دورية أكاديمية
Tenecteplase 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 trial.
| العنوان: | Tenecteplase 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 trial. |
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| المؤلفون: | Parsons MW; Department of Neurology, Liverpool Hospital, University of New South Wales, Ingham Institute, Liverpool, NSW, Australia; Melbourne Brain Centre, Department of Neurology, Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia; Hunter New England Local Health District, New Lambton Heights, NSW, Australia; Department of Medicine, University of Melbourne, Melbourne, VIC, Australia; Faculty of Medicine, University of Newcastle, Newcastle, NSW, Australia. Electronic address: mark.parsons@unsw.edu.au., Yogendrakumar V; Melbourne Brain Centre, Department of Neurology, Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia; Department of Medicine, University of Melbourne, Melbourne, VIC, Australia., Churilov L; Department of Medicine, University of Melbourne, Melbourne, VIC, Australia., Garcia-Esperon C; Hunter New England Local Health District, New Lambton Heights, NSW, Australia; Faculty of Medicine, University of Newcastle, Newcastle, NSW, Australia., Campbell BCV; Melbourne Brain Centre, Department of Neurology, Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia; Department of Medicine, University of Melbourne, Melbourne, VIC, Australia., Russell ML; Hunter New England Local Health District, New Lambton Heights, NSW, Australia., Sharma G; Department of Neurology, Liverpool Hospital, University of New South Wales, Ingham Institute, Liverpool, NSW, Australia; Melbourne Brain Centre, Department of Neurology, Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia., Chen C; Department of Neurology, Liverpool Hospital, University of New South Wales, Ingham Institute, Liverpool, NSW, Australia; Faculty of Medicine, University of Newcastle, Newcastle, NSW, Australia., Lin L; Department of Neurology, Liverpool Hospital, University of New South Wales, Ingham Institute, Liverpool, NSW, Australia; Faculty of Medicine, University of Newcastle, Newcastle, NSW, Australia., Chew BL; Hunter New England Local Health District, New Lambton Heights, NSW, Australia., Ng FC; Melbourne Brain Centre, Department of Neurology, Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia; Department of Medicine, University of Melbourne, Melbourne, VIC, Australia; Austin Health, Melbourne, VIC, Australia., Deepak A; Mercury Hospital, Chennai, Tamil Nadu, India., Choi PMC; Department of Neuroscience, Box Hill Hospital, Eastern Health, Melbourne, VIC, Australia., Kleinig TJ; Department of Neurology, Royal Adelaide Hospital, Adelaide, SA, Australia., Cordato DJ; Department of Neurology, Liverpool Hospital, University of New South Wales, Ingham Institute, Liverpool, NSW, Australia., Wu TY; Department of Neurology, Christchurch Hospital, Christchurch, New Zealand., Fink JN; Department of Neurology, Christchurch Hospital, Christchurch, New Zealand., Ma H; Schools of Clinical Science at Monash Health, Department of Medicine and Neurology, Monash University, Melbourne, VIC, Australia., Phan TG; Schools of Clinical Science at Monash Health, Department of Medicine and Neurology, Monash University, Melbourne, VIC, Australia., Markus HS; Stroke Research Group, Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK., Molina CA; Vall d'Hebron Stroke Center, Department of Neurology, Hospital Vall d'Hebron, Barcelona, Spain., Tsai CH; Department of Neurology, China Medical University Hospital, Taichung, Taiwan., Lee JT; Department of Neurology, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan., Jeng JS; Department of Neurology, National Taiwan University Hospital, Taipei, Taiwan., Strbian D; Department of Neurology, Helsinki University Hospital, Helsinki, Finland., Meretoja A; Department of Neurology, Helsinki University Hospital, Helsinki, Finland., Arenillas JF; Department of Neurology, Hospital Clínico Universitario, Valladolid Health Research Institute, University of Valladolid, Valladolid, Spain., Buck BH; Division of Neurology, Department of Medicine, University of Alberta, Edmonton, AB, Canada., Devlin MJ; Department of Neurology, Princess Alexandra Hospital, Brisbane, QLD, Australia., Brown H; Department of Neurology, Princess Alexandra Hospital, Brisbane, QLD, Australia., Butcher KS; School of Clinical Medicine, University of New South Wales, Sydney, NSW, Australia., O'Brien B; Gosford Hospital, Gosford, NSW, Australia., Sabet A; Gold Coast University Hospital, Southport, Queensland, Australia., Wijeratne T; Department of Medicine, University of Melbourne, Melbourne, VIC, Australia; Department of Neurology, Western Health, Sunshine Hospital, St Albans, VIC, Australia., Bivard A; Department of Medicine, University of Melbourne, Melbourne, VIC, Australia., Grimley RS; Sunshine Coast University Hospital, School of Medicine and Dentistry, Griffith University, Birtinya, QLD, Australia., Agarwal S; Department of Clinical Neurosciences, Addenbrooke's Hospital, Cambridge, UK., Munshi SK; Nottingham University Hospital NHS Trust, Nottingham, UK., Donnan GA; Melbourne Brain Centre, Department of Neurology, Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia., Davis SM; Melbourne Brain Centre, Department of Neurology, Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia., Miteff F; Hunter New England Local Health District, New Lambton Heights, NSW, Australia; Faculty of Medicine, University of Newcastle, Newcastle, NSW, Australia., Spratt NJ; Hunter New England Local Health District, New Lambton Heights, NSW, Australia; Faculty of Medicine, University of Newcastle, Newcastle, NSW, Australia., Levi CR; Hunter New England Local Health District, New Lambton Heights, NSW, Australia; Faculty of Medicine, University of Newcastle, Newcastle, NSW, Australia. |
| مؤلفون مشاركون: | TASTE investigators |
| المصدر: | The Lancet. Neurology [Lancet Neurol] 2024 Aug; Vol. 23 (8), pp. 775-786. Date of Electronic Publication: 2024 Jun 13. |
| نوع المنشور: | Journal Article; Multicenter Study; Randomized Controlled Trial; Clinical Trial, Phase III; Equivalence Trial; Comparative Study |
| اللغة: | English |
| بيانات الدورية: | Publisher: Lancet Pub. Group Country of Publication: England NLM ID: 101139309 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1474-4465 (Electronic) Linking ISSN: 14744422 NLM ISO Abbreviation: Lancet Neurol Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: London, UK ; New York, NY : Lancet Pub. Group, 2002- |
| مواضيع طبية MeSH: | Tenecteplase*/therapeutic use , Tenecteplase*/administration & dosage , Ischemic Stroke*/drug therapy , Ischemic Stroke*/diagnostic imaging , Tissue Plasminogen Activator*/therapeutic use , Tissue Plasminogen Activator*/administration & dosage , Fibrinolytic Agents*/therapeutic use , Fibrinolytic Agents*/administration & dosage , Perfusion Imaging*/methods, Humans ; Male ; Female ; Aged ; Middle Aged ; Thrombolytic Therapy/methods ; Treatment Outcome ; Aged, 80 and over |
| مستخلص: | Background: Intravenous 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. Methods: 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. Findings: 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 p Interpretation: 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. Funding: Australian National Health Medical Research Council; Boehringer Ingelheim. Competing Interests: Declaration of interests MWP is on a Boehringer-Ingelheim Advisory Board for metalyse in stroke. FCN has received grants from the National Health and Medical Research Council of Australia and the National Heart Foundation of Australia. AM participates on an advisory board for Boehringer Ingelheim and is a World Stroke Organisation board member. HSM reports grants from the British Heart Foundation, the Medical Research Council, the Alzheimer's Society, and the Stroke Association UK, and is the editor-in-chief of the World Stroke Organisation journal, International Journal of Stroke. HM has received speaking fees from the Indonesian Stroke Society and reports travel support for investigator meetings. TGP has received speaking fees from Bayer, Boehringer Ingelheim, Pfizer, and BMS. JFA reports consulting fees from Amgen, Medtronic, and BMS-Pfizer, reports speaking fees from Medtronic and BMS–Pfizer, reports travel support from Daiichi–Sankyo, participates on the advisory board for the WE-TRUST trial, and reports research grants from the Spanish Ministry of Science, the European Commission, and Astra Zeneca. RSG has received travel support from Boehringer Ingelheim. SA has received funding from the UK Stroke Clinical Research Network. KSB is in a spousal relationship with an employee of Boehringer Ingelheim and has received speaking fees from Boehringer Ingelheim and AstraZeneca. All other authors report no disclosures. (Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.) |
| فهرسة مساهمة: | Investigator: T Phan; C Selmes; K Lees; M Kaste; R MacIsaac; T Wellings; A Loiselle; E Pepper; F Miteff; V Krishnamurthy; T Ang; K Alanati; S Gangadharan; H Zareie; R Starling; S Dunkerton; J He; R Datta; A Royan; E Kerr; L Kaauwai; L Belevski; S Ormond; A Johnson; M Evans; N Lachapelle; F Ombelet; C Bladin; H Dewey; J Wong; P Park; R Cody; P Tan; E Callaly; C Senanayake; G Thomas; J Liu; T Busch; N Stuart; M Chung; N Yassi; M Valente; A Sharobeam; R Cooley; H Zhao; F Alemseged; C Williams; JL Ng; A Balabanski; A Dos Santos; J Williamson; D Pavlin-Premrl; J Beharry; M Ma; A Park; B Yan; P Hand; D Jackson; A McDonald; L Fisicchia; N Parsons; L Olenko; H Johns; P Guha; B Rokaha; N Dhimal; J Harvey; L Cagi; N Chia; R Goh; L Palanikumar; S El-Masri; J Mahadevan; C Kuranawai; M Waters; W Vallat; E Cheong; R Drew; D Cordato; A McDougall; C Cappelen-Smith; A Venkat; L Edwards; C Blair; J Thomas; J Helou; D Green; T Nguyen; T Pham; J Khan; M Miller; L Loubiere; B Buck; K Butcher; P Fairall; A Butt; H Kalashyan; A Nomani; M Lloret; S Mishra; S Thirunavukkarasu; L Sivakumar; A D'Souza; CH Tsai; B Tseng; I Tai; IH Chiang; A Kuan; V Tsai; A Hsu; S Hsu; D Alchin; E Sanjuan; J Fink; D Wilson; D Mason; A Berry-Norohna; J Winders; J Eagle; R Green; K Bremner; S Celestino; JT Lee; CH Chou; CK Tsai; YF Sung; CL Tsai; YK Lin; HW Kao; J Vuong; T Thirugnanachandran; MV Hervet; K Simmons; A Sabet; P Bailey; B Urbi; S Kurakose; N Martinez-Majander; S Räty; M Tiainen; G Sibolt; T Ivanoff; AC Sanz; EC García; MC De Lera Alfonso; MER Araque; AS Gómez; GV Peñacoba; BG Vicente; JR Muñoz; PL Muñoz Rubio; D Shah; E Harrison; C Bendall; G Subramanian; JS Jeng; SC Tang; LK Tsai; SJ Yeh; CH Chen; TC Chung; A Wong; C Muller; G Skinner; G Gunathilagan; I Natarajan; S Coutts; B Menon; C Kenney; B Clarke; R Ghatala; P Mudd; CH Chen; R Lemmens; J Demeestere; N Mahant; MC Sun |
| المشرفين على المادة: | WGD229O42W (Tenecteplase) EC 3.4.21.68 (Tissue Plasminogen Activator) 0 (Fibrinolytic Agents) |
| تواريخ الأحداث: | Date Created: 20240616 Date Completed: 20240719 Latest Revision: 20240720 |
| رمز التحديث: | 20240721 |
| DOI: | 10.1016/S1474-4422(24)00206-0 |
| PMID: | 38880118 |
| قاعدة البيانات: | MEDLINE |
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