Summary
Background
The AntiPlatelet Therapy Observational Registry (APTOR) was a prospective observational study of acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) in France, Spain, and the UK.
Aims
To evaluate patterns of ACS healthcare use, focusing on APTOR results from France.
Methods
Consecutive presenting ACS patients requiring PCI were recruited between January and August 2007. Treatments and outcomes were recorded from the qualifying ACS event to 12 months follow-up.
Results
In France, qualifying diagnosis was unstable angina/non-ST-segment elevation myocardial infarction (UA/NSTEMI) in 255 (53%) patients and ST-segment elevation myocardial infarction (STEMI) in 228 (47%) patients. Ninety-six percent underwent PCI with stent implantation. Drug eluting stents were used less frequently in France (22%) than Spain (54%) or the UK (42%). In France, antiplatelets were more frequently received in the ambulance (21%); a 200–299 mg aspirin-loading dose was most frequently received (50%) and more than a third of patients received a clopidogrel-loading dose of over 300 mg (34%). At 12 months in France, 86% were still receiving aspirin, 75% clopidogrel, and 73% combination treatment.
Conclusion
There was considerable country-variation in ACS management. These results provide a benchmark of physician practice to compare with guidelines.
Résumé
Contexte
AntiPlatelet Therapy Observational Registry (APTOR) était une étude observationnelle prospective des patients avec un syndrome coronarien aigu (SCA) traités par angioplastie coronarienne percutanée (ICP) en France, Espagne et Angleterre.
Objectifs
Évaluer les tendances d’utilisation de soins pour les SCA, plus précisément les résultats d’APTOR en France.
Méthodes
Les patients consécutifs se présentant avec un SCA nécessitant une ICP ont été inclus entre janvier et août 2007. Les traitements et les événements cliniques ont été collectés entre le SCA initial et le suivi à 12 mois.
Résultats
En France, le diagnostic initial était un angor instable/infarctus du myocarde sans sus-décalage du segment ST (UA/NSTEMI) pour 255 (53 %) patients et un infarctus du myocarde avec sus-décalage du segment ST (STEMI) pour 228 (47 %) patients. Quatre-vingt seize pour cent ont eu une ICP avec implantation de stent. Les stents actifs étaient moins souvent utilisés en France (22 %) qu’en Espagne (54 %) ou qu’en Angleterre (42 %). En France, les traitements antiplaquettaires étaient plus souvent prescrits dans l’ambulance (21 %) ; la dose de charge d’aspirine 200-299 mg était la plus souvent prescrite (50 %) et plus d’un tiers des patients ont reçu une dose de charge de clopidogrel supérieure à 300 mg (34 %). À 12 mois en France, 86 % des patients prenaient toujours l’aspirine, 75 % le clopidogrel et 73 % l’association des deux.
Conclusion
D’importantes disparités existaient entre les pays pour la prise en charge des SCA. Ces résultats permettent d’illustrer les pratiques des médecins et de les comparer aux recommandations.
Background
ACS is an umbrella term for a set of pathophysiological cardiovascular signs and symptoms and is a leading cause of morbidity and mortality in Western Europe responsible for considerable healthcare costs . ACS symptoms can be seen as a continuum ranging from UA to NSTEMI to STEMI. Treatment of ACS typically begins in the acute phase and includes interventional therapy with PCI or CABG as well as antithrombotic treatment. The oral antiplatelets aspirin and clopidogrel are considered the baseline standard of care.
The ACC/AHA and ESC guidelines recommend early diagnostic cardiac catheterisation and PCI within 2 hours for STEMI patients and 72 hours for NSTEMI patients, together with dual antiplatelet therapy for at least 12 months . Despite the availability of guideline recommendations, variation in ACS management and PCI practice patterns are evident between countries. Although a number of studies on ACS management have been published, specific details on European patient management strategies, particularly beyond hospital discharge, are lacking.
The APTOR was a 12-month, prospective, observational study of ACS patients undergoing PCI between January and August 2007 in three European countries: France, Spain, and the UK. The main purpose of APTOR was to provide ‘real world’ information on country-specific patterns of healthcare use in ACS patients, to provide a benchmark for comparison with current guidelines and therefore ultimately direct future patient care. The researchers were also interested in exploring variations between countries. The purpose of this current manuscript is to evaluate treatment practice patterns in ACS patients undergoing PCI, focusing on APTOR study results from France.
Methods
Ethical conduct of the study
The study was carried out in accordance with guidelines for Good Clinical Practice and Good Pharmacoepidemiology Practices. The study was approved wherever required by law by an independent ethics committee. All patients gave written consent to release information.
Study design
Full details of the APTOR methods and population are reported elsewhere . Briefly, APTOR was a 12-month, non-interventional, prospective, observational, cohort study that enrolled patients presenting with ACS and requiring PCI between January and August 2007 at 122 sites in France (71 sites), Spain (22 sites), and the UK (29 sites). Data were collected about country-specific patterns of healthcare use in ACS patient management at teaching and non-teaching centres. In France, in order to get a broad representation of ACS patients, all interventional cardiologists from all coronary angioplasty units (approximately 1000) were solicited by mail to participate and were asked to enrol on an average of 10 consecutive presenting patients with no more than 30 patients per site. In the other countries, fewer sites were solicited and were asked to enrol more patients. Following enrolment, patient care and treatment strategies were at the discretion of the physician.
Study population
Patients were required to be at least 18 years of age with a diagnosis of ACS requiring PCI with either initiation or continuation of any antiplatelet therapy. Patients who were simultaneously participating in another study including an investigational drug or procedure were excluded from this study. Once the study was initiated at a site, all consecutive presenting ACS patients who were undergoing PCI with associated antiplatelet therapy were invited to join the study.
Outcome measures
The study design is shown in Fig. 1 . Demographic characteristics, medical history, qualifying ACS diagnosis (UA, NSTEMI, or STEMI), clinical characteristics, medical treatments and procedures, and clinical outcomes were recorded for each patient using an electronic web-based data collection system at hospital admission (baseline), time of PCI, hospital discharge, and at follow-up at 3 months after hospital discharge and 12 months after PCI. In-hospital measures were collected by review of hospital records by trained nurses and physicians. Postdischarge data were collected by primary care physicians.
Statistical methods
The data were evaluated by standard exploratory and descriptive summary statistics: median, IQR, frequency, and percentage. P values, ORs, and 95% CIs are reported for comparisons between France and the two combined countries, Spain and the UK; these are taken from logistic regression models which adjusted the country difference by potential confounders (the models included age, type of qualifying ACS, weight, sex, and past medical history). Logistic regression models were run to compare country differences on use of drug eluting stents, time from ACS to PCI in STEMI and UA/NSTEMI patients, clopidogrel loading dose administered in the ambulance, clopidogrel use before ACS event, statin use before ACS event, and dual antiplatelet use at 12 months. Analyses were done using SAS version 9.1.
Results
Patients studied
One thousand five hundred and sixty-three ACS patients were enrolled into the full APTOR study; of these, 1525 patients (98%) were eligible for analysis. In France, 497 patients were enrolled by 59 interventional cardiologists from public university hospitals (36%), public non-university hospitals (45%), and private hospitals (19%). 483 patients (97%) were eligible for analysis. Of the 14 patients (3%) not eligible for analysis, the reasons for exclusion were: patient did not have an ACS diagnosis ( n = 11), patient did not present within the normal course of care for PCI ( n = 9), and patient did not provide consent to release information ( n = 3); note: patients could have more than one reason for exclusion.
Demographic and baseline characteristics by qualifying ACS event and country are summarised in Table 1 . The French cohort had a median age of 59 years compared with 62 years for both Spain and the UK. The French cohort also had the lowest number of female patients and rates of previous vascular events and procedures, MI, and stroke.
| France | Other countries | ||||
|---|---|---|---|---|---|
| Qualifying ACS event | |||||
| UA/NSTEMI ( n = 255) | STEMI ( n = 228) | Total ( n = 483) | Spain ( n = 538) | UK ( n = 504) | |
| Qualifying ACS event, n (%) | |||||
| UA/NSTEMI | – | – | 255 (52.8) | 361 (67.1) | 327 (64.9) |
| STEMI | – | – | 228 (47.2) | 177 (32.9) | 177 (35.1) |
| Age, years | |||||
| Median (IQR) | 61 (54, 72) | 58 (50, 69) | 59 (52, 71) | 62 (53, 72) | 62 (53, 70) |
| ≥ 75 years, n (%) | 51 (20.0) | 36 (15.8) | 87 (18.0) | 99 (18.4) | 70 (13.9) |
| Sex, n (%) | |||||
| Male | 215 (84.3) | 182 (79.8) | 397 (82.2) | 420 (78.1) | 371 (73.6) |
| Female | 40 (15.7) | 46 (20.2) | 86 (17.8) | 118 (21.9) | 133 (26.4) |
| Median (IQR) height, cm | – | – | 170 (165, 176) | 167 (160, 172) | 170 (164, 178) |
| Median (IQR) weight, kg | – | – | 79 (70, 90) | 78 (70, 85) | 81 (71, 92) |
| Median (IQR) BMI | 27.0 (24.2, 29.7) | 26.9 (24.6, 29.7) | 27.0 (24.5, 29.7) | 27.9 (25.7, 30.8) | 27.7 (24.8, 30.7) |
| Previous diagnosis of vascular event, n (%) | – | – | 123 (25.5) | 236 (43.9) | 197 (39.1) |
| Undergone previous vascular procedures, n (%) | – | – | 83 (17.2) | 113 (21.0) | 98 (19.4) |
| Medical history, n (%) | |||||
| Diabetes | 50 (19.6) | 28 (12.3) | 78 (16.1) | 165 (30.7) | 62 (12.3) |
| Previous MI | 38 (14.9) | 18 (7.9) | 56 (11.6) | 148 (27.5) | 129 (25.6) |
| Previous stroke | 4 (1.6) | 3 (1.3) | 7 (1.5) | 13 (2.4) | 13 (2.6) |
Among French patients, the qualifying ACS diagnosis was UA in 85 patients (18%), NSTEMI in 170 patients (35%), and STEMI in 228 patients (47%). A STEMI diagnosis was more common in France than in Spain or the UK, and in the overall APTOR population (38%). On average, STEMI patients had the lowest age and rate of cardiovascular risk factors including diabetes and previous MI compared with NSTEMI patients in France.
Revascularisation and stent use
In the APTOR study overall, 1504 patients (99%) underwent PCI and 1411 patients (93%) underwent stent implantation.
Revascularisation and stent use by country is shown in Table 2 . In France, 96% of patients received stents compared with 85% in the UK and 97% in Spain. The use of DES was considerably lower in France (22%) than in Spain (54%) or the UK (42%; France versus Spain and the UK: OR 0.28; 95% CI 0.22, 0.37; p < 0.0001). In France, and in the APTOR study overall, more than one stent was used in approximately one third of patients. Stent use was the same in UA/NSTEMI and STEMI patients in France (96%), but slightly higher in STEMI patients in APTOR overall (UA/NSTEMI: 91%; STEMI: 95%).
| France ( n = 483) | Spain ( n = 538) | UK ( n = 504) | |
|---|---|---|---|
| PCI procedure, n (%) | 481 (99.6) | 533 (99.1) | 489 (97.0) |
| With stent, n (%) | 462 (95.7) | 521 (96.8) | 428 (84.9) |
| BMS | 305 (63.1) | 143 (26.6) | 187 (37.1) |
| DES | 104 (21.5) | 290 (53.9) | 209 (41.5) |
| BMS + DES | 48 (9.9) | 85 (15.8) | 27 (5.4) |
| > 1 stent | 165 (35.7) | 245 (47.0) | 179 (41.8) |
| Days from ACS event to PCI | |||
| All patients, median (IQR) | 1 (0, 2) | 1 (0, 4) | 4 (1, 8) |
| STEMI < 1 day, n (%) | 136 (60.7) a | 98 (57.7) | 65 (39.2) |
| UA/NSTEMI ≤ 3 days, n (%) | 202 (81.1) b | 214 (64.9) | 91 (31.6) |
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