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Randomized Controlled Trial
. 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

Adriane E Napp  1 , Robert Haase  1 , Michael Laule  2 , Georg M Schuetz  1 , Matthias Rief  1 , Henryk Dreger  2 , Gudrun Feuchtner  3 , Guy Friedrich  4 , Miloslav Špaček  5 , Vojtěch Suchánek  6 , Klaus Fuglsang Kofoed  7 , Thomas Engstroem  8 , Stephen Schroeder  9 , Tanja Drosch  9 , Matthias Gutberlet  10 , Michael Woinke  11 , Pál Maurovich-Horvat  12 , Béla Merkely  12 , Patrick Donnelly  13 , Peter Ball  14 , Jonathan D Dodd  15 , Martin Quinn  16 , Luca Saba  17 , Maurizio Porcu  18 , Marco Francone  19 , Massimo Mancone  20 , Andrejs Erglis  21 , Ligita Zvaigzne  22 , Antanas Jankauskas  23 , Gintare Sakalyte  24 , Tomasz Harań  25 , Malgorzata Ilnicka-Suckiel  26 , Nuno Bettencourt  27 , Vasco Gama-Ribeiro  27 , Sebastian Condrea  28 , Imre Benedek  28 , Nada Čemerlić Adjić  29 , Oto Adjić  30 , José Rodriguez-Palomares  31 , Bruno Garcia Del Blanco  31 , Giles Roditi  32 , Colin Berry  32 , Gershan Davis  33 , Erica Thwaite  34 , Juhani Knuuti  35 , Mikko Pietilä  36 , Cezary Kępka  37 , Mariusz Kruk  38 , Radosav Vidakovic  39 , Aleksandar N Neskovic  39 , Ignacio Díez  40 , Iñigo Lecumberri  41 , Jacob Geleijns  42 , Christine Kubiak  43 , Anke Strenge-Hesse  44 , The-Hoang Do  45 , Felix Frömel  45 , Iñaki Gutiérrez-Ibarluzea  46 , Gaizka Benguria-Arrate  46 , Hans Keiding  47 , Christoph Katzer  1 , Jacqueline Müller-Nordhorn  48 , Nina Rieckmann  48 , Mario Walther  49 , Peter Schlattmann  49 , Marc Dewey  50 ; DISCHARGE Trial Group
Affiliations
Randomized Controlled Trial

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

Adriane E Napp et al. Eur Radiol. 2017 Jul.

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.

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