Evaluation of mechanical thrombectomy in acute ischemic stroke related to a distal arterial occlusion: A randomized controlled trial
2024
Clarençon, Frédéric | Durand-Zaleski, Isabelle | Premat, Kévin | Baptiste, Amandine | Chabert, Emmanuel | Ferrier, Anna | Labeyrie, Marc-Antoine | Reiner, Peggy | Spelle, Laurent | Denier, Christian | Tuilier, Titien | Hosseini, Hassan | Rodriguez-Régent, Christine | Turc, Guillaume | Fauché, Cédric | Lamy, Matthias | Lapergue, Bertrand | Consoli, Arturo | Barbier, Charlotte | Boulanger, Marion | Bricout, Nicolas | Henon, Hilde | Gory, Benjamin | Richard, Sébastien | Rouchaud, Aymeric | Macian-Montoro, Francisco | Eker, Omer | Cho, Tae-Hee | Soize, Sébastien | Moulin, Solène | Gentric, Jean-Christophe | Timsit, Serge | Darcourt, Jean | Albucher, Jean-François | Janot, Kévin | Annan, Mariam | Pico, Fernando | Costalat, Vincent | Arquizan, Caroline | Marnat, Gautier | Sibon, Igor | Pop, Raoul | Wolff, Valérie | Shotar, Eimad | Lenck, Stéphanie | Sourour, Nader-Antoine | Radenne, Anne | Alamowitch, Sonia | Dechartres, Agnès | CHU Pitié-Salpêtrière [AP-HP] ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU) | Centre for Research in Epidemiology and Statistics | Centre de Recherche Épidémiologie et Statistiques (CRESS (U1153 / UMR_A 1125)) ; Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE) | CHU Clermont-Ferrand | Hôpital Lariboisière-Fernand-Widal [APHP] ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP) | Hôpital Bicêtre [AP-HP, Le Kremlin-Bicêtre] ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP) | UFR Sciences de la santé Simone Veil (UVSQ Santé) ; Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Saclay | CHU Henri Mondor [Créteil] | Hôpital universitaire Robert Debré [Reims] (CHU Reims) | Department of Neuroradiology, CHU Creteil, Creteil, France | Groupe hospitalier universitaire Paris psychiatrie & neurosciences [Paris] (GHU Paris Psychiatrie et Neurosciences) | Institut de psychiatrie et neurosciences de Paris (IPNP - U1266 Inserm) ; Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité) | Centre hospitalier universitaire de Poitiers = Poitiers University Hospital (CHU de Poitiers [La Milétrie]) | Hôpital Foch [Suresnes] | Azienda Ospedaliero Universitaria Careggi [Firenze] = Careggi University Hospital [Florence, Italy] (AOUC) | CHU Caen ; Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN) | Centre Hospitalier Régional Universitaire [CHU Lille] (CHRU Lille) | Service de Neuroradiologie interventionnelle [CHU Limoges] ; CHU Limoges | BIO-SANTÉ (XLIM-BIO-SANTÉ) ; XLIM (XLIM) ; Université de Limoges (UNILIM)-Centre National de la Recherche Scientifique (CNRS)-Université de Limoges (UNILIM)-Centre National de la Recherche Scientifique (CNRS)
International audience
显示更多 [+] 显示较少 [-]英语. Rationale: Mechanical thrombectomy (MT) associated with the best medical treatment (BMT) has recently shown efficacy for the management of acute ischemic stroke (AIS) secondary to a large vessel occlusion. However, evidence is lacking regarding the benefit of MT for more distal occlusions. Aim: To evaluate the efficacy in terms of good clinical outcome at 3 months of MT associated with the BMT over the BMT alone in AIS related to a distal occlusion. Methods: The DISCOUNT trial is a multicenter open-label randomized controlled trial involving French University hospitals. Adult patients (⩾18 years) with an AIS involving the anterior or posterior circulation secondary to a distal vessel occlusion within 6 h of symptom onset or within 24 h if no hyperintense signal on fluid attenuation inversion recovery acquisition will be randomized 1:1 to receive either MT associated with the BMT (experimental group) or BMT alone (control group). The number of patients to be included is 488. Study outcomes: The primary outcome is the rate of good clinical outcome at 3 months defined as a modified Rankin scale (mRS) ⩽2 and evaluated by an independent assessor blinded to the intervention arm. Secondary outcomes include recanalization of the occluded vessel within 48 h, angiographic reperfusion in the experimental group, 3-month excellent clinical outcome (mRS ⩽ 1), all adverse events, and death. A cost utility analysis will estimate the incremental cost per quality-adjusted life year (QALY) gained. Discussion: If positive, this study will open new insights in the management of AISs. Trial registration: ClinicalTrials.gov: NCT05030142 registered on 1 September 2021.
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