Summary
Background
The CONNECT study compared clinician adherence to guideline-recommended secondary prevention therapies prescribed at discharge for patients hospitalized for acute coronary syndrome (ACS) in those managed initially with percutaneous coronary intervention (PCI; revascularized) and those who did not undergo revascularization.
Methods
Patients aged greater than or equal to 18 years, hospitalized for a documented ST-segment elevation or non-ST-segment elevation ACS, were enrolled consecutively over 1 month at 238 sites in France.
Results
Compared with revascularized patients ( n = 870), non-revascularized patients ( n = 706) were significantly older, and a greater proportion were women, had high-blood pressure, type-2 diabetes or a history of atherothrombotic or cardiac disease, but a smaller proportion had a history of coronary angioplasty. On discharge, non-revascularized patients were prescribed beta-blockers, aspirin, statins, angiotensin-converting enzyme inhibitors or adenosine diphosphate receptor antagonists less frequently than revascularized patients. An adherence score greater than or equal to 80% (at least four of the five recommended agents prescribed at discharge) was found in 96.7% of revascularized patients and 74.4% of non-revascularized patients ( P < 0.001).
Conclusions
Despite a similar or even higher level of cardiovascular risk, non-revascularized ACS patients were prescribed guideline-recommended secondary prevention therapy less frequently than revascularized patients.
Résumé
Objectifs
L’étude CONNECT a comparé la prise en charge thérapeutique, à la sortie de l’hôpital au décours d’un syndrome coronaire aigu (SCA), des patients ayant bénéficié d’une revascularisation coronaire percutanée par rapport aux patients non revascularisés, au moyen d’un score d’adhésion aux recommandations européennes.
Méthodes
Les patients âgés d’au moins 18 ans, et présentant un SCA avec ou sans sus-décalage du segment ST, ont été inclus, de façon consécutive, sur une période d’un mois par 238 centres investigateurs français.
Résultats
Comparés aux patients revascularisés ( n = 870), les patients non revascularisés étaient significativement plus âgés, plus fréquemment des femmes, et présentaient plus souvent des antécédents d’hypertension artérielle, de diabète de type 2, d’insuffisance cardiaque, d’insuffisance rénale, avec une moindre fréquence d’antécédents d’angioplastie coronaire. À la sortie de l’hôpital, les patients non revascularisés bénéficiaient moins souvent d’un traitement par bêtabloquants, aspirine, statines, inhibiteurs de l’enzyme de conversion (IEC), antagonistes des récepteurs à l’ADP par rapport aux patients revascularisés. Un score d’adhésion aux traitements BASIC supérieur ou égal à 80 % (au moins quatre traitements recommandés présents sur l’ordonnance de sortie) était observé chez 96,7 % de patients revascularisés et chez 70,4 % de patients non revascularisés ( p < 0,001).
Conclusion
Alors même que leur niveau de risque était au moins équivalent sinon supérieur, les patients présentant un SCA et non revascularisés recevaient moins souvent à la sortie de l’hospitalisation les traitements validés par rapport aux patients revascularisés.
Introduction
Coronary disease remains the principal cause of death in the Western world, with acute coronary syndrome (ACS) contributing greatly to cardiovascular morbidity and mortality. The constant advances in the treatments available have made effective therapeutic management of ACS extremely complex . Recently, international clinical practice guidelines were published to define the optimum therapeutic strategies for the management of ACS by cardiologists . It is important for these guidelines to be implemented by cardiologists when treating patients with ACS because adherence to guidelines is associated with a better patient prognosis, not only in the acute phase of the syndrome but also in the long-term for secondary prevention .
The intervention-based strategy plays a major role in the management of acute-phase patients because of the cardiovascular benefits demonstrated in numerous randomized trials . International guidelines, European as well as North American, therefore advocate early coronary angiography in anticipation of revascularization . In France, this approach is facilitated by the often easy and rapid access to a department of interventional cardiology.
Several recent studies have found that the interventional management of patients hospitalized for ACS would appear to be followed by better secondary prevention management than that of non-revascularized patients . We designed and conducted the CONNECT study (“observational study of the adherence to international guidelines in the management of acute coronary syndrome patients both during hospitalization and at discharge, in revascularized as compared with non-revascularized patients”) to determine whether the same differences in patient management exist in hospitals in France, both for secondary prevention and during the acute phase, and the possible reasons for less than optimal management of patients who do not receive revascularization. The ultimate purpose of examining current management of ACS in France is to stimulate efforts to improve patient care.
Methods
The CONNECT study is a prospective, cross-sectional, observational, multicentre survey conducted in metropolitan France.
Hospital-based cardiologists in public or private cardiology units treating patients with acute-phase ACS were invited to participate in the survey. Patient management was entirely at the discretion of the treating physicians. Patient informed consent was not required. The study protocol was reviewed by the National Council of the Order of Physicians and was performed in accordance with French regulatory requirements, the Declaration of Helsinki and the principles of Good Epidemiologic Practice.
Patients
Male and female patients aged greater than or equal to 18 years who were hospitalized for ST-segment elevation ACS (Q-wave myocardial infarction [MI], STEMI) or non-ST-segment elevation ACS (non-Q-wave MI [non-ST-segment elevation myocardial infarction, NSTEMI]) and unstable angina, and who had not undergone coronary artery bypass graft (CABG) surgery for the present episode and who were not currently participating in a therapeutic trial of a medicinal product were enrolled in the study at the time of their discharge from hospital. Participating physicians recruited the first four consecutive patients who met the selection and revascularization criteria and the first four consecutive patients who met selection and non-revascularization criteria over the period of 1 month at each study center. Study investigators used the standard revascularization and non-revascularization criteria of their cardiology unit. Revascularization was by percutaneous coronary intervention (PCI), which was defined as coronary angioplasty with or without stenting. Patients in either group could receive fibrinolytic treatment; non-revascularized patients were not excluded if they received pharmacological reperfusion therapy with fibrinolytics.
Data collection
Physicians completed a standardized case report form to collect information on patient clinical characteristics, cardiovascular risk factors, medical history, clinical examination, laboratory test results, details of the intervention-based strategy, the treatments prescribed during the acute phase (hospitalization), treatments and reasons for non-prescription at discharge (for treatments for secondary prevention). Reasons were selected from the following list: absence of indication; contraindication; replaced by another therapeutic class; poor tolerability; deemed to have an inadequate benefit-to-risk ratio; refused by patient; and other.
Study endpoints
The main objective was to compare the therapeutic management at discharge of patients who had presented with ACS who underwent revascularization with those who received conservative treatment without revascularization, both overall and according to the type of ACS (with or without ST-segment elevation) by comparing the proportion of patients with a ‘good’ adherence score. Adherence scores were calculated by assigning one point for prescription of any of each of the following treatments as recommended for secondary prevention in the European Society of Cardiology guidelines on the management of ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation ACS (NSTE ACS): beta-blockers, aspirin, 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors (statins), and angiotensin-converting enzyme (ACE) inhibitors or adenosine diphosphate (ADP) receptor antagonists . One point was assigned when a treatment was not prescribed because of the presence of a contraindication to that treatment because this was considered to be adherence, and thus reducing bias in the interpretation of guideline adherence. The score for each patient was expressed as a percentage of the maximum possible score (five points). Good adherence was defined as an adherence score of greater than or equal to 80% (at least four of the five recommended treatments).
The secondary objectives included the following: a comparison between revascularized and non-revascularized patients (and according to the type of ACS) for clinician adherence to recommendations for patient management at discharge and patient management in the acute phase; an analysis of the predictors of clinician non-adherence; and an analysis of the reasons for lack of prescription of secondary prevention therapies on discharge. An exploratory analysis comparing the risk of death and ischaemic events in the NSTE ACS group (using the thrombolysis in myocardial infarction [TIMI] risk score ) between revascularized and non-revascularized patients was also conducted.
Statistical methods
Data from all patients enrolled in the study (the study population) were analyzed descriptively as follows: the sample size, mean and standard deviation ± SD, median and range from first to third quartile were calculated for continuous variables, and the number and percentage in relation to the total number of patients was calculated for qualitative variables. Patients in the non-revascularized group who had a normal coronary angiography result were excluded from the statistical analysis in order to avoid bias in interpretation of adherence to secondary prevention treatment.
The search for predictors of non-adherence was carried out using a multivariable logistic regression analysis incorporating variables such as characteristics of the evaluable patients. The statistical analyses were carried out using SAS software V8 (SAS Institute Inc, Cary, NC).
Results
A total of 1735 patients were recruited at 238 sites between September 2006 and June 2007, of whom 23 did not meet selection criteria. Thus, 1712 patients were included in the study population, of whom 870 patients were revascularized and 842 were not revascularized. In the latter group, 60% had a diagnostic coronary angiography of whom most had coronary lesions, but 136 had a normal result and were excluded from the evaluable patient population. Thus results are reported for 1576 patients.
Patients
Patient demographic and clinical characteristics are presented in Tables 1 and 2 . The mean age was 67.5 ± 14.7 years and there was a predominance of men (69.8% of patients). The proportion of overweight (body mass index [BMI] ≥ 25 kg/m 2 but < 30 kg/m 2 ) or obese (BMI ≥ 30 kg/m 2 ) patients was 43.3% and 18.6%, respectively. A family history of early onset coronary disease, smoking, dyslipidaemia, hypertension or diabetes mellitus was observed frequently in this cohort (20.9–59.2%). Of the 1576 patients, 553 had Q-wave MI (35.1%) and 1023 had NSTE ACS (64.9%). Of the latter, 528 had non-Q-wave MI and 495 had unstable angina.
| Revascularized patients | Non-revascularized patients | Total | P a | |
|---|---|---|---|---|
| Sex, n (%) | ( n = 870) | ( n = 706) | ( n = 1576) | < 0.001 |
| Male | 652 (74.9) | 448 (63.5) | 1100 (69.8) | |
| Female | 218 (25.1) | 258 (36.5) | 548 (30.2) | |
| Age (years) | ( n = 870) | ( n = 706) | ( n = 1576) | < 0.001 |
| Mean ± SD | 63.0 ± 13.9 | 73.0 ± 13.7 | 67.5 ± 14.7 | |
| Median (range b ) | 63.0 (52.0–75.0) | 76.5 (64.0–84.0) | 70.0 (56.0–80.0) | |
| Age in years, n (%) | ( n = 870) | ( n = 706) | ( n = 1576) | < 0.001 |
| < 50 | 161 (18.5) | 48 (6.8) | 209 (13.3) | |
| 50–59 | 215 (24.7) | 86 (12.2) | 301 (19.1) | |
| 60–69 | 167 (19.2) | 103 (14.6) | 270 (17.1) | |
| 70–79 | 210 (24.1) | 190 (26.9) | 400 (25.4) | |
| 80–89 | 113 (13.0) | 237 (33.6) | 350 (22.2) | |
| ≥ 90 | 4 (0.5) | 42 (5.9) | 46 (2.9) | |
| BMI (kg/m 2 ) | ( n = 837) | ( n = 675) | ( n = 1512) | 0.002 |
| Mean ± SD | 26.8 ± 4.2 | 26.2 ± 4.6 | 26.5 ± 4.4 | |
| Median (range b ) | 26.4 (24.1–29.1) | 25.8 (23.1–28.6) | 26.1 (23.7–28.9) | |
| BMI class in kg/m 2 , n (%) | ( n = 837) | ( n = 675) | ( n = 1512) | 0.084 |
| < 25 | 299 (35.7) | 278 (41.2) | 577 (38.2) | |
| 25–30 | 373 (44.6) | 281 (41.6) | 654 (43.3) | |
| ≥ 30 | 165 (19.7) | 116 (17.2) | 281 (18.6) | |
| Smoking, n (%) | ( n = 866) | ( n = 699) | ( n = 1565) | < 0.001 |
| Non-smoker | 301 (34.8) | 342 (48.9) | 643 (41.1) | |
| Stopped > 1 year previously | 248 (28.6) | 219 (31.3) | 467 (29.8) | |
| Stopped between 1 month and 1 year prior | 32 (3.7) | 21 (3.0) | 53 (3.4) | |
| Current smoker | 285 (32.9) | 117 (16.8) | 402 (25.7) | |
| Dyslipidaemia, n (%) | ( n = 868) | ( n = 703) | ( n = 1571) | 0.123 |
| Yes | 509 (58.6) | 385 (54.8) | ||
| Hypertension, n (%) | ( n = 870) | ( n = 705) | ( n = 1575) | < 0.001 |
| Yes | 467 (53.7) | 466 (66.1) | 933 (59.2) | |
| Type 1 or 2 diabetes mellitus, n (%) | ( n = 870) | ( n = 705) | ( n = 1575) | 0.003 |
| Yes | 200 (23.0) | 209 (29.6) | 409 (26.0) | |
| Family history of early onset c coronary disease, n (%) | ( n = 868) | ( n = 702) | ( n = 1570) | |
| Yes | 210 (24.2) | 118 (16.8) | 328 (20.9) | < 0.001 |
a All group comparisons were conducted using a Chi-square test with the exception of BMI and age, where a Wilcoxon test was used.
b Ranges are quoted for first to third quartiles.
c Defined as before age 55 years in men and 65 years in women.
| Revascularized patients ( n = 870) | Non-revascularized patients ( n = 706) | Total ( n = 1576) | P a | |
|---|---|---|---|---|
| History of | ||||
| NSTE ACS b | 291 (33.4) | 317 (44.9) | 608 (38.6) | < 0.001 |
| Q-wave MI | 238 (27.4) | 190 (26.9) | 428 (27.2) | 0.84 |
| Coronary angioplasty | 301 (34.6) | 115 (16.3) | 416 (26.4) | < 0.001 |
| Aortocoronary bypass | 21 (2.4) | 67 (9.5) | 88 (5.6) | < 0.001 |
| Known coronary stenosis ≥ 50% | 131 (15.1) | 171 (24.2) | 302 (19.2) | < 0.001 |
| Stable angina | 72 (8.3) | 128 (18.1) | 200 (12.7) | < 0.001 |
| Heart failure | 56 (6.4) | 153 (21.7) | 209 (13.3) | < 0.001 |
| Ischaemic CVA | 26 (3.0) | 56 (7.9) | 82 (5.2) | < 0.001 |
| PAD of the lower limbs | 54 (6.2) | 89 (12.6) | 143 (9.1) | < 0.001 |
| Current episode | ||||
| ≥ 2 episodes of angina in the 24 h preceding hospitalization | 316 (36.3) | 227 (32.2) | 543 (34.5) | 0.083 |
| Q-wave MI | 363 (41.7) | 190 (26.9) | 553 (35.1) | < 0.001 |
| Non Q-wave MI | 259 (29.8) | 269 (38.1) | 528 (33.5) | |
| Unstable angina | 248 (28.5) | 247(35.0) | 495 (31.4) | |
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