Thrombectomy for Stroke With Large Infarct on Noncontrast CT
Authors: Rhonda White, Kerry Gembreska, Varun Chaubal, Mohammad AlMajali, Yazan Ashouri, Jasmine M. Olvany, Laila A. Ibrahim, Michael Previti, Shannon Huffaker, Dione Froman, Peter Balousek, Bridget Gatscher, Amy Erickson, Laura Nguyen, Teji Dulai, Gustavo J. Rodriguez, Faheem Sheriff, Zeguang Ren, Waldo Guerrero, Kunal Vakharia, Anjan Ballekere, Rania Abdelkhaleq, Ananya Iyyangar, Hussain Azeem, Michael Nahhas, Ashutosh Mahapatra, Raquel Rulloda, Rami Z. Morsi, Sonam Thind, Ali Mansour, Harrison Lee, Sara M Calhoun, Misty L Burns, Kolikonda Murali, Kenneth Liu, Kathleen Gross, Lynn Perez, Nabil Ghazal, Katharine Gross, Danielle Otis, Tatiana Burkholder, Kelly Torres, Lisa Carolan-Katz, Timothy Carew, Trudy Pyle, Anita Buitenwerf, Courtney VanderBroek, Julie Harning, Christine Holmstedt, Ghada Mohamed, Kimberly Kicielinski, Jonathan Lena, Shelly Ozark, Chirantan Banerjee, Parneet Grewal, Ashley Wabnitz, Richard Libman, Henry Woo, Ina Teron Molina, Erin Schwartz, Alicia Dee, Sandra Anghel, Daphne Batanero, Thomas Scicutella, Rohan Arora, Christina Kelly, Gaurav Kapoor, Thomas Link, Prateeka Koul, Siddharth Dalal, Ahmad Ballout, Kirendra Pasram, Emma Lao, Charell Brinkley, Richard Dima, Sabah Iqbal, Parita Bhuva, Paul Hansen, Jazba Soomro, Osman Mir, Norman Ajoboye, Christian Cajavilca, Charoskhon Turabova, Imran Farooqui, Mary-Ann Fares, Kevin Yeboah, Jonathan Greco, Jessica Whitis, Sowmya Rao, Peggy Vo, Lametria West, Jing Lu, Pauline Matheri, Rocio Sauder, Brenda Jackson, Scott Paradise, Shonda Clark, Charles R. Hughes, Yong H. Park, Joseph J. Park, Sabeen Dhand, Paul J. O'Connor, Margaret Gaston, Stephanie M. Raygoza, Krystal J. Valdez, Priyank Khandelwal, Pradeep Joseph, Roxanne Nagurka, Shashvat M Desai, Enrique Leira, Amir Shaban, Malik Ghannam, Hannah Roeder, Heena Olalde, Katheleen Dlouhy, Colin Derdeyn, Minako Hayaawa, Siddhart Mehta, Farah Fourcand, Abdallah Amireh, Haralabos Zacharatos, Vimla Parboji, Harish N. Shownkeen, Avi Mazumdar, Bryan Fill, Eva Chwastowska, Izabela Holanday, Rosemarie R. Baligod, Jennifer Schmidt, SoHyun Boo, Abdul Tarabishy, Phong Vu, Ryan Turner, Michael Czaplicki, Jennifer Domico, Paramjot Kaur, Vasu Saini, Joshua Burks Burks, Joshua Abecassis, Guillermo Linares, Jay Vanchhani, Paul Foreman, Charlene Carlo, Melanie B. Pakulski, Diane L. Philip, Richard E. Burgess, Vieh (Lisa) M. Kung, Julie Shawver, Melinda Hendricks-Jones, Monica M. Hajjar, Sarah Robbins, Emily Sedlak, Trisha A. Dwyer, Christopher Crayne, Rahul R. Rao, Swayamprava Panda, Sherry L Mosier, Jasmeet Singh, Elad I Levy, Jason Davies, Kenneth Snyder, Scott Brown, Thanh N. Nguyen, Daryl Gress, Diederik W.J. Dippel, Wade S. Smith, Ziad Darkhabani, Sudeepta Dandapat, Kindy Szarzynski, Batul Dhariwala, Tonya Hollrith, Laura Thoreson, Margaret Scott, Veronica Kerr, Gursant Atwal, Linda Rose-Finnell, Christine Maley, Madhav Sukhumaran, Babak Jahromi, Donald Cantrell, Ramez Abdalla, Matthew Potts, Ali Shaibani, Ayesha Muzaffar, Esmeralda Cardoso-Mendoza, Vivek Reddy, Peter Hannon, Lee Chung, Peter Tekiela, Knut Hoversten, Dana DeWitt, Jana Wold, Craig Kilburg, Phil Taussky, Matthew Alexander, David Renner, Muhammed Chauhan, Safdar Ansari, Tom Ross, Pankaj Sharma, Junaid Ansari, Luis DeAlba, Nimer Adeeb, Amey Savardekar, Roger Kelly, Oleg Chernyshev, Kimberly Carroll, Nathaniel Glassy, Scott Geraghty, Diana Sullivan, Mira Pasawala, April Levesque, Laura Atkin, Emma Hall, Elida Romo, Mahmoud Rayes, Bharath Naravetla, Jonathan Stearn, Valentyna Onishchuk, Emily Thompson, Marci Roberts, Amit Singla, Volodymyr Vulkanov, Esther Nimchinsky, Arundhati Biswas, Andrea Hidalgo, Nora Montealegre, Yesenia Sanchez, Anastasia Vechera, Nicole Mercado, Jennifer Unzen, Ahmad Khaldi, Chris Horn, Kumiko Owada, Raisa Martinez, Ugo Nwosu, Erica Ononiwu, Janhavi Modak, Kasey Grimmett, Sharon Aureli, Sandy Mitchell, Jenny Boak, Lonna Blaske, Vivien Lee, Ciaran Powers, Shahid Minjee, Patrick Youssef, Weiping Ye, Mohammad Hamed, Luke Herren, Albert J. Yoo, Osama O. Zaidat, Sunil A. Sheth, Ansaar T. Rai, Santiago Ortega-Gutierrez, Curtis A. Given, Syed F. Zaidi, Ramesh Grandhi, Hugo Cuellar, Maxim Mokin, Jeffrey M. Katz, Amer Alshekhlee, Muhammad A. Taqi, Sameer A. Ansari, Adnan H. Siddiqui, Nobl Barazangi, Joey D. English, Alberto Maud, Jawad Kirmani, Rishi Gupta, Dileep R. Yavagal, Jason Tarpley, Dhruvil J. Pandya, Marshall C. Cress, Sushrut Dharmadhikari, Kaiz S. Asif, Tareq Kass-Hout, Ajit S. Puri, Nazli Janjua, Aniel Q. Majjhoo, Aamir Badruddin, Randall C. Edgell, Rakesh Khatri, Larry Morgan, Anmar Razak, Alicia Zha, Priyank Khandelwal, Nils Mueller-Kronast, Dennis J. Rivet, Thomas Wolfe, Brian Snelling, Ali Sultan-Qurraie, Shao-Pow Lin, Rajkamal Khangura, Alejandro M. Spiotta, Parita Bhuva, Sergio Salazar-Marioni, Eugene Lin, Abdul R. Tarabishy, Edgar A. Samaniego, Murali K. Kolikonda, Mouhammad A. Jumaa, Vivek K. Reddy, Pankaj Sharma, Olvert A. Berkhemer, Pieter-Jan van Doormaal, Adriaan C. G. M. van Es, Wim H. van Zwam, Bart J. Emmer, Ludo F. Beenen, Charles B. L. M. Majoie, Nancy Buderer, Michelle A. Detry, Anna Bosse, Todd L. Graves, Christina Saunders, Lucas Elijovich, Ashutosh Jadhav, Mary Patterson, Hannah Slight, Kristine Below, Sami Al Kasab
Journal: JAMA (2024)

Importance Recent large infarct thrombectomy trials used heterogeneous imaging modalities and time windows for patient selection. Noncontrast computed tomographic (CT) scan is the most common stroke imaging approach. It remains uncertain whether thrombectomy is effective for patients with large infarcts identified using noncontrast CT alone within 24 hours of stroke onset. Objective To evaluate the effect of thrombectomy in patients with a large infarct on a noncontrast CT scan within 24 hours of onset. Design, Setting, and Participants Open-label, blinded–end point, bayesian-adaptive randomized trial with interim analyses for early stopping (futility or success) or population enrichment, which was conducted at 47 US academic and community-based stroke thrombectomy centers. Three hundred patients presenting within 24 hours with anterior-circulation, large-vessel occlusion and large infarct on noncontrast CT scan, with Alberta Stroke Program Early CT Scores of 2 to 5, were randomized to undergo thrombectomy or usual care. Enrollment occurred July 16, 2019 to October 17, 2022; final follow-up, January 25, 2023. Intervention The intervention patients (n = 152) underwent endovascular treatment using standard thrombectomy devices and usual medical care. Control patients (n = 148) underwent usual medical care alone. Main Outcomes and Measures The primary efficacy end point was improvement in 90-day functional outcome measured using mean utility-weighted modified Rankin Scale (UW-mRS) scores (range, 0 [death or severe disability] to 10 [no symptoms]; minimum clinically important difference, 0.3). A bayesian model determined the posterior probability that the intervention would be superior to usual care; statistical significance was a 1-sided posterior probability of .975 or more. The primary adverse event end point was 90-day mortality; secondary adverse event end points included symptomatic intracranial hemorrhage and radiographic intracranial hemorrhage. Results The trial enrolled 300 patients (152 intervention, 148 control; 138 females [46%]; median age, 67 years), without early stopping or enrichment; 297 patients completed the 90-day follow-up. The mean (SD) 90-day UW-mRS score was 2.93 (3.39) for the intervention group vs 2.27 (2.98) for the control group with an adjusted difference of 0.63 (95% credible interval [CrI], −0.09 to 1.34; posterior probability for superiority of thrombectomy, .96). The 90-day mortality was similar between groups: 35.3% (53 of 150) for the intervention group vs 33.3% (49 of 147) for the control group. Six of 151 patients (4.0%) in the intervention group and 2 of 149 (1.3%) in the control group experienced 24-hour symptomatic intracranial hemorrhage. Fourteen patients of 148 (9.5%) in the intervention group vs 4 of 146 (2.7%) in the control group experienced parenchymal hematoma type 1 hemorrhages; 14 (9.5%) in the intervention group vs 5 (3.4%) in the control group experienced parenchymal hematoma type 2 hemorrhages; and 24 (16.2%) in the intervention group vs 9 (6.2%) in the control group experienced subarachnoid hemorrhages. Conclusions and Relevance Among patients with a large infarct on noncontrast CT within 24 hours, thrombectomy did not demonstrate improvement in functional outcomes. But the width of the credible interval around the effect estimate includes the possibility of both no important effect and a clinically relevant benefit, so the potential role of thrombectomy with this imaging approach and time window will likely require additional study. Trial Registration ClinicalTrials.gov Identifier: NCT03805308