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

Humans Coronary Artery Bypass / methods Extracorporeal Membrane Oxygenation / adverse effects Fibrinolytic Agents / therapeutic use Myocardial Infarction / complications Myocardial Revascularization / methods Prognosis Prospective Studies Quality of Life Sample Size Shock, Cardiogenic / etiology Multicenter Studies as Topic Randomized Controlled Trials as Topic

Journal

American heart journal

ISSN: 1097-6744

Titre abrégé: Am Heart J

Pays: United States

ID NLM: 0370465

Informations de publication

Date de publication:
04 2021

Historique:

received: 01 10 2020

accepted: 05 01 2021

pubmed: 12 1 2021

medline: 22 4 2021

entrez: 11 1 2021

Statut: ppublish

Résumé

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. 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. 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.

Sections du résumé

BACKGROUND

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.

Identifiants

DOI: 10.1016/j.ahj.2021.01.002 PMID: 33428901

pubmed: 33428901

pii: S0002-8703(21)00004-1

doi: 10.1016/j.ahj.2021.01.002

pii:

doi:

Substances chimiques

Fibrinolytic Agents 0

Types de publication

Clinical Trial Protocol Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

1-11