• Susanne G H Olthuis, F Anne V Pirson, Florentina M E Pinckaers, Wouter H Hinsenveld, Daan Nieboer, Angelique Ceulemans, Robrecht R M M Knapen, M M Quirien Robbe, Olvert A Berkhemer, van WalderveenMarianne A AMAADepartment of Radiology, Leiden University Medical Center, Leiden, Netherlands., Lycklama À NijeholtGeert JGJDepartment of Radiology, Haaglanden Medical Center, The Hague, Netherlands., Maarten Uyttenboogaart, Wouter J Schonewille, P Matthijs van der Sluijs, Lennard Wolff, Henk van Voorst, Alida A Postma, Stefan D Roosendaal, Anouk van der Hoorn, Bart J Emmer, Menno G M Krietemeijer, Pieter-Jan van Doormaal, Bob Roozenbeek, Robert-Jan B Goldhoorn, Julie Staals, Inger R de Ridder, Christiaan van der Leij, Jonathan M Coutinho, H Bart van der Worp, LoRob T HRTHDepartment of Radiology, University Medical Center Utrecht, Utrecht, Netherlands., BokkersReinoud P HRPHDepartment of Radiology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands., Ewoud I van Dijk, Hieronymus D Boogaarts, WermerMarieke J HMJHDepartment of Neurology, Leiden University Medical Center, Leiden, Netherlands., Adriaan C G M van Es, Julia H van Tuijl, Hans G J Kortman, GonsRob A RRARDepartment of Neurology, Catharina Hospital, Eindhoven, Netherlands., Lonneke S F Yo, Jan-Albert Vos, Karlijn F de Laat, Lukas C van Dijk, Ido R van den Wijngaard, Jeannette Hofmeijer, Jasper M Martens, BrouwersPaul J A MPJAMDepartment of Neurology, Medisch Spectrum Twente, Enschede, Netherlands., Tomas Bulut, RemmersMichel J MMJMDepartment of Neurology, Amphia Hospital, Breda, Netherlands., Thijs E A M de Jong, Heleen M den Hertog, van HasseltBoudewijn A A MBAAMDepartment of Radiology, Isala Hospital, Zwolle, Netherlands., Anouk D Rozeman, ElgersmaOtto E HOEHDepartment of Radiology, Albert Schweitzer Hospital, Dordrecht, Netherlands., Bas van der Veen, Davy R Sudiono, Hester F Lingsma, RoosYvo B W E MYBWEMDepartment of Neurology, Amsterdam UMC location University of Amsterdam, Amsterdam, Netherlands., MajoieCharles B L MCBLMDepartment of Radiology and Nuclear Medicine, Amsterdam Neurosciences, Amsterdam UMC location University of Amsterdam, Amsterdam, Netherlands., Aad van der Lugt, DippelDiederik W JDWJDepartment of Neurology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, Netherlands., Wim H van Zwam, Robert J van Oostenbrugge, and MR CLEAN-LATE investigators.
• Department of Neurology, Maastricht University Medical Center+, Maastricht, Netherlands; School for Cardiovascular Diseases, Maastricht University, Maastricht, Netherlands. Electronic address: susan.olthuis@mumc.nl.
• Lancet. 2023 Apr 22; 401 (10385): 137113801371-1380.

BackgroundEndovascular treatment for anterior circulation ischaemic stroke is effective and safe within a 6 h window. MR CLEAN-LATE aimed to assess efficacy and safety of endovascular treatment for patients treated in the late window (6-24 h from symptom onset or last seen well) selected on the basis of the presence of collateral flow on CT angiography (CTA).MethodsMR CLEAN-LATE was a multicentre, open-label, blinded-endpoint, randomised, controlled, phase 3 trial done in 18 stroke intervention centres in the Netherlands. Patients aged 18 years or older with ischaemic stroke, presenting in the late window with an anterior circulation large-vessel occlusion and collateral flow on CTA, and a neurological deficit score of at least 2 on the National Institutes of Health Stroke Scale were included. Patients who were eligible for late-window endovascular treatment were treated according to national guidelines (based on clinical and perfusion imaging criteria derived from the DAWN and DEFUSE-3 trials) and excluded from MR CLEAN-LATE enrolment. Patients were randomly assigned (1:1) to receive endovascular treatment or no endovascular treatment (control), in addition to best medical treatment. Randomisation was web based, with block sizes ranging from eight to 20, and stratified by centre. The primary outcome was the modified Rankin Scale (mRS) score at 90 days after randomisation. Safety outcomes included all-cause mortality at 90 days after randomisation and symptomatic intracranial haemorrhage. All randomly assigned patients who provided deferred consent or died before consent could be obtained comprised the modified intention-to-treat population, in which the primary and safety outcomes were assessed. Analyses were adjusted for predefined confounders. Treatment effect was estimated with ordinal logistic regression and reported as an adjusted common odds ratio (OR) with a 95% CI. This trial was registered with the ISRCTN, ISRCTN19922220.FindingsBetween Feb 2, 2018, and Jan 27, 2022, 535 patients were randomly assigned, and 502 (94%) patients provided deferred consent or died before consent was obtained (255 in the endovascular treatment group and 247 in the control group; 261 [52%] females). The median mRS score at 90 days was lower in the endovascular treatment group than in the control group (3 [IQR 2-5] vs 4 [2-6]), and we observed a shift towards better outcomes on the mRS for the endovascular treatment group (adjusted common OR 1·67 [95% CI 1·20-2·32]). All-cause mortality did not differ significantly between groups (62 [24%] of 255 patients vs 74 [30%] of 247 patients; adjusted OR 0·72 [95% CI 0·44-1·18]). Symptomatic intracranial haemorrhage occurred more often in the endovascular treatment group than in the control group (17 [7%] vs four [2%]; adjusted OR 4·59 [95% CI 1·49-14·10]).InterpretationIn this study, endovascular treatment was efficacious and safe for patients with ischaemic stroke caused by an anterior circulation large-vessel occlusion who presented 6-24 h from onset or last seen well, and who were selected on the basis of the presence of collateral flow on CTA. Selection of patients for endovascular treatment in the late window could be primarily based on the presence of collateral flow.FundingCollaboration for New Treatments of Acute Stroke consortium, Dutch Heart Foundation, Stryker, Medtronic, Cerenovus, Top Sector Life Sciences & Health, and the Netherlands Brain Foundation.Copyright © 2023 Elsevier Ltd. All rights reserved.

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