| Title: |
Outcomes After Endovascular Therapy With Procedural Sedation vs General Anesthesia in Patients With Acute Ischemic Stroke: The AMETIS Randomized Clinical Trial |
| Authors: |
Chabanne, Russell; Geeraerts, Thomas; Begard, Marc; Balança, Baptiste; Rapido, Francesca; Degos, Vincent; Tavernier, Benoit; Molliex, Serge; Velly, Lionel; Verdonk, Franck; Lukaszewicz, Anne-Claire; Perrigault, Pierre-François; Albucher, Jean-François; Cognard, Christophe; Guyot, Adrien; Fernandez, Charlotte; Masgrau, Aurélie; Moreno, Ricardo; Ferrier, Anna; Jaber, Samir; Bazin, Jean-Etienne; Pereira, Bruno; Futier, Emmanuel; Lagarde, Kevin; Cosserant, Bernard; Cammas, Thibaut; Pascal, Julien; Grimaldi, Florian; Laroche, Erwan; Boissy, Camille; Grobost, Romain; Pioche, Pierre-Antoine; Joffredo, Jean-Baptiste; Johanny, Audrey; Savranin, Denis; Massardier,, Julien; Levrier, Katia; Brandely, Antoine; Langlade, Isabelle; Saurel, Danielle; Rascol, Nicolas; Bailleau, Mélanie; Fayon, Julie; Vallet, Laurent; Caumon, Elodie; Rolhion, Christine; Morand, Dominique; Amat, Julien; Jean, Betty; Chabert, Emmanuel; Zerroug, Abderahim; Gabrillargues, Jean; Bourgois, Nathalie; Moisset, Xavier; Clavelou, Pierre; Vitello, Nicolas; Beilvert, Maxime; Aldige, Etienne; Mrozek, Ségolène; Delort, Francois; Naboulsi, Edouard; Tardif, Elsa; Parry, Elodie; Pommier, Maxime; Prezman-Pietri, Maud; Rousset, David; Larcher, Claire; Delamarre, Louis; Martin, Charlotte; Osinski,, Diane; Fourcade, Olivier; Olivot, Jean-Marc; Calviere, Lionel; Raposo, Nicolas; Viguier, Alain; Bonneville, Fabrice; Januel, Anne-Christine; Tall, Philippe; Michelozzi, Caterina; Darcourt, Jean; Bapteste, Lionel; Gemanar, Anisoara; Mottolese, Catherine; Silve, Roxane; Garnier, Océane; Ridolfo, Jérôme; Bouhaddjar, Mokhtar; Fendeleur, Julien; Lau, Jean Clement; Ratié, Mélanie; Costalat, Vincent; Cagnazzo, Federico; Pasqualotto, Romain; Clarencon, Frédéric; Torkomian, Grégory; Battisti, Valentine; Jozefowicz, Elsa; Kazemihru, Apolline; Henon, Hilde; Lafanechere, Aurelie; Henry, Lois; Bellet, Julie; Gaudet, Alexandre; Foltzer, Fanny; Parmentier, Laurie; Magand, Clément; Aggour, Mohamed; Pregny, Anaele; Bonnefoi, Marlène; Bruder, Nicolas; Vaisse, Camille; Bertrandy, Michele; Doukhan, Laure; Cataldi, Sophie; Imane, Inal; Verdier, Valentine; Sanchez, Didier; Dumont, Jean-Claude; Fellous, Souad; Garnier, Marc; Lavabre, Olivier; Bernstein, David; Baranger, Violaine; Thomas, Elie; Papagiannaki, Chrysanthi; Lenormand, Elisabeth; Payen, Jean-François; Zuber, Mathieu; Molinari, Nicolas |
| Contributors: |
CHU Clermont-Ferrand; Toulouse NeuroImaging Center (ToNIC); Université Toulouse III - Paul Sabatier (UT3); Communauté d'universités et établissements de Toulouse (Comue de Toulouse)-Communauté d'universités et établissements de Toulouse (Comue de Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Toulouse Mind & Brain Institut (TMBI); Université Toulouse - Jean Jaurès (UT2J); Communauté d'universités et établissements de Toulouse (Comue de Toulouse)-Communauté d'universités et établissements de Toulouse (Comue de Toulouse)-Université Toulouse III - Paul Sabatier (UT3); Communauté d'universités et établissements de Toulouse (Comue de Toulouse)-Université Toulouse - Jean Jaurès (UT2J); Communauté d'universités et établissements de Toulouse (Comue de Toulouse)-Université Toulouse III - Paul Sabatier (UT3); Communauté d'universités et établissements de Toulouse (Comue de Toulouse); Pôle Anesthésie Réanimation CHU de Toulouse; Centre Hospitalier Universitaire de Toulouse (CHU Toulouse); Centre de recherche en neurosciences de Lyon - Lyon Neuroscience Research Center (CRNL); Université Claude Bernard Lyon 1 (UCBL); Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS); Hôpital Gui de Chauliac CHU Montpellier; Centre Hospitalier Régional Universitaire Montpellier (CHRU Montpellier); CHU Pitié-Salpêtrière AP-HP; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU); Evaluation des technologies de santé et des pratiques médicales - ULR 2694 (METRICS); Université de Lille-Centre Hospitalier Régional Universitaire CHU Lille (CHRU Lille); Centre Hospitalier Universitaire de Saint-Etienne CHU Saint-Etienne (CHU ST-E); Institut de Neurosciences des Systèmes (INS); Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM); Mécanismes Moléculaires du Vieillissement Pathologique et Physiologique / Molecular Mechanisms of Pathological and Physiological Ageing; Institut Pasteur Paris (IP)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité); CHU Saint-Antoine AP-HP; Département Neurologie CHU Toulouse; Pôle Neurosciences CHU Toulouse; Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse); Service Neuroradiologie Diagnostique et Thérapeutique CHU Toulouse; Pôle imagerie médicale CHU Toulouse; Physiologie & médecine expérimentale du Cœur et des Muscles U 1046 (PhyMedExp); Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM); Institut Desbrest d'Epidémiologie et de Santé Publique (IDESP); Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM); Médecine de précision par intégration de données et inférence causale (PREMEDICAL); Centre Inria d'Université Côte d'Azur; Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)-Institut Desbrest d'Epidémiologie et de Santé Publique (IDESP); Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM); This work was supported by a grant from the French Ministry of Health under its clinical research program (PHRCI-16-011) and by the Clermont-Ferrand University Hospital. |
| Source: |
ISSN: 2168-6149. |
| Publisher Information: |
CCSD; American Medical Association |
| Publication Year: |
2023 |
| Collection: |
Université Toulouse III - Paul Sabatier: HAL-UPS |
| Subject Terms: |
MESH: Adult; MESH: Aged; MESH: Ischemic Stroke* / etiology; MESH: Male; MESH: Procedural Sedation; MESH: Stroke* / drug therapy; MESH: Thrombectomy / adverse effects; MESH: Treatment Outcome; MESH: Anesthesia; General; MESH: Brain Ischemia* / complications; MESH: Endovascular Procedures* / adverse effects; MESH: Female; MESH: Humans; [SDV]Life Sciences [q-bio] |
| Description: |
International audience ; Importance: General anesthesia and procedural sedation are common practice for mechanical thrombectomy in acute ischemic stroke. However, risks and benefits of each strategy are unclear. Objective: To determine whether general anesthesia or procedural sedation for anterior circulation large-vessel occlusion acute ischemic stroke thrombectomy are associated with a difference in periprocedural complications and 3-month functional outcome. Design, setting, and participants: This open-label, blinded end point randomized clinical trial was conducted between August 2017 and February 2020, with final follow-up in May 2020, at 10 centers in France. Adults with occlusion of the intracranial internal carotid artery and/or the proximal middle cerebral artery treated with thrombectomy were enrolled. Interventions: Patients were assigned to receive general anesthesia with tracheal intubation (n = 135) or procedural sedation (n = 138). Main outcomes and measures: The prespecified primary composite outcome was functional independence (a score of 0 to 2 on the modified Rankin Scale, which ranges from 0 [no neurologic disability] to 6 [death]) at 90 days and absence of major periprocedural complications (procedure-related serious adverse events, pneumonia, myocardial infarction, cardiogenic acute pulmonary edema, or malignant stroke) at 7 days. Results: Among 273 patients evaluable for the primary outcome in the modified intention-to-treat population, 142 (52.0%) were women, and the mean (SD) age was 71.6 (13.8) years. The primary outcome occurred in 38 of 135 patients (28.2%) assigned to general anesthesia and in 50 of 138 patients (36.2%) assigned to procedural sedation (absolute difference, 8.1 percentage points; 95% CI, -2.3 to 19.1; P = .15). At 90 days, the rate of patients achieving functional independence was 33.3% (45 of 135) with general anesthesia and 39.1% (54 of 138) with procedural sedation (relative risk, 1.18; 95% CI, 0.86-1.61; P = .32). The rate of patients without major periprocedural ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/37010829; PUBMED: 37010829; PUBMEDCENTRAL: PMC10071397 |
| DOI: |
10.1001/jamaneurol.2023.0413 |
| Availability: |
https://hal.science/hal-04060339; https://hal.science/hal-04060339v1/document; https://hal.science/hal-04060339v1/file/2023%20Chabanne%20et%20al.,%20Outcomes%20After%20.pdf; https://doi.org/10.1001/jamaneurol.2023.0413 |
| Rights: |
https://about.hal.science/hal-authorisation-v1/ ; info:eu-repo/semantics/OpenAccess |
| Accession Number: |
edsbas.96F9C092 |
| Database: |
BASE |