TY - JOUR
AU - Weidinger, Franz
AB - Abstract Treatment of patients with acute ST-segment elevation myocardial infarction has improved over past decades, with reperfusion therapy being the cornerstone in the acute phase. Based on the results of large randomised trials the current ST-segment elevation myocardial infarction guidelines of the European Society of Cardiology (ESC) recommend acute treatments and secondary prevention therapies. However, there are large variations between ESC countries in the treatment of patients presenting with ST-segment elevation myocardial infarction. Therefore the ESC has initiated a prospective registry to evaluate the current treatments and outcomes of these patients with a special focus on adherence to the ESC guidelines and on differences between countries and regions. This paper describes the methodology and design of the ST-segment elevation myocardial infarction registry conducted in collaboration of the Acute Cardiac Care Association and the European Association of Percutaneous Coronary Intervention. ST-segment elevation myocardial infarction, primary percutaneous coronary intervention, registry, reperfusion therapy Introduction Acute coronary syndromes (ACSs) include unstable angina pectoris, non-ST-segment elevation myocardial infarction (NSTEMI) and ST-segment elevation myocardial infarction (STEMI).1,2 The management of these different types of ACSs have rapidly been evolving during the past decade, which has been associated with an improvement in short and long-term outcomes.3,4 Nevertheless, the highest short-term mortality is observed in patients with STEMI defined by chest pain or equivalent symptoms and ST-segment elevation or a left bundle branch block in the diagnostic electrocardiogram (ECG), and subsequent confirmation of diagnosis by the elevation of cardiac troponin.5 Based on the results of randomised controlled trials, the European Society of Cardiology (ESC) has issued practice guidelines for patients with STEMI, the two latest versions being published in 2012 and 2017.1,6 The cornerstone of treatment of STEMI is acute reperfusion therapy preferably with primary percutaneous coronary intervention (PCI). Previous ACS surveys within the Euro Heart Survey Programme collecting data on ACS presentation, treatment and outcome in Europe in 2000, 2004 and 2008 and the Snapshot registry in 2009 showed gaps between recommendations by guidelines and their implementation in clinical practice.7–10 In addition, wide variations in the treatment of STEMI between countries have been noted, especially in the use of primary PCI. The ‘stent for life’ initiative of the ESC has been created to increase the rate of patients treated with primary PCI in Europe and the Mediterranean basin.11–13 Therefore, it is appropriate to evaluate the current treatment of STEMI in these regions on a regular basis, to monitor and help guide the evolution of reperfusion therapy for STEMI. Study objectives The main objective of this study is to describe the demographic, clinical and biological characteristics of patients with STEMI admitted to a representative setting of cardiology centres in ESC member countries in Europe. Other objectives are to assess management patterns and in particular the current use of reperfusion therapies and to evaluate how recommendations of most recent STEMI European guidelines1,6 regarding reperfusion therapies and adjunctive pharmacological and non-pharmacological treatments are adopted in clinical practice, and how their application can impact on patients’ outcomes. Information on the reasons why evidence-based treatments are not utilised will also be collected. Another interesting objective will be to evaluate the organisation of STEMI management across Europe and Mediterranean countries specifically regarding the diagnostic and admission process and treatment pathways. The influence of a hospital’s membership of a formal STEMI network on treatment patterns and outcomes will be evaluated. The registry will validate the prognostic predictors of inhospital outcomes and evaluate how these predictors perform in different countries and regions. A special focus will be drawn to the patients requiring cardiopulmonary resuscitation and/or presenting in cardiogenic shock, who still have a high mortality rate despite reperfusion therapy. The use of reperfusion therapies, interventional features and pharmacological and mechanical support therapies will be recorded. The association between the use of mechanical support devices and outcomes will be evaluated. The use of secondary prevention therapies at discharge will be recorded and the adherence to the recommendations given in the current ESC guidelines will be determined.1,6 Patient subgroups (e.g. women vs. men, age groups, people with diabetes vs. those without diabetes, normal vs. impaired ejection fraction, revascularised vs. non-revascularised patients) will be compared with respect to the use of guideline-adherent secondary prevention therapies. The Acute Cardiovascular Care Association (ACCA) has recently issued a set of quality indicators for treatment of patients with STEMI and non-ST-segment elevation ACS.14 This registry will provide an opportunity to evaluate how these quality indicators perform in clinical practice and how they relate to clinical outcomes. Study flow chart The design of the registry is summarised in Table 1. Table 1. Study flow chart of the ACCA–EAPCI STEMI registry of the ESC Main part . Patient characteristics  1. Inclusion criteria   • Patients having signed an informed consent   • Patients aged ≥18 years old   • Patient’s relatives signed informed consent, if applicable for patients dying in the hospital before they can sign an informed consent An admission diagnosis of STEMI occurring in the community as evidenced by the following:   ✓ Chest pain or equivalent symptoms of more than 20 minutes duration within the last 24 hours before admission   ✓ ST-segment elevations or LBBB at the diagnostic ECG  2. Exclusion criteria   • Patients developing STEMI after admission for another reason in hospital   • Patients developing STEMI after percutaneous coronary angioplasty or coronary bypass surgery  3. Patient characteristics and patient clinical history Pre-hospital phase, admission and acute reperfusion therapy  4. Pre-hospital diagnostics and treatments, admission process, time intervals  5. Presentation and initial assessment  6. Acute reperfusion therapy (treatment intention, treatment given, details of coronary anatomy and PCI procedure)  7. Acute medical therapy Hospital phase and discharge  8. Diagnostic and therapeutic procedures during hospitalisation until discharge  9. Complications until discharge Medications  10. Medications during the hospital phase and at discharge (antiplatelets, anticoagulants, other cardiac medications) 12 Months follow-up  Vital status, major clinical events, other hospitalisations, clinical procedures, laboratory and other examinations, medications Main part . Patient characteristics  1. Inclusion criteria   • Patients having signed an informed consent   • Patients aged ≥18 years old   • Patient’s relatives signed informed consent, if applicable for patients dying in the hospital before they can sign an informed consent An admission diagnosis of STEMI occurring in the community as evidenced by the following:   ✓ Chest pain or equivalent symptoms of more than 20 minutes duration within the last 24 hours before admission   ✓ ST-segment elevations or LBBB at the diagnostic ECG  2. Exclusion criteria   • Patients developing STEMI after admission for another reason in hospital   • Patients developing STEMI after percutaneous coronary angioplasty or coronary bypass surgery  3. Patient characteristics and patient clinical history Pre-hospital phase, admission and acute reperfusion therapy  4. Pre-hospital diagnostics and treatments, admission process, time intervals  5. Presentation and initial assessment  6. Acute reperfusion therapy (treatment intention, treatment given, details of coronary anatomy and PCI procedure)  7. Acute medical therapy Hospital phase and discharge  8. Diagnostic and therapeutic procedures during hospitalisation until discharge  9. Complications until discharge Medications  10. Medications during the hospital phase and at discharge (antiplatelets, anticoagulants, other cardiac medications) 12 Months follow-up  Vital status, major clinical events, other hospitalisations, clinical procedures, laboratory and other examinations, medications ACCA: Acute Cardiac Care Association; EAPCI: European Association of Percutaneous Coronary Intervention; STEMI: ST-segment elevation myocardial infarction; ESC: European Society of Cardiology; ECG: electrocardiogram; LBBB: left bundle branch block; PCI: percutaneous coronary intervention. Open in new tab Table 1. Study flow chart of the ACCA–EAPCI STEMI registry of the ESC Main part . Patient characteristics  1. Inclusion criteria   • Patients having signed an informed consent   • Patients aged ≥18 years old   • Patient’s relatives signed informed consent, if applicable for patients dying in the hospital before they can sign an informed consent An admission diagnosis of STEMI occurring in the community as evidenced by the following:   ✓ Chest pain or equivalent symptoms of more than 20 minutes duration within the last 24 hours before admission   ✓ ST-segment elevations or LBBB at the diagnostic ECG  2. Exclusion criteria   • Patients developing STEMI after admission for another reason in hospital   • Patients developing STEMI after percutaneous coronary angioplasty or coronary bypass surgery  3. Patient characteristics and patient clinical history Pre-hospital phase, admission and acute reperfusion therapy  4. Pre-hospital diagnostics and treatments, admission process, time intervals  5. Presentation and initial assessment  6. Acute reperfusion therapy (treatment intention, treatment given, details of coronary anatomy and PCI procedure)  7. Acute medical therapy Hospital phase and discharge  8. Diagnostic and therapeutic procedures during hospitalisation until discharge  9. Complications until discharge Medications  10. Medications during the hospital phase and at discharge (antiplatelets, anticoagulants, other cardiac medications) 12 Months follow-up  Vital status, major clinical events, other hospitalisations, clinical procedures, laboratory and other examinations, medications Main part . Patient characteristics  1. Inclusion criteria   • Patients having signed an informed consent   • Patients aged ≥18 years old   • Patient’s relatives signed informed consent, if applicable for patients dying in the hospital before they can sign an informed consent An admission diagnosis of STEMI occurring in the community as evidenced by the following:   ✓ Chest pain or equivalent symptoms of more than 20 minutes duration within the last 24 hours before admission   ✓ ST-segment elevations or LBBB at the diagnostic ECG  2. Exclusion criteria   • Patients developing STEMI after admission for another reason in hospital   • Patients developing STEMI after percutaneous coronary angioplasty or coronary bypass surgery  3. Patient characteristics and patient clinical history Pre-hospital phase, admission and acute reperfusion therapy  4. Pre-hospital diagnostics and treatments, admission process, time intervals  5. Presentation and initial assessment  6. Acute reperfusion therapy (treatment intention, treatment given, details of coronary anatomy and PCI procedure)  7. Acute medical therapy Hospital phase and discharge  8. Diagnostic and therapeutic procedures during hospitalisation until discharge  9. Complications until discharge Medications  10. Medications during the hospital phase and at discharge (antiplatelets, anticoagulants, other cardiac medications) 12 Months follow-up  Vital status, major clinical events, other hospitalisations, clinical procedures, laboratory and other examinations, medications ACCA: Acute Cardiac Care Association; EAPCI: European Association of Percutaneous Coronary Intervention; STEMI: ST-segment elevation myocardial infarction; ESC: European Society of Cardiology; ECG: electrocardiogram; LBBB: left bundle branch block; PCI: percutaneous coronary intervention. Open in new tab Patients The inclusion and exclusion criteria are given in Table 1. Treatment Management of patients with STEMI should follow the recommendations of the ESC guidelines, specifically with respect to primary PCI or fibrinolysis.1,6 However, drug prescriptions and indications for performing diagnostic and therapeutic procedures will be at the discretion of the participating cardiologists. No specific protocols or recommendations for evaluation, management and/or treatment will be put forth during this observational study. Case report form The case report form (CRF) is shown in Appendix 1. The first part is related to the participating centre and records the structure of the centre. Overall hospital size, availability of a catheterisation laboratory, membership of a myocardial infarction network and other logistic issues will be assessed. The second part deals with the individual patient. Baseline characteristics and medical history will be recorded. Time intervals between symptom onset, diagnosis of STEMI and start of reperfusion will be recorded and patient pathways admitted to centres with and without cathetherisation laboratories will be documented. One part relates to technical aspects of primary PCI recording, including angiographic findings, the use of thrombectomy devices, stents and the success of the procedure as determined by the final thrombolysis in myocardial infarction flow after PCI. The complications (e.g. death, reinfarction, cardiogenic shock, stroke, etc.) and additional procedures (angiography, PCI, coronary artery bypass surgery, pacemaker implantation, defibrillator implantation, etc.) occurring up to hospital discharge will be recorded. The final inhospital section will document the clinical status and medication prescribed at discharge. After 12 months vital status and cardiovascular events after discharge will be recorded. Follow-up will be conducted by personal contact with the patients, in most cases this will be a telephone interview. Selection of centres The investigator centres are accepted on a voluntary basis through central assessment by the national coordinators and ESC, according to the criteria reported below. The national coordinators will supply to the executive committee a list of potential cardiology centres in their country that would be potentially suitable to set up such a registry. The national coordinator will be requested to outline the profile of the cardiology centre and to indicate whether the proposed cardiology centre is with/without interventional cardiology performing primary PCI. The number of centres in each country varies according to its approximate size. The choice of centres should allow for a representation of each category of hospitals in proportion to the distribution of the different types of centre in the individual country. The national cardiac societies in collaboration with the national coordinators are requested to select a defined number of centres (i.e. one centre/2 million people, but no more than 25 per country) in their own country so as to participate in the registry. The type and number of the participating centres in each country should be representative of that country, including both a representative ratio of interventional cardiology centres performing and not performing PCI. As far as possible, the centres should reflect an appropriate geographical distribution to be representative of the populations within each country. The site characteristics will be described on a specific site questionnaire form as part of the CRF. Characteristics of the type, reference area and population of the selected hospital system will be collected. There will be two types of participating centres: non PCI centres and PCI centres. The data entry from the non-PCI centres will be performed completely by the non-PCI centre, with the PCI centre to which the patients will be transferred providing information on PCI to the non-PCI centres. For the PCI centres, the data entry will only be performed by these actual PCI centres. The study was approved by all central or local ethics committees depending on the legal requirements of the participating countries. Study organisation This registry is a joint initiative of ACCA and the European Association of Percutaneous Coronary Intervention (EAPCI) under the umbrella of the EURObservational Research Programme (EORP). Centres with and without PCI facilities were selected to give a representative sample in the participating countries and a description of hub and spoke networks will be provided. Each centre should enrol at least 30 up to 60 consecutive patients presenting with STEMI in the community within 24 hours after symptom onset. To ensure high quality data local audits will be performed in randomly selected centres. It is planned to enrol a total of 10,000 patients. Currently, of 56 ESC country members invited 31 have agreed to participate. The registry has been successfully launched in 2015 in 20 countries, while it is expected that 15 more will start enrolment of patients in 2017. The current status of enrolment since launch is shown in Figure 1. In addition, some ESC-affiliated countries will participate and provide the opportunity to compare their results with the ESC member countries. Figure 1. Open in new tabDownload slide Current status of cumulative enrolment Discussion The ACCA–EAPCI STEMI registry will document the current status of management and outcomes of patients admitted with an initial diagnosis of STEMI in a large number of ESC member countries. This registry provides the opportunity to evaluate if recommendations given in the current ESC STEMI guidelines are followed in clinical practice. Despite common guidelines, previous ESC registries have documented a large variation in the treatment of STEMI patients between countries and regions. This registry will be able to establish if the differences have diminished over time. The stent for life initiative of the ESC was specifically thought to increase the rate of patients treated with primary PCI all over Europe, and this registry will document the progress made over past years. Of special interest are patients at particularly high risk, those admitted after cardiopulmonary resuscitation or with cardiogenic shock. These patients have still a high mortality despite the use of early reperfusion therapy and the registry will determine the frequency of the use of additional therapeutic measures such as mechanical support devices. Since the last Snapshot registry a number of new drugs have been introduced into clinical practice. The uptake of the use of these new compounds differs between countries and the registry will help to determine how large these differences are. In 2016 ACCA published indicators for the quality of care of STEMI patients.13 This registry will provide an opportunity to evaluate how these quality indicators are performed in clinical practice and how they relate to clinical outcomes. In summary, the current ACCA–EAPCI registry is part of the ESC initiative for the improvement of care of cardiac patients around Europe. It will help to close the gap between evidence derived from randomised trials, recommendations given by SC guidelines and real world clinical practice. Acknowledgement The authors are grateful to: The EORP–STEMI Registry Executive Committee. Nicholas Danchin (ACCA), Petr Kala (Stent for life), Peter Ludman (EAPCI), Franz Weidinger (EAPCI), Uwe Zeymer (ACCA). The EORP–STEMI Registry Steering Committee/national coordinators. Albania: Artan Goda; Armenia: Parounak Zelveian; Austria: Franz Weidinger; Bulgaria: Kiril Karamfilov; Czech Republic: Zuzana Motovska; Denmark: Bent Raungaard; Egypt: Sameh Shaheen; Estonia: Toomas Marandi; Finland: Pasi Karjalainen; Georgia: Zviad Kereselidze; Germany: Uwe Zeymer; Greece: Dimitrios Alexopoulos; Hungary: David Becker; Iran: Masoumeh Sadeghi; Iraq: Hasan Al-Farhan; Ireland: Martin Quinn; Israel: Zaza Iakobishvili; Italy: Roberto Caporale and Francesco Romeo; Kosovo: Gani Bajraktari; Kyrgyzstan: Erkin Mirrakhimov; Latvia: Andrejs Erglis; Lithuania: Pranas Serpytis; Macedonia, Former Yugoslav Republic of: Sasko Kedev; Malta: Alice May Moore and Matthew Mercieca Balbi; Poland: Dariusz Dudek and Jacek Legutko; Portugal: Jorge Mimoso; Romania: Gabriel Tatu-Chitoiu; Russian Federation: Evgeny Shlyakhto; Saudi Arabia: Khalid F AlHabib; Serbia: Sinisa Stojkovic; Slovakia: Martin Studenčan; Slovenia: Matjaz Bunc; Spain: Rosa-Maria Lidón; Tunisia: Mohamed Sami Mourali. The EORP Department. Data collection was conducted by the EORP Department from the ESC by Marème Konte and Florian Larras as data managers, Elin Folkesson Lefrancq as project officer and Souad Mekhaldi as clinical project manager. Statistical analyses were performed by Cécile Laroche. Overall activities were coordinated by Aldo P Maggioni (scientific coordinator EORP). Conflict of interest The authors declare that there is no conflict of interest. Funding Since the start of EORP, the following companies have supported the programme: Abbott Vascular Int. (2011–2014); Amgen Cardiovascular (2009–2018); AstraZeneca (2014–2017); Bayer (2009–2018); Boehringer Ingelheim (2009–2019); Boston Scientific (2009–2012); the Bristol Myers Squibb and Pfizer Alliance (2011–2016); the Daiichi Sankyo Europe GmbH and Eli Lilly and Company Alliance (2011–2017); Edwards (2016–2019); Gedeon Richter Plc (2014–2017); Menarini Int. Op. (2009–2012); MSD-Merck & Co. (2011–2014); Novartis Pharma AG (2014–2017); ResMed (2014–2016); Sanofi (2009–2011); Servier (2010–2018). References 1 Steg P G , James S K, Atar Det al. . ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation . Eur Heart J 2012 ; 33 : 2569 – 2619 . Google Scholar Crossref Search ADS PubMed WorldCat 2 Roffi M , Patrono C, Collet J Pet al. . 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-segment Elevation of the European Society of Cardiology (ESC) . Eur Heart J 2016 ; 37 : 267 – 315 . Google Scholar Crossref Search ADS PubMed WorldCat 3 Anderson J L , Morrow D A Acute myocardial infarction . N Engl J Med 2017 ; 376 : 2053 – 2064 . Google Scholar Crossref Search ADS PubMed WorldCat 4 Puymirat E , Simon T, Cayla Get al. . 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Reperfusion therapy for ST elevation acute myocardial infarction 2010/2011: current status in 37 ESC countries . Eur Heart J 2014 ; 35 : 1957 – 1970 . Google Scholar Crossref Search ADS PubMed WorldCat 14 Schiele F , Gale C, Capuano Fet al. .; for the Acute Cardiovascular Care Association. Quality indicators for acute myocardial infarction. A position paper of the Acute Cardiovascular Care Association . Eur Heart J Acute Cardiovasc Care 2017 ; 6 : 34 – 59 . Google Scholar Crossref Search ADS PubMed WorldCat © The European Society of Cardiology 2018 This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model) © The European Society of Cardiology 2018
TI - Background and design of the ACCA–EAPCI registry on ST-segment elevation myocardial infarction of the European Society of Cardiology
JF - European Heart Journal. Acute Cardiovascular Care
DO - 10.1177/2048872617745008
DA - 2019-02-01
UR - https://www.deepdyve.com/lp/oxford-university-press/background-and-design-of-the-acca-eapci-registry-on-st-segment-zp0gl80fZm
SP - 63
EP - 67
VL - 8
IS - 1
DP - DeepDyve
ER -