Safety and Outcomes of Tenecteplase in Moderate and Severe Ischemic Stroke.

Authors:
Christopher Elnan Kvistad
Christopher Elnan Kvistad
Haukeland University Hospital
Norway
Vojtech Novotny
Vojtech Novotny
University of South Bohemia
Czech Republic
Martin Wilhelm Kurz
Martin Wilhelm Kurz
Stavanger University Hospital
Norway
Bente Thommessen
Bente Thommessen
Akershus University Hospital
Norway
Maria Carlsson
Maria Carlsson
Uppsala University
Sweden

Stroke 2019 May;50(5):1279-1281

Department of Neurosurgery (N.L.), Haukeland University Hospital, Bergen, Norway.

Background and Purpose- Tenecteplase represents a promising alternative to alteplase as thrombolytic treatment in acute ischemic stroke. There are limited data on tenecteplase 0.4 mg/kg in patients with increased stroke severity. We aimed to assess safety and efficacy of tenecteplase 0.4 mg/kg in patients with moderate and severe ischemic stroke. Methods- NOR-TEST (Norwegian Tenecteplase Stroke Trial) was a phase III trial designed to investigate the safety and efficacy of tenecteplase 0.4 mg/kg versus alteplase 0.9 mg/kg in ischemic stroke. In this post hoc analysis, moderate stroke was defined as admission National Institutes of Health Stroke Scale; 6 to 14 and severe stroke as National Institutes of Health Stroke Scale; ≥15. Rates of favorable outcome at 90 days, symptomatic intracerebral hemorrhage (sICH), and mortality after 7 and 90 days were assessed. Results- In patients with moderate stroke (n=261), there were no differences in rates of favorable outcome, sICH, or mortality between tenecteplase and alteplase. In patients with severe stroke (n=87), there were no differences in outcome, frequency of sICH, or mortality at 7 days, but all-cause mortality at 90 days was increased in patients treated with tenecteplase (10 [26.3%] versus 4 [9.1%]; P=0.045). One patient died of sICH in the tenecteplase group, and 2 patients died of sICH in the alteplase group. Conclusions- Rates of favorable outcome and sICH were similar between treatment groups in patients with moderate and severe stroke. Mortality after 90 days was increased in patients with severe stroke receiving tenecteplase. Future studies assessing tenecteplase 0.4 mg/kg should monitor safety parameters closely in patients with severe stroke. Clinical Trial Registration- URL: https://www.clinicaltrials.gov . Unique identifier: NCT01949948.

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http://dx.doi.org/10.1161/STROKEAHA.119.025041DOI Listing
May 2019
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