Optimising clinical trials in acute myocardial infarction complicated by cardiogenic shock: a statement from the 2020 Critical Care Clinical Trialists Workshop
Por:
Arrigo, M, Price, S, Baran, DA, Poss, J, Aissaoui, N, Bayes-Genis, A, Bonello, L, Francois, B, Gayat, E, Gilard, M, Kapur, NK, Karakas, M, Kostrubiec, M, Leprince, P, Levy, B, Rosenberg, Y, Thiele, H, Zeymer, U, Harhay, MO and Mebazaa, A
Publicada:
1 oct 2021
Ahead of Print:
1 sep 2021
Resumen:
Acute myocardial infarction complicated by cardiogenic shock (AMICS) is a critical syndrome with a high risk of morbidity and mortality. Current management consists of coronary revascularisation, vasoactive drugs, and circulatory and ventilatory support, which are tailored to patients mainly on the basis of clinicians' experience rather than evidence-based recommendations. For many therapeutic interventions in AMICS, randomised clinical trials have not shown a meaningful survival benefit, and a disproportionately high rate of neutral and negative results has been reported. In this context, an accurate definition of the AMICS syndrome for appropriate patient selection and optimisation of study design are warranted to achieve meaningful results and pave the way for new, evidence-based therapeutic options. In this Position Paper, we provide a statement of priorities and recommendations agreed by a multidisciplinary group of experts at the Critical Care Clinical Trialists Workshop in February, 2020, for the optimisation and harmonisation of clinical trials in AMICS. Implementation of proposed criteria to define the AMICS population-moving beyond a cardio-centric definition to that of a systemic disease-and steps to improve the design of clinical trials could lead to improved outcomes for patients with this life-threatening syndrome.
Filiaciones:
Arrigo, M:
Triemli Hosp Zurich, Dept Internal Med, Zurich, Switzerland
Univ Zurich, Zurich, Switzerland
Price, S:
Royal Brompton Hosp, London, England
Imperial Coll London, Natl Heart & Lung Inst, London, England
Baran, DA:
Sentara Heart Hosp, Eastern Virginia Med Sch, Adv Heart Failure Ctr, Norfolk, VA USA
Poss, J:
Univ Leipzig, Dept Cardiol, Heart Ctr Leipzig, Leipzig, Germany
Aissaoui, N:
Penn State Univ, Inst Heart & Vasc, Crit Care Unit, Hershey Med Ctr, Harrisburg, PA USA
Hop Europeen Georges Pompidou, AP HP, Dept Crit Care, Paris, France
:
Germans Trias & Pujol Badalona, Inst Heart, Madrid, Spain
Inst Salud Carlos III, Ctr Invest Biomed Red Enfermedades Cardiovasc, Madrid, Spain
Bonello, L:
Aix Marseille Univ, Aix En Provence, France
Hop Nord Marseille, AP HM, Dept Cardiol, Intens Care Unit,Mediterranean Assoc Res & Studie, Marseille, France
Francois, B:
Dupuytren Univ Hosp, Dept Intens Care, Limoges, France
Dupuytren Univ Hosp, INSERM CIC1435 & UMR1092, Limoges, France
Gayat, E:
Hop Univ St Louis Lariboisiere, AP HP, Dept Anesthesia Burn & Crit Care Med, FHU PROMICE INICRCT, Paris, France
Univ Paris, MASCOT, INSERM, Paris, France
Gilard, M:
Brest Univ Hosp, Dept Cardiol, Brest, France
Kapur, NK:
Cardiovasc Ctr Res & Innovat, Acute Circulatory Support Program, Intervent Res Labs, Boston, MA USA
Karakas, M:
Univ Med Ctr, Dept Intens Care Med, Hamburg, Germany
Univ Heart & Vasc Ctr Hamburg, Dept Cardiol, Hamburg, Germany
German Ctr Cardiovasc Res DZHK, Hamburg, Germany
Kostrubiec, M:
Univ Warsaw, Dept Internal Med & Cardiol, Warsaw, Poland
Mid & South Essex NHS Fdn Trust, Broomfield, England
Leprince, P:
Pitie Salpetrere Hosp, AP HP, Dept Cardiovasc Surg, Paris, France
Sorbonne Univ, Paris, France
Levy, B:
Univ Lorraine, Med Intens & Reanimat Brabois, CHRU Nancy, Nancy, France
Univ Lorraine, INSERM U1116, Nancy, France
Rosenberg, Y:
Natl Heart Lung & Blood Inst, Bethesda, MD USA
Thiele, H:
Univ Leipzig, Dept Cardiol, Heart Ctr Leipzig, Leipzig, Germany
Zeymer, U:
Klinikum Ludwigshafen, Ludwigshafen, Germany
Inst Herzinfarktforschung, Ludwigshafen, Germany
Harhay, MO:
Univ Penn, Palliat & Adv Illness Res PAIR, Ctr Clin Trials Methods & Outcomes Lab, Philadelphia, PA USA
Univ Penn, Dept Biostat Epidemiol & Informat, Perelman Sch Med, Philadelphia, PA USA
Mebazaa, A:
Hop Univ St Louis Lariboisiere, AP HP, Dept Anesthesia Burn & Crit Care Med, FHU PROMICE INICRCT, Paris, France
Univ Paris, MASCOT, INSERM, Paris, France
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