1. A similar proportion of patients in the alteplase group reported a modified Rankin Scale score of 0-1 compared to patients in the tenecteplase group.
2. The incidence of symptomatic intracranial hemorrhage was comparable in both groups.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Current guidelines suggest the use of intravenous alteplase in patients with acute ischemic stroke. Tenecteplase is a known thrombolytic that is easier to administer and has practical advantages compared to alteplase. However, little is known about its use in ischemic stroke patients and efficacy compared to alteplase. This randomized controlled trial aimed to assess the non-inferiority of tenecteplase versus alteplase in patients with acute ischemic stroke undergoing intravenous thrombolysis. The primary efficacy outcome was the proportion of patients with a modified Rankin Scale (mRS) score of 0-1 at 90 days while the primary safety outcome was symptomatic intracranial hemorrhage within 36 hours of presentation. According to study results, tenecteplase was non-inferior to alteplase for long-term clinical outcomes in patients with acute ischemic stroke. Furthermore, the risk of symptomatic intracranial bleeding was similar between groups. This study was strengthened by a randomized design with representation of patients from different age groups, thus increasing its validity.
Click to read the study in The Lancet
Relevant Reading: A Randomized Trial of Intravenous Alteplase before Endovascular Treatment for Stroke
In-depth [randomized-controlled trial]: Between Jun 12, 2021, and May 29, 2022, 1434 patients were assessed for eligibility across 53 centres in China. Included were patients with an acute ischemic stroke undergoing intravenous thrombolysis with a modified Rankin Scale score of 0-1 and a National Institutes of Health Stroke Scale (NIHSS) score of 5-25. Altogether, 1313 patients (671 in tenecteplase and 642 in alteplase) were included in the per-protocol analysis. With regards to the primary efficacy outcome, the non-inferiority criteria was met with numerically more patients in the tenecteplase group reporting an mRS score of 0-1 within 90 days compared to the alteplase group (62% vs. 58%, relative risk [RR] 1.07, 95% confidence interval [CI] 0.98-1.16). In addition, symptomatic intracranial hemorrhage was comparable between both groups (2% each, RR 1.18, 95% CI 0.56-2.50). Patients in the tenecteplase group reported a greater incidence of 90-day mortality versus alteplase (7% vs. 5%, RR 1.31, 95% CI 0.86-2.01). Findings from this study suggest non-inferiority between tenecteplase and alteplase.
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