Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial.

Autor:	Bendszus M; Neuroradiologie, Universitätsklinikum Heidelberg, Heidelberg, Germany., Fiehler J; Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; eppdata GmbH, Hamburg, Germany., Subtil F; Service de Biostatistique, Hospices Civils de Lyon, Lyon, France; Laboratoire de Biométrie et Biologie Évolutive, Université de Lyon, Villeurbanne, France., Bonekamp S; Neuroradiologie, Universitätsklinikum Heidelberg, Heidelberg, Germany., Aamodt AH; Department of Neurology, Oslo University Hospital, Oslo, Norway., Fuentes B; Department of Neurology and Stroke Center, Hospital La Paz Institute for Health Research-La Paz University Hospital-Universidad Autonoma de Madrid, Madrid, Spain., Gizewski ER; Department of Neuroradiology, Medical University Innsbruck, Innsbruck, Austria., Hill MD; Department of Clinical Neurosciences, Hotchkiss Brain Institute, Health Science Centre, University of Calgary & Foothills Medical Centre, Calgary, AB, Canada., Krajina A; Department of Radiology, Faculty of Medicine in Hradec Kralove, Charles University, Czech Republic., Pierot L; Department of Neuroradiology, Hôpital Maison-Blanche, Université Reims-Champagne-Ardenne, Reims, France., Simonsen CZ; Department of Neurology, Aarhus University Hospital, Aarhus, Denmark., Zeleňák K; Clinic of Radiology, Jessenius Faculty of Medicine, Comenius University, Martin, Slovakia., Blauenfeldt RA; Department of Neurology, Aarhus University Hospital, Aarhus, Denmark., Cheng B; Klinik und Poliklinik für Neurologie, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany., Denis A; Service de Biostatistique, Hospices Civils de Lyon, Lyon, France; Laboratoire de Biométrie et Biologie Évolutive, Université de Lyon, Villeurbanne, France., Deutschmann H; Division of Neuroradiology, Vascular and Interventional Radiology, Department of Radiology, Medical University Graz, Graz, Austria., Dorn F; Klinik für Diagnostische und Interventionelle Neuroradiologie, Universitätsklinikum Bonn, Bonn, Germany., Flottmann F; Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany., Gellißen S; Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany., Gerber JC; Institute of Neuroradiology, Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Dresden, Germany; Dresden Neurovascular Center, Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Dresden, Germany., Goyal M; Department of Clinical Neurosciences, Hotchkiss Brain Institute, Health Science Centre, University of Calgary & Foothills Medical Centre, Calgary, AB, Canada., Haring J; Department of Neurology, Faculty Hospital Trnava, Trnava, Slovakia., Herweh C; Neuroradiologie, Universitätsklinikum Heidelberg, Heidelberg, Germany., Hopf-Jensen S; Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie, DIAKO Krankenhaus gGmbH, Flensburg, Germany., Hua VT; Department of Neurology, Hôpital Maison-Blanche, Université Reims-Champagne-Ardenne, Reims, France., Jensen M; Klinik und Poliklinik für Neurologie, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany., Kastrup A; Klinik für Neurologie, Klinikum Bremen Mitte, Bremen, Germany., Keil CF; Institut für Neuroradiologie, Universitätsklinikum Frankfurt, Frankfurt am Main, Germany., Klepanec A; Department of Radiology, Faculty Hospital Trnava, Trnava, Slovakia., Kurča E; Clinic of Neurology, Jessenius Faculty of Medicine, Comenius University, Martin, Slovakia., Mikkelsen R; Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark., Möhlenbruch M; Neuroradiologie, Universitätsklinikum Heidelberg, Heidelberg, Germany., Müller-Hülsbeck S; Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie, DIAKO Krankenhaus gGmbH, Flensburg, Germany., Münnich N; Klinikum Dortmund gGmbH, Klinikum der Universität Witten/Herdecke, Dortmund, Germany., Pagano P; Department of Neuroradiology, Hôpital Maison-Blanche, Université Reims-Champagne-Ardenne, Reims, France., Papanagiotou P; Klinik für Diagnostische und Interventionelle Neuroradiologie, Klinikum Bremen Mitte, Bremen, Germany; Department of Radiology, Aretaieion University Hospital, National and Kapodistrian University of Athens, Athens, Greece., Petzold GC; Vascular Neurology Research Group, German Center for Neurodegenerative Diseases (DZNE), Bonn, Germany; Division of Vascular Neurology, Department of Neurology, University Hospital Bonn, Bonn, Germany., Pham M; Institut für Diagnostische und Interventionelle Neuroradiologie, Universitätsklinikum Würzburg, Würzburg, Germany., Puetz V; Department of Neurology, Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Dresden, Germany; Dresden Neurovascular Center, Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Dresden, Germany., Raupach J; Department of Radiology, Faculty of Medicine in Hradec Kralove, Charles University, Czech Republic., Reimann G; Klinikum Dortmund gGmbH, Klinikum der Universität Witten/Herdecke, Dortmund, Germany., Ringleb PA; Neurologie, Universitätsklinikum Heidelberg, Heidelberg, Germany., Schell M; Klinik und Poliklinik für Neurologie, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany., Schlemm E; Klinik und Poliklinik für Neurologie, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany., Schönenberger S; Neurologie, Universitätsklinikum Heidelberg, Heidelberg, Germany., Tennøe B; Department of Neuroradiology, Oslo University Hospital, Oslo, Norway., Ulfert C; Neuroradiologie, Universitätsklinikum Heidelberg, Heidelberg, Germany., Vališ K; St Anne's University Hospital Brno, Brno, Czech Republic., Vítková E; Department of Neurology, Faculty of Medicine in Hradec Kralove, Charles University, Czech Republic., Vollherbst DF; Neuroradiologie, Universitätsklinikum Heidelberg, Heidelberg, Germany., Wick W; Neurologie, Universitätsklinikum Heidelberg, Heidelberg, Germany., Thomalla G; Klinik und Poliklinik für Neurologie, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany. Electronic address: thomalla@uke.de.
Jazyk:	angličtina
Zdroj:	Lancet (London, England) [Lancet] 2023 Nov 11; Vol. 402 (10414), pp. 1753-1763. Date of Electronic Publication: 2023 Oct 11.
DOI:	10.1016/S0140-6736(23)02032-9
Abstrakt:	Background: Recent evidence suggests a beneficial effect of endovascular thrombectomy in acute ischaemic stroke with large infarct; however, previous trials have relied on multimodal brain imaging, whereas non-contrast CT is mostly used in clinical practice. Methods: In a prospective multicentre, open-label, randomised trial, patients with acute ischaemic stroke due to large vessel occlusion in the anterior circulation and a large established infarct indicated by an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) of 3-5 were randomly assigned using a central, web-based system (using a 1:1 ratio) to receive either endovascular thrombectomy with medical treatment or medical treatment (ie, standard of care) alone up to 12 h from stroke onset. The study was conducted in 40 hospitals in Europe and one site in Canada. The primary outcome was functional outcome across the entire range of the modified Rankin Scale at 90 days, assessed by investigators masked to treatment assignment. The primary analysis was done in the intention-to-treat population. Safety endpoints included mortality and rates of symptomatic intracranial haemorrhage and were analysed in the safety population, which included all patients based on the treatment they received. This trial is registered with ClinicalTrials.gov, NCT03094715. Findings: From July 17, 2018, to Feb 21, 2023, 253 patients were randomly assigned, with 125 patients assigned to endovascular thrombectomy and 128 to medical treatment alone. The trial was stopped early for efficacy after the first pre-planned interim analysis. At 90 days, endovascular thrombectomy was associated with a shift in the distribution of scores on the modified Rankin Scale towards better outcome (adjusted common OR 2·58 [95% CI 1·60-4·15]; p=0·0001) and with lower mortality (hazard ratio 0·67 [95% CI 0·46-0·98]; p=0·038). Symptomatic intracranial haemorrhage occurred in seven (6%) patients with thrombectomy and in six (5%) with medical treatment alone. Interpretation: Endovascular thrombectomy was associated with improved functional outcome and lower mortality in patients with acute ischaemic stroke from large vessel occlusion with established large infarct in a setting using non-contrast CT as the predominant imaging modality for patient selection. Funding: EU Horizon 2020. Competing Interests: Declaration of interests MB reports funding from EU Horizon 2020 and Deutsche Forschungsgemeinschaft (payments to the institution); honoraria for lectures from Novartis, Boehringer Ingelheim, and Seagen; and consulting fees from NeuroScios and Boehringer Ingelheim and is an editor in chief of Clinical Neuroradiology (Springer). JF reports funding from the European Commission; personal consulting fees from Acandis, Cerenovus, Medtronic, Microvention, Phenox, Stryker, and Roche; consulting at Philips (no payments); payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Penumbra and Tonbridge; support for attending meetings or travel from Medtronic and Penumbra; stock or stock options from Tegus Medical, Eppdata, and Vastrax; and participation in a Data Safety Monitoring Board or Advisory Board at Phenox (personal fees) and Stryker (personal fees) and is a past president of ESMINT. SB reports funding from the EU Horizon 2020 research and innovation programme (754640; payments made to the institution); and support for attending meetings or travel from Medtronic and Penumbra; AHA reports unrestricted research grants from Boehringer Ingelheim; honoraria for lectures from BMS/Pfizer, Teva, Roche, Abbvie, Lundbeck, and Novartis; and participation in Advisory Boards for MSD, BMS/Pfizer, Lundbeck, Lilly, and Abbvie. BF reports research grants from Carlos III Institute of Health; personal payment for educational lectures from Servicio Madrileño de Salud; payment for lectures from Euromedice to the institution; personal payment for educational lectures from Takeda; support for attending meetings from Daiichi Sankyo; receipt of materials for research from Abbot. MDH reports funding from Nil; grants to the University of Calgary for the TEMPO-2 trial from Boehringer Ingelheim, Biogen, NoNO (ESCAPE-NA1 trial and ESCAPE-NEXT trial), Canadian Institute for Health Research (ESCAPE-NA1 trial and ESCAPE-NEXT trial), Medtronic (HERMES collaboration), Alberta Innovates (QuICR Alberta Stroke Program); that some of the funds were used for the ESCAPE-NA1 trial from Alberta Innovates; consulting fees from Sun Pharma Brainsgate (paid work for adjudication of clinical trial outcomes); US patents 62/086,077 (licensed to Circle NVI) and 10,916,346 (licensed to Circle NVI); private stock ownership from Circle and PUreWeb; participation as data and safety monitoring committee chair of the RACECAT trial (end 2020), the Oncovir Hiltonel trial (ongoing), and the DUMAS trial (ongoing); participation as a data and safety monitoring committee member of the ARTESIA trial (ongoing), and the BRAIN-AF trial (ongoing); and is president of the Canadian Neurological Sciences Federation (not for profit) and a Board member of the Canadian Stroke Consortium (not for profit). AK reports grants from the European Commission for the TENSION study (payment to the institution). LP reports consulting fees from Balt, Microvention, and Phenox; and support for attending meetings or travel for the TENSION investigator meeting (transport and accommodation was reimbursed by the organization). CZS reports grants from Novo Nordisk Foundation and Health Research Foundation of Central Denmark Region. RAB reports speakers fees from Novo Nordisk and Beyer. HD reports financial compensation for the start-up fee and the obligatory payment to the hospital administration paid by the sponsor (Medical University Heidelberg) to the clinical division (no personal payments); personal consulting fees from Stryker; speakers honorary from Medtronic; support for attending meetings or travel from Medtronic; and past presidency of the Austrian Society of Interventional Radiology and past presidency Austrian Society of Neuroradiology. FD reports consulting fees from Cerenovus, Phenox, Balt, Cerus Endovascular, Stryker; payment for expert testimony from Cerenovus; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Cerenovus, Stryker, Acandis, Asahi, and Penumbra; participation in a Data Safety Monitoring Board or Advisory Board at Cerenovus; and previously work as an associate editor for Journal of NeuroInterventional Surgery and Journal of Clinical Medicine. FF reports consulting fees from Eppdata and support for attending meetings or travel from Microvention, Medtronic, Cerebrovascular Research and Education Foundation (CREF), and Acandis. SG reports consulting fees from Eppdata. CH reports consulting fees from Brainomix and lecture fees from Stryker. SH-J reports funding for data collection, payment, or honoraria for lectures, presentations, speakers' bureaus, manuscript writing, or educational events from Terumo. MG reports research grants from Medtronic and Cerenovus (payments to the University of Calgary); royalties or licenses from Microvention (systems of intracranial access); personal consulting fees from Microvention, Medtronic, Stryker, Mentice, Philips, and Penumbra; and stock or stock options from Circle Neurovascular. CFK was chair of the German stroke registry (unpaid). RM reports payments for a stroke lecture from TMC Academy. MM reports grants from Balt, Medtronic, MicroVention, and Stryker; consulting fees from Siemens; and support for attending meetings or travel from Europa Group. SM-H reports consulting fees from Terumo and Boston Scientific Corporation; payment or honoraria for lectures, presentations, speakers' bureaus, manuscript writing, or educational events from Terumo and Boston Scientific Corporation. NM reports the provision of study materials. PP reports support for attending meetings or travel for the TENSION investigator meeting (transport and accommodation was reimbursed by the organisation). MP reports grants from the German Research Foundation (DFG SFB 1158 A10, DFG KFO 5001 P02, DFG KFO 5001 Z, and DFG SFB TR 240 B02); speaker honoraria unrelated from Merck Serono and Bayer; and support for attending meetings or travel from Merck Serono (travel reimbursement) and Bayer (travel reimbursement). PAR reports consulting fees to the institution from Boehringer Ingelheim and Bayer; and payment or honoraria for lectures, presentations, speakers' bureaus, manuscript writing, or educational events from Boehringer Ingelheim, Bayer, Pfizer, and BMS (all made to the institution). ES reports grants from Hamburg Innovation and Hertie Foundation. DFV reports research grants from MicroVention; consulting fees from Medtronic; and paid lectures from Cerenovus and Johnson & Johnson. WW reports consulting fees to the institution from Abbvie, BMS, GSK, and Servier. GT reports funding from the European Commission (EUHorizon 2020 research and innovation programme, 754640; payments to the institution); personal consulting fees from Acandis, AstraZeneca, Bayer, Boehringer Ingelheim, and Stryker; personal payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Acandis, Alexion, Marin, Bayer, Boehringer Ingelheim, BristolMyersSquibb/Pfizer, Daiichi Sankyo, and Stryker; participation as DSMB member for the TEA Stroke Trial (no payments) and ReSCInD trial (no payments); work as a speaker of the Commission for Cerebrovascular Diseases of the German Society of Neurology (DGN; no payments); and membership of the Board of Directors of the European Stroke Organisation (ESO; no payments). All other authors declare no competing interests. (Copyright © 2023 Elsevier Ltd. All rights reserved.)
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