Magali Sartral

Differences in the use of guideline-recommended therapies among 14 European countries in patients with acute coronary syndromes undergoing PCI

Aims: Despite common European Society of Cardiology recommendations, adherence to guideline therapy varies, both temporally and geographically. We sought to examine current differences in the use of guideline-recommended therapies among 14 European countries in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). Methods and Results: Data were obtained from the Antiplatelet Therapy Observational Registry (APTOR), a non-interventional, prospective observational cohort study enrolling patients with ACS undergoing PCI. Medication data were captured through 1 year. The large majority of patients in the APTOR registry received statins at hospital discharge (89%) and remained on statins at 1 year (87%), a finding that was consistent across countries. Likewise, beta-blocker use was similar at discharge and 1 year (83 and 81%, respectively). There was large disparity in aspirin loading dose between countries, but the discharge maintenance dose was more consistent, with most receiving ≤100 mg (87%). While 95% of patients were discharged on dual antiplatelet therapy, 71% remained on both treatments by 1 year, with wide variation by country in 1-year use. Conclusions: These data from the APTOR study provide key information on current European ACS patient care management from hospitalization through 1 year. Even with European Society of Cardiology (ESC) guidelines, variations in practice patterns exist among ACS patients treated with PCI between the 14 European countries studied, including the use of proven therapies, as well as appropriate duration and dosing of antiplatelet regimens. Efforts are needed to further explain why such variation exists and to continue to improve adherence to ESC guidelines to improve patient care.

Treatment patterns in patients with acute coronary syndrome undergoing percutaneous coronary intervention

Abstract Background: The Antiplatelet Therapy Observational Registry (APTOR) is a prospective observational study of acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) in a ‘real world’ clinical setting. Here the authors report on the management of ACS patients in three European countries during the hospital phase and through 12-months’ follow-up, including use of antiplatelet agents, co-medications and stents, as well as clinical outcomes at 12 months. Methods: ACS patients undergoing PCI (N = 1525) from January to August 2007 were planned to be consecutively recruited in France, Spain and the UK. Results: Index diagnosis was unstable angina/non-ST-segment elevation myocardial infarction (MI) in 62% and ST-segment elevation MI in 38%. Prior to the index ACS event, 17% were prescribed both aspirin and clopidogrel. While in-hospital clopidogrel and aspirin use was similar across countries, considerable variation was observed between countries at 12 months (clopidogrel 66–75%; aspirin 86–95%). The UK most frequently used a 300-mg clopidogrel loading dose (70%) compared with France (53%) and Spain (56%), while >300 mg was used in 21%, 34% and 16% patients, respectively. Bare metal stents only were used in 42% of subjects, drug-eluting stents (DES) only in 40%, and both in 10%, with the highest rates of DES use in Spain (70%) followed by the UK (47%) and France (31%). The composite endpoint of cardiovascular (CV) death, MI or stroke occurred in 4.7% of patients by 12 months. Conclusions: APTOR shows marked variation in ACS management between countries in antiplatelet therapy, co-medications and stent use. Due to the observational design of the registry, statistical testing was not applied and data should be seen as hypothesis generating. These data provide a useful benchmark for comparison with current guidelines.

Predictors, cost, and outcomes of patients with acute coronary syndrome who receive optimal secondary prevention therapy: results from the antiplatelet treatment observational registries (APTOR).

BACKGROUND We sought to evaluate outcomes, costs of care, quality of life and predictors at 12 months in patients with an acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI) and evaluated use of optimal secondary prevention therapy, defined as use of aspirin and clopidogrel along with ≥ 3 of the following 4 therapies at both hospital discharge and at one-year post-PCI: statins, beta-blockers, ARB/ACE-inhibitors, and exercise or diet. METHODS Data were from the prospective, observational APTOR study of 14 European countries from 2007 to 2009 (n=4184 patients). RESULTS Optimal therapy was received in 43% of patients. Use of optimal therapy varied significantly by country. Diet or exercise at 1 year was more likely prescribed to the optimal cohort (34% vs 16%) as was dual antiplatelet therapy (99% vs 49%). Rates of CV event (3.1% vs 3.5%), bleeding (2.9% vs 2.8%) and mortality (0.9% vs 1.3%) at 1 year were similar between the optimal and non-optimal cohorts, respectively. Total costs were similar for both cohorts, but differences in post-discharge costs were observed (optimal: £1760 [£1682-£1844]; non-optimal: £1492 [£1434-£1554]), primarily due to post-discharge medication and resource use. CONCLUSIONS In conclusion, in this contemporary, European ACS-PCI registry, optimal therapy was low (<50%) overall, particularly for diet or exercise and dual antiplatelet therapy, highlighting a considerable gap between evidence-based guidelines and implementation of such treatments. Whether this gap reflects a missed opportunity to improve patient outcomes or whether it reflects appropriate deviation from guidelines by front-line clinicians requires further investigation.

Treatment, outcomes, costs, and quality of life of women and men with acute coronary syndromes who have undergone percutaneous coronary intervention: results from the antiplatelet therapy observational registry.

Abstract Background: Treatment, outcomes, costs, and quality of life after percutaneous coronary intervention (PCI) were compared between women and men with acute coronary syndromes (ACS) using data from the Antiplatelet Therapy Observational Registry (APTOR). Methods: Fourteen European countries participated in this noninterventional, prospective, observational cohort registry, which enrolled patients with ACS who underwent PCI from 2007 to 2009. The 12-month outcomes included bleeding, cardiovascular events, and mortality. Quality of life was measured using the EQ-5D™ (EuroQol Group) health index and the visual analog scale. Results: The APTOR registry included 4546 patients, of whom 1047 (23%) were women and 3499 (77%) were men. The women were older (mean age, 67 vs 61 years) and had higher rates of diabetes mellitus and hypertension. A greater proportion of the men were smokers (40% vs 30%). Approximately 70% of the patients underwent PCI on the day of the qualifying ACS event. Women and men received similar medications at the time of PCI, hospital discharge, and 12-month follow-up visit. Bleeding, cardiovascular events, and mortality occurred at higher rates in women than in men, but the differences were not statistically significant. At 12 months post-PCI, women reported lower quality-of-life scores on the EQ-5D™ health index and the visual analog scale than did men. The mean total cost of care was £6252 (€7189) for women and £5841 (€6717) for men; the differences may be driven by resource use after discharge from the hospital. Conclusion: Women with ACS tended to be older and had more comorbidities than men, but both sexes experienced similar outcomes after 1 year. This study indicated no differences in treatment between sexes.

International data on supportive therapies at 1 year in acute coronary syndrome patients undergoing PCI: results from the APTOR study.

Background: Supportive therapies of exercise and diet-modifying secondary prevention programmes are associated with reduced morbidity and mortality in acute coronary syndrome (ACS) patients. We sought to evaluate the frequency and correlates of referral to these supportive therapies, and their impact on concordance with prescribed secondary prevention medications at 1 year among ACS patients undergoing percutaneous coronary intervention (PCI) in three European countries. Design/Methods: Data on referral for exercise and diet supportive therapies were collected at discharge through to 1 year in the Antiplatelet Therapy Observational Registry (APTOR) prospective observational study conducted in France, Spain and the UK in 1335 patients. Results: 40% of patients received referral for exercise or diet, while three out of five patients received neither, with large variation between countries. Predictors of recommendation for either diet or exercise when excluding country were enrolment in a non-teaching centre (odds ratio [OR] 1.62, 95% CI [confidence interval] 1.33–1.97, p < 0.0001) and use of only a bare metal stent during PCI (OR 1.59, 95% CI 1.30–1.92, p = 0.0002), while weight and BMI had no bearing. Patients recommended either diet or exercise programmes had significantly more secondary prevention medication rates for each of the five predefined evidence-based BASIC (beta-blockers, aspirin, statins, ACE-inhibitors/ARBs and clopidogrel) medication therapies at 1 year. Conclusion: Following an ACS treated with PCI, by 1 year the majority of European patients were not recommended supportive therapies of exercise and dietary secondary prevention programmes, which have previously been associated with reduced morbidity and mortality and are recommended in the guidelines. Those recommended such therapies had considerably improved concordance with evidence-based therapies such as aspirin, clopidogrel and statins prescribed at 1 year. These data show a need for greater adherence to the European guidelines to ensure ACS patients are recommended such therapies.

A prospective observational study of treatment practice patterns in acute coronary syndrome patients undergoing percutaneous coronary intervention in Europe.

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 200-299mg aspirin-loading dose was most frequently received (50%) and more than a third of patients received a clopidogrel-loading dose of over 300mg (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.

Treatment patterns in acute coronary syndrome patients in the United Kingdom undergoing PCI

AIMS To evaluate practice patterns in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI), focusing on the United Kingdom (UK). METHODS AND RESULTS The Antiplatelet Therapy Observational Registry (APTOR) is a prospective observational study of consecutive ACS patients undergoing PCI (N=1525) from January-August 2007 in the UK, France, and Spain. In the UK, median time from hospital admission to PCI was one day post-admission (IQR 0,4) among STEMI patients and five days (IQR 2,9) among unstable angina/non-ST-segment elevation myocardial infarction (UA/NSTEMI) patients. Patients in the UK most frequently received a 300 mg aspirin loading dose (85%), 300 mg clopidogrel loading dose (70%), and 75 mg clopidogrel maintenance dose (99%). Loading dose was given on the day of hospitalisation to 80% of STEMI patients and 68% of UA/NSTEMI patients. Clopidogrel was discontinued by 12 months in 30% of UK patients. Length of hospitalisation was similar between the three countries. CONCLUSIONS Despite established consensus guidelines for ACS patient management, APTOR data show disparity in management practices for ACS patients undergoing PCI in the UK and two other European countries. These data can help provide focus for areas of ACS management requiring improvements to meet guideline therapy, including reducing time from hospitalisation to PCI and maintaining 12 months of dual antiplatelet therapy for all ACS patients undergoing stenting.

001 Risk of cardiovascular and bleeding events and mortality in patients with chronic kidney disease and acute coronary syndrome undergoing percutaneous coronary intervention: the APTOR-II study

Jean Ferrieres [Orateur] (1), Guy Berkenboom (2), Zdenek Coufal (3), Stefan James (4), Attila MohaCsi (5), Gregory Pavlides (6), Kirsi Norrbacka (7), Magali Sartral (8), Marie-Ange Paget (8), Molly Tomlin (9), Uwe Zeymer (10) (1) CHU Rangueil, Cardiologie B, Toulouse, France – (2) ULB Erasme University Hospital, Department of Cardiology, Brussels, Belgium – (3) Batova Krajska Nemocnice Zlin, Department of Cardiology, Zlin, Republique Tcheque – (4) Uppsala University Hospital, Dept. of Cardiology and Uppsala Clinical Research Center, Uppsala, Suede – (5) Gottsegen Institute of Hungarian Cardiology, Budapest, Hungaria – (6) Onassis Cardiac Surgery Center, Kallithea, Grece – (7) Lilly Research Laboratories, Eli Lilly and Company, Vantaa, Finlande – (8) Lilly Research Laboratories, Eli Lilly and Company, Paris, France – (9) Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, United-States – (10) Klinikum Ludwigshafen, Ludwigshafen, Allemagne

030 Management of patients with acute coronary syndrome undergoing percutaneous coronary intervention: one year follow-up results from the French cohort in the AntiPlatelet Treatment Observational study

Purpose To describe antiplatelet treatment patterns over 12 months in patients with acute cornary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). Methods The AntiPlatelet Treatment Observational Registry (APTOR) is a prospective, international observational study that recruited ACS patients undergoing PCI in 2007-08, capturing practice patterns, treatment and ressources use over 12 months. Interventional cardiologists collected data from ACS event to hospital discharge and general practitioners and cardiologists collected follow-up data. Results 483 eligible ACS-PCI patients had mean age 61 (13) years, mean weight 80 (15) kg, were 18% female, 47% with ST-elevation MI (STEMI) and 53% with unstable angina or non-ST elevation MI (UA/NSTEMI). Follow-up data up to 12 months are available for 396 (82%) patients. Among patients who were discharged and had follow-up data, 94% were receving clopidogrel at time of hospital discharge. Cardiovascular combination therapy was prescribed as follows: aspirin (95%), statins (82%), beta-blockers (82%), ACE inhibitors/ARBs (68%); each of these treatments was globally maintained over 12 months. Lifestyle therapies increased over 12 months from 12% to 57% for formal diet program and 11% to 48% for formal exercise program. Over 12 months, on 394 patients, overall clopidogrel use was 94% at 30 days, 80% at 6 months, and 75% at 12 months. Amongst 83 patients who stopped clopidogrel before 12 months, 48% discontinued during the first three months. Conclusions These prospective data showed that after an ACS event 20% of patients have already dropped out their clopidogrel treatment at 6 months and 25% at 12 months.

PCV161 HEALTH CARE RESOURCES UTILIZATION IN ACUTE CORONARY SYNDROME PATIENTS ONE YEAR AFTER PCI : FRENCH RESULTS FROM THE ANTIPLATELET TREATMENT OBSERVATIONAL REGISTRY (APTOR)

PCV157 MEDICATION ADHERENCE AND PERSISTENCE OF CLOPIDOGREL IN ACUTE CORONARY SYNDROME PATIENTS WITH AND WITHOUT DIABETES MELLITUS Zhu B, Zhao Z, Bayt T, Bae JP, McCollam PL, Anderson J, LeNarz L Lilly USA, LLC, Indianapolis, IN, USA, Eli Lilly and Company, Indianapolis, IN, USA OBJECTIVES: The recent ACC/AHA guidelines recommend the use of clopidogrel for at least 1 year in ACS-PCI patients who are not at high risk of bleeding. However, use of clopidogrel may not meet this guidance due to compliance issues. In this study, 1-year compliance of clopidogrel by ACS patients with or without diabetes mellitus (DM) was studied. METHODS: A total of N 12,502 ACS patients, aged 18–64 years and hospitalized with a primary diagnosis of ACS between January 1, 2005 and December 31, 2006 were identified with complete 1-year follow-up eligibility and drug use information in the MarketScan claims database. Patients were categorized into two cohorts: DM (N 3040) and non-DM (N 9462). Adherence was measured by the medication possession ratio (MPR). Persistence was reported using the time from index hospitalization to the first gap of 30 days between exhausting the supplied medication and filling the next prescription. Adherence and persistence between cohorts was compared using propensity score-adjusted bootstrapping method. RESULTS: A total of 72.1% (2193/3040) DM patients and 76.1% (7197/9462, p 0.01) non-DM patients had at least 1 outpatient fill for clopidogrel in the 1-year after the index hospitalization. Among the clopidogrel users (64.9% PCI, 30.8% medical management, 4.3% CABG), the average MPR was 0.78 for DM patients and 0.80 for non-DM patients (p 0.189). Significantly lower persistence was observed for DM patients vs. non-DM patients (257.6 vs. 274.7 days, p 0.012). ACS patients undergoing PCI had significantly higher persistence compared to medical management patients (280.7 vs. 231.4 days, p 0.001 for DM; 285.7 vs. 254.6 days, p 0.001 for nonDM). CONCLUSIONS: Approximately three-fourths of patients in this study had used clopidogrel after being hospitalized for ACS. ACS patients with prior diabetic history were less likely to be persistent with medication than non-diabetic ACS patients. This finding might have clinical consequences since DM patients typically have higher risk of cardiac events.