Please use this identifier to cite or link to this item:
Title: Thrombolysis Guided by Perfusion Imaging up to 9 Hours after Onset of Stroke
Authors: Sturm, Jonathan ;Ma, H.;Campbell, B.C.V.;Parsons, M.W.;Churilov, L.;Levi, C.R.;Hsu, C.;Kleinig, T.J.;Wijeratne, T.;Curtze, S.;Dewey, H.M.;Miteff, F.;Tsai, C.H.;Lee, J.T.;Phan, T.G.;Mahant, N.;Sun, M.C.;Krause, Martin;Grimley, R.;Chen, C.H.;Hu, C.J.;Wong, A.A.;Field, D.;Sun, Y.;Barber, P.A.;Sabet, A.;Jannes, J.;Jeng, J.S.;Clissold, B.;Markus, R.;Lin, C.H.;Lien, L.M.;Bladin, C.F.;Christensen, S.;Yassi, N.;Sharma, G.;Bivard, A.;Desmond, P.M.;Yan, B.;Mitchell, P.J.;Thijs, V.;Carey, L.;Meretoja, A.;Davis, S.M.;Donnan, G.A.
Affliation: Central Coast Local Health District
Gosford Hospital
Wyong Hospital
Issue Date: May-2019
Source: 380(19):1795-1803
Journal title: New England Journal of Medicine
Department: Neurology
Abstract: BACKGROUND: The time to initiate intravenous thrombolysis for acute ischemic stroke is generally limited to within 4.5 hours after the onset of symptoms. Some trials have suggested that the treatment window may be extended in patients who are shown to have ischemic but not yet infarcted brain tissue on imaging. METHODS: We conducted a multicenter, randomized, placebo-controlled trial involving patients with ischemic stroke who had hypoperfused but salvageable regions of brain detected on automated perfusion imaging. The patients were randomly assigned to receive intravenous alteplase or placebo between 4.5 and 9.0 hours after the onset of stroke or on awakening with stroke (if within 9 hours from the midpoint of sleep). The primary outcome was a score of 0 or 1 on the modified Rankin scale, on which scores range from 0 (no symptoms) to 6 (death), at 90 days. The risk ratio for the primary outcome was adjusted for age and clinical severity at baseline. RESULTS: After 225 of the planned 310 patients had been enrolled, the trial was terminated because of a loss of equipoise after the publication of positive results from a previous trial. A total of 113 patients were randomly assigned to the alteplase group and 112 to the placebo group. The primary outcome occurred in 40 patients (35.4%) in the alteplase group and in 33 patients (29.5%) in the placebo group (adjusted risk ratio, 1.44; 95% confidence interval [CI], 1.01 to 2.06; P = 0.04). Symptomatic intracerebral hemorrhage occurred in 7 patients (6.2%) in the alteplase group and in 1 patient (0.9%) in the placebo group (adjusted risk ratio, 7.22; 95% CI, 0.97 to 53.5; P = 0.05). A secondary ordinal analysis of the distribution of scores on the modified Rankin scale did not show a significant between-group difference in functional improvement at 90 days. CONCLUSIONS: Among the patients in this trial who had ischemic stroke and salvageable brain tissue, the use of alteplase between 4.5 and 9.0 hours after stroke onset or at the time the patient awoke with stroke symptoms resulted in a higher percentage of patients with no or minor neurologic deficits than the use of placebo. There were more cases of symptomatic cerebral hemorrhage in the alteplase group than in the placebo group. (Funded by the Australian National Health and Medical Research Council and others; EXTEND numbers, NCT00887328 and NCT01580839.).
DOI: 10.1056/NEJMoa1813046
ISSN: 0028-4793
Publicaton type: Journal Article
Keywords: Stroke
Study or Trial: Randomized Controlled Clinical Trial/Controlled Clinical Trial
Appears in Collections:Neurology

Show full item record

Page view(s)

checked on Feb 2, 2023

Google ScholarTM



Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.