Objective:

To assess real-world outcomes in patients with acute ischemic stroke (AIS) treated with tenecteplase versus alteplase

Background:

Clinical trials and recent FDA approval have led to increasing use of tenecteplase in place of alteplase for treatment of AIS. Comparisons of outcomes in real-world settings remain ongoing.

Design/Methods:

This retrospective study included adults (aged ≥18 years) with AIS admitted to a US comprehensive stroke center: 63 received alteplase (01/05/2021-11/10/2023) and 47 received tenecteplase (03/18/2022-03/31/2024). Pearson chi-square tests were used to compare demographics, anti-coagulant use, stroke severity (NIHSS ≤5), stroke subtype, and intraarterial thrombectomy (IAT) following thrombolytic administration. Primary outcomes included functional independence at discharge (mRS 0-2), 90-day mortality, and intracerebral hemorrhage (ICH) illustrated on MRI. Successful reperfusion (TICI scores 2B, 2C, or 3) was assessed in patients who received IAT. Adjusted logistic regression models were used to assess the associations between tenecteplase and primary outcomes.

Results:

Among 110 patients (median age 70.5 years, 52.7% Male, 63.6% White) treated with either thrombolytic, demographics and anti-coagulant use were similar. Likewise, no differences were observed in stroke severity or subtype yet more patients given tenecteplase also received IAT (48.9% vs 25.4%; p=0.01) compared to patients given alteplase. In unadjusted analyses, there were no differences between patients given tenecteplase or alteplase in functional independence at discharge (43.5% vs 37.7%; p=0.55), 90-day mortality (13.6% vs 17.0%; p=0.65), ICH (10.6% vs 23.8%; p=0.08), or successful reperfusion (82.6% vs 87.5%; p=0.68). In models adjusted for IAT, the association between tenecteplase and ICH approached significance (OR: 0.29 [95% CI: 0.08-1.03]; p = 0.05).

Conclusions:

These findings support non-inferiority of tenecteplase compared to alteplase for patients admitted for AIS with a potential reduction in hemorrhagic risk. The recent FDA approval of tenecteplase for AIS underscores the importance of this research and supports our continued efforts to extend this investigation to a larger, matched sample.