During the project, the Consortium focused on advancing the clinical trial at the centre of the project. The COVID-19 pandemic impacted EURO SHOCK in particular as the primary therapeutic intervention (ECMO) was extensively repurposed for the treatment of advanced COVID pneumonitis, and many of the health care professionals supporting EURO SHOCK were prioritised to the care of COVID patients. Professor Tony Gershlick, scientific lead for EURO SHOCK, also sadly passed away from COVID in November 2020. Following this, Professors Marcus Flather and Manel Sabate took over consortium leadership responsibilities with Dr Dave Adlam as sientific lead. Unfortunately, the clinical trial was unable to achieve its recruitment target and this was discussed with the Consortium, Trials Steering Committee and European Commission. A decision to suspend the trial was taken on 26th January 2022. Following this, close-down activities were commenced in February 2022.
At the time of suspension, there were 19 active recruiting sites in 8 countries. In total 35 participants were recruited and data were collected using an electronic CRF. The governance infrastructure for the programme was in place, including the Trial Steering Committee, the Independent Data Safety Monitoring Committee and Clinical Events Committee. Robust monitoring of patient data was supported by the experienced Cardiovascular European Research Centre (CERC).
To raise awareness for EURO SHOCK, a project website (www.euroshock-study.eu) tailored to different audiences was created. Outreach and dissemination activities were supported by materials, such as a roll-up and a project factsheet. Work on a pilot cardiac MRI study in CGS and novel approaches to remote patient monitoring is ongoing.
The number of patients recruited to the trial means that no definite conclusions could be drawn from the data available regarding the efficacy of VA-ECMO in cardiogenic shock. However, the data suggest a trend to a benefit with VA-ECMO with a numerically lower rate of 30-day and 1-year mortality with VA-ECMO compared to standard therapy alone. The 30-day all-cause mortality was 43.8% in patients randomised to VA-ECMO and 61.1% in 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 51.8% in the VA-ECMO group and 81.5% in the standard therapy group (HR=0.52 95% CI=0.21-1.26 P=0.14). There were also numerically lower rates of the composite endpoint of all-cause mortality and readmission with heart failure and 12-month rate for readmission with heart failure. Vascular and bleeding complications occurred more often in the patients randomised to VA-ECMO compared to standard therapy (vascular complications VA-ECMO= 21.4%, standard therapy = 0%; bleeding complications VA-ECMO=35.7%, standard therapy = 5.6%), reflective of the highly invasive nature of this mechanical circulatory support device.
The findings from the main trial were presented by Prof Manel Sabate at the EuroPCR 2023 conference as a “late breaking trial” on 19th May 2023. The results were also published simultaneously in the peer-reviewed journal “EuroIntervention” (Banning AS, Sabate M et al. EuroIntervention 2023. DOI: 10.4244/EIJ-D-23-00204). The presentation and publication of the results disseminates the findings from this trial to the wider interventional cardiology community as well as other healthcare specialists involved in the care of patients with cardiogenic shock such as intensivists and heart failure specialists.
