Elsevier

American Heart Journal

Volume 234, April 2021, Pages 1-11
American Heart Journal

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

https://doi.org/10.1016/j.ahj.2021.01.002Get rights and content

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.

Section snippets

Study objectives

The ECLS-SHOCK trial is a prospective, randomized, international, multicenter, open-label trial in patients with acute myocardial infarction including ST- and non-ST-elevation myocardial infarction (STEMI and NSTEMI) complicated by severe CS (Figure 1).

It will determine if the use of ECLS in addition to early revascularization is superior to early revascularization alone (with potential escalation to other MCS devices if necessary).

The trial is registered under www.clinicaltrials.gov:NCT03637205

Discussion

Current guidelines recommend the use of short-term MCS in refractory CS and in selected patients. Based on this recommendation, active MCS – excluding IABP - are currently used in approximately 10% of patients presenting with CS,8,11 although data derived from large-scale randomized clinical trials to assess their benefit/harm are still missing. The few published studies assessing the use of Impella are too small to draw meaningful conclusions with regard to clinical endpoints such as

Summary

At present, a relevant group of patients with acute myocardial infarction complicated by CS receives MCS such as ECLS for stabilization. However, prospective randomized data on the benefit of ECLS are lacking and current guidelines base their recommendation of using ECLS in refractory CS primarily on expert opinions.

The ECLS-SHOCK trial has been designed to test the hypothesis that in patients with severe CS complicating acute myocardial infarction ECLS use in addition to revascularization will

Funding source

Else Kröner Fresenius Foundation, German Heart Research Foundation, Leipzig Heart Institute

Acknowledgment

Funding: Else Kröner Fresenius Foundation: Grant number: 2018_A102, German Heart Research Foundation: Grant number: F/10/18, Leipzig Heart Institute: Grant number: None

References (32)

  • H Thiele et al.

    Intraaortic balloon support for myocardial infarction with cardiogenic shock

    N Engl J Med

    (2012)
  • H Thiele et al.

    Intraaortic balloon pump in cardiogenic shock complicating acute myocardial infarction. Long-term 6-year outcome of the randomized IABP-SHOCK II Trial

    Circulation

    (2019)
  • B Ibanez et al.

    2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevationThe Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC)

    Eur Heart J

    (2018)
  • M Shah et al.

    Trends in mechanical circulatory support use and hospital mortality among patients with acute myocardial infarction and non-infarction related cardiogenic shock in the United States

    Clin Res Cardiol

    (2018)
  • AP Amin et al.

    The evolving landscape of Impella use in the United States among patients undergoing percutaneous coronary intervention with mechanical circulatory support

    Circulation

    (2020)
  • SS Dhruva et al.

    Association of use of intravascular microaxial left ventricular assist device vs intra-aortic balloon pump on in-hospital mortality and major bleeding among patients with acute myocardial infarction complicated by cardiogenic shock

    JAMA

    (2020)
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