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1. A randomized pragmatic care trial on endovascular acute stroke interventions (EASI): criticisms, responses, and ethics of integrating research and clinical care

Author

Robert Fahed, Stefanos Finitsis, Naim Khoury, Yan Deschaintre, Nicole Daneault, Laura Gioia, Gregory Jacquin, Céline Odier, Alexande Y. Poppe, Alain Weill, Daniel Roy, Tim E. Darsaut, Thanh N. Nguyen, and Jean Raymond

Subjects
Thrombectomy, Stroke, Trial, Methodology, Ethics, Medicine (General), R5-920
Abstract

Abstract Background The Endovascular Acute Stroke Intervention (EASI) trial was conceived as a pragmatic care trial, designed to integrate trial methods with clinical practice. Reporting the EASI experience was met with objections and criticisms during peer review concerning both scientific and ethical issues. Our goal is to discuss these criticisms in order to promote the pragmatic approach of care trials in outcome-based medical care. Methods The comments and criticisms of 11 reviewers from 5 journals were collected and analyzed. The EASI protocol was also compared to the protocols of seven thrombectomy trials using the pragmatic-explanatory continuum indicator summary (PRECIS). Results Main criticisms of EASI concerned selection criteria that were judged to be too vague and too inclusive, brain and vascular imaging methods that were not sufficiently prescribed by protocol, lack of blinding of outcome assessment, and lack of power. EASI was at the pragmatic end of the spectrum of thrombectomy trials. Conclusion The pragmatic care trial methodology is not currently well-established. More work needs to be done to integrate scientific methods and ethical care in the best medical interest of current patients.

Published
2018
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2. Neurovascular complications of antiphospholipid syndrome: a narrative review

Author

George Nilton Nunes Mendes, Alessandra Braga Cruz Guedes de Morais, Laura Catherine Gioia, Grégory Jacquin, Alexandre Y. Poppe, Felipe Hideki Soga, and João Brainer Clares de Andrade

Subjects
Antiphospholipid Syndrome, Stroke, Cognition, Venous Thrombosis, Complications, Síndrome Antifosfolipídica, Acidente Vascular Cerebral, Cognição, Trombose Venosa, Complicações, Neurosciences. Biological psychiatry. Neuropsychiatry, RC321-571
Abstract

Background Antiphospholipid syndrome (APS) is a systemic autoimmune disorder characterized by thrombosis, pregnancy complications, and other nonthrombotic manifestations in the presence of antiphospholipid antibodies. Neurovascular complications, including ischemic stroke, cerebral venous thrombosis and cognitive impairment, pose significant challenges in management.

Published
2024
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3. 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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