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

  • Adriane E. Napp
  • Robert Haase
  • Michael Laule
  • Georg M. Schuetz
  • Matthias Rief
  • Henryk Dreger
  • Gudrun Feuchtner
  • Guy Friedrich
  • Miloslav Špaček
  • Vojtěch Suchánek
  • Klaus Fuglsang Kofoed
  • Thomas Engstroem
  • Stephen Schroeder
  • Tanja Drosch
  • Matthias Gutberlet
  • Michael Woinke
  • Pál Maurovich-Horvat
  • Béla Merkely
  • Patrick Donnelly
  • Peter Ball
  • Jonathan D. Dodd
  • Martin Quinn
  • Luca Saba
  • Maurizio Porcu
  • Marco Francone
  • Massimo Mancone
  • Andrejs Erglis
  • Ligita Zvaigzne
  • Antanas Jankauskas
  • Gintare Sakalyte
  • Tomasz Harań
  • Malgorzata Ilnicka-Suckiel
  • Nuno Bettencourt
  • Vasco Gama-Ribeiro
  • Sebastian Condrea
  • Imre Benedek
  • Nada Čemerlić Adjić
  • Oto Adjić
  • José Rodriguez-Palomares
  • Bruno Garcia del Blanco
  • Giles Roditi
  • Colin Berry
  • Gershan Davis
  • Erica Thwaite
  • Juhani Knuuti
  • Mikko Pietilä
  • Cezary Kępka
  • Mariusz Kruk
  • Radosav Vidakovic
  • Aleksandar N. Neskovic
  • Ignacio Díez
  • Iñigo Lecumberri
  • Jacob Geleijns
  • Christine Kubiak
  • Anke Strenge-Hesse
  • The-Hoang Do
  • Felix Frömel
  • Iñaki Gutiérrez-Ibarluzea
  • Gaizka Benguria-Arrate
  • Hans Keiding
  • Christoph Katzer
  • Jacqueline Müller-Nordhorn
  • Nina Rieckmann
  • Mario Walther
  • Peter Schlattmann
  • Marc Dewey
  • The DISCHARGE Trial Group
Computed Tomography

DOI: 10.1007/s00330-016-4620-z

Cite this article as:
Napp, A.E., Haase, R., Laule, M. et al. Eur Radiol (2016). doi:10.1007/s00330-016-4620-z

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

Computed tomography Angiography Invasive coronary angiography Adverse events Comparative effectiveness 

Supplementary material

330_2016_4620_MOESM1_ESM.pdf (1.7 mb)
ESM 1(PDF 1722 kb)
330_2016_4620_MOESM2_ESM.pdf (120 kb)
ESM 2(PDF 120 kb)
330_2016_4620_MOESM3_ESM.pdf (313 kb)
ESM 3(PDF 312 kb)

Copyright information

© European Society of Radiology 2016

Authors and Affiliations

  • 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
    • 1
  • The DISCHARGE Trial Group
  1. 1.Department of RadiologyCharité – Universitätsmedizin BerlinBerlinGermany
  2. 2.Department of CardiologyCharité – Universitätsmedizin BerlinBerlinGermany
  3. 3.Department of RadiologyMedical University InnsbruckInnsbruckAustria
  4. 4.Department of CardiologyMedical University InnsbruckInnsbruckAustria
  5. 5.Department of CardiologyUniversity Hospital MotolPrague 5Czech Republic
  6. 6.Department of RadiologyUniversity Hospital MotolPrague 5Czech Republic
  7. 7.Department of Radiology and Department of CardiologyRigshospitalet Region HovedstadenCopenhagenDenmark
  8. 8.Department of CardiologyRigshospitalet Region HovedstadenCopenhagenDenmark
  9. 9.Department of CardiologyALB FILS KLINIKEN GmbHGoeppingenGermany
  10. 10.Department of RadiologyUniversity of Leipzig Heart CentreLeipzigGermany
  11. 11.Department of CardiologyUniversity of Leipzig Heart CentreLeipzigGermany
  12. 12.MTA-SE Cardiovascular Imaging Center, Heart and Vascular CenterSemmelweis UniversityBudapestHungary
  13. 13.Department of CardiologySoutheastern Health and Social Care TrustBelfastUK
  14. 14.Department of RadiologySoutheastern Health and Social Care TrustBelfastUK
  15. 15.Department of RadiologySt. Vincent’s University Hospital and National University of IrelandDublinIreland
  16. 16.Department of CardiologySt. Vincent’s University HospitalDublinIreland
  17. 17.Department of RadiologyAzienda Ospedaliero Universitaria di CagliariMonserratoItaly
  18. 18.Department of CardiologyAzienda Ospedaliera BrotzuCagliariItaly
  19. 19.Department of RadiologySapienza University of RomeRomeItaly
  20. 20.Department of Cardiovascular, Respiratory, Nephrology, Anesthesiology and Geriatric SciencesSapienza University of RomeRomeItaly
  21. 21.Department of CardiologyPaul Stradins Clinical University HospitalRigaLatvia
  22. 22.Department of RadiologyPaul Stradins Clinical University HospitalRigaLatvia
  23. 23.Department of RadiologyLithuanian University of Health SciencesKaunasLithuania
  24. 24.Department of CardiologyLithuanian University of Health SciencesKaunasLithuania
  25. 25.Department of RadiologyWojewodzki Szpital Specjalistyczny We WroclawiuWroclawPoland
  26. 26.Department of CardiologyWojewodzki Szpital Specjalistyczny We WroclawiuWroclawPoland
  27. 27.Department of CardiologyCentro Hospitalar de Vila Nova de GaiaVila Nova de GaiaPortugal
  28. 28.Department of CardiologyCardio Med Medical CenterTargu-MuresRomania
  29. 29.Department of CardiologyInstitute of Cardiovascular Diseases of VojvodinaNovi SadSerbia
  30. 30.Radiology Department Imaging CenterInstitute of Cardiovascular Diseases of VojvodinaNovi SadSerbia
  31. 31.Department of Cardiology (Barcelona Spain), Hospital Universitari Vall d’Hebron, Institut de Recerca (VHIR)Universitat Autònoma de BarcelonaBarcelonaSpain
  32. 32.Institute of Cardiovascular and Medical SciencesUniversity of GlasgowGlasgowUK
  33. 33.Department of CardiologyAintree University HospitalLiverpoolUK
  34. 34.Department of RadiologyAintree University HospitalLiverpoolUK
  35. 35.Turku PET CentreTurku University Hospital and University of TurkuTurkuFinland
  36. 36.Heart CentreTurku University HospitalTurkuFinland
  37. 37.Department of RadiologyThe Institute of Cardiology in WarsawWarsawPoland
  38. 38.Department of CardiologyThe Institute of Cardiology in WarsawWarsawPoland
  39. 39.Department of CardiologyClinical Hospital Center ZemunBelgrade-ZemunSerbia
  40. 40.Department of CardiologyBasurto University HospitalBilbaoSpain
  41. 41.Department of RadiologyBasurto University HospitalBilbaoSpain
  42. 42.Department of RadiologyLeiden University Medical CenterLeidenNetherlands
  43. 43.European Clinical Research Infrastructure Network (ECRIN-ERIC), Management OfficeParisFrance
  44. 44.European Clinical Research Infrastructure Network (ECRIN-ERIC), National ECRIN office/KKS NetworkUniversity CologneCologneGermany
  45. 45.Clinical Coordinating CentreCharité – Universitätsmedizin BerlinBerlinGermany
  46. 46.Basque Office for Health Technology AssessmentVitoria-GasteizSpain
  47. 47.Department of Economics, Department of EconomicsUniversity of CopenhagenCopenhagenDenmark
  48. 48.Institute of Public HealthCharité - Universitätsmedizin BerlinBerlinGermany
  49. 49.Institute of Medical Statistics, Computer Sciences and DocumentationJena University Hospital, Friedrich Schiller University JenaJenaGermany