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1. Time Course of Early Hematoma Expansion in Acute Spot-Sign Positive Intracerebral Hemorrhage: Prespecified Analysis of the SPOTLIGHT Randomized Clinical Trial

Author

Fahad S. Al-Ajlan, David J. Gladstone, Dongbeom Song, Kevin E. Thorpe, Rick H. Swartz, Kenneth S. Butcher, Martin del Campo, Dar Dowlatshahi, Henrik Gensicke, Gloria Jooyoung Lee, Matthew L. Flaherty, Michael D. Hill, Richard I. Aviv, Andrew M. Demchuk, Richard H. Swartz, Karl Boyle, Maria Braganza, Nadia Fedasko, Dolores Golob, Edith Bardi, Samantha Senyshyn, Megan Cayley, Connie Colavecchia, Shelagh Coutts, Gary Klein, Bijoy Menon, Tim Watson, Eric Smith, Suresh Subramaniam, Simerpreet Bal, Philip Barber, Marie-Christine Camden, Myles Horton, Sachin Mishra, Vivek Nambiar, Andres Venegas Torres, Sweta Adatia, Amjad Alseraya, Jamsheed Desai, Jennifer Mandzia, Michel Shamy, Anurag Trivedi, Philip Choi, Veronique Dubuc, Evgenia Klourfeld, Thalia Field, Dilip Singh, Tapuwa Musuka, Sarah Bloujney, Davar Nikneshan, Oje Imoukhuede, Amy Yu, Ramana Appireddy, Jamie Evans, Karla Ryckborst, Carly Calvert, Dariush Dowlatshahi, Grant Stotts, Mukul Sharma, Sohail Robert, Melodie Mortensen, Rany Shamloul, Martin Del Campo, Frank L. Silver, Leanne Casaubon, Cheryl Jaigobin, Yael Perez, Libby Kalman, Jemini Abraham, Relu Wiegner, Anne Cayley, Victoria Riediger, Ken Butcher, Mahesh Kate, Thomas Jeerakathil, Ashfaq Shuaib, Sylvia Gaucher, Leka Sivakumar, Samuel Yip, Philip Teal, Andrew Woolfenden, Oscar Benavente, Jeff Beckman, Colleen Murphy, Negar Asdaghi, Karina Villaluna-MurrVay, Demetrios J. Sahlas, Almunder Algird, Jordan Knapman, Sue Macmillan, Janice Sancan, Manu Mehdiratta, Verity John, AlNoor Dhanani, Bryan Temple, Andre Douen, Daniel Selchen, Gustavo Saposnik, Pawel Kostyrko, Richard Chan, Bryan Young, Balagopal Kumar, Peter Soros, Kimberley Hesser, Mary Wright, Connie Frank, Belinda Amato-Marziali, Yan Deschaintre, Alexandre Poppe, Marlene Lapierre, Jean-Martin Boulanger, Leo Berger, Lise Blais, Christel Simard, Jeanne Teitelbaum, Natasha Campbell, Al Jin, Adriana Breen, and Suzanne Bickford

Subjects
Advanced and Specialized Nursing, Neurology (clinical), Cardiology and Cardiovascular Medicine
Abstract

Background: In the SPOTLIGHT trial (Spot Sign Selection of Intracerebral Hemorrhage to Guide Hemostatic Therapy), patients with a computed tomography (CT) angiography spot-sign positive acute intracerebral hemorrhage were randomized to rFVIIa (recombinant activated factor VIIa; 80 μg/kg) or placebo within 6 hours of onset, aiming to limit hematoma expansion. Administration of rFVIIa did not significantly reduce hematoma expansion. In this prespecified analysis, we aimed to investigate the impact of delays from baseline imaging to study drug administration on hematoma expansion. Methods: Hematoma volumes were measured on the baseline CT, early post-dose CT, and 24 hours CT scans. Total hematoma volume (intracerebral hemorrhage+intraventricular hemorrhage) change between the 3 scans was calculated as an estimate of how much hematoma expansion occurred before and after studying drug administration. Results: Of the 50 patients included in the trial, 44 had an early post-dose CT scan. Median time (interquartile range) from onset to baseline CT was 1.4 hours (1.2–2.6). Median time from baseline CT to study drug was 62.5 (55–80) minutes, and from study drug to early post-dose CT was 19 (14.5–30) minutes. Median (interquartile range) total hematoma volume increased from baseline CT to early post-dose CT by 10.0 mL (−0.7 to 18.5) in the rFVIIa arm and 5.4 mL (1.8–8.3) in the placebo arm ( P =0.96). Median volume change between the early post-dose CT and follow-up scan was 0.6 mL (−2.6 to 8.3) in the rFVIIa arm and 0.7 mL (−1.6 to 2.1) in the placebo arm ( P =0.98). Total hematoma volume decreased between the early post-dose CT and 24-hour scan in 44.2% of cases (rFVIIa 38.9% and placebo 48%). The adjusted hematoma growth in volume immediately post dose for FVIIa was 0.998 times that of placebo ([95% CI, 0.71–1.43]; P =0.99). The hourly growth in FFVIIa was 0.998 times that for placebo ([95% CI, 0.994–1.003]; P =0.50; Table 3). Conclusions: In the SPOTLIGHT trial, the adjusted hematoma volume growth was not associated with Factor VIIa treatment. Most hematoma expansion occurred between the baseline CT and the early post-dose CT, limiting any potential treatment effect of hemostatic therapy. Future hemostatic trials must treat intracerebral hemorrhage patients earlier from onset, with minimal delay between baseline CT and drug administration. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01359202.

Published
2023
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2. Intravenous tenecteplase compared with alteplase for acute ischaemic stroke in Canada (AcT): a pragmatic, multicentre, open-label, registry-linked, randomised, controlled, non-inferiority trial

Author

Bijoy K Menon, Brian H Buck, Nishita Singh, Yan Deschaintre, Mohammed A Almekhlafi, Shelagh B Coutts, Sibi Thirunavukkarasu, Houman Khosravani, Ramana Appireddy, Francois Moreau, Gord Gubitz, Aleksander Tkach, Luciana Catanese, Dar Dowlatshahi, George Medvedev, Jennifer Mandzia, Aleksandra Pikula, Jai Shankar, Heather Williams, Thalia S Field, Alejandro Manosalva, Muzaffar Siddiqui, Atif Zafar, Oje Imoukhuede, Gary Hunter, Andrew M Demchuk, Sachin Mishra, Laura C Gioia, Shirin Jalini, Caroline Cayer, Stephen Phillips, Elsadig Elamin, Ashkan Shoamanesh, Suresh Subramaniam, Mahesh Kate, Gregory Jacquin, Marie-Christine Camden, Faysal Benali, Ibrahim Alhabli, Fouzi Bala, MacKenzie Horn, Grant Stotts, Michael D Hill, David J Gladstone, Alexandre Poppe, Arshia Sehgal, Qiao Zhang, Brendan Cord Lethebe, Craig Doram, Ayoola Ademola, Michel Shamy, Carol Kenney, Tolulope T Sajobi, Richard H Swartz, Abhilekh Srivastava, Ahmed M Aljammaz, Akintomide Femi Akindotun, Albert Y Jin, Alexander Fraser, Alexander V Khaw, Alexandru Lemnaru, Alisia Southwell, Alnar Ramji, Alonso Alvarado-Bolaños, Amr Mouminah, Amro B Lahlouh, Amy Y Yu, Anas Alrohimi, Andre Lavoie, Andrea Rogge, Andrew Micieli, Andrew Linh Nguyen, Angelique Callaghan-Brown, Anita Florendo-Cumbermack, Ankur Wadhwa, Ann-Marie Beaudoin, Anne Cayley, Anne Marie Liddy, Anurag Trivedi, Aristeidis H Katsanos, Ashfaq Shuaib, Asif Javed Butt, Olena Bereznyakova, Beth Beauchamp, Breane Mahlitz, Brett R Graham, Brian Dewar, Bryce A Durafourt, Caitlin Holtby, Caitlin S Jackson-Tarlton, Caitlyn Bockus, Caroline Stephenson, Camille Galloway, Céline Odier, Charles Deacon, Charlotte Zerna, Chetan C Vekhande, Christian Bocti, Christian Stapf, Christine Hawkes, Christine Anne Stables, Chrysi Bogiatzi, Claudia Rodriguez, Claudia Candale-Radu, Colleen Murphy, Courtney Sarah Casserly, Daniel Fok, Danielle de Sa Boasquevisque, Daryl Wile, David Volders, Demetrios J Sahlas, Elaine Shand, Elena Adela Cora, Eliane Di Battista, Eileen Stewart, Emily Junk, Emma L Harrison, Eric Frenette, Ericka Teleg, Eslam Abdellah, Esseddeeg Ghrooda, Farhana Akthar, François Evoy, Gary M Klein, Genoveva Maclean, Glen C Jickling, Glenda Hawthorne, Gordon Boyd, Gregory Walker, Gustavo Saposnik, H Lee Lau, Hanan E Badr, Hassanain Toma, Hayrapet Kalashyan, Hugo Marion-Moffet, Ian Grant, Idris Fatakdawala, Isabelle Beaulieu-Boire, Janice Williams, Jaskiran Brar, Jean Rivest, Jeffrey Z Wang, Jessica Dawe, Jillian Stang, Joanne Day, Jodi Miller, Johnathon Gorman, Julia Jasmine Hopyan, Julian Lee, Julie Kromm, Kaitlyn Foster, Kanchana Ratnayake, Kanjana S Perera, Karina Villaluna Murray, Karla Ryckborst, Katie Lin, Kayla Sage, Keithan Sivakuma, Kelly A MacDonald, Kelvin Kuan Ng, Ketki Merchant, Khurshid Khan, Kimia Ghavami, Kyra Johnston, Lauren M Mai, Leah White, Lee Barratt, Linda Longpre, Lisa Crellin, Lissa Peeling, Lori Piquette, Lysa Boissé Lomax, Mahsa Sadeghi, Maneesha Kamra, Manuel Lavoie-April, Margaret Moores, Maria Bres Bullrich, Marie McClelland, Marina Salluzzi, Mark Wilcox, Mark I Boulos, Martha Marko, Matthew Boyko, Maude Lantagne-Hurtubise, May Adel AlHamid, Mays Shawawrah, Michael E Kelly, Michael W D Thorne, Miguel Bussiere, Ming Yin Dominc Tse, Mowad Benguzzi, Mukul Sharma, Myles Horton, Nancy Newcommon, Nandy-Shelwine Simon, Natalie E Parks, Nazeem Sultan, Nevena Markovic, Nicole Daneault, Noman Ishaque, Paige Fairall, Pawel B Kostyrko, Peter K Stys, Philip Teal, Philippe Couillard, Princess King-Azote, Quentin Collier, Rachel Epp, Radhika Nair, Raed A Joundi, Rajive Jassal, Raphael Schneider, Reza Hosseini, Rosalie Bouchard, Ruth Whelan, S Regan Cooley, Sajeevan Sujanthan, Salman Mansoor, Samuel Yip, Sanchea Wasyliw, Sean W. Taylor, Sebastian Friedman, Sharan Mann, Sharleen Weese Maley, Sherry Chiasson, Sherry Xueying Hu, Shorog Althubait, Shuhira Himed, Shuo Chen, Simerpreet S Bal, Stacey A Page, Stacey D Beck, Stephanie Woodroffe, Stephanie D Reiter, Stephen van Gaal, Steven Ray Peters, Sultan Darvesh, Supriya Save, Susan Alcock, Susannah Piercey, Suzie Adam, Sylvie Gosselin, Tess Fitzpatrick, Thomas-Louis Perron, Tim Stewart, Timothy J Benstead, Vishaya Naidoo, Wasan Abd Wahab, Wiesław Oczkowski, William Kingston, William Leduc, William T H To, Yeyao Joe Yu, Zhongyu A Liu, and Ziad Ezzat Aljundi

Subjects
Male, Canada, General Medicine, Brain Ischemia, Stroke, Treatment Outcome, Fibrinolytic Agents, Tissue Plasminogen Activator, Tenecteplase, Humans, Female, Registries, Aged, Ischemic Stroke
Abstract

Intravenous thrombolysis with alteplase bolus followed by infusion is a global standard of care for patients with acute ischaemic stroke. We aimed to determine whether tenecteplase given as a single bolus might increase reperfusion compared with this standard of care.In this multicentre, open-label, parallel-group, registry-linked, randomised, controlled trial (AcT), patients were enrolled from 22 primary and comprehensive stroke centres across Canada. Patients were eligible for inclusion if they were aged 18 years or older, with a diagnosis of ischaemic stroke causing disabling neurological deficit, presenting within 4·5 h of symptom onset, and eligible for thrombolysis per Canadian guidelines. Eligible patients were randomly assigned (1:1), using a previously validated minimal sufficient balance algorithm to balance allocation by site and a secure real-time web-based server, to either intravenous tenecteplase (0·25 mg/kg to a maximum of 25 mg) or alteplase (0·9 mg/kg to a maximum of 90mg; 0·09 mg/kg as a bolus and then a 60 min infusion of the remaining 0·81 mg/kg). The primary outcome was the proportion of patients who had a modified Rankin Scale (mRS) score of 0-1 at 90-120 days after treatment, assessed via blinded review in the intention-to-treat (ITT) population (ie, all patients randomly assigned to treatment who did not withdraw consent). Non-inferiority was met if the lower 95% CI of the difference in the proportion of patients who met the primary outcome between the tenecteplase and alteplase groups was more than -5%. Safety was assessed in all patients who received any of either thrombolytic agent and who were reported as treated. The trial is registered with ClinicalTrials.gov, NCT03889249, and is closed to accrual.Between Dec 10, 2019, and Jan 25, 2022, 1600 patients were enrolled and randomly assigned to tenecteplase (n=816) or alteplase (n=784), of whom 1577 were included in the ITT population (n=806 tenecteplase; n=771 alteplase). The median age was 74 years (IQR 63-83), 755 (47·9%) of 1577 patients were female and 822 (52·1%) were male. As of data cutoff (Jan 21, 2022), 296 (36·9%) of 802 patients in the tenecteplase group and 266 (34·8%) of 765 in the alteplase group had an mRS score of 0-1 at 90-120 days (unadjusted risk difference 2·1% [95% CI - 2·6 to 6·9], meeting the prespecified non-inferiority threshold). In safety analyses, 27 (3·4%) of 800 patients in the tenecteplase group and 24 (3·2%) of 763 in the alteplase group had 24 h symptomatic intracerebral haemorrhage and 122 (15·3%) of 796 and 117 (15·4%) of 763 died within 90 days of starting treatment INTERPRETATION: Intravenous tenecteplase (0·25 mg/kg) is a reasonable alternative to alteplase for all patients presenting with acute ischaemic stroke who meet standard criteria for thrombolysis.Canadian Institutes of Health Research, Alberta Strategy for Patient Oriented Research Support Unit.

Published
2022

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