attention was made to adjusting the medication dose in relation to the risk level. Most coronary patients have not reached the recommended LDL cholesterol target levels, specifically due to underdosage of the cholesterol-lowering medication [5]. Insufficient medication was identified as a predictive factor independent of the coronary event after the ACS [22]. This insufficient medication adjustment may be extended to other risk factors, specifically hypertension and or diabetes [23, 24];
the uniqueness of our programme lies in a hospital stay lasting 48h, 3 months after ACS. It has been shown that the benefit of cardiac rehabilitation following ACS is only partially maintained during the first year [25, 26]. For example, among the patients who were prescribed the key medications following their discharge from rehabilitation, 8 to 20% no longer took this drug after 6 months [27]. The reasons for this poor long-term compliance are complex, but we have shown that a staggered programme is a better strategy to target the compliance problem and to improve the long-term outcome of the coronary patient.

A multifactorial approach requires a structured and intensive strategy that goes beyond the simple treatment of blood cholesterol or hypertension, by addressing the extension of the atheroma and its consequences, and all cardiovascular risk factors. This programme does not use any new medications or a behaviour modification model, but includes an introduction and tailor-made adjustment of medications in relation to the established targets, and explanations on the relevance of each medication taken by the patient [27]. In this study, we observed a positive impact on the adherence to treatment 20 months after ACS with platelet antiaggregates, β-blockers or statin. This adherence is well above the one observed in the French cohort of Euroaspire II, in which the average follow-up period was much shorter [5]. The rate of treatment discontinuation in the GRACE Registry was 8% for aspirin, 12% for β-blockers and 13% for statins at 6 months, namely a higher discontinuation rate than our cohort for a shorter follow-up period [27].

This is reflected in a reduction of long-term risk factors with better efficacy on the secondary prevention objectives. In the absence of a control group, this study does not enable us to evaluate the impact of this programme on cardiovascular events, but the rate of cardiovascular events or of death is decreased by half compared with the results recently published on this type of patient cohort. In the GRACE registry, the death rate at 6 months in ACS survivors is 4.8% in patients presenting myocardial infarction with ST-segment elevation and 6.2% in patients presenting with ACS without ST-segment elevation [6]. Mortality in our study is decreased by nearly half and yet our follow-up is three times longer. Moreover, the mortality rate of patients is more than half lower than that reported in the USIC 2000 study, which studied the mortality at 1 year after myocardial infarction [28, 29].

A significant limitation of our study is the lack of a control group. We had planned to study the patient group which would not have agreed to undergo the programme 3 months after their ACS but only 20 patients refused this programme. On the other hand, management during the acute phase and especially the high rate of direct angioplasties may have a positive impact on long-term events.

The characteristics of this population are comparable to those reported in the ACS series, with a great proportion of men presenting with an ACS and ST-segment elevation and a high percentage with anterior infarction. The 5% rate of heart failure or recurrence of ACS during the acute phase is comparable with the published data and demonstrates the severe myocardial condition of our patients. The prevalence of diabetes or peripheral arterial disease is also comparable with the reported series.

Regardless, this study demonstrates the benefit of a global and staggered management of atherosclerosis in 660 consecutive patients 3 months after ACS on the long-term control of risk factors and adherence to treatment, which are determining elements in reducing the cardiovascular morbidity and mortality after ACS.


Acknowledgment

We are indebted to the members of the CEPTA team: dieticians, nurses and psychotherapist.

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