Pál Maurovich-Horvat1, Maria Bosserdt1, Klaus F Kofoed1, Nina Rieckmann1, Theodora Benedek1, Patrick Donnelly1, José Rodriguez-Palomares1, Andrejs Erglis1, Cyril Štěchovský1, Gintare Šakalyte1, Nada Čemerlić Adić1, Matthias Gutberlet1, Jonathan D Dodd1, Ignacio Diez1, Gershan Davis1, Elke Zimmermann1, Cezary Kępka1, Radosav Vidakovic1, Marco Francone1, Małgorzata Ilnicka-Suckiel1, Fabian Plank1, Juhani Knuuti1, Rita Faria1, Stephen Schröder1, Colin Berry1, Luca Saba1, Balazs Ruzsics1, Christine Kubiak1, Iñaki Gutierrez-Ibarluzea1, Kristian Schultz Hansen1, Jacqueline Müller-Nordhorn1, Bela Merkely1, Andreas D Knudsen1, Imre Benedek1, Clare Orr1, Filipa Xavier Valente1, Ligita Zvaigzne1, Vojtěch Suchánek1, Laura Zajančkauskiene1, Filip Adić1, Michael Woinke1, Mark Hensey1, Iñigo Lecumberri1, Erica Thwaite1, Michael Laule1, Mariusz Kruk1, Aleksandar N Neskovic1, Massimo Mancone1, Donata Kuśmierz1, Gudrun Feuchtner1, Mikko Pietilä1, Vasco Gama Ribeiro1, Tanja Drosch1, Christian Delles1, Gildo Matta1, Michael Fisher1, Bálint Szilveszter1, Linnea Larsen1, Mihaela Ratiu1, Stephanie Kelly1, Bruno Garcia Del Blanco1, Ainhoa Rubio1, Zsófia D Drobni1, Birgit Jurlander1, Ioana Rodean1, Susan Regan1, Hug Cuéllar Calabria1, Melinda Boussoussou1, Thomas Engstrøm1, Roxana Hodas1, Adriane E Napp1, Robert Haase1, Sarah Feger1, Lina M Serna-Higuita1, Konrad Neumann1, Henryk Dreger1, Matthias Rief1, Viktoria Wieske1, Melanie Estrella1, Peter Martus1, Marc Dewey1. 1. The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University, Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).
Abstract
BACKGROUND: In the diagnosis of obstructive coronary artery disease (CAD), computed tomography (CT) is an accurate, noninvasive alternative to invasive coronary angiography (ICA). However, the comparative effectiveness of CT and ICA in the management of CAD to reduce the frequency of major adverse cardiovascular events is uncertain. METHODS: We conducted a pragmatic, randomized trial comparing CT with ICA as initial diagnostic imaging strategies for guiding the treatment of patients with stable chest pain who had an intermediate pretest probability of obstructive CAD and were referred for ICA at one of 26 European centers. The primary outcome was major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) over 3.5 years. Key secondary outcomes were procedure-related complications and angina pectoris. RESULTS: Among 3561 patients (56.2% of whom were women), follow-up was complete for 3523 (98.9%). Major adverse cardiovascular events occurred in 38 of 1808 patients (2.1%) in the CT group and in 52 of 1753 (3.0%) in the ICA group (hazard ratio, 0.70; 95% confidence interval [CI], 0.46 to 1.07; P = 0.10). Major procedure-related complications occurred in 9 patients (0.5%) in the CT group and in 33 (1.9%) in the ICA group (hazard ratio, 0.26; 95% CI, 0.13 to 0.55). Angina during the final 4 weeks of follow-up was reported in 8.8% of the patients in the CT group and in 7.5% of those in the ICA group (odds ratio, 1.17; 95% CI, 0.92 to 1.48). CONCLUSIONS: Among patients referred for ICA because of stable chest pain and intermediate pretest probability of CAD, the risk of major adverse cardiovascular events was similar in the CT group and the ICA group. The frequency of major procedure-related complications was lower with an initial CT strategy. (Funded by the European Union Seventh Framework Program and others; DISCHARGE ClinicalTrials.gov number, NCT02400229.).
BACKGROUND: In the diagnosis of obstructive coronary artery disease (CAD), computed tomography (CT) is an accurate, noninvasive alternative to invasive coronary angiography (ICA). However, the comparative effectiveness of CT and ICA in the management of CAD to reduce the frequency of major adverse cardiovascular events is uncertain. METHODS: We conducted a pragmatic, randomized trial comparing CT with ICA as initial diagnostic imaging strategies for guiding the treatment of patients with stable chest pain who had an intermediate pretest probability of obstructive CAD and were referred for ICA at one of 26 European centers. The primary outcome was major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) over 3.5 years. Key secondary outcomes were procedure-related complications and angina pectoris. RESULTS: Among 3561 patients (56.2% of whom were women), follow-up was complete for 3523 (98.9%). Major adverse cardiovascular events occurred in 38 of 1808 patients (2.1%) in the CT group and in 52 of 1753 (3.0%) in the ICA group (hazard ratio, 0.70; 95% confidence interval [CI], 0.46 to 1.07; P = 0.10). Major procedure-related complications occurred in 9 patients (0.5%) in the CT group and in 33 (1.9%) in the ICA group (hazard ratio, 0.26; 95% CI, 0.13 to 0.55). Angina during the final 4 weeks of follow-up was reported in 8.8% of the patients in the CT group and in 7.5% of those in the ICA group (odds ratio, 1.17; 95% CI, 0.92 to 1.48). CONCLUSIONS: Among patients referred for ICA because of stable chest pain and intermediate pretest probability of CAD, the risk of major adverse cardiovascular events was similar in the CT group and the ICA group. The frequency of major procedure-related complications was lower with an initial CT strategy. (Funded by the European Union Seventh Framework Program and others; DISCHARGE ClinicalTrials.gov number, NCT02400229.).
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