Thrombolysis With Tenecteplase for Minor Disabling Stroke

Importance: Outcomes following intravenous thrombolysis for minor ischemic stroke may vary based on the presence of disabling deficits. Objective: To determine whether intravenous tenecteplase improves outcomes according to US National Institutes of Health Stroke Scale (NIHSS) score–based definitions of pretreatment disabling deficits. Design, Setting, and Participants: This is a secondary analysis of the TEMPO-2 (Tenecteplase vs Standard of Care for Minor Ischemic Stroke With Proven Occlusion) randomized clinical trial, conducted between April 27, 2015, and January 19, 2024. Patients were followed up for 90 days. The TEMPO-2 trial was conducted across 48 sites globally among patients with minor ischemic stroke (NIHSS 0-5) and proven intracranial occlusion within 12 hours of onset. Patients were divided into having nondisabling vs disabling syndromes at presentation as per the TREAT Task Force consensus. Other established definitions of disabling stroke from the ARAMIS trial and the National Institute of Neurological Disorders and Stroke trial were explored. Data analysis was completed from July 2024 to September 2024. Interventions: Intravenous tenecteplase (0.25 mg/kg) vs nonthrombolytic standard of care. Main Outcomes and Measures: The primary outcome was a return to baseline modified Rankin scale score at 90 days. Results: Among 886 enrolled patients, 2 withdrew consent and 884 were included in the secondary analysis. Among 884 patients analyzed (369 women [41.7%]; median [IQR] age, 72 [61-80] years), 100 (11.3%) had disabling and 784 (88.7%) had nondisabling deficits. Patients with disabling deficits had higher median (IQR) baseline NIHSS scores (4 [3-5] vs 2 [1-3]), later presentations (onset to hospital arrival time: 288 [153-412] minutes vs 133 [70-310] minutes), and longer onset to treatment time (411 [307-560] minutes vs 278 [170-462] minutes) than those with nondisabling deficits. In the disabling group, the primary outcome following tenecteplase, compared with standard of care, occurred in 29 patients (54.7%) vs 32 patients (68.1%) (adjusted risk ratio [aRR], 0.81; 95% CI, 0.60-1.10). This neutral treatment effect was consistent in patients without disabling deficits (280 [73.9%] vs 306 [75.6%]; aRR, 0.98; 95% CI, 0.91-1.07; P for interaction = .32). Conclusions and Relevance: In this secondary analysis of the TEMPO-2 randomized clinical trial, current definitions of disabling symptoms based on NIHSS score at baseline did not modify the neutral treatment effect of intravenous tenecteplase in patients with minor stroke and intracranial occlusion. Together with converging evidence comparing intravenous thrombolysis to nonthrombolytic standard of care, this analysis suggests the need to reevaluate thrombolysis in minor disabling stroke.

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UCL Discovery (University College London)
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2025-10-27
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Acute Ischemic Stroke Management
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article

Thrombolysis With Tenecteplase for Minor Disabling Stroke

N H Day, M. Garcia Lloret, Mohammed A. Alskaini, A. Noura Ghafan Sultan et al.
UCL Discovery (University College London)
Acute Ischemic Stroke Management
article

Thrombolysis With Tenecteplase for Minor Disabling Stroke

N H Day, M. Garcia Lloret, Mohammed A. Alskaini, A. Noura Ghafan Sultan, Kenny C. Li, Matheus Bernardon Morillos, Darshan Ghia, Natalia Murray, Lauren M. Quinn, Lissa Peeling, Sheila Mashate, Ward Kl, Thaís Secchi, TL Taylor, J. Brian de Souza, Lucy Fleming, Anas Alrohimi, Piyush Ojha, Amy YX Yu, Alexander Khaw, Gabriel Pereira Modolo, G. J. S. Hunter, Richard Perry, Dr Akshay Deepak, Carol E. Kenney, Mowad Benguzzi, Kim Hatherley, W. G. J. Smith, Janice M. Williams, Haylee Berrill, Rita Ghatala, MacKenzie Horn, Elizabeth Hayter, S. McMillan, Susan B. Roberts, Jennifer L. Mandzia, Rupal Shah, Oishik Raha, Gail M. Wilkes, Camille Hutchinson, Raúl Fuentes, John Williamson, Sue McMillan, Elizabeth Pepper, Roy Drew, G. Valle Peñacoba, Nathan Pavey, Carol Huilian Tham, Lídia Segura, Shorog Althubait, James Beharry, Michael Kwan, Carolina Oldoni, Ariane Mackey, Christine Cabrera, Aravind Ganesh, Anne Marie Liddy, Millene Rodrigues Camilo, Felix Ng, Edward Littleton, Juline Jabs, C. Clark, Mónica Recamán, Rachel Siew, Sucharita Ray, Brunna Pileggi Rimoli, F Akthar, Marc F. Österdahl, Chris Brown, J Vieira, Sheila Cristina Ouriques Martins, Jackson D. Harvey, Mohamed Sayed, Emma Harrison, Edith Bardi, Jeethu K. Joseph, Biji Joseph, N. Spratt, Cheryl Rapier, Jennifer Good, Kailash Krishnan, Marie-Christine Camden, A Dawson, E. Church, Ashkan Shoamanesh, Stephanie Reiter, Amanda Hedstrom, Rick F. Sánchez, J Wong, Gillian Edmonds, Jelena Blagojević, Atsushi ESAKI, Brian Richardson Drumm, Mathew Hannouche, Heidemarie Zach, Tulsi Patel, Nicole J. Sylvain, H C McEvoy, Ankur Wadhwa, Rachel W. Teal, Andre Loiselle, Karen McGuire, Rana Alnasser Alsukhni, Lindsay Lambourn, Cai Hua Sim, Danielle Roberts, Frederick W. Vonberg, R Wiegner, A. Dudley Gardner, Martha Marko, Agnieszka Kieliszkowska, Otavio Costa Vincenzi, Arthur Pille, Hayrapet Kalashyan, Aristeidis H. Katsanos, Babawale Arabambi, Oscar Benavente, Siming Chen, George Harston, Arshi Iqbal, Andrew M. Penn, Sophie Waller, Brian Clarke, Laura Pardo, Michel Christopher Frank Shamy, Nathaniel Lizak, A. M. N. Ferguson, Yee H Mah, Wolfgang Series, Ali Zohair Nomani, Shabnam Vatanpour, Olalla Pancorbo, William Whiteley, Frances Taylor, T. Sugumar, Shez Feerick, Stefan Roberts, Michael Valente, Eleanor Taylor, Karina Villaluna, A Blight, Das Sc, Rick Swartz, Alexandra Muccilli, Dennis Yeow, Noelia Alonso‐Rodríguez, Enda Kerr, Laisa Zanella, Olli Suomalainen, Surbhi Chaturvedi, Shoba Barath. Singh, Janka Hegedus, Natália Ferreira, Fernanda Cristina Winckler, Logesh Palanikumar, Elisa Cortijo García, Walid Alesefir, Anna J. Black, Jeanne Teitelbaum, Gayle L. Garcia, Omid Halse, Cameron Williams, Stephen A. Gaal, Matthew Boyko, Jithin George, Amy McDonald, Johnathon Gorman, Henry E. Rice, S Obarey, Mccarthy Cj, Ivy Sebastian, Angela Royan, M. I. S. Cortes, Victòria Pons Sala, Andrew Lockey, Yew Li Dang, Jean Roberts, Jasmin Aquino, Kerry A.E. Courtney, Supriya S. Save, Anushka Engineer, Don Sims, Milan R. Voško, Alyson Plecash, Bikram Prasad Gajurel, Nikitha Shenoy, Ahmed El-Masry, Suyi Ooi, P. Park, Sabrina Kalam, Lauren Binnie, Karen Roberts, Stefan Macher, Andreia Martini Pazini, Branko Borojevic, Frost Tj, Helena Janssen, Rodrigo Bazán, Bruce D. Gelb, C. Caroline O’Hare, Steven Peters, Annabelle Lee, A Buck, Mark I. Boulos, Casey Linton, Robert Simister, Shirley Mitchell, Ruaridh Cameron Smail, Heather Duffy, Bruna Cristine Chwal, Resti Varquez, Bonny Granfield, Stephen D. Auger, Tan My, José C.V. Moreira, Ashley Park, Maria Doheny, E Sanjuan, S. Eirola, Naomi Priestley, Naila Pachani, Sonja Wieszmuellner, Bismah Ghoari, Nadia Ben-Amor, Laura-Leena Kupari, Linda Belevski, Cyrille Cahoy, Georgia Raingold, Maria Tibajia, Dimitrios Nouvakis, Quentin Collier, Luana Aparecido Muondo Bonome, Andrew Micielli, Tongtong Yu, A. I. Butt, Jessie Chen, A. Jin, Rachel Moore, Arunima Kapoor, Patricia Fearon, Angela Davies, Bridget Hughes, Sachin Mishra, Nina Francia, Julia J. Hopyan, Achraf Boutayeb, M. Saleem Ismail, Joao Paulo de Queiroz, S. Dugad, Keith W Muir, John McCabe, F. A. Dias, Rudy Goh, D Gladstone, B. C. Smith, S. Haider, A. Roe, L. Zhou, S. Hu, Evgenia Klourfeld, Fernando Muñoz, Atif Zafar, Yin May Chin, V Lo, Jennifer Elliot, Nicholas Maraj, Sharan Mann, K. Nowak, Sandra Boned, Ana Jiménez Gil, Katherine Santana, Jackie Man, Sohaa Jamil, Matti Ahlström, Lana Toussaint, Oral Williams, Ariel Gómez, Joanne B. Allen, DH Crawford, Philip Teal, Mamoun Saeed, I. H. Jenkins, Jo-Lyn Ng, Arman Sabet, Sandeep Ankolekar, Amith Sitaram, Maksim Son, N. Parsons, K Boyle, Rabail Karim, G. B. Thomas, Peter Wilding, Elizabeth Callaly, Marian Muchada, Kayla D. Sage, Richard H. Swartz, Kala Bolt, Lauren Mai, Shashank Bhoothanakudige Nagendra, Tarek Matar, May AlHamind, Anna H. Balabanski, S Lawrence, Robson Sarmento [UNESP] Teodoro, Ahmad Nehme, Salman Mansoor, Julia Hopyan, Raed Joundi, Katie Lin, Ryan Muir, Vivian Fu, Carson Ma, Samuel Yip, Genoveva MacLean, Luciana Catanese, Beth Beauchamp, Kimia Ghavami, Najla Popel, Stefan Krebs, Julia Ferrari, Silja Räty, Sam J Neilson, Henry Zhao, Liisa Tomppo, Nawaf Yassi, Sandra Leason, Ranjan Sanyal, Jesús M. Juega, Liqun Zhang, Brian Dewar, Gerli Sibolt, Edrich Rodrigues, Bijoy K Menon, Barry Martin, Aimen Moussaddy, Leah White, Yiran Zhang, Matias Deck, Ken S Butcher, Tim Stewart, Dheeraj Kalladka, Urszula Bojaryn, Colleen Murphy, Myintzu Min, Wyllians Borelli, Myriam Aissa, Tim Webster, Idris Fatakdawala, William To, Philip MC Choi, Phavalan Rajendram, Linda Smith, Noman Ishaque, Seyed Hosseini, Charlotte Zerna, Narelle Stuart, Ammad Mahmood, Dilip Singh, Rany Shamloul, Matthew Evans, George Mendes, Tom Wellings, Stephan Blechinger, Cheyanne Vandervelde, Diana Kim, Nesreen Laham, Emily Junk, David McShane, Arumugam Nallasivan, Vesselin Todorov, Peter Tan, Frederico Carpani, Victor Vera molina, Mini Matthew, Joshua Mahadevan, Jodie Newham, Mathide Pauls, Jattinder Khaira, Sheilah Frost, Davor Pavlin-Premri, Marta Olive, Marcelo Soma, Marilena Marinescu, Melanie Penn, Jobbin Francis, Philippe Couillard, Azra Banaras, Rachael Dunning, Katherine Lucas, Frank Silver, Paige Fairall, Gary Ford, Christopher Levi, Saima Viturro, Harsha Kamble, Jessica Tsoleridis, Sanchea Wasyliw, N Martinez Majander, Megan Ewing, Daniel Selchen, Miho Tsuda, Margaret Moores, Atlantic D'Souza, Vinaya Bhandari, Qiao Zhang, Terhi Ivanoff, Robert G Hart, Fabrico O Lima, Christopher Seet, Yee-Chin Lee, Karla Ryckborst, Elisabeth Rounis, Alan Murillo Hernandez, S Pralhad Kelavkar, Elieen Fox, Diana Day, Juan Rodriguez, Alex McGovern, Paula Ramirez, Bruno Pegorer Santos, Marcia Pena Pereira, Aleksandra Pikula, Jorge Pagola, Alvin Chew, Alvaro Garcia-Tornel, Chetan Vekhande, Renato ds Cruz, Mitchell Lycett, Nina Bason, Viveka Biswas, James Kennedy, Frederico Alves, Anna Gisold, Vruti Patel, Michael D Hill, Ericka Teleg, Mena Farag, Vanessa Norouzi, Juan F Arenillas, Carlos Molina, Christine Shin, M Garcia Pardo, Sadanand Dey, Ross Cody, Libby Kalman, Jiacheng He, Mark W Parsons, Lori Piquette, Luciano Sposato, Tess Fitzpatrick, Annette Hache, Lara Kaauwai, Ndifreke Atang, Steven Tu, Ruth Whelan, Olena 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Durafourt, Lilian Urroz, Phoebe Lee, Salma Khalil, Vincent Sapaen, Shirin Jalini, Aaron Tan, Peter Bailey, Alexandre Imthon, Lucie Dews, Gerallt Roberts, Sumole Kuriakose, Giovani Noll, Matthew Benger, Amy Ashton, Sarah Coveney, Michael Kelly, Dar Dowlatshahi, Salwa Elmamoun, Helen Dewey, Ryan Forbes, Sharleen Maley, Rebecca Williams, Angela Santos, Chrysi Bogiatzi, D Lopez Dominguez, John Homer, Anna Haber, Mayank Goyal, Nazeem Arsalan, Katrina Tobin, Karin Werner, Mireia Sanchis, Ajay Bhalla, Kaitlyn Foster, Yolanda Silva Blas, Leila Aparecida Machado Galvao Mondin, Suresh Subramaniam, Christine Hawkes, Amy Wagner, Carlos Massote Fontanini, Alessandra Braga Cruz Guedes de Morais, Gabriel Mantovani, R Starling de Barros, Leony Sebastian, Divia Jose, Ramana Appireddy, Sarah Stratton, Robert Irons, Peter Stys, Peter Bello, Gary Klein, Vignan Yogendrakumar, Beatrix Sari, Kien To, Stephen Murphy, Reza Azarpazhooh, Martin del Campo, Evangelia Theochari, David Williams, Agnes Langer, Mohamed Badawy, M Terceno Izaga, Maria Bres Bullrich, Jennifer Liu, Darshan Doshi, Beatriz Gomez, Anna Feliu, Octavio Marques Pontes Neto, Phillip Ferdinand, J Anonuevo Reyes, Rodrigo Martins, Jennifer Cranefield, Natacha Fleck, Puja Punjabivaryani, Hassanain Toma, Timothy J Kleinig, George Zachariah, Anna Robinson, Laura Wilson, Shelly Bohn, Nishita Singh, Catherine Legault, Philip A Barber, T Canento Sanchez, Shannon Smith, Harjit Bains, M Anonuevo Reyes, Stephanie Gosselin-Lefebvre, Robert Samiento, Tapas Chakraborty, Rose Lee, Angela Welch, Sharish Kazi, Kate Kennedy, Michele Demetroff, Christine Roffe, George Medvedev, David Kent, Keith Sivakumar, Terry Chad, Andrew M Demchuck, Emma MacRae, HA Manosalva Alzate, Sabaa Gauhar, Leka Sivakumar, Caroline Domingos Belo, Claire Buchanan, Anne Cayley, Steve Verreault, Kate Lilley, Barry Moynihan, Eric Ehrensperger, Stefen Greisenegger, Kate Dodd, Shaddy El-Masri, Oneil Bhalala, Alicia Murray, Julian Lee, Renee H Martin, Sandy Weatherby, Melissa Tang, Erin Cole, Ana Sanz, Michelle Russell, Josh King-Robson, Lisa Crellin, Robert Fahed, Melissa Naylor, Kamila Santos Ferreira, Elaine Shand, Jim McIImoyle, Rodrigo Barbosa Cerantola, James Evans, Craig Doram, Thalia S Field, Kar Law, Bailey McNamara, Simerpreet Bal, Narmathey Thanbirajah, Brian H Buck, Darshan Shah, Daniel Fabiano Barbosa dos Santos, Sophie Dunkerton, Kausik Chatterjee, Ashwathi Menon, Alisia Southwell, Ria Asuncion, Zhi Ling, Tianming Tu, David Werring, Naomi Ike, Tessa Busch, Montse Reina
article en

Abstract

Importance: Outcomes following intravenous thrombolysis for minor ischemic stroke may vary based on the presence of disabling deficits. Objective: To determine whether intravenous tenecteplase improves outcomes according to US National Institutes of Health Stroke Scale (NIHSS) score–based definitions of pretreatment disabling deficits. Design, Setting, and Participants: This is a secondary analysis of the TEMPO-2 (Tenecteplase vs Standard of Care for Minor Ischemic Stroke With Proven Occlusion) randomized clinical trial, conducted between April 27, 2015, and January 19, 2024. Patients were followed up for 90 days. The TEMPO-2 trial was conducted across 48 sites globally among patients with minor ischemic stroke (NIHSS 0-5) and proven intracranial occlusion within 12 hours of onset. Patients were divided into having nondisabling vs disabling syndromes at presentation as per the TREAT Task Force consensus. Other established definitions of disabling stroke from the ARAMIS trial and the National Institute of Neurological Disorders and Stroke trial were explored. Data analysis was completed from July 2024 to September 2024. Interventions: Intravenous tenecteplase (0.25 mg/kg) vs nonthrombolytic standard of care. Main Outcomes and Measures: The primary outcome was a return to baseline modified Rankin scale score at 90 days. Results: Among 886 enrolled patients, 2 withdrew consent and 884 were included in the secondary analysis. Among 884 patients analyzed (369 women [41.7%]; median [IQR] age, 72 [61-80] years), 100 (11.3%) had disabling and 784 (88.7%) had nondisabling deficits. Patients with disabling deficits had higher median (IQR) baseline NIHSS scores (4 [3-5] vs 2 [1-3]), later presentations (onset to hospital arrival time: 288 [153-412] minutes vs 133 [70-310] minutes), and longer onset to treatment time (411 [307-560] minutes vs 278 [170-462] minutes) than those with nondisabling deficits. In the disabling group, the primary outcome following tenecteplase, compared with standard of care, occurred in 29 patients (54.7%) vs 32 patients (68.1%) (adjusted risk ratio [aRR], 0.81; 95% CI, 0.60-1.10). This neutral treatment effect was consistent in patients without disabling deficits (280 [73.9%] vs 306 [75.6%]; aRR, 0.98; 95% CI, 0.91-1.07; P for interaction = .32). Conclusions and Relevance: In this secondary analysis of the TEMPO-2 randomized clinical trial, current definitions of disabling symptoms based on NIHSS score at baseline did not modify the neutral treatment effect of intravenous tenecteplase in patients with minor stroke and intracranial occlusion. Together with converging evidence comparing intravenous thrombolysis to nonthrombolytic standard of care, this analysis suggests the need to reevaluate thrombolysis in minor disabling stroke.

UCL Discovery (University College London)
Openalex Percentile: Top 26%
Acute Ischemic Stroke Management
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