Combined use of contact aspiration and the stent retriever technique versus stent retriever alone for recanalization in acute cerebral infarction: the randomized ASTER 2 study protocol.

Autor:	Lapergue B; Stroke Center Neurology Division, Hôpital Foch, Suresnes, France b.lapergue@hopital-foch.org.; Department of Stroke Center and Diagnostic and Interventional Neuroradiology, University of Versailles and Saint Quentin en Yvelines Foch Hospital, Surenes, France., Labreuche J; Department of Biostatistics, University of Lille, CHU Lille, Lille, France., Blanc R; Fondation Ophtalmologique Adolphe de Rothschild, Paris, France., Marnat G; Interventional and Diagnostic Neuroradiology, Bordeaux University Hospital, Bordeaux, France., Consoli A; Interventional Neuroradiologie, Hôpital Foch, Suresnes, France., Rodesch G; Department of Diagnostic and Interventional Neuroradiology, Hôpital Foch, Suresnes, France., Saleme S; University Hospital of Limoges, Limoges, France., Costalat V; Neuroradiology, CHRU Gui de Chauliac, Montpellier, France.; Neuroradiology Department, University Hospital Güi-de-Chauliac, Centre Hospitalier Universitaire de Montpellier, Montpellier, France., Bracard S; Department of Diagnostic and Therapeutic Neuroradiology, CHRU Nancy, Hôpital Central Nancy, Nancy, France., Desal H; Neuroradiology, University Hospital of Nantes, Nantes, France., Duhamel A; Biostatistics, University of Lille, Lille, France., Mazighi M; Department of Interventional Neuroradiology, Fondation Ophtalmologique Adolphe de Rothschild, Paris, France., Spelle L; Department of Diagnostic and Therapeutic Neuroradiology, Hôpitaux Universitaires Paris-Sud, Hôpital du Kremlin-Bicetre, Le Kremlin-Bicetre, France., Houdart E; Department of Interventional Neuroradiology, Hôpital Lariboisière, Paris, France., Shotar E; Department of Neuroradiology, Pitié-Salpêtrière Hospital, APHP, Paris, France., Ben Maacha M; Biostatistics, Fondation Rothschild Hospital, Paris, France., Lopez D; University of Versailles and Saint Quentin en Yvelines, Foch Hospital, Suresnes, France., Ferre JC; Radiology Department, University Hospital University Rennes Inria CNRS INSERM, Rennes F30533, France., Prevot C; Clinical Research Department, University of Versailles and Saint Quentin en Yvelines, Foch Hospital, Suresnes, France., Gory B; Department of Diagnostic and Interventional Neuroradiology, CHRU Nancy, Nancy, France., Piotin M; Department of Interventional Neuroradiology, Fondation Rothschild Hospital, Paris, France.
Jazyk:	angličtina
Zdroj:	Journal of neurointerventional surgery [J Neurointerv Surg] 2020 May; Vol. 12 (5), pp. 471-476. Date of Electronic Publication: 2020 Jan 08.
DOI:	10.1136/neurintsurg-2019-014735
Abstrakt:	Rationale: Mechanical thrombectomy (MT) using a stent retriever (SR) device is currently the recommended treatment in ischemic stroke due to anterior circulation large vessel occlusion. Combining contact aspiration (CA) with SR is a promising new treatment, although it was not found to be superior to SR alone as first-line treatment for achieving successful reperfusion. Aim: To determine whether endovascular treatment combining first-line use of CA and SR is more efficient than SR alone. Methods: The ASTER 2 clinical trial is a prospective, randomized, multicenter, open-label trial with a blinded endpoint. We included patients admitted with suspected anterior circulation ischemic stroke secondary to large vessel occlusion <8 hours from symptom onset. They were randomly allocated in a 1:1 ratio to one of two treatment groups (combined CA and SR or SR alone). In the case of failure of the assigned technique after three attempts, other adjunctive techniques were applied. Study Outcome: The primary outcome is the rate of successful/complete reperfusion (modified Thrombolysis In Cerebral Infarction (mTICI) score 2c/3) after the entire endovascular procedure. Secondary outcomes include reperfusion rates after the assigned first-line intervention alone and at the end of the procedure, procedural times, change in NIH Stroke Scale score at 24 hours, intracerebral hemorrhage at 24 hours, procedure-related serious adverse events, the modified Rankin Scale score, and all-cause mortality at 90 days and 1 year. The cost effectiveness of the two procedures will also be analyzed. Discussion: This is the first head-to-head randomized trial to directly compare the efficacy of the combined use of CA and SR versus SR alone. This prospective trial aims to demonstrate the synergistic effects of CA and SR devices in first-line endovascular treatment. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu