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^{1

2}, Manel Sabaté³, Martin Orban⁴, Jay Gracey², Teresa López-Sobrino³, Steffen Massberg⁵, Adnan Kastrati⁵, Kris Bogaerts⁶, Tom Adriaenssens⁷, Colin Berry⁸, Andrejs Erglis⁹, Steven Haine¹⁰, Truls Myrmel¹¹, Sameer Patel¹², Irene Buera¹³, Alessandro Sionis¹⁴, Victoria Vilalta¹⁵, Hakeem Yusuff¹, Christiaan Vrints¹⁰, David Adlam², Marcus Flather¹⁶, Anthony H Gershlick^{1

2}

Affiliations

¹ Glenfield Hospital, University Hospitals of Leicester NHS Trust, Leicester, UK.
² Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.
³ Consorci Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Cardiovascular Institute, Hospital Clinic, Barcelona, Spain.
⁴ Medizinische Klinik und Poliklinik I, LMU University Hospital Munich, Munich, Germany.
⁵ Department of Cardiology, Deutsches Herzzentrum Muenchen, German Center for Cardiovascular Research (DZHK), Munich, Germany and Partner Site Munich Heart Alliance, Munich, Germany.
⁶ Department of Public Health and Primary Care, KU Leuven, I-BioStat, Leuven, Belgium and UHasselt, I-BioStat, Diepenbeek, Belgium.
⁷ University Hospitals Leuven, Leuven, Belgium and Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium.
⁸ University of Glasgow, Institute of Cardiovascular and Medical Sciences, Glasgow, UK and Robertson Centre for Biostatistics, Glasgow, UK.
⁹ Pauls Stradins Clinical University Hospital, Riga, Latvia and the University of Latvia, Riga, Latvia.
¹⁰ Department of Cardiology, Antwerp University Hospital, Antwerp, Belgium and Department of Cardiovascular Sciences, University of Antwerp, Antwerp, Belgium.
¹¹ Universitetssykehuset Nord-Norge, Tromsø, Norway.
¹² King's College Hospital and Faculty of Life Sciences & Medicine, King's College London, London, UK.
¹³ Hospital Universitario Vall d'Hebron, VHIR, Universidad Autonoma de Barcelona, Barcelona, Spain.
¹⁴ Cardiology Department, Intensive Cardiac Care Unit, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain and Universitat Autònoma de Barcelona, Barcelona, Spain and Centro de Investigación Biomèdica en Red de Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.
¹⁵ Interventional Cardiology Unit, Cardiology Department, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.
¹⁶ University of East Anglia, Norwich, UK and Norfolk and Norwich University Hospitals, Norwich, UK.

PMID: 37334659
PMCID: PMC10436068
DOI: 10.4244/EIJ-D-23-00204

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. 2023.

. 2023 Aug 21;19(6):482-492.

doi: 10.4244/EIJ-D-23-00204.

Authors

Affiliations

¹ Glenfield Hospital, University Hospitals of Leicester NHS Trust, Leicester, UK.
² Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.
³ Consorci Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Cardiovascular Institute, Hospital Clinic, Barcelona, Spain.
⁴ Medizinische Klinik und Poliklinik I, LMU University Hospital Munich, Munich, Germany.
⁵ Department of Cardiology, Deutsches Herzzentrum Muenchen, German Center for Cardiovascular Research (DZHK), Munich, Germany and Partner Site Munich Heart Alliance, Munich, Germany.
⁶ Department of Public Health and Primary Care, KU Leuven, I-BioStat, Leuven, Belgium and UHasselt, I-BioStat, Diepenbeek, Belgium.
⁷ University Hospitals Leuven, Leuven, Belgium and Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium.
⁸ University of Glasgow, Institute of Cardiovascular and Medical Sciences, Glasgow, UK and Robertson Centre for Biostatistics, Glasgow, UK.
⁹ Pauls Stradins Clinical University Hospital, Riga, Latvia and the University of Latvia, Riga, Latvia.
¹⁰ Department of Cardiology, Antwerp University Hospital, Antwerp, Belgium and Department of Cardiovascular Sciences, University of Antwerp, Antwerp, Belgium.
¹¹ Universitetssykehuset Nord-Norge, Tromsø, Norway.
¹² King's College Hospital and Faculty of Life Sciences & Medicine, King's College London, London, UK.
¹³ Hospital Universitario Vall d'Hebron, VHIR, Universidad Autonoma de Barcelona, Barcelona, Spain.
¹⁴ Cardiology Department, Intensive Cardiac Care Unit, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain and Universitat Autònoma de Barcelona, Barcelona, Spain and Centro de Investigación Biomèdica en Red de Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.
¹⁵ Interventional Cardiology Unit, Cardiology Department, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.
¹⁶ University of East Anglia, Norwich, UK and Norfolk and Norwich University Hospitals, Norwich, UK.

PMID: 37334659
PMCID: PMC10436068
DOI: 10.4244/EIJ-D-23-00204

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.

References

1. Kolte D, Khera S, Aronow WS, Mujib M, Palaniswamy C, Sule S, Jain D, Gotsis W, Ahmed A, Frishman WH, Fonarow GC. Trends in incidence, management, and outcomes of cardiogenic shock complicating ST-elevation myocardial infarction in the United States. J Am Heart Assoc. 2014;3:e000590. - PMC - PubMed
1. Helgestad OKL, Josiassen J, Hassager C, Jensen LO, Holmvang L, Sørensen A, Frydland M, Lassen AT, Udesen NLJ, Schmidt H, Ravn HB, Møller JE. Temporal trends in incidence and patient characteristics in cardiogenic shock following acute myocardial infarction from 2010 to 2017: a Danish cohort study. Eur J Heart Fail. 2019;21:1370–8. - PubMed
1. Hochman JS, Sleeper LA, Webb JG, Sanborn TA, White HD, Talley JD, Buller CE, Jacobs AK, Slater JN, Col J, McKinlay SM, LeJemtel TH. Early revascularization in acute myocardial infarction complicated by cardiogenic shock. SHOCK Investigators. Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock. N Engl J Med. 1999;341:625–34. - PubMed
1. Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Fuhrmann J, Böhm M, Ebelt H, Schneider S, Schuler G, Werdan K IABP-SHOCK II Trial Investigators. Intraaortic balloon support for myocardial infarction with cardiogenic shock. N Engl J Med. 2012;367:1287–96. - PubMed
1. Thiele H, Akin I, Sandri M, Fuernau G, de Waha, Meyer-Saraei R, Nordbeck P, Geisler T, Landmesser U, Skurk C, Fach A, Lapp H, Piek JJ, Noc M, Goslar T, Felix SB, Maier LS, Stepinska J, Oldroyd K, Serpytis P, Montalescot G, Barthelemy O, Huber K, Windecker S, Savonitto S, Torremante P, Vrints C, Schneider S, Desch S, Zeymer U CULPRIT-SHOCK Investigators. PCI Strategies in Patients with Acute Myocardial Infarction and Cardiogenic Shock. N Engl J Med. 2017;377:2419–32. - PubMed

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

References

Publication types

MeSH terms

LinkOut - more resources

Medical