Clinical outcomes and safety profile of Tenecteplase in wake‐up stroke

Abstract

Background: Tenecteplase has probably pharmacological and clinical advantages in the treatment of acute ischemic stroke. There are lacking data about safety and efficacy of tenecteplase in wake-up stroke (WUPS). Aims: To investigate safety and efficacy of tenecteplase compared to alteplase in WUPS patients included in NOR-TEST. Methods: WUPS patients in NOR-TEST were included in the study based on DWI-FLAIR mismatch. Included patients randomly assigned (1:1) to receive intravenous tenecteplase 0.4 mg/kg (to a maximum of 40 mg) or alteplase 0.9 mg/kg (to a maximum of 90 mg). Neurological improvement was defined as 1) favorable functional outcome at 90 days modified Rankin Scale (mRS) of 0 or 1 and 2) neurological improvement measured with the National Institutes of Health Stroke Scale (NIHSS) of 4 points within 24 hours as compared to admission NIHSS or NIHSS 0 at 24 hours. Results: Of 1100 patients from 13 stroke centers included in NOR-TEST, 45 were WUPS patients. Of these, 5 patients were stroke mimics and excluded. Of the remaining 40 patients (3.6%), 24 were treated with alteplase (60%). There was no difference in the number of patients achieving a good clinical outcome (mRS 0-1) in either treatment group. Patients treated with tenecteplase showed a better early neurological improvement (87.5% vs 54.2%, P = 0.027). No ICH was detected on MRI/CT 24-28 hours after thrombolysis. Conclusions: In WUPS patients treated in NOR-TEST, there was no difference in clinical outcomes at 90 days and no ICH events or deaths were observed in either alteplase-or tenecteplase-treated patients.

Safety and efficacy of intravenous thrombolytic treatment in wake‐up stroke: Experiences from a single center

“…A study by Ahmed et al (2020) that compared tenecteplase to alteplase for wake-up stroke thrombolysis showed no significant difference in the favorable outcomes after three months and safety In terms of safety and effectiveness, the results obtained in this study were consistent with other reports on this topic. However, in most cases, the current diagnostic and treatment guidelines were followed.…”

“…However, despite the updated guidelines and increasingly common diagnostic options in neuroimaging, including perfusion and diffusion neuroimaging (Fink et al, 2002), there are still little data on the safety and efficacy of intravenous alteplase or mechanical thrombectomy in wake-up stroke. Ahmed et al (2020) demonstrated that most patients (65.2%) who were treated using a wake-up protocol that included alteplase and that was based on DWI/FLAIR mismatch exhibited a favorable functional outcomes 90 days after thrombolysis (mRs score = 0-1). A study by Aoki et al (2011) that was based on DWI/FLAIR mismatch found no incidence of symptomatic hemorrhage and a moderate rate (40%) of asymptomatic hemorrhage among patients with wake-up strokes who were treated with alteplase.…”

Tenecteplase in Ischemic Stroke: Challenge and Opportunity

“…A subgroup analysis 35 of the NOR-TEST trial 16 showed that among patients with DWI-fluid attenuated inversion recovery (FLAIR) mismatch, those in the 0.4 mg/kg TNK group had greater early neurological improvement than patients in the alteplase group (NIHSS reduction≥4: 87.5% vs 54.2%, P=0.027). However, selection bias cannot be neglected for the small sample size and low baseline NIHSS score in this subgroup study.…”

Multicentre registration of wake-up stroke in China (MCRWUSC): a protocol for a prospective, multicentre, registry-based cohort study

“…23 However, numerous investigations have demonstrated no substantial difference in clinical severity or outcomes between WUS and stroke with known onset time, implying the feasibility of reperfusion therapy for patients who had a WUS. [24][25][26] Considering afore-mentioned literatures, there is still some debate about whether or not to treat patients who had a WUS with recanalisation therapy. As a result, further research is needed to validate the feasibility of recanalisation therapy for patients with WUS.…”

“…Patients with WUS had a greater likelihood of experiencing adverse outcomes and had a substantial effect on the modified Rankin Scale (mRS) Score increasing functional dependence 23. However, numerous investigations have demonstrated no substantial difference in clinical severity or outcomes between WUS and stroke with known onset time, implying the feasibility of reperfusion therapy for patients who had a WUS 24–26. Considering afore-mentioned literatures, there is still some debate about whether or not to treat patients who had a WUS with recanalisation therapy.…”