Extracorporeal life support in patients with acute myocardial infarction complicated by cardiogenic shock - Design and rationale of the ECLS-SHOCK trial

TY - JOUR

T1 - Extracorporeal life support in patients with acute myocardial infarction complicated by cardiogenic shock - Design and rationale of the ECLS-SHOCK trial

AU - Thiele, Holger

AU - Freund, Anne

AU - Gimenez, Maria Rubini

AU - de Waha-Thiele, Suzanne

AU - Akin, Ibrahim

AU - Pöss, Janine

AU - Feistritzer, Hans-Josef

AU - Fuernau, Georg

AU - Graf, Tobias

AU - Nef, Holger

AU - Hamm, Christian

AU - Böhm, Michael

AU - Lauten, Alexander

AU - Schulze, P Christian

AU - Voigt, Ingo

AU - Nordbeck, Peter

AU - Felix, Stephan B

AU - Abel, Peter

AU - Baldus, Stephan

AU - Laufs, Ulrich

AU - Lenk, Karsten

AU - Landmesser, Ulf

AU - Skurk, Carsten

AU - Pieske, Burkert

AU - Tschöpe, Carsten

AU - Hennersdorf, Marcus

AU - Wengenmayer, Tobias

AU - Preusch, Michael

AU - Maier, Lars S

AU - Jung, Christian

AU - Kelm, Malte

AU - Clemmensen, Peter

AU - Westermann, Dirk

AU - Seidler, Tim

AU - Schieffer, Bernhard

AU - Rassaf, Tienush

AU - Mahabadi, Amir-Abbas

AU - Vasa-Nicotera, Mariuca

AU - Meincke, Felix

AU - Seyfarth, Melchior

AU - Kersten, Alexander

AU - Rottbauer, Wolfgang

AU - Boekstegers, Peter

AU - Muellenbach, Ralf

AU - Dengler, Thomas

AU - Kadel, Christoph

AU - Schempf, Benjamin

AU - Karagiannidis, Christian

AU - Hopf, Hans-Bernd

AU - Lehmann, Ralf

AU - Bufe, Alexander

AU - Baumanns, Stefan

AU - Öner, Alper

AU - Linke, Axel

AU - Sedding, Daniel

AU - Ferrari, Markus

AU - Bruch, Leonhard

AU - Goldmann, Britta

AU - John, Stefan

AU - Möllmann, Helge

AU - Franz, Jutta

AU - Lapp, Harald

AU - Lauten, Philipp

AU - Noc, Marko

AU - Goslar, Tomaz

AU - Oerlecke, Ilka

AU - Ouarrak, Taoufik

AU - Schneider, Steffen

AU - Desch, Steffen

AU - Zeymer, Uwe

AU - ECLS-SHOCK Investigators

N1 - Copyright © 2021 Elsevier Inc. All rights reserved.

PY - 2021/4

Y1 - 2021/4

N2 - BACKGROUND: In acute myocardial infarction complicated by cardiogenic shock the use of mechanical circulatory support devices remains controversial and data from randomized clinical trials are very limited. Extracorporeal life support (ECLS) - venoarterial extracorporeal membrane oxygenation - provides the strongest hemodynamic support in addition to oxygenation. However, despite increasing use it has not yet been properly investigated in randomized trials. Therefore, a prospective randomized adequately powered clinical trial is warranted.STUDY DESIGN: The ECLS-SHOCK trial is a 420-patient controlled, international, multicenter, randomized, open-label trial. It is designed to compare whether treatment with ECLS in addition to early revascularization with percutaneous coronary intervention or alternatively coronary artery bypass grafting and optimal medical treatment is beneficial in comparison to no-ECLS in patients with severe infarct-related cardiogenic shock. Patients will be randomized in a 1:1 fashion to one of the two treatment arms. The primary efficacy endpoint of ECLS-SHOCK is 30-day mortality. Secondary outcome measures such as hemodynamic, laboratory, and clinical parameters will serve as surrogate endpoints for prognosis. Furthermore, a longer follow-up at 6 and 12 months will be performed including quality of life assessment. Safety endpoints include peripheral ischemic vascular complications, bleeding and stroke.CONCLUSIONS: The ECLS-SHOCK trial will address essential questions of efficacy and safety of ECLS in addition to early revascularization in acute myocardial infarction complicated by cardiogenic shock.

AB - BACKGROUND: In acute myocardial infarction complicated by cardiogenic shock the use of mechanical circulatory support devices remains controversial and data from randomized clinical trials are very limited. Extracorporeal life support (ECLS) - venoarterial extracorporeal membrane oxygenation - provides the strongest hemodynamic support in addition to oxygenation. However, despite increasing use it has not yet been properly investigated in randomized trials. Therefore, a prospective randomized adequately powered clinical trial is warranted.STUDY DESIGN: The ECLS-SHOCK trial is a 420-patient controlled, international, multicenter, randomized, open-label trial. It is designed to compare whether treatment with ECLS in addition to early revascularization with percutaneous coronary intervention or alternatively coronary artery bypass grafting and optimal medical treatment is beneficial in comparison to no-ECLS in patients with severe infarct-related cardiogenic shock. Patients will be randomized in a 1:1 fashion to one of the two treatment arms. The primary efficacy endpoint of ECLS-SHOCK is 30-day mortality. Secondary outcome measures such as hemodynamic, laboratory, and clinical parameters will serve as surrogate endpoints for prognosis. Furthermore, a longer follow-up at 6 and 12 months will be performed including quality of life assessment. Safety endpoints include peripheral ischemic vascular complications, bleeding and stroke.CONCLUSIONS: The ECLS-SHOCK trial will address essential questions of efficacy and safety of ECLS in addition to early revascularization in acute myocardial infarction complicated by cardiogenic shock.

KW - Coronary Artery Bypass/methods

KW - Extracorporeal Membrane Oxygenation/adverse effects

KW - Fibrinolytic Agents/therapeutic use

KW - Humans

KW - Myocardial Infarction/complications

KW - Myocardial Revascularization/methods

KW - Prognosis

KW - Prospective Studies

KW - Quality of Life

KW - Sample Size

KW - Shock, Cardiogenic/etiology

U2 - 10.1016/j.ahj.2021.01.002

DO - 10.1016/j.ahj.2021.01.002

M3 - SCORING: Journal article

C2 - 33428901

VL - 234

SP - 1

EP - 11

JO - AM HEART J

JF - AM HEART J

SN - 0002-8703

ER -