The EURO SHOCK Trial: Design, aims and objectives
Selected in EuroIntervention by M. Alasnag
Randomised comparison of extra corporeal membrane oxygenation (ECMO) delivered after acute-PCI plus standard of care versus standard of care alone after acute PCI, in patients presenting with ACS and cardiogenic shock
References
Authors
Amerjeet Singh Banning, 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 Sabate, Christiaan Vrints, Anthony Gershlick
Reference
DOI: 10.4244/EIJ-D-20-01076
Published
November 2020
Link
Read the abstractReviewer
My Comment
Why this study? – the rationale/objective
Cardiogenic shock (CGS) occurs in 6-10% of patients with acute coronary syndromes (ACS). Over the last few years, the interventional community has defined shock, compiled clinical protocols, and established shock teams and centres.
With such efforts, the mortality rate for those presenting with shock in the setting of ACS has fallen to approximately 50%. The primary driver for survival, however, remains early revascularization. Once advanced stages of shock are reached, escalation to mechanical circulatory support (MCS) should be weighed against futility. The purpose of the EURO SHOCK trial is to specifically examine the role of veno-arterial extra-corporeal membrane oxygenation (VA-ECMO) in such a setting.
How was it executed? – the methodology
The trial is designed to enrol 428 patients with CGS complicating ACS. After primary PCI (PPCI) patients will be randomized to ECMO plus standard pharmacotherapy or to standard pharmacotherapy alone. 39 European centres have been recruited. The primary endpoint is 30-day all-cause mortality. The secondary endpoints include 12-month all-cause mortality or admission for heart failure, 12-month all-cause mortality, or 12-month admission for heart failure. A sub-analysis that includes cost-effectiveness and quality of life have been pre-specified.
What is the main result?
The main results are of course still pending.
Critical reading and the relevance for clinical practice:
The EURO SHOCK Trial is one that is direly needed to guide practice. At the moment individual centre protocols dictate escalation and de-escalation of therapy which includes MCS devices and their combination. Since it is both randomized and multicentric, it is bound to be informative and representative. It is critical; however, that investigators use the more recent definitions of shock and shed light in particular on futility with advanced shock states. Analyses depending on baseline left ventricular systolic function, lactate levels, PAPi, number of occluded vessels and success of PPCI will need to be evaluated closely as they provide a better understanding of the practicality of current protocols. The study is examining early initiation of VA-ECMO, which means use of this device as a bailout or escalation therapy may not be addressed in this study. With early initiation, I project it will not be cost-effective. I also project the rate of complications, particularly vascular & coagulopathies, will be higher than accepted if early shock is included.
These, of course, are all hypotheses that this study may prove or disprove. With the number expected for enrollment, sex differences in outcomes are important. Irrespective of the results, this randomized study is necessary and a similar one for other devices would be equally informative as it addresses hard endpoints, namely 30-day and 12-month mortality.
Finally, the algorithm the trialists propose takes into account that there are centres without ECMO capabilities. This design is very representative of real-world circumstances. Ultimately, all trials should inform real-world practice.
EURO SHOCK Algorithm based on site
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