Andrew Bivard1, Xuya Huang2, Christopher R Levi2, Neil Spratt2, Bruce C V Campbell2, Bharath Kumar Cheripelli2, Dheeraj Kalladka2, Fiona Catherine Moreton2, Ian Ford2, Christopher F Bladin2, Stephen M Davis2, Geoffrey A Donnan2, Keith W Muir2, Mark W Parsons2. 1. From the Department of Neurology (A.B., C.R.L., N.S., M.W.P.), John Hunter Hospital, University of Newcastle, Australia; Institute of Neuroscience and Psychology, Queen Elizabeth University Hospital (X.H., B.K.C., D.K., F.C.M., I.F., K.W.M.), and Robertson Centre for Biostatistics (I.F.), University of Glasgow, UK; Department of Medicine and Neurology, Royal Melbourne Hospital (B.C.V.C., S.M.D.), and The Florey Institute of Neuroscience & Mental Health (C.F.B., G.A.D.), University of Melbourne, Parkville; and the Department of Neurology (C.F.B.), Eastern Health Clinical School, Monash University, Clayton, Australia. Andrew.bivard@newcastle.edu.au. 2. From the Department of Neurology (A.B., C.R.L., N.S., M.W.P.), John Hunter Hospital, University of Newcastle, Australia; Institute of Neuroscience and Psychology, Queen Elizabeth University Hospital (X.H., B.K.C., D.K., F.C.M., I.F., K.W.M.), and Robertson Centre for Biostatistics (I.F.), University of Glasgow, UK; Department of Medicine and Neurology, Royal Melbourne Hospital (B.C.V.C., S.M.D.), and The Florey Institute of Neuroscience & Mental Health (C.F.B., G.A.D.), University of Melbourne, Parkville; and the Department of Neurology (C.F.B.), Eastern Health Clinical School, Monash University, Clayton, Australia.
Abstract
OBJECTIVE: To test whether patients with complete vessel occlusion show greater recanalization at 24 hours and have improved clinical outcomes at 24 hours and 90 days when treated with tenecteplase compared to alteplase. METHODS: Pooled clinical and imaging data from 2 phase 2 randomized trials comparing tenecteplase with alteplase allowed CT angiography (CTA) scans to be assessed centrally for occlusion status at baseline and at 24 hours post thrombolysis using the modified thrombolysis in cerebral infarction (TICI) scale. Twenty-four-hour poststroke NIH Stroke Scale (NIHSS) and90-day modified Rankin Scale (mRS) scores were also compared between treatment groups using linear regression to generate odds ratios (ORs). RESULTS: From 146 pooled patients, 69 had a TICI 0/1 occlusion overall at baseline. Tenecteplase-treated patients with a complete vessel occlusion had greater complete recanalization rates at 24 hours (71% for tenecteplase vs 43% for alteplase, p < 0.001). Patients with a TICI 0/1 occlusion who were treated with tenecteplase also showed greater early clinical improvement (median NIHSS change with tenecteplase was 9, interquartile range [IQR] 6, alteplase 1, IQR 1, p = 0.001) and higher rates of favorable 90-day outcomes (mRS 0-1 of tenecteplase compared with alteplase, OR 4.82, 95% confidence interval 1.02-7.84, p = 0.05). CONCLUSIONS: Tenecteplase may offer greater recanalization efficacy compared to alteplase, possibly exaggerated in patients with complete vessel occlusions on baseline CTA.
RCT Entities:
OBJECTIVE: To test whether patients with complete vessel occlusion show greater recanalization at 24 hours and have improved clinical outcomes at 24 hours and 90 days when treated with tenecteplase compared to alteplase. METHODS: Pooled clinical and imaging data from 2 phase 2 randomized trials comparing tenecteplase with alteplase allowed CT angiography (CTA) scans to be assessed centrally for occlusion status at baseline and at 24 hours post thrombolysis using the modified thrombolysis in cerebral infarction (TICI) scale. Twenty-four-hour poststroke NIH Stroke Scale (NIHSS) and 90-day modified Rankin Scale (mRS) scores were also compared between treatment groups using linear regression to generate odds ratios (ORs). RESULTS: From 146 pooled patients, 69 had a TICI 0/1 occlusion overall at baseline. Tenecteplase-treated patients with a complete vessel occlusion had greater complete recanalization rates at 24 hours (71% for tenecteplase vs 43% for alteplase, p < 0.001). Patients with a TICI 0/1 occlusion who were treated with tenecteplase also showed greater early clinical improvement (median NIHSS change with tenecteplase was 9, interquartile range [IQR] 6, alteplase 1, IQR 1, p = 0.001) and higher rates of favorable 90-day outcomes (mRS 0-1 of tenecteplase compared with alteplase, OR 4.82, 95% confidence interval 1.02-7.84, p = 0.05). CONCLUSIONS: Tenecteplase may offer greater recanalization efficacy compared to alteplase, possibly exaggerated in patients with complete vessel occlusions on baseline CTA.
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