Efficacy of Tenecteplase in Large Vessel Occlusion Stroke Within 24 Hours of Symptom Onset: The ETERNAL-LVO Randomized Controlled Trial

作者：Vignan Yogendrakumar, Bruce C.V. Campbell, Leonid P. Churilov, Carlos García-Esperón, Philip M. C. Choi, Dennis John Cordato, Niruta Dhimal, Liudmyla Olenko, Prodipta Guha, Gagan Sharma, Chushuang Chen, Amy D. McDonald, Vincent Thijs, Abul Mamun, Angela Dos Santos, Anna H Balabanski, Timothy John Kleinig, Kenneth Butcher, Michael J. Devlin, Fintan O’Rourke, Geoffrey Alan Donnan, Stephen M. Davis, Christopher Royce Levi, Henry Ma, Mark William Parsons, Nawaf Yassi, Bernard Yan, Michael A. Valente, Henry H. Zhao, Angelos Sharobeam, Laura Fisicchia, David M. Jackson, Peter John Mitchell, Richard Dowling, Hannah Tabitha Johns, Birendra Rokaha, Andrew Bivard, Ashley H. Park, Margaret Ma, Presaad Pillai, James Beharry, Helen Margaret Dewey, Tessa Busch, M.F. Chung, Narelle Stuart, Peter Park, Branko Borojevic, Joseph K. Wong, Channa Senanayake, Oneil G. Bhalala, Karen A. Robinson, Bailey McNamara, Edward Callaly, Tanya Frost, Karen Stephens, Pakeeran Siriratnam, Ross Cody, Tharani Chandran, Chris Linton, Nathaniel Lizak, Shelton Leung, Peter P. C. Tan, Dennis J. Young, Felix Ng, Gayleen Chappell, Thanh G. Phan, Marie Veronic Hervet, Carol Bendall, Jennifer Cranefield, Roy Drew, Neil James Spratt, Beng Ghee Lim, Alvin Chew, Michelle Russell, Shu Ping Ren, Julie Hennessy, Leon Stephen Edwards, Christopher A. Blair, Timmy Pham, Jasmeen Khan, Longting Lin, Rumbidzai Teramayi · 发表于：Stroke · 年份：2025 · DOI：10.1161/strokeaha.125.052511 · 被引用次数：11 · 研究领域：Acute Ischemic Stroke Management、Stroke Rehabilitation and Recovery、Intracerebral and Subarachnoid Hemorrhage Research

BACKGROUND: To assess the efficacy and safety of tenecteplase in patients presenting within 24 hours of symptom onset with a large vessel occlusion and target mismatch on perfusion computed tomography. METHODS: ETERNAL-LVO (Extending the Time Window for Tenecteplase by Effective Reperfusion in Patients With Large Vessel Occlusion) was a prospective, randomized, open-label, blinded end point, phase 3, superiority trial where adult participants with a large vessel occlusion, presenting within 24 hours of onset with salvageable tissue on computed tomography perfusion, were randomized to tenecteplase 0.25 mg/kg or standard care across 11 primary and comprehensive stroke centers in Australia. The primary outcome was the modified Rankin Scale score of 0 to 1 or return to baseline at 90 days via a modified Poisson regression model. Secondary outcomes include the modified Rankin Scale, considered as an ordinal variable, and symptomatic intracerebral hemorrhage. RESULTS: Following trial initiation, a supply shortage of the investigational product hindered recruitment. When supply resumed, phase 3 evidence had emerged supporting tenecteplase use within 4.5 hours of stroke onset, including large vessel occlusion. ETERNAL-LVO was, therefore, terminated early. Two hundred forty-two participants (median age: 73 years, 43% female, 79% undergoing EVT) were included in the modified intention-to-treat analysis; 120 received tenecteplase and 122 received standard care. No difference in the prim...