Endovascular treatment versus no endovascular treatment after 6–24 h in patients with ischaemic stroke and collateral flow on CT angiography (MR CLEAN-LATE) in the Netherlands:a multicentre, open-label, blinded-endpoint, randomised, controlled, phase 3 trial

Verfasser:	Olthuis, Susanne G.H. Pirson, F. Anne V. Pinckaers, Florentina M.E. Hinsenveld, Wouter H. Nieboer, Daan Ceulemans, Angelique Knapen, Robrecht R.M.M. Robbe, M. M.Quirien Berkhemer, Olvert A. van Walderveen, Marianne A.A. Lycklama à Nijeholt, Geert J. Uyttenboogaart, Maarten Schonewille, Wouter J. van der Sluijs, P. Matthijs Wolff, Lennard van Voorst, Henk Postma, Alida A. Roosendaal, Stefan D. van der Hoorn, Anouk Emmer, Bart J. Krietemeijer, Menno G.M. van Doormaal, Pieter Jan Roozenbeek, Bob Goldhoorn, Robert Jan B. Staals, Julie de Ridder, Inger R. van der Leij, Christiaan Coutinho, Jonathan M. van der Worp, H. Bart Lo, Rob T.H. Bokkers, Reinoud P.H. van Dijk, Ewoud I. Boogaarts, Hieronymus D. Wermer, Marieke J.H. van Es, Adriaan C.G.M. van Tuijl, Julia H. Kortman, Hans G.J. Gons, Rob A.R. Yo, Lonneke S.F. Vos, Jan Albert de Laat, Karlijn F. van Dijk, Lukas C. van den Wijngaard, Ido R. Hofmeijer, Jeannette Martens, Jasper M. Brouwers, Paul J.A.M. den Hertog, Heleen M. Lingsma, Hester F. van der Lugt, Aad Dippel, Diederik W.J.
Dokumenttyp:	Artikel
Erscheinungsdatum:	2023
Reihe/Periodikum:	Olthuis , S G H , MR CLEAN-LATE investigators , Pirson , F A V , Pinckaers , F M E , Hinsenveld , W H , Nieboer , D , Ceulemans , A , Knapen , R R M M , Robbe , M M Q , Berkhemer , O A , van Walderveen , M A A , Lycklama à Nijeholt , G J , Uyttenboogaart , M , Schonewille , W J , van der Sluijs , P M , Wolff , L , van Voorst , H , Postma , A A , Roosendaal , S D , van der Hoorn , A , Emmer , B J , Krietemeijer , M G M , van Doormaal , P J , Roozenbeek , B , Goldhoorn , R J B , Staals , J , de Ridder , I R , van der Leij , C , Coutinho , J M , van der Worp , H B , Lo , R T H , Bokkers , R P H , van Dijk , E I , Boogaarts , H D , Wermer , M J H , van Es , A C G M , van Tuijl , J H , Kortman , H G J , Gons , R A R , Yo , L S F , Vos , J A , de Laat , K F , van Dijk , L C , van den Wijngaard , I R , Hofmeijer , J , Martens , J M , Brouwers , P J A M , den Hertog , H M , Lingsma , H F , van der Lugt , A & Dippel , D W J 2023 , ' Endovascular treatment versus no endovascular treatment after 6–24 h in patients with ischaemic stroke and collateral flow on CT angiography (MR CLEAN-LATE) in the Netherlands : a multicentre, open-label, blinded-endpoint, randomised, controlled, phase 3 trial ' , The Lancet , vol. 401 , no. 10385 , pp. 1371-1380 . https://doi.org/10.1016/S0140-6736(23)00575-5
Sprache:	Englisch
Permalink:	https://search.fid-benelux.de/Record/base-27616877
Datenquelle:	BASE; Originalkatalog
Powered By:	BASE
Link(s) :	https://pure.eur.nl/en/publications/ebf39f51-141a-4a05-a937-49906aa9009b

Background: Endovascular 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). Methods: MR 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. Findings: Between Feb 2, 2018, and Jan 27, 2022, 535 patients were randomly ...