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Eur Radiol. 2017 Jul;27(7):2957-2968. doi: 10.1007/s00330-016-4620-z. Epub 2016 Nov 18.

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

Author information

1
Department of Radiology, Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Germany.
2
Department of Cardiology, Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Germany.
3
Department of Radiology, Medical University Innsbruck, Anichstr. 35, 6020, Innsbruck, Austria.
4
Department of Cardiology, Medical University Innsbruck, Anichstr. 35, 6020, Innsbruck, Austria.
5
Department of Cardiology, University Hospital Motol, Vuvalu 84, 150 06, Prague 5, Czech Republic.
6
Department of Radiology, University Hospital Motol, Vuvalu 84, 150 06, Prague 5, Czech Republic.
7
Department of Radiology and Department of Cardiology, Rigshospitalet Region Hovedstaden, Rigshospitalet 9, 2100, Copenhagen, Denmark.
8
Department of Cardiology, Rigshospitalet Region Hovedstaden, Rigshospitalet 9, 2100, Copenhagen, Denmark.
9
Department of Cardiology, ALB FILS KLINIKEN GmbH, Eichertstrasse 3, 73035, Goeppingen, Germany.
10
Department of Radiology, University of Leipzig Heart Centre, Strümpellstrasse 39, 04289, Leipzig, Germany.
11
Department of Cardiology, University of Leipzig Heart Centre, Strümpellstrasse 39, 04289, Leipzig, Germany.
12
MTA-SE Cardiovascular Imaging Center, Heart and Vascular Center, Semmelweis University, Varosmajor u 68, 1122, Budapest, Hungary.
13
Department of Cardiology, Southeastern Health and Social Care Trust, Upper Newtownards Road Ulster, BT16 1RH, Belfast, UK.
14
Department of Radiology, Southeastern Health and Social Care Trust, Upper Newtownards Road Ulster, BT16 1RH, Belfast, UK.
15
Department of Radiology, St. Vincent's University Hospital and National University of Ireland, Belfield Campus, 4, Dublin, Ireland.
16
Department of Cardiology, St. Vincent's University Hospital, Belfield Campus, 4, Dublin, Ireland.
17
Department of Radiology, Azienda Ospedaliero Universitaria di Cagliari, AOU di Cagliari - Polo di Monserrato, 09042, Monserrato, CA, Italy.
18
Department of Cardiology, Azienda Ospedaliera Brotzu, Cagliari, CA, Italy.
19
Department of Radiology, Sapienza University of Rome, Viale Regina Elena 324, 00161, Rome, Italy.
20
Department of Cardiovascular, Respiratory, Nephrology, Anesthesiology and Geriatric Sciences, Sapienza University of Rome, Viale Regina Elena 324, 00161, Rome, Italy.
21
Department of Cardiology, Paul Stradins Clinical University Hospital, Pilsoņu Street 13, 1002, Riga, Latvia.
22
Department of Radiology, Paul Stradins Clinical University Hospital, Pilsoņu Street 13, 1002, Riga, Latvia.
23
Department of Radiology, Lithuanian University of Health Sciences, Eivelniu 2, 50009, Kaunas, Lithuania.
24
Department of Cardiology, Lithuanian University of Health Sciences, Eivelniu 2, 50009, Kaunas, Lithuania.
25
Department of Radiology, Wojewodzki Szpital Specjalistyczny We Wroclawiu, Ul. Henryka Michala Kamienskiego, 51124, Wroclaw, Poland.
26
Department of Cardiology, Wojewodzki Szpital Specjalistyczny We Wroclawiu, Ul. Henryka Michala Kamienskiego, 51124, Wroclaw, Poland.
27
Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia, Rua Conceicao Fernandes, 4434 502, Vila Nova de Gaia, Portugal.
28
Department of Cardiology, Cardio Med Medical Center, 22 decembrie 1989, 540156, Targu-Mures, Romania.
29
Department of Cardiology, Institute of Cardiovascular Diseases of Vojvodina, Put dr Goldmana 4, 212014, Novi Sad, Sremska Kamenica, Serbia.
30
Radiology Department Imaging Center, Institute of Cardiovascular Diseases of Vojvodina, Put dr Goldmana 4, 212014, Novi Sad, Sremska Kamenica, Serbia.
31
Department of Cardiology (Barcelona Spain), Hospital Universitari Vall d'Hebron, Institut de Recerca (VHIR), Universitat Autònoma de Barcelona, Passeig de Vall d'Hebron 119, 08035, Barcelona, Spain.
32
Institute of Cardiovascular and Medical Sciences, University of Glasgow, University Place 126, G12 8TA, Glasgow, UK.
33
Department of Cardiology, Aintree University Hospital, Longmoor Lane, L9 7AL, Liverpool, UK.
34
Department of Radiology, Aintree University Hospital, Longmoor Lane, L9 7AL, Liverpool, UK.
35
Turku PET Centre, Turku University Hospital and University of Turku, Kiinamyllynkatu 4-8, FI 20120, Turku, Finland.
36
Heart Centre, Turku University Hospital, Kiinamyllynkatu 4-8, FI 20120, Turku, Finland.
37
Department of Radiology, The Institute of Cardiology in Warsaw, Ul. Alpejska 42, 04-628, Warsaw, Poland.
38
Department of Cardiology, The Institute of Cardiology in Warsaw, Ul. Alpejska 42, 04-628, Warsaw, Poland.
39
Department of Cardiology, Clinical Hospital Center Zemun, Vukova 9, 11080, Belgrade-Zemun, Serbia.
40
Department of Cardiology, Basurto University Hospital, Avenida Montevideo 18, 48013, Bilbao, Spain.
41
Department of Radiology, Basurto University Hospital, Avenida Montevideo 18, 48013, Bilbao, Spain.
42
Department of Radiology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, Netherlands.
43
European Clinical Research Infrastructure Network (ECRIN-ERIC), Management Office, 5 Rue Watt, 75013, Paris, France.
44
European Clinical Research Infrastructure Network (ECRIN-ERIC), National ECRIN office/KKS Network, University Cologne, Kerpener Str. 62, 50937, Cologne, Germany.
45
Clinical Coordinating Centre, Charité - Universitätsmedizin Berlin, Campus Virchow - Klinikum, Augustenburger Platz 1, 13353, Berlin, Germany.
46
Basque Office for Health Technology Assessment, Donostia-San Sebastian 1, 01010, Vitoria-Gasteiz, Spain.
47
Department of Economics, Department of Economics, University of Copenhagen, 26, Building 26.1.00, Copenhagen, Denmark.
48
Institute of Public Health, Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Germany.
49
Institute of Medical Statistics, Computer Sciences and Documentation, Jena University Hospital, Friedrich Schiller University Jena, Bachstraße 18, 07743, Jena, Germany.
50
Department of Radiology, Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Germany. marc.dewey@charite.de.

Abstract

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.

KEYWORDS:

Adverse events; Angiography; Comparative effectiveness; Computed tomography; Invasive coronary angiography

PMID:
27864607
DOI:
10.1007/s00330-016-4620-z
[Indexed for MEDLINE]

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