稳定型胸痛的CT或有创冠状动脉造影

CT or Invasive Coronary Angiography in Stable Chest Pain.

作者信息

Maurovich-Horvat Pál, Bosserdt Maria, Kofoed Klaus F, Rieckmann Nina, Benedek Theodora, Donnelly Patrick, Rodriguez-Palomares José, Erglis Andrejs, Štěchovský Cyril, Šakalyte Gintare, Čemerlić Adić Nada, Gutberlet Matthias, Dodd Jonathan D, Diez Ignacio, Davis Gershan, Zimmermann Elke, Kępka Cezary, Vidakovic Radosav, Francone Marco, Ilnicka-Suckiel Małgorzata, Plank Fabian, Knuuti Juhani, Faria Rita, Schröder Stephen, Berry Colin, Saba Luca, Ruzsics Balazs, Kubiak Christine, Gutierrez-Ibarluzea Iñaki, Schultz Hansen Kristian, Müller-Nordhorn Jacqueline, Merkely Bela, Knudsen Andreas D, Benedek Imre, Orr Clare, Xavier Valente Filipa, Zvaigzne Ligita, Suchánek Vojtěch, Zajančkauskiene Laura, Adić Filip, Woinke Michael, Hensey Mark, Lecumberri Iñigo, Thwaite Erica, Laule Michael, Kruk Mariusz, Neskovic Aleksandar N, Mancone Massimo, Kuśmierz Donata, Feuchtner Gudrun, Pietilä Mikko, Gama Ribeiro Vasco, Drosch Tanja, Delles Christian, Matta Gildo, Fisher Michael, Szilveszter Bálint, Larsen Linnea, Ratiu Mihaela, Kelly Stephanie, Garcia Del Blanco Bruno, Rubio Ainhoa, Drobni Zsófia D, Jurlander Birgit, Rodean Ioana, Regan Susan, Cuéllar Calabria Hug, Boussoussou Melinda, Engstrøm Thomas, Hodas Roxana, Napp Adriane E, Haase Robert, Feger Sarah, Serna-Higuita Lina M, Neumann Konrad, Dreger Henryk, Rief Matthias, Wieske Viktoria, Estrella Melanie, Martus Peter, Dewey Marc

机构信息

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).

出版信息

N Engl J Med. 2022 Apr 28;386(17):1591-1602. doi: 10.1056/NEJMoa2200963. Epub 2022 Mar 4.

DOI:10.1056/NEJMoa2200963

PMID:35240010

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.).

摘要

背景

在阻塞性冠状动脉疾病（CAD）的诊断中，计算机断层扫描（CT）是侵入性冠状动脉造影（ICA）的一种准确、非侵入性替代方法。然而，CT和ICA在CAD管理中降低主要不良心血管事件发生率方面的比较效果尚不确定。

方法

我们进行了一项实用的随机试验，比较CT与ICA作为初始诊断成像策略，以指导患有稳定胸痛且阻塞性CAD预测试验概率为中等并被转诊至26个欧洲中心之一进行ICA的患者的治疗。主要结局是3.5年内的主要不良心血管事件（心血管死亡、非致命性心肌梗死或非致命性中风）。关键次要结局是与手术相关的并发症和心绞痛。

结果

在3561例患者中（56.2%为女性），3523例（98.9%）完成随访。CT组1808例患者中有38例（2.1%）发生主要不良心血管事件，ICA组1753例中有52例（3.0%）发生（风险比，0.70；95%置信区间[CI]，0.46至1.07；P = 0.10）。CT组9例患者（0.5%）发生主要手术相关并发症，ICA组33例（1.9%）发生（风险比，0.26；95%CI，0.13至0.55）。CT组8.8%的患者和ICA组7.5%的患者报告在随访最后4周内心绞痛（比值比，1.17；95%CI，0.92至1.48）。