| Title: |
Tenecteplase versus alteplase for acute stroke within 4·5 h of onset (ATTEST-2): a randomised, parallel group, open-label trial |
| Authors: |
Muir, Keith; Ford, Gary A.; Ford, Ian; Wardlaw, Joanna M.; McConnachie, Alex; Greenlaw, Nicola; Mair, Grant; Sprigg, Nikola; Price, Christopher I.; MacLeod, Mary Joan; Dima, Sofia; Venter, Marius; Zhang, Liqun; O’Brien, Eoin; Sanyal, Ranjan; Reid, John; Sztriha, Laszlo K.; Haider, Syed; Whiteley, William N.; Kennedy, James; Perry, Richard; Marigold, Richard; Raghunathan, Senthil; Sims, Don; Bhandari, Mohit; Wiggam, Ivan; Rashed, Khalid; Douglass, Chris |
| Publisher Information: |
The Lancet Publishing Group |
| Publication Year: |
2024 |
| Collection: |
University of Glasgow: Enlighten - Publications |
| Description: |
Background: Tenecteplase has potential benefits over alteplase, the standard agent for intravenous thrombolysis in acute ischaemic stroke, because it is administered as a single bolus and might have superior efficacy. The ATTEST-2 trial investigated whether tenecteplase was non-inferior or superior to alteplase within 4·5 h of onset. Methods: We undertook a prospective, randomised, parallel-group, open-label trial with masked endpoint evaluation in 39 UK stroke centres. Previously independent adults with acute ischaemic stroke, eligible for intravenous thrombolysis less than 4·5 h from last known well, were randomly assigned 1:1 to receive intravenous alteplase 0·9 mg/kg or tenecteplase 0·25 mg/kg, by use of a telephone-based interactive voice response system. The primary endpoint was the distribution of the day 90 modified Rankin Scale (mRS) score and was analysed using ordinal logistic regression in the modified intention-to-treat population. We tested the primary outcome for non-inferiority (odds ratio for tenecteplase vs alteplase non-inferiority limit of 0·75), and for superiority if non-inferiority was confirmed. Safety outcomes were mortality, symptomatic intracranial haemorrhage, radiological intracranial haemorrhage, and major extracranial bleeding. The trial was prospectively registered on ClinicalTrials.gov (NCT02814409). Findings: Between Jan 25, 2017, and May 30, 2023, 1858 patients were randomly assigned to a treatment group, of whom 1777 received thrombolytic treatment and were included in the modified intention-to-treat population (n=885 allocated tenecteplase and n=892 allocated alteplase). The mean age of participants was 70·4 (SD 12·9) years and median National Institutes of Health Stroke Scale was 7 (IQR 5–13) at baseline. Tenecteplase was non-inferior to alteplase for mRS score distribution at 90 days, but was not superior (odds ratio 1·07; 95% CI 0·90–1·27; p value for non-inferiority |
| Document Type: |
article in journal/newspaper |
| File Description: |
text |
| Language: |
English |
| Relation: |
https://eprints.gla.ac.uk/339583/1/339583.pdf; Muir, K. et al. (2024) Tenecteplase versus alteplase for acute stroke within 4·5 h of onset (ATTEST-2): a randomised, parallel group, open-label trial. Lancet Neurology , 23(11), pp. 1087-1096. (doi:10.1016/S1474-4422(24)00377-6 ) |
| Availability: |
https://eprints.gla.ac.uk/339583/; https://eprints.gla.ac.uk/339583/1/339583.pdf |
| Rights: |
cc_by_4 |
| Accession Number: |
edsbas.241BC577 |
| Database: |
BASE |