Optimising clinical trials in acute myocardial infarction complicated by cardiogenic shock: a statement from the 2020 Critical Care Clinical Trialists Workshop
- PMID: 34245691
- DOI: 10.1016/S2213-2600(21)00172-7
Optimising clinical trials in acute myocardial infarction complicated by cardiogenic shock: a statement from the 2020 Critical Care Clinical Trialists Workshop
Abstract
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.
Copyright © 2021 Elsevier Ltd. All rights reserved.
Conflict of interest statement
Declaration of interests AM reports personal fees from Novartis, Orion, Roche, Servier, and Abiomed, grants and personal fees from Adrenomed and Abbott, and grants from 4TEEN4 Pharmaceuticals, outside of the submitted work. DAB reports personal fees from Getinge, Abiomed, Livanova, Abbott, MC3, Procyrion, Pfizer, and Novartis, outside of the submitted work. NA reports personal fees from AstraZeneca, Medtronic, and Sanofi, outside of the submitted work. AB-G reports personal fees from Boehringer Ingelheim, AstraZeneca, Vifor, Novartis, Abbott, and Roche Diagnostics, and non-financial support from Critical Diagnostics, outside of the submitted work. LB reports research grants from Abbott, Biotronik, Boston, and AstraZeneca, and lectures fees from Abiomed and Boston, outside of the submitted work. EG reports grants from Philips and Radiometer, and personal fees from Edwards Lifescience and Baxter, outside of the submitted work. NKK reports grants and personal fees from Abbott, Abiomed, Boston Scientific, Getinge, and LivaNova, outside of the submitted work. MKa reports grants and personal fees from Adrenomed and Vifor, and personal fees from Sphingotec, Amgen, Sanofi, and 4TEEN4 Pharmaceuticals, outside of the submitted work. PL reports personal fees from Medtronic, and grants from Abiomed and Getinge, outside of the submitted work. BL reports grants and personal fees from Orion, Amomed, Getinge, and Baxter, and personal fees from Novartis and Sanofi, outside of the submitted work. UZ reports grants and personal fees from AstraZeneca, Bayer, and Bristol Myers Squibb, and personal fees from Amgen, Boehringer Ingelheim, Daiichi Sankyo, Ferrer, Novartis, Sanofi, and The Medicines Company, outside of the submitted work. All other authors declare no competing interests.
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