Please use this identifier to cite or link to this item: https://hdl.handle.net/1/2696
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dc.contributor.authorParsons, Mark W-
dc.contributor.authorYogendrakumar, Vignan-
dc.contributor.authorChurilov, Leonid-
dc.contributor.authorGarcia-Esperon, Carlos-
dc.contributor.authorCampbell, Bruce C V-
dc.contributor.authorRussell, Michelle L-
dc.contributor.authorSharma, Gagan-
dc.contributor.authorChen, Chushuang-
dc.contributor.authorLin, Longting-
dc.contributor.authorChew, Beng Lim-
dc.contributor.authorNg, Felix C-
dc.contributor.authorDeepak, Akshay-
dc.contributor.authorChoi, Philip M C-
dc.contributor.authorKleinig, Timothy J-
dc.contributor.authorCordato, Dennis J-
dc.contributor.authorWu, Teddy Y-
dc.contributor.authorFink, John N-
dc.contributor.authorMa, Henry-
dc.contributor.authorPhan, Thanh G-
dc.contributor.authorMarkus, Hugh S-
dc.contributor.authorMolina, Carlos A-
dc.contributor.authorTsai, Chon-Haw-
dc.contributor.authorLee, Jiunn-Tay-
dc.contributor.authorJeng, Jiann-Shing-
dc.contributor.authorStrbian, Daniel-
dc.contributor.authorMeretoja, Atte-
dc.contributor.authorArenillas, Juan F-
dc.contributor.authorBuck, Brian H-
dc.contributor.authorDevlin, Michael J-
dc.contributor.authorBrown, Helen-
dc.contributor.authorButcher, Ken S-
dc.contributor.authorO'Brien, Billy-
dc.contributor.authorSabet, Arman-
dc.contributor.authorWijeratne, Tissa-
dc.contributor.authorBivard, Andrew-
dc.contributor.authorGrimley, Rohan S-
dc.contributor.authorAgarwal, Smriti-
dc.contributor.authorMunshi, Sunil K-
dc.contributor.authorDonnan, Geoffrey A-
dc.contributor.authorDavis, Stephen M-
dc.contributor.authorMiteff, Ferdinand-
dc.contributor.authorSpratt, Neil J-
dc.contributor.authorLevi, Christopher R-
dc.date.accessioned2024-08-16T01:26:53Z-
dc.date.available2024-08-16T01:26:53Z-
dc.date.issued2024-08-
dc.identifier.citation23(8):775-786en
dc.identifier.urihttps://hdl.handle.net/1/2696-
dc.description.abstractIntravenous tenecteplase increases reperfusion in patients with salvageable brain tissue on perfusion imaging and might have advantages over alteplase as a thrombolytic for ischaemic stroke. We aimed to assess the non-inferiority of tenecteplase versus alteplase on clinical outcomes in patients selected by use of perfusion imaging. This international, multicentre, open-label, parallel-group, randomised, clinical non-inferiority trial enrolled patients from 35 hospitals in eight countries. Participants were aged 18 years or older, within 4·5 h of ischaemic stroke onset or last known well, were not being considered for endovascular thrombectomy, and met target mismatch criteria on brain perfusion imaging. Patients were randomly assigned (1:1) by use of a centralised web server with randomly permuted blocks to intravenous tenecteplase (0·25 mg/kg) or alteplase (0·90 mg/kg). The primary outcome was the proportion of patients without disability (modified Rankin Scale 0-1) at 3 months, assessed via masked review in both the intention-to-treat and per-protocol populations. We aimed to recruit 832 participants to yield 90% power (one-sided alpha=0·025) to detect a risk difference of 0·08, with an absolute non-inferiority margin of -0·03. The trial was registered with the Australian New Zealand Clinical Trials Registry, ACTRN12613000243718, and the European Union Clinical Trials Register, EudraCT Number 2015-002657-36, and it is completed. Recruitment ceased early following the announcement of other trial results showing non-inferiority of tenecteplase versus alteplase. Between March 21, 2014, and Oct 20, 2023, 680 patients were enrolled and randomly assigned to tenecteplase (n=339) and alteplase (n=341), all of whom were included in the intention-to-treat analysis (multiple imputation was used to account for missing primary outcome data for five patients). Protocol violations occurred in 74 participants, thus the per-protocol population comprised 601 people (295 in the tenecteplase group and 306 in the alteplase group). Participants had a median age of 74 years (IQR 63-82), baseline National Institutes of Health Stroke Scale score of 7 (4-11), and 260 (38%) were female. In the intention-to-treat analysis, the primary outcome occurred in 191 (57%) of 335 participants allocated to tenecteplase and 188 (55%) of 340 participants allocated to alteplase (standardised risk difference [SRD]=0·03 [95% CI -0·033 to 0·10], one-tailed pnon-inferiority=0·031). In the per-protocol analysis, the primary outcome occurred in 173 (59%) of 295 participants allocated to tenecteplase and 171 (56%) of 306 participants allocated to alteplase (SRD 0·05 [-0·02 to 0·12], one-tailed pnon-inferiority=0·01). Nine (3%) of 337 patients in the tenecteplase group and six (2%) of 340 in the alteplase group had symptomatic intracranial haemorrhage (unadjusted risk difference=0·01 [95% CI -0·01 to 0·03]) and 23 (7%) of 335 and 15 (4%) of 340 died within 90 days of starting treatment (SRD 0·02 [95% CI -0·02 to 0·05]). The findings in our study provide further evidence to strengthen the assertion of the non-inferiority of tenecteplase to alteplase, specifically when perfusion imaging has been used to identify reperfusion-eligible stroke patients. Although non-inferiority was achieved in the per-protocol population, it was not reached in the intention-to-treat analysis, possibly due to sample size limtations. Nonetheless, large-scale implementation of perfusion CT to assist in patient selection for intravenous thrombolysis in the early time window was shown to be feasible. Australian National Health Medical Research Council; Boehringer Ingelheim.en
dc.description.sponsorshipNeurologyen
dc.subjectNeurologyen
dc.titleTenecteplase versus alteplase for thrombolysis in patients selected by use of perfusion imaging within 4·5 h of onset of ischaemic stroke (TASTE): a multicentre, randomised, controlled, phase 3 non-inferiority trialen
dc.typeJournal Articleen
dc.identifier.doi10.1016/S1474-4422(24)00206-0en
dc.description.pubmedurihttps://pubmed.ncbi.nlm.nih.gov/38880118en
dc.description.affiliatesCentral Coast Local Health Districten
dc.description.affiliatesGosford Hospitalen
dc.identifier.journaltitleThe Lancet Neurologyen
dc.type.studyortrialRandomized Controlled Clinical Trial/Controlled Clinical Trialen
dc.type.contentTexten
item.fulltextNo Fulltext-
item.grantfulltextnone-
item.openairetypeJournal Article-
item.cerifentitytypePublications-
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
Appears in Collections:Neurology
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