January 13, 2023
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Disclosure: Roaldsen reports receiving a grant from the Norwegian National Public Health Association. See research for relevant financial disclosures of all other authors.
According to a study published in , treatment with IV tenecteplase was not associated with improved functional outcomes after 90 days in wake-up stroke patients selected using advanced imaging. of lancet neurology.
“Treatment with intravenous alteplase is currently recommended in clinical guidelines for conscious stroke patients. [diffusion-weighted imaging-fluid-attenuated inversion recovery] CT or magnetic resonance perfusion mismatch or perfusion mismatch” Melinda B. RoarsenMD, Written by PhDs, Department of Clinical Research, Northern Norway University Hospital. “Limited access to MRI and perfusion imaging in emergencies may prevent patients with awake stroke from receiving reperfusion therapy.”
Researchers sought to assess whether thrombolytic therapy with intravenous tenecteplase improves functional outcomes in selected morning stroke patients using non-enhanced CT scans.
They conducted a multicenter, open-label, randomized controlled trial with blinded endpoint assessment conducted at 77 hospitals in 10 countries (Denmark, Estonia, Finland, Latvia, Lithuania, New Zealand, Norway, Sweden, Switzerland, United Kingdom). have started.
Eligible adults have acute ischemic stroke symptoms on awakening, limb weakness, National Institutes of Health Stroke Scale (NIHSS) score ≥3 or aphasia, non-contrast cranial CT scan, and undergoing tenecteplase within 4-5 days diagnosed as competent. waking hours.
A total of 578 individuals (median age, 73.7 years, 57% male) were randomized on a 1:1 basis to receive a single bolus dose of 0.25 mg/kg body weight (maximum 25 mg) of IV tenecteplase. , and without thrombolytic therapy. Patient assessments were performed at baseline and 1 week after admission or at discharge, whichever came first.
The primary data point was functional outcome measured by the modified Rankin scale (mRS) at 90 days and analyzed using ordinal logistic regression in the intention-to-treat population.
Results showed that tenecteplase treatment was not associated with better functional outcome according to the mRS score after 90 days (adjusted OR = 1.18; 95% CI, 0.88–1.58). Symptomatic intracranial hemorrhage occurred in 6 patients in the tenecteplase group and 3 him in the control group (aOR = 2.17; 95% CI, 0.53–8.87). On the other hand, intracranial hemorrhage was reported in 33 patients in the tenecteplase group and his 30 control patients. (aOR = 1.14; 95% CI, 0.67-1.94). The investigator also reported that there was no significant difference in he 90-day mortality between the treatment and control groups (28 vs. 23 patients, respectively; adjusted HR = 1.29; 95% CI 0.74 -2.26).
“Current evidence does not support treatment with tenecteplase in selected patients on non-enhanced CT,” write Roaldsen and colleagues.