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

被引：33

作者：

Napp, Adriane E. ^{[1
]}

Haase, Robert ^{[1
]}

Laule, Michael ^{[2
]}

Schuetz, Georg M. ^{[1
]}

Rief, Matthias ^{[1
]}

Dreger, Henryk ^{[2
]}

Feuchtner, Gudrun ^{[3
]}

Friedrich, Guy ^{[4
]}

Spacek, Miloslav ^{[5
]}

Suchanek, Vojtech ^{[6
]}

Kofoed, Klaus Fuglsang ^{[7
,8
]}

Engstroem, Thomas ^{[8
]}

Schroeder, Stephen ^{[9
]}

Drosch, Tanja ^{[9
]}

Gutberlet, Matthias ^{[10
]}

Woinke, Michael ^{[11
]}

Maurovich-Horvat, Pal ^{[12
]}

Merkely, Bela ^{[12
]}

Donnelly, Patrick ^{[13
]}

Ball, Peter ^{[14
]}

Dodd, Jonathan D. ^{[15
,16
]}

Quinn, Martin ^{[17
]}

Saba, Luca ^{[18
]}

Porcu, Maurizio ^{[19
]}

Francone, Marco ^{[20
]}

Mancone, Massimo ^{[21
]}

Erglis, Andrejs ^{[22
]}

Zvaigzne, Ligita ^{[23
]}

Jankauskas, Antanas ^{[24
]}

Sakalyte, Gintare ^{[25
]}

Haran, Tomasz ^{[26
]}

Ilnicka-Suckiel, Malgorzata ^{[27
]}

Bettencourt, Nuno ^{[28
]}

Gama-Ribeiro, Vasco ^{[28
]}

Condrea, Sebastian ^{[29
]}

Benedek, Imre ^{[29
]}

Adjic, Nada Cemerlic ^{[30
]}

Adjic, Oto ^{[31
]}

Rodriguez-Palomares, Jose ^{[32
]}

del Blanco, Bruno Garcia ^{[32
]}

Roditi, Giles ^{[33
]}

Berry, Colin ^{[33
]}

Davis, Gershan ^{[34
]}

Thwaite, Erica ^{[35
]}

Knuuti, Juhani ^{[36
,37
]}

Pietila, Mikko ^{[38
]}

Kepka, Cezary ^{[39
]}

Kruk, Mariusz ^{[40
]}

Vidakovic, Radosav ^{[41
]}

Neskovic, Aleksandar N. ^{[41
]}

机构：

[1] Charite Univ Med Berlin, Dept Radiol, Charitepl 1, D-10117 Berlin, Germany

[2] Charite Univ Med Berlin, Dept Cardiol, Charitepl 1, D-10117 Berlin, Germany

[3] Med Univ Innsbruck, Dept Radiol, Anichstr 35, A-6020 Innsbruck, Austria

[4] Med Univ Innsbruck, Dept Cardiol, Anichstr 35, A-6020 Innsbruck, Austria

[5] Univ Hosp Motol, Dept Cardiol, Vuvalu 84, Prague 15006 5, Czech Republic

[6] Univ Hosp Motol, Dept Radiol, Vuvalu 84, Prague 15006 5, Czech Republic

[7] Rigshosp 9, Rigshosp Reg Hovedstaden, Dept Radiol, DK-2100 Copenhagen, Denmark

[8] Rigshosp 9, Rigshosp Reg Hovedstaden, Dept Cardiol, DK-2100 Copenhagen, Denmark

[9] ALB FILS KLINIKEN GmbH, Dept Cardiol, D-73035 Goeppingen, Germany

[10] Univ Leipzig, Dept Radiol, Ctr Heart, Strumpellstr 39, D-04289 Leipzig, Germany

[11] Univ Leipzig, Dept Cardiol, Ctr Heart, Strumpellstr 39, D-04289 Leipzig, Germany

[12] Semmelweis Univ, MTA SE Cardiovasc Imaging Ctr, Heart & Vasc Ctr, Varosmajor U 68, H-1122 Budapest, Hungary

[13] Southeastern Hlth & Social Care Trust, Dept Cardiol, Upper Newtownards Rd Ulster, Belfast BT16 1RH, Antrim, North Ireland

[14] Southeastern Hlth & Social Care Trust, Dept Radiol, Upper Newtownards Rd Ulster, Belfast BT16 1RH, Antrim, North Ireland

[15] St Vincents Univ Hosp, Dept Radiol, Belfield Campus, Dublin 4, Ireland

[16] Natl Univ Ireland, Belfield Campus, Dublin 4, Ireland

[17] St Vincents Univ Hosp, Dept Cardiol, Belfield Campus, Dublin 4, Ireland

[18] Azienda Osped Univ Cagliari, AOU Cagliari Polo Monserrato, Dept Radiol, I-09042 Monserrato, CA, Italy

[19] Azienda Osped Brotzu, Dept Cardiol, Cagliari, CA, Italy

[20] Sapienza Univ Rome, Dept Radiol, Viale Regina Elena 324, I-00161 Rome, Italy

[21] Sapienza Univ Rome, Dept Cardiovasc Resp Nephrol Anesthesiol & Geriat, Viale Regina Elena 324, I-00161 Rome, Italy

[22] Paul Stradins Clin Univ Hosp, Dept Cardiol, Pilsonu St 13, LV-1002 Riga, Latvia

[23] Paul Stradins Clin Univ Hosp, Dept Radiol, Pilsonu St 13, LV-1002 Riga, Latvia

[24] Lithuanian Univ Hlth Sci, Dept Radiol, Eivelniu 2, LT-50009 Kaunas, Lithuania

[25] Lithuanian Univ Hlth Sci, Dept Cardiol, Eivelniu 2, LT-50009 Kaunas, Lithuania

[26] Wojewodzki Szpital Specjalistyczny Wroclawiu, Dept Radiol, Ul Henryka Michala Kamienskiego, PL-51124 Wroclaw, Poland

[27] Wojewodzki Szpital Specjalistyczny Wroclawiu, Dept Cardiol, Ul Henryka Michala Kamienskiego, PL-51124 Wroclaw, Poland

[28] Ctr Hosp Vila Nova de Gaia, Dept Cardiol, Rua Conceicao Fernandes, P-4434502 Vila Nova De Gaia, Portugal

[29] Cardio Med Med Ctr, Dept Cardiol, 22 Decembrie 1989, Targu Mures 540156, Romania

[30] Inst Cardiovasc Dis Vojvodina, Dept Cardiol, Put Dr Goldmana 4, Novi Sad 212014, Sremska Kamenic, Serbia

[31] Inst Cardiovasc Dis Vojvodina, Radiol Dept Imaging Ctr, Put Dr Goldmana 4, Novi Sad 212014, Sremska Kamenic, Serbia

[32] Univ Autonoma Barcelona, Dept Cardiol Barcelona Spain, Hosp Univ Vall dHebron, Inst Recerca VHIR, Passeig Vall dHebron 119, Barcelona 08035, Spain

[33] Univ Glasgow, Inst Cardiovasc & Med Sci, Univ Pl 126, Glasgow G12 8TA, Lanark, Scotland

[34] Aintree Univ Hosp NHS Fdn Trust, Dept Cardiol, Longmoor Lane, Liverpool L9 7AL, Merseyside, England

[35] Aintree Univ Hosp NHS Fdn Trust, Dept Radiol, Longmoor Lane, Liverpool L9 7AL, Merseyside, England

[36] Turku Univ Hosp, Turku PET Ctr, Kiinamyllynkatu 4-8, FI-20120 Turku, Finland

[37] Univ Turku, Kiinamyllynkatu 4-8, FI-20120 Turku, Finland

[38] Turku Univ Hosp, Ctr Heart, Kiinamyllynkatu 4-8, FI-20120 Turku, Finland

[39] Inst Cardiol Warsaw, Dept Radiol, Ul Alpejska 42, PL-04628 Warsaw, Poland

[40] Inst Cardiol Warsaw, Dept Cardiol, Ul Alpejska 42, PL-04628 Warsaw, Poland

[41] Clin Hosp Ctr Zemun, Dept Cardiol, Vukova 9, Belgrade 11080, Serbia

[42] Basurto Univ Hosp, Dept Cardiol, Ave Montevideo 18, Bilbao 48013, Spain

[43] Basurto Univ Hosp, Dept Radiol, Ave Montevideo 18, Bilbao 48013, Spain

[44] Leiden Univ, Dept Radiol, Med Ctr, Albinusdreef 2, NL-2333 ZA Leiden, Netherlands

[45] European Clin Res Infrastruct Network ECRIN ERIC, Management Off, 5 Rue Watt, F-75013 Paris, France

[46] Univ Cologne, European Clin Res Infrastruct Network ECRIN ERIC, Natl ECRIN Off, KKS Network, Kerpener Str 62, D-50937 Cologne, Germany

[47] Charite Univ Med Berlin, Clin Coordinating Ctr, Campus Virchow Klinikum, Augustenburger Pl 1, D-13353 Berlin, Germany

[48] Basque Off Hlth Technol Assessment, Donostia San Sebastian 1, Vitoria 01010, Spain

[49] Univ Copenhagen, Dept Econ, 26,Bldg 26-1-00, Copenhagen, Denmark

[50] Charite Univ Med Berlin, Inst Publ Hlth, Charitepl 1, D-10117 Berlin, Germany

来源：

EUROPEAN RADIOLOGY | 2017年 / 27卷 / 07期

基金：

芬兰科学院;

关键词：

Computed tomography; Angiography; Invasive coronary angiography; Adverse events; Comparative effectiveness; CT ANGIOGRAPHY; CARDIAC-CATHETERIZATION; COST-EFFECTIVENESS; CLINICAL-TRIALS; CHEST-PAIN; TASK-FORCE; METAANALYSIS; PERFORMANCE; GUIDELINES; MANAGEMENT;

D O I：

10.1007/s00330-016-4620-z

中图分类号：

R8 [特种医学]; R445 [影像诊断学];

学科分类号：

1002 ; 100207 ; 1009 ;

摘要：

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. aEuro cent Coronary artery disease (CAD) is a major cause of morbidity and mortality. aEuro cent Invasive coronary angiography (ICA) is the reference standard for detection of CAD. aEuro cent Noninvasive computed tomography angiography excludes CAD with high sensitivity. aEuro cent CT may effectively reduce the approximately 2 million negative ICAs in Europe. aEuro cent DISCHARGE addresses this hypothesis in patients with low-to-intermediate pretest probability for CAD.

引用

页码：2957 / 2968

页数：12

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