Intravenous tenecteplase non-inferior to alteplase for thrombolysis in acute ischemic stroke
1. IV tenecteplase was non-inferior to IV alteplase for treatment of acute ischemic stroke regarding the primary outcome of a mRS of 0-1 after 90-120 days post-treatment.
2. Adverse events, including intracerebral hemorrhage within 24 hours of treatment and death within 90 days, were comparable between the two drug groups.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Intravenous alteplase has been the standard of care for managing acute ischemic stroke in patients eligible for thrombolysis. The study drug, tenecteplase, is a variant of alteplase now preferred in thrombolytic treatment of acute myocardial infarction. This study aimed to determine if tenecteplase was non-inferior to alteplase for patients with acute ischemic stroke eligible for thrombolysis. Patients with acute ischemic stroke were randomized (1:1) to either IV tenecteplase bolus or IV alteplase bonus followed by an infusion. The primary outcome was measured by modified Rankin Scale at 90-120 days after treatment. In result, the study found that tenecteplase was non-inferior to alteplase based on pre-defined criteria in the treatment of acute ischemic stroke. Adverse events were also comparable between the two drugs. Limitations of this study include the challenges posed by the COVID-19 pandemic, as well as inability to record baseline mRS scores. Nevertheless, this study provides support for a potentially safer alternative to standard of care for patients requiring IV thrombolysis for acute ischemic stroke.
Click to read the study in The Lancet
In-Depth [randomized controlled trial]: The Alteplase compared to Tenecteplase (AcT) trial was a non-inferiority study comparing IV tenecteplase to alteplase in all patients with acute ischemic stroke who were eligible for IV thrombolysis. The trial was conducted in 22 centres across Canada and included all patients presenting with acute ischemic stroke who met the eligibility criteria for thrombolysis with IV alteplase based on pre-existing CSBPR 2018 guidelines. Participants were randomized 1:1 to either one-time bolus dose of 0.25 mg/kg IV tenecteplase (n = 816) or IV alteplase given as 0.09 mg/kg bolus followed by 60 min infusion (n = 784). The median age of participants was 74 years with 47.9% being female. The primary outcome was measured by modified Rankin Scale (mRS) score of 0-1 at 90-120 days after treatment via blinded assessment. In the intention-to-treat analysis, 296/802 (36.9%) of the tenecteplase group versus 266/765 (34.8%) reached the primary outcome (unadjusted risk difference 2.1% [95% CI -2.6 to 6.9]). This met the pre-defined non-inferiority criteria of the lower 95% CI being greater than -5%. Adverse events were collected for 24 hours after thrombolysis given the short half-life of the drugs. Both groups had comparable rates of intracerebral hemorrhage in 24 hours following treatment and similar rates of death within 90 days.
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