Optimal Timing of Intervention in NSTE-ACS Without Pre -Treatment The EARLY Randomized Trial
2020
Lemesle, Gilles | Laine, Marc | Pankert, Mathieu | Boueri, Ziad | Motreff, Pascal | Paganelli, Franck | Baumstarck, Karine | Roch, Antoine | Kerbaul, Francois | Puymirat, Etienne | Bonello, Laurent | Récepteurs Nucléaires, Maladies Métaboliques et Cardiovasculaires - U 1011 (RNMCD) ; Institut Pasteur de Lille ; Pasteur Network (Réseau International des Instituts Pasteur)-Pasteur Network (Réseau International des Instituts Pasteur)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [CHU Lille] (CHRU Lille) | Institut Coeur Poumon [CHU Lille] ; Centre Hospitalier Régional Universitaire [CHU Lille] (CHRU Lille) | Faculté de Médecine Henri Warembourg - Université de Lille | Alliance française pour les essais cliniques cardio-vasculaires - French Alliance for Cardiovascular Trials (FACT) | Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN) ; Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE) | Assistance Publique - Hôpitaux de Marseille (APHM) | Mediterranean Association for Research and Studies in Cardiology (MARS cardio) | Centre Hospitalier Henri Duffaut (Avignon) | Centre Hospitalier Bastia (CHB) | CHU Clermont-Ferrand | Centre d'études et de recherche sur les services de santé et la qualité de vie (CEReSS) ; Aix Marseille Université (AMU) | Hôpital Nord [CHU - APHM] | Dysoxie, suractivité : aspects cellulaires et intégratifs thérapeutiques (DS-ACI / UMR MD2) ; Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS) | Paris-Centre de Recherche Cardiovasculaire (PARCC (UMR_S 970/ U970)) ; Hôpital Européen Georges Pompidou [APHP] (HEGP) ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité) | Programme Hospitalier de RechercheClinique 2016-A00379-42
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Show more [+] Less [-]English. ObjectivesThe aim of this study was to compare a delayed and a very early invasive strategy in patients with non–ST-segment elevation acute coronary syndromes (NSTE-ACS) without pre-treatment.BackgroundThe optimal delay of the invasive strategy in patients with NSTE-ACS remains debated and has never been investigated in patients not pre-treated with P2Y12–adenosine diphosphate receptor antagonists.MethodsA prospective, open-label, randomized controlled trial was conducted. Altogether, 741 patients presenting with intermediate- or high-risk NSTE-ACS intended for an invasive strategy were included. The modified intention-to-treat analysis was composed of 709 patients after 32 withdrew consent. Patients were randomized 1:1 to the delayed invasive group (DG) (n = 363) with coronary angiography (CA) performed 12 to 72 h after randomization or the very early invasive group (EG) (n = 346) with CA within 2 h. No pre-treatment with a loading dose of a P2Y12–adenosine diphosphate receptor antagonist was allowed before CA. The primary endpoint was the composite of cardiovascular death and recurrent ischemic events at 1 month, as determined by a blinded adjudication committee.ResultsMost patients had high-risk NSTE-ACS in both groups (93% in the EG vs. 92.5% in the DG). The median time between randomization and CA was 0 h (interquartile range [IQR]: 0 to 1 h) in the EG group and 18 h (IQR: 11 to 23 h) in the DG. The primary endpoint rate was significantly lower in the EG (4.4% vs. 21.3% in the DG; hazard ratio: 0.20; 95% confidence interval: 0.11 to 0.34; p < 0.001), driven by a reduction in recurrent ischemic events (19.8% vs. 2.9%; p < 0.001). No difference was observed for cardiovascular death.ConclusionsWithout pre-treatment, a very early invasive strategy was associated with a significant reduction in ischemic events at the time of percutaneous coronary intervention in patients with intermediate- and high-risk NSTE-ACS. (Early or Delayed Revascularization for Intermediate and High-Risk Non ST-Elevation Acute Coronary Syndromes; NCT02750579)
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