Rationale and design of the ULYSS trial: A randomized multicenter evaluation of the efficacy of early Impella CP implantation in acute coronary syndrome complicated by cardiogenic shock.


Journal

American heart journal
ISSN: 1097-6744
Titre abrégé: Am Heart J
Pays: United States
ID NLM: 0370465

Informations de publication

Date de publication:
Nov 2023
Historique:
received: 23 05 2023
revised: 26 08 2023
accepted: 28 08 2023
pubmed: 2 9 2023
medline: 2 9 2023
entrez: 1 9 2023
Statut: ppublish

Résumé

Despite 20 years of improvement in acute coronary syndromes care, patients with acute myocardial infarction complicated by cardiogenic shock (AMICS) remains a major clinical challenge with a stable incidence and mortality. While intra-aortic balloon pump (IABP) did not meet its expectations, percutaneous mechanical circulatory supports (pMCS) with higher hemodynamic support, large availability and quick implementation may improve AMICS prognosis by enabling early hemodynamic stabilization and unloading. Both interventional and observational studies suggested a clinical benefit in selected patients of the IMPELLA The ULYSS trial is a prospective randomized open label, 2 parallel multicenter clinical trial that plans to enroll patients with AMICS for whom an emergent percutaneous coronary intervention (PCI) is intended. Patients will be randomized to an experimental therapeutic strategy with pre-PCI implantation of an IMPELLA NCT05366452.

Identifiants

pubmed: 37657594
pii: S0002-8703(23)00265-X
doi: 10.1016/j.ahj.2023.08.066
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT05366452']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

203-212

Informations de copyright

Copyright © 2023 Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Disclosures CD report consulting and lectures fees for ABIOMED, LB report consulting and lectures fees for ABIOMED, GS report lectures fees for ABIOMED, Other authors have nothing to report.

Auteurs

Clement Delmas (C)

Department of Cardiology, Intensive Cardiac Care Unit, Rangueil University Hospital, Toulouse, France; INSERM U1048, I2MC, Toulouse, France; REICATRA, Institut Saint Jacques, Toulouse, France. Electronic address: clement23185@hotmail.fr.

Marc Laine (M)

Aix-Marseille Université, F-13385 Marseille, France; Intensive Care Unit, Department of Cardiology, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, F-13385 Marseille, France; Mediterranean Association for Research and Studies in Cardiology (MARS Cardio), Marseille, France.

Guillaume Schurtz (G)

Department of Cardiology, Intensive Cardiac Care Unit, Lille University Hospital, Lille, France.

Francois Roubille (F)

PhyMedExp, Université de Montpellier, INSERM, CNRS, Cardiology Department, CHU de Montpellier, France.

Pierre Coste (P)

Cardiology Department, Bordeaux University Hospital, Pessac, France.

Guillaume Leurent (G)

Intensive Cardiac Care Unit, Cardiology Department, Rennes University Hospital, Rennes, France.

Sami Hraiech (S)

Medical Intensive Care Unit, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Marseille, France.

Mathieu Pankert (M)

Cardiology Department, CH Avignon, France.

Quaino Gonzalo (Q)

Cardiology Department, CH Toulon, France.

Thibaut Dabry (T)

Cardiology Department, CH Aix en Provence, France.

Vincent Letocart (V)

Department of Cardiology, Nantes Université, CHU Nantes, l'institut du thorax, Nantes, France.

Sandrine Loubière (S)

Department of Epidemiology and Health Economics, APHM, Marseille, France; CEReSS-Health Service Research and Quality of Life Center, School of Medicine Aix-Marseille University Marseille France.

Noémie Resseguier (N)

Department of Epidemiology and Health Economics, APHM, Marseille, France; CEReSS-Health Service Research and Quality of Life Center, School of Medicine Aix-Marseille University Marseille France.

Laurent Bonello (L)

Aix-Marseille Université, F-13385 Marseille, France; Intensive Care Unit, Department of Cardiology, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, F-13385 Marseille, France; Mediterranean Association for Research and Studies in Cardiology (MARS Cardio), Marseille, France.

Classifications MeSH