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The following is a summary of “Tenecteplase versus alteplase for acute stroke within 4·5 h of onset (ATTEST-2): a randomised, parallel group, open-label trial,” published in the November 2024 issue of Neurology by Muir et al.
Researchers conducted a prospective study to assess whether tenecteplase is non-inferior or superior to alteplase in treating acute ischemic stroke within 4.5 hours of symptom onset.
They involved 39 United Kingdom (UK) stroke centers, adults with acute ischemic stroke, eligible for intravenous thrombolysis within 4.5 hours from last known well, were randomly assigned 1:1 to receive alteplase (0.9 mg/kg) or tenecteplase (0.25 mg/kg). The primary endpoint was the modified Rankin Scale (mRS) score distribution at 90 days, analyzed using ordinal logistic regression in the modified intention-to-treat (mITT) population. Non-inferiority was tested with a limit of 0.75 (OR for tenecteplase vs. alteplase) and superiority if non-inferiority was confirmed.
The results showed that tenecteplase was non-inferior to alteplase for mRS score distribution at 90 days but not superior (OR 1.07; 95% CI 0.90–1.27; P-value for non-inferiority <0.0001; P=0.43 for superiority). Mortality occurred in 68 (8%) of patients in the tenecteplase group and 75 (8%) in the alteplase group. Symptomatic intracranial hemorrhage (SICH) occurred in 20 (2%) vs. 15 (2%) patients, parenchymal hematoma type 2 in 37 (4%) vs. 26 (3%) patients, and post-treatment intracranial bleeding in 94 (11%) vs. 78 (9%) patients. Significant extracranial hemorrhage occurred in 13 (1%) vs. 6 (1%) patients, and angioedema occurred in 6 (1%) of both groups.
They concluded that tenecteplase (0.25 mg/kg) was non-inferior to alteplase (0.9 mg/kg) for acute ischemic stroke within 4.5 hours, and easier administration makes this a preferred option.
Source: thelancet.com/journals/laneur/article/PIIS1474-4422(24)00377-6/fulltext