Tenecteplase in Acute Ischemic Stroke: A Scientific Statement From the Korean Stroke Society
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Background and Purpose Tenecteplase (TNK) is a promising alternative thrombolytic agent for the treatment of acute ischemic stroke (AIS). However, its potential use is being impeded by the lack of regulatory approval and reimbursement policies for TNK in AIS in many countries, including South Korea. To address this therapeutic gap, the Korean Stroke Society developed scientific statement intended to inform policy changes and support the introduction of TNK in regions where it is not yet accessible, with the aim of enabling AIS patients to benefit from this advancement in thrombolytic therapy. Methods We reviewed randomized controlled trials (RCTs), meta-analyses, and systematic reviews published between January 2010 and November 2024 involving AIS patients treated with intravenous TNK. Meta-analyses were included if they exclusively evaluated RCTs and provided clinical evidence on the efficacy and safety of TNK. The statements were thoroughly reviewed and finalized by international expert panels after iterative revisions. Results The statements suggest that TNK at 0.25 mg/kg can be considered as an alternative to alteplase for intravenous thrombolysis within 4.5 hours of the onset of AIS. The clinical outcomes in patients with large-vessel occlusion who are candidates for endovascular thrombectomy are better for TNK at 0.25 mg/kg than for alteplase. Conclusions These statements are intended to support the adoption of TNK in countries where it is not yet available, including South Korea, by providing up-to-date clinical evidence. Their implementation may broaden the therapeutic options for AIS patients and help align acute stroke care practices with international standards.
Abstract
Background and Purpose Tenecteplase (TNK) is a promising alternative thrombolytic agent for the treatment of acute ischemic stroke (AIS). However, its potential use is being impeded by the lack of regulatory approval and reimbursement policies for TNK in AIS in many countries, including South Korea. To address this therapeutic gap, the Korean Stroke Society developed scientific statement intended to inform policy changes and support the introduction of TNK in regions where it is not yet accessible, with the aim of enabling AIS patients to benefit from this advancement in thrombolytic therapy. Methods We reviewed randomized controlled trials (RCTs), meta-analyses, and systematic reviews published between January 2010 and November 2024 involving AIS patients treated with intravenous TNK. Meta-analyses were included if they exclusively evaluated RCTs and provided clinical evidence on the efficacy and safety of TNK. The statements were thoroughly reviewed and finalized by international expert panels after iterative revisions. Results The statements suggest that TNK at 0.25 mg/kg can be considered as an alternative to alteplase for intravenous thrombolysis within 4.5 hours of the onset of AIS. The clinical outcomes in patients with large-vessel occlusion who are candidates for endovascular thrombectomy are better for TNK at 0.25 mg/kg than for alteplase. Conclusions These statements are intended to support the adoption of TNK in countries where it is not yet available, including South Korea, by providing up-to-date clinical evidence. Their implementation may broaden the therapeutic options for AIS patients and help align acute stroke care practices with international standards.