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

Publikation: Beitrag in FachzeitschriftForschungsartikelBeigetragenBegutachtung

Beitragende

  • TENSION Investigators - (Autor:in)
  • Institut und Poliklinik für Diagnostische und Interventionelle Neuroradiologie
  • Poliklinik für Zahnärztliche Prothetik
  • Zentraler Bereich
  • Klinik und Poliklinik für Neurologie
  • Dresdner NeurovaskuläresCentrum
  • Junge Neuroradiologie der Deutschen Gesellschaft für Neuroradiologie e.V.
  • Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention
  • Service de Biostatistique
  • Oslo University Hospital & Institute of Clinical Medicine
  • Hospital La Paz Institute for Health Research-La Paz University Hospital-Universidad Autonoma de Madrid
  • Medizinische Universität Innsbruck
  • Charles Sturt University
  • Aarhus University Hospital (AUH)
  • Comenius University Children's Hospital
  • Klinik und Poliklinik für Neurologie
  • Klinikum Klagenfurt and Section for Surgical Research Medical University Graz
  • Klinik für Diagnostische und Interventionelle Neuroradiologie
  • Faculty Hospital Trnava
  • DIAKO Krankenhaus Flensburg gGmbH
  • Klinik für Neurologie mit Institut für Translationale Neurologie
  • Universitätsklinikum Frankfurt
  • Hochschule für Musik und Darstellende Kunst Frankfurt am Main
  • Klinikum Dortmund gGmbH
  • Aretaieion University Hospital
  • Universitätsklinikum Bonn
  • St Anne's University Hospital Brno
  • Hôpital Maison Blanche
  • University of Calgary
  • Foothills Medical Centre
  • Universitätsklinikum Würzburg

Abstract

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.

Details

OriginalspracheEnglisch
Seiten (von - bis)1753-1763
Seitenumfang11
FachzeitschriftThe Lancet
Jahrgang402
Ausgabenummer10414
PublikationsstatusVeröffentlicht - 11 Nov. 2023
Peer-Review-StatusJa

Externe IDs

Scopus 85175870744
ORCID /0000-0001-7465-8700/work/150329232

Schlagworte

Schlagwörter

  • Humans, Stroke/diagnostic imaging, Brain Ischemia/diagnostic imaging, Prospective Studies, Thrombectomy/methods, Intracranial Hemorrhages/etiology, Ischemic Stroke/diagnostic imaging, Endovascular Procedures/methods, Infarction/complications, Alberta, Treatment Outcome