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Randomized Controlled Trial
. 2021 Feb 5;16(15):e1227-e1236.
doi: 10.4244/EIJ-D-20-01076.

Veno-arterial extracorporeal membrane oxygenation (ECMO) in patients with cardiogenic shock: rationale and design of the randomised, multicentre, open-label EURO SHOCK trial

Amerjeet Singh Banning  1 , Tom Adriaenssens, Colin Berry, Kris Bogaerts, Andrejs Erglis, Klaus Distelmaier, Giulio Guagliumi, Steven Haine, Adnan Kastrati, Steffen Massberg, Martin Orban, Truls Myrmel, Alain Vuylsteke, Fernando Alfonso, Frans Van de Werf, Freek Verheugt, Marcus Flather, Manel Sabaté, Christiaan Vrints, Anthony H Gershlick; Collaborators
Collaborators, Affiliations
Randomized Controlled Trial

Veno-arterial extracorporeal membrane oxygenation (ECMO) in patients with cardiogenic shock: rationale and design of the randomised, multicentre, open-label EURO SHOCK trial

Amerjeet Singh Banning et al. EuroIntervention. .

Abstract

Aims: Cardiogenic shock (CGS) occurs in 6-10% of patients with acute coronary syndromes (ACS). Mortality has fallen over time from 80% to approximately 50% consequent on acute revascularisation but has plateaued since the 1990s. Once established, patients with CGS develop adverse compensatory mechanisms that contribute to the downward spiral towards death, which becomes difficult to reverse. We aimed to test in a robust, prospective, randomised controlled trial whether early support with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) provides clinical benefit by improving mortality and morbidity.

Methods and results: The EURO SHOCK trial will test the benefit or otherwise of mechanical cardiac support using VA-ECMO, initiated early after acute percutaneous coronary intervention (PCI) for CGS. The trial sets out to randomise 428 patients with CGS complicating ACS, following primary PCI (P-PCI), to either very early ECMO plus standard pharmacotherapy, or standard pharmacotherapy alone. It will be conducted in 39 European centres. The primary endpoint is 30-day all-cause mortality with key secondary endpoints: 1) 12-month all-cause mortality or admission for heart failure, 2) 12-month all-cause mortality, 3) 12-month admission for heart failure. Cost-effectiveness analysis (including quality of life measures) will be embedded. Mechanistic and hypothesis-generating substudies will be undertaken.

Conclusions: The EURO SHOCK trial will determine whether early initiation of VA-ECMO in patients presenting with ACS-CGS persisting after PCI improves mortality and morbidity.

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Conflict of interest statement

The following authors disclose grants from the European Union Horizons 2020 programme for the EURO SHOCK study: T. Adriaenssens, C. Berry, K. Bogaerts, A.K. Erglis, G. Guagliumi, S. Haine, A. Kastrati, T. Myrmel, S. Massberg, M. Flather, M. Sabaté, C. Vrints and A. Gershlick. M. Sabate reports personal fees from Abbott Vascular and iVascular. M. Orban reports personal fees from AstraZeneca, Abiomed, Bayer Vital, Cytosorbents, and Sedana Medical, outside the submitted work. C. Berry reports grants and other from Abbott Vascular and AstraZeneca, non-financial support and other from Coroventis, grants and other from GSK, Novartis, other from Neovasc, Medyria, and Siemens Healthcare, and grants and other from HeartFlow, outside the submitted work. G. Guagliumi reports grants and personal fees from Abbott Vascular, personal fees from Boston Scientific, and grants and personal fees from Infraredx, outside the submitted work. P. Bousfield (the managing director of Chalice Medical) is a supplier of equipment used for ECMO in the UK and Europe and as such has commercial interests. Their involvement in the EURO SHOCK trial is such that the use of their equipment is not actively promoted because centres are encouraged to use whatever ECMO devices they are familiar with and use under their current practice. The other authors/study collaborators have no conflicts of interest to declare.

Figures

Figure 1
Figure 1
The effect of assessed interventions on outcomes from cardiogenic shock. Modified from Thiele et al.
Figure 2
Figure 2
EURO SHOCK trial flow diagram.
Figure 3
Figure 3
Patient flow diagram based on type of presenting centre.
See this image and copyright information in PMC

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