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Tenecteplase Suitable for Patients With Acute Ischemic Stroke
In patients with acute ischemic stroke eligible for intravenous thrombolysis within 4.5 hours of symptom onset, tenecteplase was noninferior to alteplase for achieving an excellent functional outcome at day 90, according to study findings published in JAMA.
“Tenecteplase is a bioengineered variant of alteplase with greater fibrin specificity and a longer half-life, allowing single-bolus administration,” wrote corresponding author Yongjun Wang, MD, of the China National Clinical Research Center for Neurological Diseases, Beijing, China, and study coauthors.
The ORIGINAL randomized trial investigated tenecteplase and alteplase in 1465 patients from 55 neurology clinics and stroke centers in China. Patients had acute ischemic stroke with measurable neurologic deficit and were symptomatic for at least 30 minutes without significant improvement. Within 4.5 hours of symptom onset, 732 patients were randomized to receive intravenous tenecteplase (0.25 mg/kg) and 733 were randomized to receive intravenous alteplase (0.9 mg/kg).
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The median age of patients in the study was 66.0 years, and 30.4% were female. Just over half received treatment within 3 hours after onset of stroke symptoms.
According to the study, 72.7% of patients who received tenecteplase achieved the primary outcome of a modified Rankin Scale score of 0 or 1, reflecting no symptoms or no significant disability, at day 90 compared with 70.3% of patients who received alteplase. Meanwhile, the proportion of patients with a score of 0 to 2 at day 90 was 80.9% with tenecteplase and 79.9% with alteplase.
Regarding the safety end points, the rate of symptomatic intracerebral hemorrhage was 1.2% with both tenecteplase and alteplase (9 patients in each group experienced the event). The rate of 90-day mortality was 4.6% in the tenecteplase group and 5.8% in the alteplase group.
“Findings from this study support tenecteplase as a suitable alternative to alteplase for patients with acute ischemic stroke eligible for thrombolysis,” researchers advised.
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