Intravenous tenecteplase non-inferior to alteplase for thrombolysis in acute ischemic stroke

1. IV tenecteplase was not inferior to IV alteplase for the treatment of acute ischemic stroke with respect to the primary outcome of an mRS of 0-1 90-120 days after treatment.

2. Adverse reactions, including intracerebral haemorrhage within 24 hours of treatment and death within 90 days, were comparable between the two drug groups.

Evidence Rating Level: 1 (Excellent)

Study overview: Intravenous alteplase has been the standard of care for the management of acute ischemic stroke in patients eligible for thrombolysis. The investigational drug, tenecteplase, is a now preferred variant of alteplase in thrombolytic treatment of acute myocardial infarction. This study was designed to determine whether tenecteplase was non-inferior to alteplase for patients with acute ischemic stroke who were candidates for thrombolysis. Patients with acute ischemic stroke were randomized (1:1) to either IV tenecteplase bolus or IV alteplase bonus followed by infusion. The primary outcome measure was measured 90-120 days after treatment using the modified Rankin scale. As a result, the study found that tenecteplase was non-inferior to alteplase based on predefined criteria in the treatment of acute ischemic stroke. Side effects were also similar between the two drugs. Limitations of this study include the challenges of the COVID-19 pandemic, as well as the inability to capture baseline mRS scores. Nevertheless, this study provides support for a potentially safer alternative to standard care for patients requiring IV thrombolysis for acute ischemic stroke.

Click to read the study in The Lancet

Relevant Literature: Canadian Stroke Best Practice Recommendations for Acute Stroke Management: Prehospital, Emergency Department, and Acute Inpatient Stroke Care, 6th Edition, Update 2018

in-depth [randomized controlled trial]: The Alteplase compared to Tenecteplase (AcT) study was a non-inferiority study comparing IV tenecteplase to alteplase in all acute ischemic stroke patients eligible for IV thrombolysis. The study was conducted at 22 centers across Canada and included all patients with acute ischemic stroke who met eligibility criteria for thrombolysis with IV alteplase based on pre-existing CSBPR 2018 guidelines. Participants were randomized 1:1 to either a 0.25 mg/kg single bolus dose of IV tenecteplase (n = 816) or IV alteplase given as a 0.09 mg/kg bolus followed by a 60-minute infusion (n = 784). The median age of the participants was 74 years and 47.9% were female. The primary outcome measure was measured by a modified Rankin Scale (mRS) score from 0-1 90-120 days post-treatment via blinded assessment. In the intention-to-treat analysis, 296/802 (36.9%) of the tenecteplase group versus 266/765 (34.8%) achieved the primary outcome (unadjusted risk difference 2.1% [95% CI -2.6 to 6.9]). This met the predefined non-inferiority criteria with the lower 95% CI being greater than -5%. Adverse reactions were collected during 24 hours after thrombolysis due to the short half-life of the drugs. Both groups had similar rates of intracerebral bleeding within 24 hours of treatment and similar rates of death within 90 days.

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