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

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 p...

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Published in:The Lancet (British edition) 2023-04, Vol.401 (10385), p.1371-1380
Main Authors: 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, Bulut, Tomas, Remmers, Michel J M, de Jong, Thijs E A M, den Hertog, Heleen M, van Hasselt, Boudewijn A A M, Rozeman, Anouk D, Elgersma, Otto E H, van der Veen, Bas, Sudiono, Davy R, Lingsma, Hester F, Roos, Yvo B W E M, Majoie, Charles B L M, van der Lugt, Aad, Dippel, Diederik W J, van Zwam, Wim H, van Oostenbrugge, Robert J
Format: Article
Language:English
Subjects:
Angiography
Brain Ischemia - diagnostic imaging
Brain Ischemia - surgery
Brain research
Cardiovascular system
Carotid arteries
Cerebral blood flow
Clinical trials
Computed tomography
Computed Tomography Angiography
Consent
Female
Health services
Hemorrhage
Humans
Intracranial Hemorrhages - etiology
Ischemia
Ischemic Stroke - complications
Male
Medical imaging
Medical treatment
Mortality
Netherlands
Neuroimaging
Occlusion
Patients
Randomization
Safety
Stroke
Stroke - drug therapy
Stroke - therapy
Treatment Outcome
Veins & arteries
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Summary: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). 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. Between 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 no
ISSN:0140-6736
1474-547X
DOI:10.1016/S0140-6736(23)00575-5