Amerjeet Singh Banning1, BSc (Hons), MBBS, PhD, MRCP; Tom Adriaenssens2, MD; Colin Berry3, MB, PhD, ChB, FRCP, FACC; Kris Bogaerts4, PhD; Andrejs Erglis5, MD, PhD, FESC, FACC; Klaus Distelmaier6, MD, PhD, FESC; Giulio Guagliumi7, MD, FESC; Steven Haine8, MD, PhD; Adnan Kastrati9, MD, FESC; Steffen Massberg10, MD, PhD; Martin Orban10, MD; Truls Myrmel11, MD, PhD; Alain Vuylsteke12, BSc, MA, MD, FRCA; Fernando Alfonso13, MD, PhD, FESC; Frans Van de Werf2, MD, PhD; Freek Verheugt14, MD, PhD; Marcus Flather15, MBBS, FRCP, MBA; Manel Sabaté16, MD, PhD, FESC; Christiaan Vrints8, MD, PhD, FESC, FACC; Anthony H. Gershlick1, BSc, MBBS, FRCP
1. University of Leicester, University Hospitals of Leicester, Leicester Biomedical Research Centre, Leicester, United Kingdom; 2. University Hospitals Leuven, and Katholieke Universiteit Leuven, Department of Cardiovascular Sciences, Leuven, Belgium; 3. University of Glasgow, Institute of Cardiovascular and Medical Sciences and Robertson Centre for Biostatistics, Glasgow, United Kingdom; 4. Katholieke Universiteit Leuven, Department of Public Health and Primary Care, I-BioStat, and Universiteit Hasselt, I-BioStat, Leuven, Belgium; 5. Paula Stradina Kliniska Universitates Slimnica AS, Department of Cardiovascular Sciences, Riga, Latvia; 6. Medical University of Vienna, Department of Internal Medicine II, Division of Cardiology, Vienna, Austria; 7. Azienda Ospedaliera Papa Giovanni XXIII, Department of Cardiovascular Sciences, Bergamo, Italy; 8. Antwerp University Hospital, Department of Cardiology and University of Antwerp, Department of Cardiovascular Diseases, Antwerp, Belgium; 9. Deutsches Herzzentrum München, Department of Cardiology, Munich, Germany; 10. Medizinische Klinik und Poliklinik I, LMU University Hospital Munich, Munich, Germany; 11. The Heart and Lung Clinic, University Hospital North Norway, Tromsø, Norway; 12. Royal Papworth Hospital, Department of Anaesthesia and Intensive Care, Cambridge, United Kingdom; 13. Cardiac Department, La Princesa University Hospital, IIS-IP, CIBERCV, Madrid, Spain; 14. Heartcenter, Onze Lieve Vrouwe Gasthuis (OLVG), Amsterdam, the Netherlands; 15. University of East Anglia and Norfolk and Norwich University Hospital, Norwich, United Kingdom; 16. Consorci Institut D’Investicacions Biomediques August Pi i Sunyer, Cardiovascular Institute, Hospital Clínic, Barcelona, Spain
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.