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Randomized Controlled Trial Multicenter Study Comparative Study
Timing of Complete Revascularization with Multivessel PCI for Myocardial Infarction.
- Barbara E Stähli, Ferdinando Varbella, Axel Linke, Bettina Schwarz, Stephan B Felix, Moritz Seiffert, Rahel Kesterke, Peter Nordbeck, Bernhard Witzenbichler, Irene M Lang, Mirjam Kessler, Christian Valina, Alban Dibra, Miklos Rohla, Marco Moccetti, Matteo Vercellino, Luise Gaede, Lorenz Bott-Flügel, Philipp Jakob, Julia Stehli, Alessandro Candreva, Christian Templin, Matthias Schindler, Manfred Wischnewsky, Greca Zanda, Giorgio Quadri, Norman Mangner, Aurel Toma, Giulia Magnani, Peter Clemmensen, Thomas F Lüscher, Thomas Münzel, P Christian Schulze, Karl-Ludwig Laugwitz, Wolfgang Rottbauer, Kurt Huber, Franz-Josef Neumann, Steffen Schneider, Franz Weidinger, Stephan Achenbach, Gert Richardt, Adnan Kastrati, Ian Ford, Willibald Maier, Frank Ruschitzka, and MULTISTARS AMI Investigators.
- From the Department of Cardiology, University Heart Center, University Hospital Zurich, the Center for Translational and Experimental Cardiology, and the Faculty of Medicine (B.E.S., R.K., P.J., J.S., A.C., C.T., M. Schindler, W.M., F.R.) and Center for Molecular Cardiology, University of Zurich (T.F.L.), Zurich, the Department of Cardiology, Bern University Hospital, University of Bern, Bern (M.R.), and Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano (M.M.) - all in Switzerland; the Department of Internal Medicine, Cardiology Unit, Rivoli Hospital, Turin (F.V., G.Z., G.Q.), the Department of Internal Medicine, Santi Antonio e Biagio e Cesare Arrigo Hospital, Alessandria (M.V.), and the Division of Cardiology, Parma University Hospital, Parma (G.M.) - all in Italy; Technische Universität Dresden, Department of Internal Medicine and Cardiology, Herzzentrum Dresden, University Clinic, Dresden (A.L., N.M.), the Heart Center, Segeberger Kliniken, Academic Teaching Hospital for the Universities of Kiel, Lübeck and Hamburg, Bad Segeberg (B.S., G.R.), the Department of Internal Medicine B, University Medicine Greifswald, and the German Center for Cardiovascular Research (DZHK) Partner Site Greifswald, Greifswald (S.B.F.), the Department of Cardiology, University Heart and Vascular Center Hamburg, Center for Population Health Innovation, University Clinic Hamburg-Eppendorf, and DZHK Partner site Hamburg/Kiel/Lübeck, Hamburg (M. Seiffert, P.C.), the Department of Internal Medicine I, University Hospital Würzburg, Würzburg (P.N.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum, Dachau (B.W.), the Department of Cardiology, Friedrich-Alexander-University Erlangen-Nürnberg, Erlangen (L.G., S.A.), Cardiology and Pneumology, Klinikum Landkreis Erding, Erding (L.B.-F.), FB Mathematics and Computer Science, University of Bremen, Bremen (M.W.), the Department of Cardiology, Ulm University Heart Center, Ulm (M.K., W.R.), the Department of Cardiology and Angiology, University of Freiburg Medical Center, and the Faculty of Medicine, University of Freiburg, Freiburg (C.V., F.-J.N.), the Department of Cardiology, University Medical Center Mainz, and the Center for Cardiovascular Research, Johannes Gutenberg University Partner Site Rhine Main, Mainz (T.M.), the Department of Internal Medicine I, Division of Cardiology, Pneumology, and Angiology, and the Intensive Medical Care, University Hospital Jena, Friedrich-Schiller-University, Jena (P.C.S.), Clinic and Policlinic Internal Medicine I, Cardiology and Angiology, Klinikum rechts der Isar (K.-L.L.), and Klinik für Herz und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, and DZHK, partner site Munich Heart Alliance (A.K.), Munich, and Institut für Herzinfarktforschung, Ludwigshafen (S.S.) - all in Germany; the Department of Internal Medicine II, Division of Cardiology, Medical University of Vienna (I.M.L., A.T.), the 3rd Department of Medicine, Cardiology, and Intensive Care Medicine, Clinic Ottakring and Sigmund Freud University Medical School (M.R., K.H.), and the 2nd Medical Department with Cardiology and Intensive Care Medicine, Klinik Landstrasse (F.W.) - all in Vienna; the Department of Cardiovascular Diseases, University of Medicine, University Hospital Mother Teresa, Tirana, Albania (A.D.); the Department of Medicine, Nykøbing Falster Hospital, Nykøbing Falster, Denmark (P.C.); and the Heart Division, Royal Brompton and Harefield Hospitals, and the National Heart and Lung Institute, Imperial College London, London (T.F.L.), and the Robertson Centre for Biostatistics, University of Glasgow, Glasgow (I.F.) - all in the United Kingdom.
- N. Engl. J. Med. 2023 Oct 12; 389 (15): 136813791368-1379.
BackgroundIn patients with ST-segment elevation myocardial infarction (STEMI) with multivessel coronary artery disease, the time at which complete revascularization of nonculprit lesions should be performed remains unknown.MethodsWe performed an international, open-label, randomized, noninferiority trial at 37 sites in Europe. Patients in a hemodynamically stable condition who had STEMI and multivessel coronary artery disease were randomly assigned to undergo immediate multivessel percutaneous coronary intervention (PCI; immediate group) or PCI of the culprit lesion followed by staged multivessel PCI of nonculprit lesions within 19 to 45 days after the index procedure (staged group). The primary end point was a composite of death from any cause, nonfatal myocardial infarction, stroke, unplanned ischemia-driven revascularization, or hospitalization for heart failure at 1 year after randomization. The percentages of patients with a primary or secondary end-point event are provided as Kaplan-Meier estimates at 6 months and at 1 year.ResultsWe assigned 418 patients to undergo immediate multivessel PCI and 422 to undergo staged multivessel PCI. A primary end-point event occurred in 35 patients (8.5%) in the immediate group as compared with 68 patients (16.3%) in the staged group (risk ratio, 0.52; 95% confidence interval, 0.38 to 0.72; P<0.001 for noninferiority and P<0.001 for superiority). Nonfatal myocardial infarction and unplanned ischemia-driven revascularization occurred in 8 patients (2.0%) and 17 patients (4.1%), respectively, in the immediate group and in 22 patients (5.3%) and 39 patients (9.3%), respectively, in the staged group. The risk of death from any cause, the risk of stroke, and the risk of hospitalization for heart failure appeared to be similar in the two groups. A total of 104 patients in the immediate group and 145 patients in the staged group had a serious adverse event.ConclusionsAmong patients in hemodynamically stable condition with STEMI and multivessel coronary artery disease, immediate multivessel PCI was noninferior to staged multivessel PCI with respect to the risk of death from any cause, nonfatal myocardial infarction, stroke, unplanned ischemia-driven revascularization, or hospitalization for heart failure at 1 year. (Supported by Boston Scientific; MULTISTARS AMI ClinicalTrials.gov number, NCT03135275.).Copyright © 2023 Massachusetts Medical Society.
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