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Thrombolysis Guided by Perfusion Imaging up to 9 Hours after Onset of Stroke.

Journal article
Authors Henry Ma
Bruce C V Campbell
Mark W Parsons
Leonid Churilov
Christopher R Levi
Chung Hsu
Timothy J Kleinig
Tissa Wijeratne
Sami Curtze
Helen M Dewey
Ferdinand Miteff
Chon-Haw Tsai
Jiunn-Tay Lee
Thanh G Phan
Neil Mahant
Mu-Chien Sun
Martin Krause
Jonathan Sturm
Rohan Grimley
Chih-Hung Chen
Chaur-Jong Hu
Andrew A Wong
Deborah Field
Yu Sun
P Alan Barber
Arman Sabet
Jim Jannes
Jiann-Shing Jeng
Benjamin Clissold
Romesh Markus
Ching-Huang Lin
Li-Ming Lien
Christopher F Bladin
Søren Christensen
Nawaf Yassi
Gagan Sharma
Andrew Bivard
Patricia M Desmond
Bernard Yan
Peter J Mitchell
Vincent Thijs
Leeanne Carey
Atte Meretoja
Stephen M Davis
Geoffrey A Donnan
Turgut Tatlisumak
Published in The New England journal of medicine
Volume 380
Issue 19
Pages 1795-1803
ISSN 1533-4406
Publication year 2019
Published at
Pages 1795-1803
Language en
Keywords Aged, Aged, 80 and over, Brain, diagnostic imaging, Brain Ischemia, diagnostic imaging, drug therapy, Cerebral Hemorrhage, chemically induced, Computed Tomography Angiography, Female, Fibrinolytic Agents, adverse effects, therapeutic use, Humans, Infusions, Intravenous, Magnetic Resonance Angiography, Male, Middle Aged, Nervous System Diseases, epidemiology, prevention & control, Perfusion Imaging, Stroke, diagnostic imaging, drug therapy, mortality, Therapeutic Equipoise, Time-to-Treatment, Tissue Plasminogen Activator, adverse effects, therapeutic use
Subject categories Neurology


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.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.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.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.).

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