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 Engstrøm; Stephen Schroeder; Tanja Drosch; Matthias Gutberlet; Michael Woinke; Pál Maurovich-Horvat; Bela 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; Discharge Trial Group The Discharge Trial Group

doi:10.1007/s00330-016-4620-z

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 Engstrøm, Stephen Schroeder, Tanja Drosch, Matthias Gutberlet, Michael Woinke, Pál Maurovich-Horvat, Bela Merkely, Patrick Donnelly, Peter BallJonathan 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^*, Discharge Trial Group The Discharge Trial Group

^*Corresponding author af dette arbejde

Institut for Klinisk Medicin

19 Citationer (Scopus)

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.

Originalsprog	Engelsk
Tidsskrift	European Radiology
Vol/bind	27
Sider (fra-til)	2957-2968
Antal sider	12
ISSN	0938-7994
DOI	https://doi.org/10.1007/s00330-016-4620-z
Status	Udgivet - 1 jul. 2017

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10.1007/s00330-016-4620-z

Citationsformater

Napp, A. E., Haase, R., Laule, M., Schuetz, G. M., Rief, M., Dreger, H., Feuchtner, G., Friedrich, G., Špaček, M., Suchánek, V., Fuglsang Kofoed, K., Engstrøm, T., Schroeder, S., Drosch, T., Gutberlet, M., Woinke, M., Maurovich-Horvat, P., Merkely, B., Donnelly, P., ... The Discharge Trial Group, D. T. G. (2017). Computed tomography versus invasive coronary angiography: design and methods of the pragmatic randomised multicentre DISCHARGE trial. European Radiology, 27, 2957-2968. https://doi.org/10.1007/s00330-016-4620-z

Napp, AE, Haase, R, Laule, M, Schuetz, GM, Rief, M, Dreger, H, Feuchtner, G, Friedrich, G, Špaček, M, Suchánek, V, Fuglsang Kofoed, K , Engstrøm, T, Schroeder, S, Drosch, T, Gutberlet, M, Woinke, M, Maurovich-Horvat, P, Merkely, B, Donnelly, P, Ball, P, Dodd, JD, Quinn, M, Saba, L, Porcu, M, Francone, M, Mancone, M, Erglis, A, Zvaigzne, L, Jankauskas, A, Sakalyte, G, Harań, T, Ilnicka-Suckiel, M, Bettencourt, N, Gama-Ribeiro, V, Condrea, S, Benedek, I, Čemerlić Adjić, N, Adjić, O, Rodriguez-Palomares, J, Garcia Del Blanco, B, Roditi, G, Berry, C, Davis, G, Thwaite, E, Knuuti, J, Pietilä, M, Kępka, C, Kruk, M, Vidakovic, R, Neskovic, AN, Díez, I, Lecumberri, I, Geleijns, J, Kubiak, C, Strenge-Hesse, A, Do, TH, Frömel, F, Gutiérrez-Ibarluzea, I, Benguria-Arrate, G, Keiding, H, Katzer, C, Müller-Nordhorn, J, Rieckmann, N, Walther, M, Schlattmann, P, Dewey, M & The Discharge Trial Group, DTG 2017, 'Computed tomography versus invasive coronary angiography: design and methods of the pragmatic randomised multicentre DISCHARGE trial', European Radiology, bind 27, s. 2957-2968. https://doi.org/10.1007/s00330-016-4620-z

@article{14bfdabc66654d73908fc09217aaf240,

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

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",

author = "Napp, {Adriane E.} and Robert Haase and Michael Laule and Schuetz, {Georg M.} and Matthias Rief and Henryk Dreger and Gudrun Feuchtner and Guy Friedrich and Miloslav {\v S}pa{\v c}ek and Vojt{\v e}ch Such{\'a}nek and {Fuglsang Kofoed}, Klaus and Thomas Engstr{\o}m and Stephen Schroeder and Tanja Drosch and Matthias Gutberlet and Michael Woinke and P{\'a}l Maurovich-Horvat and Bela Merkely and Patrick Donnelly and Peter Ball and Dodd, {Jonathan D.} and Martin Quinn and Luca Saba and Maurizio Porcu and Marco Francone and Massimo Mancone and Andrejs Erglis and Ligita Zvaigzne and Antanas Jankauskas and Gintare Sakalyte and Tomasz Hara{\'n} and Malgorzata Ilnicka-Suckiel and Nuno Bettencourt and Vasco Gama-Ribeiro and Sebastian Condrea and Imre Benedek and {{\v C}emerli{\'c} Adji{\'c}}, Nada and Oto Adji{\'c} and Jos{\'e} Rodriguez-Palomares and {Garcia Del Blanco}, Bruno and Giles Roditi and Colin Berry and Gershan Davis and Erica Thwaite and Juhani Knuuti and Mikko Pietil{\"a} and Cezary K{\c e}pka and Mariusz Kruk and Radosav Vidakovic and Neskovic, {Aleksandar N} and Ignacio D{\'i}ez and I{\~n}igo Lecumberri and Jacob Geleijns and Christine Kubiak and Anke Strenge-Hesse and Do, {The Hoang} and Felix Fr{\"o}mel and I{\~n}aki Guti{\'e}rrez-Ibarluzea and Gaizka Benguria-Arrate and Hans Keiding and Christoph Katzer and Jacqueline M{\"u}ller-Nordhorn and Nina Rieckmann and Mario Walther and Peter Schlattmann and Marc Dewey and {The Discharge Trial Group}, {Discharge Trial Group}",

year = "2017",

month = jul,

day = "1",

doi = "10.1007/s00330-016-4620-z",

language = "English",

volume = "27",

pages = "2957--2968",

journal = "European Radiology",

issn = "0938-7994",

publisher = "Springer",

}

TY - JOUR

T1 - Computed tomography versus invasive coronary angiography

T2 - design and methods of the pragmatic randomised multicentre DISCHARGE trial

AU - Napp, Adriane E.

AU - Haase, Robert

AU - Laule, Michael

AU - Schuetz, Georg M.

AU - Rief, Matthias

AU - Dreger, Henryk

AU - Feuchtner, Gudrun

AU - Friedrich, Guy

AU - Špaček, Miloslav

AU - Suchánek, Vojtěch

AU - Fuglsang Kofoed, Klaus

AU - Engstrøm, Thomas

AU - Schroeder, Stephen

AU - Drosch, Tanja

AU - Gutberlet, Matthias

AU - Woinke, Michael

AU - Maurovich-Horvat, Pál

AU - Merkely, Bela

AU - Donnelly, Patrick

AU - Ball, Peter

AU - Dodd, Jonathan D.

AU - Quinn, Martin

AU - Saba, Luca

AU - Porcu, Maurizio

AU - Francone, Marco

AU - Mancone, Massimo

AU - Erglis, Andrejs

AU - Zvaigzne, Ligita

AU - Jankauskas, Antanas

AU - Sakalyte, Gintare

AU - Harań, Tomasz

AU - Ilnicka-Suckiel, Malgorzata

AU - Bettencourt, Nuno

AU - Gama-Ribeiro, Vasco

AU - Condrea, Sebastian

AU - Benedek, Imre

AU - Čemerlić Adjić, Nada

AU - Adjić, Oto

AU - Rodriguez-Palomares, José

AU - Garcia Del Blanco, Bruno

AU - Roditi, Giles

AU - Berry, Colin

AU - Davis, Gershan

AU - Thwaite, Erica

AU - Knuuti, Juhani

AU - Pietilä, Mikko

AU - Kępka, Cezary

AU - Kruk, Mariusz

AU - Vidakovic, Radosav

AU - Neskovic, Aleksandar N

AU - Díez, Ignacio

AU - Lecumberri, Iñigo

AU - Geleijns, Jacob

AU - Kubiak, Christine

AU - Strenge-Hesse, Anke

AU - Do, The Hoang

AU - Frömel, Felix

AU - Gutiérrez-Ibarluzea, Iñaki

AU - Benguria-Arrate, Gaizka

AU - Keiding, Hans

AU - Katzer, Christoph

AU - Müller-Nordhorn, Jacqueline

AU - Rieckmann, Nina

AU - Walther, Mario

AU - Schlattmann, Peter

AU - Dewey, Marc

AU - The Discharge Trial Group, Discharge Trial Group

PY - 2017/7/1

Y1 - 2017/7/1

N2 - 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.

AB - 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.

KW - Adverse events

KW - Angiography

KW - Comparative effectiveness

KW - Computed tomography

KW - Invasive coronary angiography

U2 - 10.1007/s00330-016-4620-z

DO - 10.1007/s00330-016-4620-z

M3 - Journal article

C2 - 27864607

AN - SCOPUS:84995812356

SN - 0938-7994

VL - 27

SP - 2957

EP - 2968

JO - European Radiology

JF - European Radiology

ER -

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

Abstract

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