Computed tomography versus invasive coronary angiography: design and methods of the pragmatic randomised multicentre DISCHARGE trial

. 2017 Jul ; 27 (7) : 2957-2968. [epub] 20161118

Jazyk angličtina Země Německo Médium print-electronic

Typ dokumentu časopisecké články, multicentrická studie, randomizované kontrolované studie

Perzistentní odkaz   https://www.medvik.cz/link/pmid27864607

Grantová podpora
MR/N003403/1 Medical Research Council - United Kingdom

Odkazy

PubMed 27864607
DOI 10.1007/s00330-016-4620-z
PII: 10.1007/s00330-016-4620-z
Knihovny.cz E-zdroje

OBJECTIVES: More than 3.5 million invasive coronary angiographies (ICA) are performed in Europe annually. Approximately 2 million of these invasive procedures might be reduced by noninvasive tests because no coronary intervention is performed. Computed tomography (CT) is the most accurate noninvasive test for detection and exclusion of coronary artery disease (CAD). To investigate the comparative effectiveness of CT and ICA, we designed the European pragmatic multicentre DISCHARGE trial funded by the 7th Framework Programme of the European Union (EC-GA 603266). METHODS: In this trial, patients with a low-to-intermediate pretest probability (10-60 %) of suspected CAD and a clinical indication for ICA because of stable chest pain will be randomised in a 1-to-1 ratio to CT or ICA. CT and ICA findings guide subsequent management decisions by the local heart teams according to current evidence and European guidelines. RESULTS: Major adverse cardiovascular events (MACE) defined as cardiovascular death, myocardial infarction and stroke as a composite endpoint will be the primary outcome measure. Secondary and other outcomes include cost-effectiveness, radiation exposure, health-related quality of life (HRQoL), socioeconomic status, lifestyle, adverse events related to CT/ICA, and gender differences. CONCLUSIONS: The DISCHARGE trial will assess the comparative effectiveness of CT and ICA. KEY POINTS: • Coronary artery disease (CAD) is a major cause of morbidity and mortality. • Invasive coronary angiography (ICA) is the reference standard for detection of CAD. • Noninvasive computed tomography angiography excludes CAD with high sensitivity. • CT may effectively reduce the approximately 2 million negative ICAs in Europe. • DISCHARGE addresses this hypothesis in patients with low-to-intermediate pretest probability for CAD.

Basque Office for Health Technology Assessment Donostia San Sebastian 1 01010 Vitoria Gasteiz Spain

Clinical Coordinating Centre Charité Universitätsmedizin Berlin Campus Virchow Klinikum Augustenburger Platz 1 13353 Berlin Germany

Department of Cardiology Aintree University Hospital Longmoor Lane L9 7AL Liverpool UK

Department of Cardiology ALB FILS KLINIKEN GmbH Eichertstrasse 3 73035 Goeppingen Germany

Department of Cardiology Azienda Ospedaliera Brotzu Cagliari CA Italy

Department of Cardiology Basurto University Hospital Avenida Montevideo 18 48013 Bilbao Spain

Department of Cardiology Cardio Med Medical Center 22 decembrie 1989 540156 Targu Mures Romania

Department of Cardiology Centro Hospitalar de Vila Nova de Gaia Rua Conceicao Fernandes 4434 502 Vila Nova de Gaia Portugal

Department of Cardiology Charité Universitätsmedizin Berlin Charitéplatz 1 10117 Berlin Germany

Department of Cardiology Clinical Hospital Center Zemun Vukova 9 11080 Belgrade Zemun Serbia

Department of Cardiology Institute of Cardiovascular Diseases of Vojvodina Put dr Goldmana 4 212014 Novi Sad Sremska Kamenica Serbia

Department of Cardiology Lithuanian University of Health Sciences Eivelniu 2 50009 Kaunas Lithuania

Department of Cardiology Medical University Innsbruck Anichstr 35 6020 Innsbruck Austria

Department of Cardiology Paul Stradins Clinical University Hospital Pilsoņu Street 13 1002 Riga Latvia

Department of Cardiology Rigshospitalet Region Hovedstaden Rigshospitalet 9 2100 Copenhagen Denmark

Department of Cardiology Southeastern Health and Social Care Trust Upper Newtownards Road Ulster BT16 1RH Belfast UK

Department of Cardiology St Vincent's University Hospital Belfield Campus 4 Dublin Ireland

Department of Cardiology The Institute of Cardiology in Warsaw Ul Alpejska 42 04 628 Warsaw Poland

Department of Cardiology Universitat Autònoma de Barcelona Passeig de Vall d'Hebron 119 08035 Barcelona Spain

Department of Cardiology University Hospital Motol Vuvalu 84 150 06 Prague 5 Czech Republic

Department of Cardiology University of Leipzig Heart Centre Strümpellstrasse 39 04289 Leipzig Germany

Department of Cardiology Wojewodzki Szpital Specjalistyczny We Wroclawiu Ul Henryka Michala Kamienskiego 51124 Wroclaw Poland

Department of Cardiovascular Respiratory Nephrology Anesthesiology and Geriatric Sciences Sapienza University of Rome Viale Regina Elena 324 00161 Rome Italy

Department of Economics Department of Economics University of Copenhagen 26 Building 26 1 00 Copenhagen Denmark

Department of Radiology Aintree University Hospital Longmoor Lane L9 7AL Liverpool UK

Department of Radiology and Department of Cardiology Rigshospitalet Region Hovedstaden Rigshospitalet 9 2100 Copenhagen Denmark

Department of Radiology Azienda Ospedaliero Universitaria di Cagliari AOU di Cagliari Polo di Monserrato 09042 Monserrato CA Italy

Department of Radiology Basurto University Hospital Avenida Montevideo 18 48013 Bilbao Spain

Department of Radiology Charité Universitätsmedizin Berlin Charitéplatz 1 10117 Berlin Germany

Department of Radiology Leiden University Medical Center Albinusdreef 2 2333 ZA Leiden Netherlands

Department of Radiology Lithuanian University of Health Sciences Eivelniu 2 50009 Kaunas Lithuania

Department of Radiology Medical University Innsbruck Anichstr 35 6020 Innsbruck Austria

Department of Radiology Paul Stradins Clinical University Hospital Pilsoņu Street 13 1002 Riga Latvia

Department of Radiology Sapienza University of Rome Viale Regina Elena 324 00161 Rome Italy

Department of Radiology Southeastern Health and Social Care Trust Upper Newtownards Road Ulster BT16 1RH Belfast UK

Department of Radiology St Vincent's University Hospital and National University of Ireland Belfield Campus 4 Dublin Ireland

Department of Radiology The Institute of Cardiology in Warsaw Ul Alpejska 42 04 628 Warsaw Poland

Department of Radiology University Hospital Motol Vuvalu 84 150 06 Prague 5 Czech Republic

Department of Radiology University of Leipzig Heart Centre Strümpellstrasse 39 04289 Leipzig Germany

Department of Radiology Wojewodzki Szpital Specjalistyczny We Wroclawiu Ul Henryka Michala Kamienskiego 51124 Wroclaw Poland

European Clinical Research Infrastructure Network Management Office 5 Rue Watt 75013 Paris France

European Clinical Research Infrastructure Network National ECRIN office KKS Network University Cologne Kerpener Str 62 50937 Cologne Germany

Heart Centre Turku University Hospital Kiinamyllynkatu 4 8 FI 20120 Turku Finland

Institute of Cardiovascular and Medical Sciences University of Glasgow University Place 126 G12 8TA Glasgow UK

Institute of Medical Statistics Computer Sciences and Documentation Jena University Hospital Friedrich Schiller University Jena Bachstraße 18 07743 Jena Germany

Institute of Public Health Charité Universitätsmedizin Berlin Charitéplatz 1 10117 Berlin Germany

MTA SE Cardiovascular Imaging Center Heart and Vascular Center Semmelweis University Varosmajor u 68 1122 Budapest Hungary

Radiology Department Imaging Center Institute of Cardiovascular Diseases of Vojvodina Put dr Goldmana 4 212014 Novi Sad Sremska Kamenica Serbia

Turku PET Centre Turku University Hospital and University of Turku Kiinamyllynkatu 4 8 FI 20120 Turku Finland

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