The EURO-SHOCK Trial version 1
Research type
Research Study
Full title
EURO SHOCK Testing the value of novel strategy and its cost efficacy in order to improve the poor outcomes in Cardiogenic Shock
IRAS ID
250403
Contact name
Anthony Gershlick
Contact email
Sponsor organisation
University of Leicester
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 9 months, 29 days
Research summary
Summary of Research
This study involves patients who suffer from Cardiogenic shock (CGS). This happens in 10% of people who have had a heart attack. In this small group of patients 45-50% die within 30 days. To date there have been no research studies that have had any impact on this statistic in the last 20 years.
The Euro Shock Trial is supported by the European Union Horizons 2020 programme, and is testing the benefits or otherwise a device called ECMO (Extra Corporeal Membrane Oxygenation) therapy which has been shown to support the heart while it recovers from heart attacks.
We will be randomising 428 patients with CGS from 44 EU centres to either standard treatment [stent and drug therapy] or standard treatment PLUS early intervention with ECMO therapy. ECMO therapy is expensive and usually takes place in specialised centres, so we want to see if this therapy is effective and value for money.
There will also be sub studies that will also add to the body of knowledge in this area and we will undertake blood sampling, non-invasive scans and data analyses during the patients’ treatment.They will help us understand why ECMO has worked (or not).Summary of Results
EURO SHOCK: HRA Lay Summary of ResultsStudy Title:
Testing the Value of Novel Strategy and Its Cost Efficacy in Order to Improve the Poor Outcomes in Cardiogenic Shock (EURO SHOCK).Who carried out the research?
This project was supported by the European Commission Horizons 2020 funding stream and consisted of a pan-European consortium of experts in the field of cardiovascular intervention and management of patients with heart attacks. The sponsor of the trial was the University of Leicester. There were no conflicts of interest declared by the investigators.Where and when the study took place?
A total of 11 centers from 5 countries participated in the trial between Jan 2020 and Jan 2022. Centers that recruited patients included: Barcelona –Hospital Clinic de Barcelona (8), Hospital Germans Trias I Pujol (2), Hospital Vall d’Hebron (3), Hospital de Sant Pau (2); Germany – Deutsches Herzzentrum Muenchen (2), Ludwing Maximillian Universitaet (11), Klinkium Campus Innenstadt (1); UK – University Hospitals of Leicester NHS Trust (1), King’s College Hospital (2); Norway - Universitetssykehuset Nord-Norge (3); Latvia - Paula Stradina Kliniska Universitates Slimnica AS (1).Why was the research needed?
Cardiogenic shock is a condition when there is a poor pump function of the heart resulting in significantly reduced blood supply to the organs of the body. In patients presenting with a heart attack, due to the blockage of one or more of the heart arteries supplying blood to the heart (the coronary arteries), cardiogenic shock occurs in approximately 10% of patients. Despite treatment of the heart attack by opening the occluded coronary artery with a balloon and then a stent to keep the coronary artery open (a procedure called primary percutaneous coronary intervention or Primary PCI), the mortality from cardiogenic shock remains high at 50% despite advances in treatment of patients with heart attacks.What were the main questions studied?
The EURO SHOCK trial aimed to ask whether using a heart-lung bypass machine called Veno-Arterial Extracorporeal Membrane Oxygenation (VA-ECMO) if the state of cardiogenic shock persists after primary PCI treatment could help provide sufficient organ support while the heart recovers and hence potentially improve outcomes compared with current standard therapy of trying to support the heart with drugs to encourage the heart to work harder (inotropic support).Who Participated in the study?
A total of 35 patients were recruited to the trials. Patients were recruited if they presented with cardiogenic shock secondary to a heart attack, that persistent despite treatment of the heart attack with primary PCI. Following primary PCI, a period of 30 minutes was given to ensure there was still cardiogenic shock present before recruiting and randomizing patients.What treatments or interventions did the participants take/receive?
The patients were randomised to either standard therapy or implantation of VA-ECMO. If randomised to VA-ECMO, this was implanted as early as possible and no later than 6 hours after randomization. Standard therapy included use of drugs to assist with low blood pressure secondary to cardiogenic shock (inotropic or vasopressor agents), which are used in this setting conventionally. In some cases, the use of a balloon inserted into the aorta to improve blood flow in the coronary arteries was also inserted and permitted in both groups (IABP – Intra Aortic Balloon Counterpulsation Pump).What were the results of the study?
The study showed that early use of VA-ECMO (Veno-arterial Extracorporeal Membrane Oxygenation) in patients presenting with a heart attack and persistent cardiogenic shock, following treatment of the heart attack with primary PCI was associated with numerically lower rates of 30-day and 1-year mortality compared with standard therapy only.
The primary outcome of 30-day all-cause mortality occurred in 43.8% (7/17) of patients randomised to the VA-ECMO group, and in 61.1% (11/18) of patients randomised to standard therapy (HR=0.56, 95% CI=0.21 – 1.45, p=0.22). The 1-year all-cause mortality rate was also lower in patients receiving VA-ECMO. The one-year all-cause mortality occurred in 51.8% (8/17) of patients randomised to the VA-ECMO group and in 81.5% (14/18) patients randomised to standard therapy (HR=0.52, 95% CI=0.21-1.26, p=0.14. There was however a higher rate of bleeding events and vascular complications in those patients who received VA-ECMO.
It should be noted that the study was stopped before the planned recruitment could be completed only 35 patients out of a planned 428 patients were recruited to the trial. The low recruitment rate was particularly due to the impact of the covid-19 pandemic in centres being able to recruit patients to the trial. Thus, no definitive conclusions on the efficacy of VA-ECMO in patients with cardiogenic shock could be drawn from these results. The findings from this trial would need to be confirmed in larger randomised controlled trials.How has the study helped patients and researchers?
The results of this trial suggest a potential benefit of early support with VA-ECMO in patients with cardiogenic shock that does not improve with treatment of the heart attack with primary PCI. As mentioned above this would need to be definitively confirmed in larger scale randomised trials to confirm this benefit.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
19/YH/0003
Date of REC Opinion
4 Mar 2019
REC opinion
Further Information Favourable Opinion