• N. Engl. J. Med. · Oct 2023

    Randomized Controlled Trial Multicenter Study

    Extracorporeal Life Support in Infarct-Related Cardiogenic Shock.

    • Holger Thiele, Uwe Zeymer, Ibrahim Akin, Michael Behnes, Tienush Rassaf, Amir Abbas Mahabadi, Ralf Lehmann, Ingo Eitel, Tobias Graf, Tim Seidler, Andreas Schuster, Carsten Skurk, Daniel Duerschmied, Peter Clemmensen, Marcus Hennersdorf, Stephan Fichtlscherer, Ingo Voigt, Melchior Seyfarth, Stefan John, Sebastian Ewen, Axel Linke, Eike Tigges, Peter Nordbeck, Leonhard Bruch, Christian Jung, Jutta Franz, Philipp Lauten, Tomaz Goslar, Hans-Josef Feistritzer, Janine Pöss, Eva Kirchhof, Taoufik Ouarrak, Steffen Schneider, Steffen Desch, Anne Freund, and ECLS-SHOCK Investigators.
    • From Heart Center Leipzig at University of Leipzig (H.T., H.-J.F., J.P., S.D., A.F.) and Helios Health Institute (E.K.), Leipzig, Institut für Herzinfarktforschung (U.Z., T.O., S.S.) and Klinikum Ludwigshafen (U.Z.), Ludwigshafen, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim (I.A., M.B., D.D.), the West German Heart and Vascular Center, University Hospital Essen (T.R., A.A.M.), and Contilia Elisabeth-Krankenhaus, Essen (I.V.), Essen, Asklepios Clinic Langen, Langen (R.L.), University Heart Center Lübeck and German Center for Cardiovascular Research, Partner Site Hamburg-Kiel-Lübeck, Lübeck (I.E., T. Graf), Heart Center Göttingen, University Medicine Göttingen, Göttingen (T.S., A.S.), Deutsches Herzzentrum der Charité, Department of Cardiology, Angiology and Intensive Care Medicine (C.S.), and Unfallkrankenhaus Berlin (L.B.), Berlin, University Heart and Vascular Center Hamburg (P.C.) and Asklepios Clinic St. Georg (E.T.), Hamburg, SLK Kliniken Heilbronn, Heilbronn (M.H.), University Heart and Vascular Center Frankfurt, Frankfurt (S.F.), Heart Center Wuppertal, Witten-Herdecke University, Wuppertal (M.S.), Paracelsus Private University, Clinic Nuremberg South, Nuremberg (S.J.), Saarland University Medical Center and Saarland University Faculty of Medicine, Homburg (S.E.), Technische Universität Dresden, Heart Center, Dresden (A.L.), University Clinic Würzburg, Würzburg (P.N.), University Clinic Düsseldorf, Düsseldorf (C.J.), Clinic Winnenden, Winnenden (J.F.), and Zentralklinik Bad Berka, Bad Berka (P.L.) - all in Germany; and University Medical Center Ljubljana, Ljubljana, Slovenia (T. Goslar).
    • N. Engl. J. Med. 2023 Oct 5; 389 (14): 128612971286-1297.

    BackgroundExtracorporeal life support (ECLS) is increasingly used in the treatment of infarct-related cardiogenic shock despite a lack of evidence regarding its effect on mortality.MethodsIn this multicenter trial, patients with acute myocardial infarction complicated by cardiogenic shock for whom early revascularization was planned were randomly assigned to receive early ECLS plus usual medical treatment (ECLS group) or usual medical treatment alone (control group). The primary outcome was death from any cause at 30 days. Safety outcomes included bleeding, stroke, and peripheral vascular complications warranting interventional or surgical therapy.ResultsA total of 420 patients underwent randomization, and 417 patients were included in final analyses. At 30 days, death from any cause had occurred in 100 of 209 patients (47.8%) in the ECLS group and in 102 of 208 patients (49.0%) in the control group (relative risk, 0.98; 95% confidence interval [CI], 0.80 to 1.19; P = 0.81). The median duration of mechanical ventilation was 7 days (interquartile range, 4 to 12) in the ECLS group and 5 days (interquartile range, 3 to 9) in the control group (median difference, 1 day; 95% CI, 0 to 2). The safety outcome consisting of moderate or severe bleeding occurred in 23.4% of the patients in the ECLS group and in 9.6% of those in the control group (relative risk, 2.44; 95% CI, 1.50 to 3.95); peripheral vascular complications warranting intervention occurred in 11.0% and 3.8%, respectively (relative risk, 2.86; 95% CI, 1.31 to 6.25).ConclusionsIn patients with acute myocardial infarction complicated by cardiogenic shock with planned early revascularization, the risk of death from any cause at the 30-day follow-up was not lower among the patients who received ECLS therapy than among those who received medical therapy alone. (Funded by the Else Kröner Fresenius Foundation and others; ECLS-SHOCK ClinicalTrials.gov number, NCT03637205.).Copyright © 2023 Massachusetts Medical Society.

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