Prasugrel Use in Real Life: A Report From the Outpatient Setting in France.

The objective of this study was to provide descriptive statistics on patterns of prasugrel usage in the outpatient setting in France. This retrospective study was conducted to describe treatment patterns for prasugrel in the outpatient setting in France using the Intercontinental Marketing Services (IMS) Disease Analyzer database, which collates electronic medical records updated by a nationally representative database of 1200 French general practitioners (GPs). Anonymous data were collected prospectively at each follow-up visit. The study population consisted of patients with ≥1 prescription for prasugrel in the outpatient setting from its launch date to 3 years post-launch. Patients were followed up from the date of the first prescription for prasugrel recorded in the database until they died, changed GP, or reached the end of the study, whichever came first. In France, the IMS Disease Analyzer included 1052 patients receiving ≥1 prescription of prasugrel from January 2010 until October 2012. Eighty-five percent of the population was male. The mean age was 58 years; 94.3% were age <75 years, and 95.0% weighed ≥60 kg. Of the total, 99.8% of patients were prescribed a daily maintenance dose of 10 mg, and 0.2% had a history of transient ischemic attack/stroke. Concomitant medications were antiplatelet agents (100%; aspirin, 93.7%), lipid-lowering agents (90.1%), ß-blockers (83.7%), angiotensin-converting enzyme inhibitors (62.2%), and anti-ulcer medications (55.1%). The results reflect good usage of prasugrel by French GPs in the outpatient setting, with excellent implementation of the Prasugrel European Summary Product Characteristics.

New antiplatelet agents in the treatment of acute coronary syndromes.

Effective antagonism of the P2Y12 platelet receptor is central to the treatment of acute coronary syndrome (ACS) patients, especially in the setting of percutaneous coronary intervention and stenting. According to consensus guidelines, early revascularization and intensive antiplatelet therapy are key to reducing the complications that arise from myocardial ischaemia and the recurrence of cardiovascular events. Until recently, clopidogrel was the key P2Y12 antagonist advocated, but due to several limitations as an antiplatelet agent, newer drugs with more predictable, rapid and potent effects have been developed. Prasugrel and ticagrelor are now the recommended first-line agents in patients presenting with non-ST-segment elevation ACS and ST-segment elevation ACS, due to large-scale randomized trials that demonstrated net clinical benefit of these agents over clopidogrel, as stated in the European guidelines. Although no study has directly compared the two agents, analysis of the data to date suggests that certain patient types, such as diabetics, those with ST-segment elevation myocardial infarction or renal failure and the elderly may have a better outcome with one agent over the other. Further studies are needed to confirm these differences and answer pending questions regarding the use of these drugs to optimize efficacy while minimizing adverse events, such as bleeding. The aim of this review is to provide an overview of the current P2Y12 receptor antagonists in the treatment of ACS, with a focus on issues of appropriate agent selection, timing of treatment, bleeding risk and the future role of personalized treatment using platelet function and genetic testing.

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.

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.

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.

Clinical outcomes, resource use, and costs at 1 year in patients with acute coronary syndrome undergoing PCI: results from the multinational APTOR registry.

BACKGROUND: Limited prospectively collected data are available on the total outcomes, cost estimates, and quality of life associated with treatment of acute coronary syndrome (ACS) through 1 year in a nonclinical-trial setting, or on the impact of new clinical events by 1 year on resource utilization and costs. METHODS: The Antiplatelet Therapy Observational Registry (APTOR) 12-month study followed 1,335 concurrently recruited ACS patients undergoing percutaneous coronary intervention (PCI) and treated with antiplatelet therapy from France, Spain, and the United Kingdom in a "real world" clinical setting. Data were collected on clinical events, resource utilization, quality of life, and cost estimates through 1-year follow-up. RESULTS: By 1 year, 14.4% (95% CI 12.7-16.4%) of patients experienced a clinical event of death, MI, stroke, unstable angina, urgent target vessel revascularization, or acute heart failure. Costs by 1 year were higher among those who had a new clinical event (£8,988, 95% CI £7,848, £10,395) as compared with those with no events (£5,809, 95% CI £5,486, £6,161). This increased cost was due to higher postdischarge resource use costs. Using the EQ-5D assessment at 1 year, quality of life was directionally lower in those patients who had experienced a new clinical event. CONCLUSIONS: The risk of experiencing a new clinical event during the year following an ACS, which was treated with PCI, remains high among European patients, with one-seventh of patients having a new event. These additional clinical outcomes reduce quality of life and increase health care expenditures, expanding the already high cost of treatment for ACS.

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.

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

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.