Computed tomography versus invasive coronary angiography: design and methods of the pragmatic randomised multicentre DISCHARGE trial
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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).
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.
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.
The DISCHARGE trial will assess the comparative effectiveness of CT and ICA.
• 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.
KeywordsComputed tomography Angiography Invasive coronary angiography Adverse events Comparative effectiveness
The scientific guarantor of this publication is Prof. Marc Dewey, M.D. Ph.D. The authors of this manuscript declare relationships with the following companies, foundations and government or university grants: Abbott, Academy of Finland, Centre of Excellence programs, Actelion, American Thoracic Society, Amgen, AP Møller og hustru Chastine McKinney Møllers Fond, Astra-Zeneca, Athera Biotechnologies AB, B.Braun Medical, Bayer, Bayer-Schering, Berlin Chemie, Beuth Hochschule für Technik Berlin, Biosensors, Biotie Therapies, Biotronik, Boehringer-Ingelheim, Boston Scientific, Bracco, Braun, Cardiac MR Academy Berlin, CardiRad Ltd, Comac-Medical, Cordis, Covance, Directorate-General for Health and Food Safety, Eckert & Ziegler Radiopharma GmbH, Edwards Lifesciences, Endocyte Inc, European Regional Development Fund, European Society of Cardiology, European Union, F.Hoffmann-La Roche, Finnish Foundation for Cardiovascular Research, Fundação para a Ciência e Tecnologia, Portugal, GE Healthcare, Gedeon Richter, German Federal Ministry of Education and Research (BMBF), German Research Foundation (DFG), Guerbet, Guidotti,Intermeetings Padova, Irish Lung Foundation, Jansen-Cilag, Johnson & Johnson, KRKA, Lantheus Inc, Medtronic, Medtronik, Menarini, Merck, Merck Sharp & Dohme, MSD, National Heart, Lung, and Blood Institute (NHLBI), Novartis, Orion Pharma, Pfizer, Pharma Swiss, Philips, Piramal, Portuguese Society of Cardiology, Quintiles, Research Council of Rigshopitalet, Roche, Sandoz, Sanofi Aventis, Schering, Servier, Siemens, Sigma Tau, Southeastern Health and Social Care Trust Innovation Research Development Group Fund, Spanish Society of Cardiology, St. Jude Medical, Stiftung Charité (Berlin Institute of Health), Takeda,TEKES Finland, The Danish Agency for Science Technology and Innovation by The Danish Council for Strategic Research, The Danish Heart Foundation, The John and Birthe Meyer Foundation, The Lundbeck Foundation, Toshiba Medical Systems, Turku University Hospital research funds, VITAL Images Inc., Zealand A/S
This study has received funding by the Seventh Framework Programme of the European Union (EC-GA 603266). Prof. Peter Schlattmann kindly provided statistical advice for this manuscript. Institutional review board approval was obtained. Written informed consent will be obtained from all subjects (patients) for the study. Study subjects or cohorts have not been previously reported in another journal/study. Methodology: prospective/retrospective, randomised controlled trial, multicenter study.
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