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.
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.
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 (TM) (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 (TM) health index and the visual analog scale than did men. The mean total cost of care was 6252 pound ((sic)7189) for women and 5841 pound ((sic) 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.
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
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.
To compare treatment and 12-month outcomes after percutaneous coronary intervention (PCI) of acute coronary syndrome (ACS) patients with and without diabetes mellitus (DM). Data were from APTOR, robust, prospective, observational registries of 14 European countries from 2007-2009. Kaplan-Meier (KM) estimates 12-months post-PCI were calculated for cardiovascular (CV) event (unstable angina [UA], non-ST-elevation myocardial infarction [NSTEMI], STEMI, urgent target vessel revascularization, acute heart failure, ischemic and hemorrhagic strokes or CV death), bleeding, and mortality. A total of 21% (N=942) of patients had DM (median age: 66yrs) and 79% (N=3603) did not have DM (median age: 61 yrs). More patients with DM tended to be women (28% vs. 20%); have hyperlipidaemia (64% vs. 47%) and hypertension (75% vs. 53%); and have prior MI (28% vs. 18%) or PCI (27% vs. 16%) compared to patients without DM. For DM/non-DM patients respectively, ACS presentation was 29%/21% with UA, 35%/30% with NSTEMI, 36%/49% with STEMI; the use of glycoprotein IIb/IIIa inhibitors was 28%/33% and the use of ≥1 drug-eluting stent (DES) was 52%/39%. DM/non-DM patients received similar treatment at hospital discharge and 12-months post-PCI with the exception of ARB/ACE inhibitors at discharge (75% vs. 69%) and 12-months post-PCI (79% vs. 71%). The respective DM/non-DM 12-month outcomes were 17.3% (95% CI: 14.8-19.7%) vs. 13.8% (12.7-15.0%) for CV event, 3.0% (1.9-4.1%) vs. 2.7% (2.2-3.2%) for bleeding, and 4.9% (3.5-6.3%) vs. 1.8% (1.4-2.3%) for mortality. Optimal therapy (≥5 of the following at hospital discharge and at one-year post-PCI: aspirin, clopidogrel, statins, beta-blockers, ARB/ACE-inhibitors, and exercise or diet) was observed with 49%/42% of DM/non-DM patients. Patients with DM more often received DES and ARB/ACE but still incur worse 12 month outcomes compared to non-DM. Evidence-based prescribing post ACS-PCI is still sub-optimal and newer more potent strategies should be considered for diabetic patients to reduce the cardiovascular mortality and morbidity disparity.
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.
Objectives To assess treatment, costs, and 12-month outcomes by Global Registry of Acute Coronary Events (GRACE) risk score in patients with acute coronary syndrome (ACS) undergoing percutaneous co...
To compare medication treatment and 12-month outcomes of patients aged <75 and ≥ 75 years who have acute coronary syndromes (ACS) and who have undergone percutaneous coronary intervention (PCI). Data were from APTOR, robust, prospective, observational registries from 14 European countries from 2007-2009. Kaplan-Meier (KM) estimates at 12-months post-PCI were calculated for cardiovascular (CV) event (unstable angina [UA], non-ST-elevation myocardial infarction [NSTEMI], STEMI, urgent target vessel revascularization, acute heart failure, ischemic and hemorrhagic strokes or CV death), bleeding, and mortality by age. 82% were <75 years (N=3742, median age: 59) and 18% were ≥75 years (N=803, median age: 79). Older patients tended to be women (38% vs. 20%); to weigh <60kg (10% vs. 4%); have more hypertension (72% vs. 54%) and diabetes (26% vs. 20%); have prior MI (28% vs. 18%) and PCI (22% vs. 17%). For older/younger patients, respectively, the ACS presentation was 25%/22% for UA, 39%/29% for NSTEMI, and 36%/49% for STEMI; treatment at PCI was 14%/10% for clopidogrel loading doses <300 mg, 24%/33% for GPIIb/IIIa inhibitors, and 5% /11% for thrombolytic/fibrinolytic therapy. KM (95% CI) estimates for older and younger patients, respectively, were: 19.8% (17.0%, 22.6%) vs. 13.4% (12.3%, 14.5%) for CV event, 3.7% (2.4%, 5.1%) vs. 2.6% (2.1%, 3.1%) for bleeding, and 6.8% (5.0%, 8.5%) vs. 1.5% (1.1%, 1.9%) for mortality. Older patients tended to receive GPIIb/IIIa and thrombolytic/fibrinolytic therapy less frequently at PCI, contributing to comparable bleeding rates. However, the higher post-discharge ischemic event rates suggest that the risk/benefit ratios in the elderly may need to be considered more carefully. One strategy might be that, if revascularisation is proposed in older ACS patients, those at lower bleeding risk be treated more aggressively with potent, newer peri/postprocedural, antiplatelet/antithrombotic management to balance the post-PCI outcomes disparity at 12 months.
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. (C) 2011 Elsevier Masson SAS. All rights reserved.
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.
To describe antiplatelet treatment patterns over 12 months in patients with acute cornary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). 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. 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. 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.
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.
L'aspirine a démontré depuis plusieurs années son efficacité dans le traitement de l'angor instable et de l'infarctus, même si des questions restent posées concernant les posologies optimales. L'héparine est, elle aussi, efficace à la phase aiguë de l'angor instable, mais la démonstration est moins pertinente pour l'infarctus du myocarde. Les antiplaquettaires anti-GPIIb-IIIa sont une nouvelle classe efficace d'antiagrégants plaquettaires à la disposition seulement des cardiologues interventionnels. Les anticorps monoclonaux (7E3) utilisés au cours d'angioplasties coronaires à haut risque, notamment dans les syndromes coronaires aigus ont permis de diminuer de 35 % les occlusions aiguës postangioplastie. Il faut remarquer dans cette étude EPIC que le taux d'accidents hémorragiques était excessif dans le groupe traité par 7E3 : les associations d'antithrombotiques (trithérapies) sont en grande partie responsables de ces effets secondaires. Les résultats intermédiaires sur 1 500 patients de l'étude EPILOG montrent à 30 jours de suivi un bénéfice net sur les événements ischémiques et une différence non significative sur les hémorragies majeures, cette amélioration ayant été obtenue grâce à une diminution des doses d'héparine par rapport à l'étude EPIC. À l'inverse des thrombolytiques, les hémorragies cérébrales ne sont pas majorées chez les patients recevant du 7E3. Les résultats de CAPTURE confirment le bénéfice clinique de cet antiplaquettaire dans l'angor instable. Ces résultats favorables ne sont pas retrouvés avec d'autres anti-GPIIb-IIIa comme le tirofiban ou l'intégréline, ni avec d'autres nouveaux antithrombotiques comme l'hirudine recombinante ou l'hirulog. Les avancées récentes dans ce domaine continuent de faire régresser la mortalité et les complications graves des syndromes coronaires aigus.Aspirin is effective in, treating patients with unstable angina or myocardial infarction. However, questions remain about the optimal dose of aspirin and aspirin-resistance in subgroups of patients. Heparin also has beneficial effects mostly during the acute phase of unstable angina, but thrombolytics are effective only in acute myocardial infarction and not in unstable angina. Recently, low molecular weight heparins have proved to be as effective (FRIC trial) or more effective (ESSENCE trial) than unfractionated heparin in unstable angina. Ongoing studies (TIMI 11B) are evaluating the efficacy of a prolonged administration of low molecular weight heparin to alter the chronic process of unstable angina. The new antiplatelet drugs directed against GP IIb/IIIa receptors are now available to improve the acute results of high risk percutaneous transluminal angioplasty (PTCA). This new drug (c7E3) binds rapidly to GPIIb/IIIa and prevents fibrinogen binding to the receptor. This very potent and irreversible effect prevents platelet aggregation and decreases the incidence of acute occlusions following PTCA, especially in patients with unstable angina. The counterpart is an increased risk of hemorrhage, knowing that patients receive simultaneously aspirin and heparin. The first results of the EPILOG study also demonstrate a better outcome in elective angioplasty without significant increase of serious bleeding, thanks to a low dose heparin regimen. In contrast to thrombolytics, the GP IIb/IIIa antagonist does not increase the risk of intracranial bleeding. The results of the CAPTURE trial also confirm the clinical benefit obtained with this drug in refractory unstable angina. The reduction of death and myocardial infarction is very consistent throughout the studies performed with the c7E3. The Kaplan-Meier curves of freedom of death and myocardial infarction diverge immediately after start of study medication. The acute benefits are preserved at 3 years in the EPIC trial. Similar trends were present during the acute phase with other compounds (tirofiban, integrelin), meaning that a class effect may exist but the long term results are disappointing. The results with new direct antithrombins such as hirudin, or hirulog in acute myocardial infarction or in PTCA for unstable angina are negative. The development of new potent oral antiplatelet drugs might change the treatment of acute coronary syndromes in the future. The current progress made with antithrombotic drugs should improve the prognosis of acute coronary syndroms.