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Randomized Controlled Trial
. 2023 Aug 21;19(6):482-492.
doi: 10.4244/EIJ-D-23-00204.

Venoarterial extracorporeal membrane oxygenation or standard care in patients with cardiogenic shock complicating acute myocardial infarction: the multicentre, randomised EURO SHOCK trial

Affiliations
Randomized Controlled Trial

Venoarterial extracorporeal membrane oxygenation or standard care in patients with cardiogenic shock complicating acute myocardial infarction: the multicentre, randomised EURO SHOCK trial

Amerjeet S Banning et al. EuroIntervention. .

Abstract

Background: Cardiogenic shock (CGS) occurs in 10% of patients presenting with acute myocardial infarction (MI), with in-hospital mortality rates of 40-50% despite revascularisation.

Aims: The EURO SHOCK trial aimed to determine if early use of venoarterial extracorporeal membrane oxygenation (VA-ECMO) could improve outcomes in patients with persistent CGS following primary percutaneous coronary intervention (PPCI).

Methods: This multicentre, pan-European trial randomised patients with persistent CGS 30 minutes after PPCI of the culprit lesion to receive either VA-ECMO or continue with standard therapy. The primary outcome measure was 30-day all-cause mortality in an intention-to-treat analysis. Secondary endpoints included 12-month all-cause mortality and 12-month composite of all-cause mortality or rehospitalisation due to heart failure.

Results: Due to the impact of the COVID-19 pandemic, the trial was stopped before completion of recruitment, after randomisation of 35 patients (standard therapy n=18, VA-ECMO n=17). Thirty-day all-cause mortality occurred in 43.8% of patients randomised to VA-ECMO and in 61.1% of patients randomised to standard therapy (hazard ratio [HR] 0.56, 95% confidence interval [CI]: 0.21-1.45; p=0.22). One-year all-cause mortality was 51.8% in the VA-ECMO group and 81.5% in the standard therapy arm (HR 0.52, 95% CI: 0.21-1.26; p=0.14). Vascular and bleeding complications occurred more often in the VA-ECMO arm (21.4% vs 0% and 35.7% vs 5.6%, respectively).

Conclusions: Due to the limited number of patients recruited to the trial, no definite conclusions could be drawn from the available data. Our study demonstrates the feasibility of randomising patients with CGS complicating acute MI but also illustrates the challenges. We hope these data will inspire and inform the design of future large-scale trials.

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Conflict of interest statement

M. Orban reports receiving payments or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from Abbott Medical, AstraZeneca, Abiomed, Bayer Vital, Biotronik, Bristol-Myers Squibb, CytoSorbents, Daiichi Sankyo Deutschland, Edwards Lifesciences, and Sedana Medical. T. López-Sobrino reports receiving payments or honoraria for presentations from the University of Barcelona and the European Acute Cardiac Care Association. T. Adriaenssens reports receiving honoraria from Abiomed for speakers’ bureaus. C. Berry is employed by the University of Glasgow, which holds research agreements for his work with Abbott Vascular, AstraZeneca, Boehringer Ingelheim, and HeartFlow; and holds consultancy and research agreements for his work with Abbott Vascular, AstraZeneca, Auxilius Pharma, Boehringer Ingelheim, Causeway Therapeutics, Coroventis, Genetech, GSK, HeartFlow, Menarini, Neovasc, Siemens Healthcare, and Valo Health. D. Adlam has received funding to support a clinical research fellow from Abbott Vascular; funding from AstraZeneca for unrelated research; has conducted unrelated consultancy for GE HealthCare; holds patents for medical devices, including a cardiac assist device (EP3277337A1, PCT/GB2017/050877, UK PATENT APPLICATION NUMBER 2211616.4); and has received royalties from Elsevier Inc. for ECG made Practical and ECG Problems books. M. Flather reports receiving consulting fees from Boehringer Ingelheim for consulting work unrelated to this project; speakers’ fees from Menarini International, AstraZeneca, and Bayer; support for attending meeting from AstraZeneca, and modest honorarium as Deputy Editor of the European Heart Journal ‒ Quality of Care & Clinical Outcomes. The other authors report no conflicts of interest related to the reported study.

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