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Stroke. 2019 Jan 3:STROKEAHA118024223. doi: 10.1161/STROKEAHA.118.024223. [Epub ahead of print]

Tenecteplase Versus Alteplase Between 3 and 4.5 Hours in Low National Institutes of Health Stroke Scale.

Author information

1
From the Division of Medicine, Department of Neurology, Akershus University Hospital, Lorenskog, Norway (O.M.R., B.T).
2
Institute of Clinical Medicine, University of Oslo, Norway (O.M.R.).
3
Department of Neurosurgery, Haukeland University Hospital, Bergen, Norway (N.L.).
4
Department of Neurology, Telemark Hospital, Skien, Norway (H.T.).
5
Department of Neurology, Haukeland University Hospital, Bergen, Norway (V.N., C.E.K., H.N., U.W.-A., L.T.).
6
Institute of Clinical Medicine, University of Bergen, Norway (V.N., C.E.K., H.N., L.T.).
7
Department of Neurology, Oslo University Hospital, Norway (A.H.A.).

Abstract

Background and Purpose- Thrombolysis with alteplase has beneficial effect on outcome and is safe within 4.5 hours. The present study compares the efficacy and safety of tenecteplase and alteplase in patients treated 3 to 4.5 hours after ischemic stroke. Methods- The data are from a prespecified substudy of patients included in The NOR-TEST (Norwegian Tenecteplase Stroke Trial), a randomized control trial comparing tenecteplase with alteplase. Results- The median admission National Institutes of Health Stroke Scale for this study population was 3 (interquartile range, 2-6). In the intention-to-treat analysis, 57% of patients that received tenecteplase and 53% of patients that received alteplase reached good functional outcome (modified Rankin scale score of 0-1) at 3 months (odds ratio, 1.19; 95% CI, 0.68-2.10). The rates of intracranial hemorrhage in the first 48 hours were 5.7% in the tenecteplase group and 6.7% in the alteplase group (odds ratio, 0.84; 95% CI, 0.26-2.70). At 3 months, mortality was 5.7% and 4.5%, respectively. After excluding stroke mimics and patients with modified Rankin scale score of >1 before stroke, the proportion of patients with good functional outcome was 61% in the tenecteplase group and 57% in the alteplase group (odds ratio, 1.24; 95% CI, 0.65-2.37). Conclusions- Tenecteplase is at least as effective as alteplase to achieve a good clinical outcome in patients with mild stroke treated between 3 and 4.5 hours after ischemic stroke. Clinical Trial Registration- URL: https://www.clinicaltrials.gov . Unique identifier: NCT01949948.

KEYWORDS:

intention to treat analysis; intracranial hemorrhages; mortality; odds ratio; tenecteplase

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