Tenecteplase versus alteplase in stroke thrombolysis: an individual patient data meta-analysis of randomized controlled trials

Huang, X. et al. (2016) Tenecteplase versus alteplase in stroke thrombolysis: an individual patient data meta-analysis of randomized controlled trials. International Journal of Stroke, 11(5), pp. 534-543. (doi:10.1177/1747493016641112) (PMID:27048693)

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Abstract

Background Tenecteplase, a modified plasminogen activator with higher fibrin specificity and longer half-life, may have advantages over alteplase in acute ischemic stroke thrombolysis. Aims We undertook an individual patient data meta-analysis of randomized controlled trials that compared alteplase with tenecteplase in acute stroke. Methods Eligible studies were identified by a MEDLINE search, and individual patient data were acquired. We compared clinical outcomes including modified Rankin Scale at three months, early neurological improvement at 24 h, intracerebral hemorrhage, symptomatic intracerebral hemorrhage, and mortality at three months between all dose tiers of tenecteplase and alteplase. Results Three relevant studies (Haley et al., Parsons et al., and ATTEST) included 291 patients and investigated three doses of tenecteplase (0.1, 0.25, 0.4 mg/kg). There were no differences between any dose of tenecteplase and alteplase for either efficacy or safety end points. Tenecteplase 0.25 mg/kg had the greatest odds to achieve early neurological improvement (OR [95%CI] 3.3 [1.5, 7.2], p = 0.093), excellent functional outcome (modified Rankin Scale 0–1) at three months (OR [95%CI] 1.9 [0.8, 4.4], p = 0.28), with reduced odds of intracerebral hemorrhage (OR [95%CI] 0.6 [0.2, 1.8], P = 0.43) compared with alteplase. Only 19 patients were treated with tenecteplase 0.4 mg/kg, which showed increased odds of symptomatic intracerebral hemorrhage compared with alteplase (OR [95% CI] 6.2 [0.7, 56.3]). Conclusions While no significant differences between tenecteplase and alteplase were found, point estimates suggest potentially greater efficacy of 0.25 and 0.1 mg/kg doses with no difference in symptomatic intracerebral hemorrhage, and potentially higher symptomatic intracerebral hemorrhage risk with the 0.4 mg/kg dose. Further investigation of 0.25 mg/kg tenecteplase is warranted.

Item Type:Articles
Additional Information:Haley et al. was supported by grants (R01-NS37666 and R01-NS45170) from the National Institute of Neurological Disorders and Stroke–National Institutes of Health. Genentech, Inc. supplied study drug (both tenecteplase and alteplase) for this clinical trial but no other financial or other support. Parsons et al. was supported by a grant from the Australian National Health and Medical Research Council.
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Huang, Dr Xuya and Muir, Professor Keith and Macisaac, Dr Rachael
Authors: Huang, X., Macisaac, R., Thompson, J.L.P., Levin, B., Buchsbaum, R., Haley, E.C., Levi, C., Campbell, B., Bladin, C., Parsons, M., and Muir, K.W.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cancer Sciences
College of Medical Veterinary and Life Sciences > Institute of Neuroscience and Psychology
Journal Name:International Journal of Stroke
Publisher:Wiley
ISSN:1747-4930
ISSN (Online):1747-4949
Published Online:05 April 2016
Copyright Holders:Copyright © 2016 World Stroke Organization
First Published:First published in International Journal of Stroke 11(5):534-543
Publisher Policy:Reproduced in accordance with the copyright policy of the publisher

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