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https://hdl.handle.net/2440/129924
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dc.contributor.author | Campbell, B.C.V. | - |
dc.contributor.author | Ma, H. | - |
dc.contributor.author | Parsons, M.W. | - |
dc.contributor.author | Churilov, L. | - |
dc.contributor.author | Yassi, N. | - |
dc.contributor.author | Kleinig, T.J. | - |
dc.contributor.author | Hsu, C.Y. | - |
dc.contributor.author | Dewey, H.M. | - |
dc.contributor.author | Butcher, K.S. | - |
dc.contributor.author | Yan, B. | - |
dc.contributor.author | Desmond, P.M. | - |
dc.contributor.author | Wijeratne, T. | - |
dc.contributor.author | Curtze, S. | - |
dc.contributor.author | Barber, P.A. | - |
dc.contributor.author | De Silva, D.A. | - |
dc.contributor.author | Thijs, V. | - |
dc.contributor.author | Levi, C.R. | - |
dc.contributor.author | Bladin, C.F. | - |
dc.contributor.author | Sharma, G. | - |
dc.contributor.author | Bivard, A. | - |
dc.contributor.author | et al. | - |
dc.date.issued | 2020 | - |
dc.identifier.citation | JAMA Neurology, 2020; 78(2):236-240 | - |
dc.identifier.issn | 2168-6149 | - |
dc.identifier.issn | 2168-6157 | - |
dc.identifier.uri | http://hdl.handle.net/2440/129924 | - |
dc.description.abstract | Importance: Intravenous alteplase reduces disability after ischemic stroke in patients 4.5 to 9 hours after onset and with wake-up onset stroke selected using perfusion imaging mismatch. However, whether the benefit is consistent across the 4.5- to 6-hours, 6- to 9-hours, and wake-up stroke epochs is uncertain. Objective: To examine the association of reperfusion with reduced disability, including by onset-to-randomization time strata in the Extending the Time for Thrombolysis in Emergency Neurological Deficits (EXTEND) and Echoplanar Imaging Thrombolytic Evaluation Trial (EPITHET) randomized clinical trials. Design, Setting, and Participants: Individual patient meta-analysis of randomized clinical trials performed from August 2001 to June 2018 with 3-month follow-up. Patients had acute ischemic stroke with 4.5-to 9-hours poststroke onset or with wake-up stroke were randomized to alteplase or placebo after perfusion mismatch imaging. Analysis began July 2019 and ended May 2020. Exposures: Reperfusion was defined as more than 90% reduction in time to maximum of more than 6 seconds' lesion volume at 24- to 72-hour follow-up. Main Outcomes and Measures: Ordinal logistic regression adjusted for baseline age and National Institutes of Health Stroke Scale score was used to analyze functional improvement in day 90 modified Rankin Scale score overall, including a reperfusion × time-to-randomization multiplicative interaction term, and in the 4.5- to 6-hours, 6- to 9-hours, and wake-up time strata. Symptomatic hemorrhage was defined as large parenchymal hematoma with a National Institutes of Health Stroke Scale score increase of 4 points or more. Results: Reperfusion was assessable in 270 of 295 patients (92%), 68 of 133 (51%) in the alteplase group, and 38 of 137 (28%) in the placebo reperfused group (P < .001). The median (interquartile range) age was 76 (66-81) years in the reperfusion group vs 74 (64.5-81.0) years in the group with no reperfusion. The median (interquartile range) baseline National Institutes of Health Stroke Scale score was 10 (7-15) in the reperfusion group vs 12 (8.0-17.5) in the no reperfusion group. Overall, reperfusion was associated with improved functional outcome (common odds ratio, 7.7; 95% CI, 4.6-12.8; P < .001). Reperfusion was associated with significantly improved functional outcome in each of the 4.5- to 6-hours, 6- to 9-hours, and wake-up time strata, with no evidence of association between time to randomization and beneficial effect of reperfusion (P = .63). Symptomatic hemorrhage, assessed in all 294 patients, occurred in 3 of 51 (5.9%) in the 4.5- to 6-hours group, 2 of 28 (7.1%) in the 6- to 9-hours group, and 4 of 73 (5.5%) in the wake-up stroke in patients treated with alteplase (Fisher P = .91). Conclusions and Relevance: Strong benefits of reperfusion in all time strata without differential risk in symptomatic hemorrhage support the consistent treatment effect of alteplase in perfusion mismatch-selected patients throughout the 4.5- to 9-hours and wake-up stroke time window. | - |
dc.description.statementofresponsibility | Bruce C. V. Campbell, Henry Ma, Mark W. Parsons, Leonid Churilov, Nawaf Yassi, Timothy J. Kleinig ... et al. | - |
dc.language.iso | en | - |
dc.publisher | American Medical Association | - |
dc.rights | © 2020 American Medical Association. All rights reserved. | - |
dc.source.uri | http://dx.doi.org/10.1001/jamaneurol.2020.4123 | - |
dc.subject | Humans | - |
dc.subject | Tissue Plasminogen Activator | - |
dc.subject | Fibrinolytic Agents | - |
dc.subject | Treatment Outcome | - |
dc.subject | Thrombolytic Therapy | - |
dc.subject | Cerebrovascular Circulation | - |
dc.subject | Randomized Controlled Trials as Topic | - |
dc.subject | Stroke | - |
dc.subject | Time-to-Treatment | - |
dc.title | Association of reperfusion after thrombolysis with clinical outcome across the 4.5- to 9-hours and wake-up stroke time window: a meta-analysis of the EXTEND and EPITHET randomized clinical trials | - |
dc.type | Journal article | - |
dc.identifier.doi | 10.1001/jamaneurol.2020.4123 | - |
dc.relation.grant | http://purl.org/au-research/grants/nhmrc/GNT1043242 | - |
dc.relation.grant | http://purl.org/au-research/grants/nhmrc/GNT1035688 | - |
pubs.publication-status | Published | - |
dc.identifier.orcid | Kleinig, T.J. [0000-0003-4430-3276] | - |
Appears in Collections: | Aurora harvest 8 Medicine publications |
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