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The TWIST randomized controlled trial evaluated intravenous tenecteplase in patients with wake-up ischemic stroke selected using non-contrast CT rather than advanced imaging. A total of 578 participants were randomized to tenecteplase 0.25 mg/kg, up to a maximum of 25 mg (n=288), or control treatment (n=290). The primary endpoint was functional outcome at 90 days assessed using the modified Rankin Scale. Tenecteplase did not significantly improve the 90-day distribution of functional outcomes, with an adjusted common odds ratio for a better outcome of 1.18 (95% CI, 0.88–1.58; P=0.27). Mortality at 90 days occurred in 28 participants (10%) in the tenecteplase group and 23 (8%) in the control group, with an adjusted hazard ratio of 1.29 (95% CI, 0.74–2.26; P=0.37). Symptomatic intracranial hemorrhage occurred in 6 patients (2%) receiving tenecteplase compared with 3 (1%) controls (adjusted odds ratio, 2.17; 95% CI, 0.53–8.87; P=0.28). Any intracranial hemorrhage was reported in 33 patients (11%) and 30 patients (10%), respectively (adjusted odds ratio, 1.14; 95% CI, 0.67–1.94; P=0.64). The trial did not establish a functional benefit for tenecteplase when wake-up stroke selection was based on non-contrast CT alone, and its findings should be distinguished from evidence supporting thrombolysis in patients selected using advanced imaging.
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The TWIST randomized controlled trial evaluated intravenous tenecteplase in patients with wake-up ischemic stroke selected using non-contrast CT rather than advanced imaging. A total of 578 participants were randomized to tenecteplase 0.25 mg/kg, up to a maximum of 25 mg (n=288), or control treatment (n=290). The primary endpoint was functional outcome at 90 days assessed using the modified Rankin Scale. Tenecteplase did not significantly improve the 90-day distribution of functional outcomes, with an adjusted common odds ratio for a better outcome of 1.18 (95% CI, 0.88–1.58; P=0.27). Mortality at 90 days occurred in 28 participants (10%) in the tenecteplase group and 23 (8%) in the control group, with an adjusted hazard ratio of 1.29 (95% CI, 0.74–2.26; P=0.37). Symptomatic intracranial hemorrhage occurred in 6 patients (2%) receiving tenecteplase compared with 3 (1%) controls (adjusted odds ratio, 2.17; 95% CI, 0.53–8.87; P=0.28). Any intracranial hemorrhage was reported in 33 patients (11%) and 30 patients (10%), respectively (adjusted odds ratio, 1.14; 95% CI, 0.67–1.94; P=0.64). The trial did not establish a functional benefit for tenecteplase when wake-up stroke selection was based on non-contrast CT alone, and its findings should be distinguished from evidence supporting thrombolysis in patients selected using advanced imaging.
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