Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial
Language English Country Great Britain, England Media print-electronic
Document type Randomized Controlled Trial, Multicenter Study, Journal Article, Research Support, Non-U.S. Gov't
PubMed
37837989
DOI
10.1016/s0140-6736(23)02032-9
PII: S0140-6736(23)02032-9
Knihovny.cz E-resources
- MeSH
- Stroke * diagnostic imaging surgery MeSH
- Endovascular Procedures * methods MeSH
- Infarction complications MeSH
- Intracranial Hemorrhages etiology MeSH
- Ischemic Stroke * diagnostic imaging surgery MeSH
- Brain Ischemia * diagnostic imaging surgery MeSH
- Humans MeSH
- Prospective Studies MeSH
- Thrombectomy methods MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Geographicals
- Alberta MeSH
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.
Clinic of Neurology Jessenius Faculty of Medicine Comenius University Martin Slovakia
Clinic of Radiology Jessenius Faculty of Medicine Comenius University Martin Slovakia
Department of Neurology Aarhus University Hospital Aarhus Denmark
Department of Neurology Faculty Hospital Trnava Trnava Slovakia
Department of Neurology Faculty of Medicine in Hradec Kralove Charles University Czech Republic
Department of Neurology Hôpital Maison Blanche Université Reims Champagne Ardenne Reims France
Department of Neurology Oslo University Hospital Oslo Norway
Department of Neuroradiology Aarhus University Hospital Aarhus Denmark
Department of Neuroradiology Hôpital Maison Blanche Université Reims Champagne Ardenne Reims France
Department of Neuroradiology Medical University Innsbruck Innsbruck Austria
Department of Neuroradiology Oslo University Hospital Oslo Norway
Department of Radiology Faculty Hospital Trnava Trnava Slovakia
Department of Radiology Faculty of Medicine in Hradec Kralove Charles University Czech Republic
Institut für Neuroradiologie Universitätsklinikum Frankfurt Frankfurt am Main Germany
Klinik für Diagnostische und Interventionelle Neuroradiologie Universitätsklinikum Bonn Bonn Germany
Klinik für Neurologie Klinikum Bremen Mitte Bremen Germany
Klinik und Poliklinik für Neurologie Universitätsklinikum Hamburg Eppendorf Hamburg Germany
Klinikum Dortmund gGmbH Klinikum der Universität Witten Herdecke Dortmund Germany
Neurologie Universitätsklinikum Heidelberg Heidelberg Germany
Neuroradiologie Universitätsklinikum Heidelberg Heidelberg Germany
References provided by Crossref.org
ClinicalTrials.gov
NCT03094715
