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2024•JAMAOpen access

Endovascular Thrombectomy for Large Ischemic Stroke Across Ischemic Injury and Penumbra Profiles

Amrou Sarraj, Ameer E Hassan, Michael Abraham, Santiago Ortega‐Gutiérrez, Scott E. Kasner, Muhammad Shazam Hussain, Michael Chen, Leonid Churilov, Hannah Johns, Clark Sitton, Vignan Yogendrakumar, Felix Ng, Deep Pujara, Spiros Blackburn, Sophia Sundararajan, Yin Hu, Nabeel Herial, Juan F. Arenillas, Jenny P. Tsai, Ronald F. Budzik, William J. Hicks, Osman Kozak, Bernard Yan, Dennis Cordato, Nathan Manning, Mark Parsons, Andrew Cheung, Ricardó A. Hanel, Amin N. Aghaebrahim, Teddy Y. Wu, Pere Cardona Portela, Chirag D. Gandhi, Fawaz Al‐Mufti, Natàlia Pérez de la Ossa, Joanna D. Schaafsma, Jordi Blasco, Navdeep Sangha, Steven Warach, Timothy Kleinig, Faris Shaker, Faisal Al Shaibi, Gábor Tóth, Mohammad A Abdulrazzak, Gagan Sharma, Abhishek Ray, Jeffrey L. Sunshine, Amanda Opaskar, Kelsey R. Duncan, Wei Xiong, Edgar A. Samaniego, Laith Maali, Colleen Lechtenberg, Arturo Renú, Nirav Vora, Thanh N. Nguyen, Johanna T Fifi, Stavropoula Tjoumakaris, Pascal Jabbour, Georgios Tsivgoulis, Vítor Mendes Pereira, Maarten G. Lansberg, Michael DeGeorgia, Cathy Sila, Nicholas C. Bambakidis, Michael D. Hill, Stephen M. Davis, Lawrence R. Wechsler, James C. Grotta, Marc Ribó, Gregory W. Albers, Bruce Campbell, SELECT2 Investigators, Amrou Sarraj, Sophia Sundararajan, Yin Hu, Cathy Sila, Anthony J. Furlan, Amanda Opaskar, Nicholas C. Bambakidis, Abhishek Ray, Jeffrey L. Sunshine, Michael DeGeorgia, Wei Xiong, Rose Duncan, Ali Fadhil, John H. L. Hansen, Mohit Patel, Arunit J.S. Chugh, Faisal Al-Shaibi, Majed Alomar, Soheil El-Azzouni, Rami Moussa, Dasul Jin, Katrina M Nayak, Yiyi Zhang, Nikhil S Modak, Muruj M Jumah, Deng-Yuan Dean Liou, Abdullah Alamoudi, Deep Pujara, Spiros Blackburn, James C. Grotta, Clark Sitton, Mohammad H Rahbar, Mark J. Dannenbaum, Roy Riascos, Gary Spiegel, Andrew D. Barreto, Anjail Sharieff, Joseph Cochran, Arthur L. Day, Nicole R. Gonzales, Sujan Reddy, Lauren E Fournier, Erica Jones, Pamela Zelini, Haris Kamal, Felix Guerra Castanon, Naveed Asim, Faris Shaker, Manouchehr Hessabi, Amirali Tahanan, Michael Abraham, Laith Maali, Koji Ebersole, Jorge Kawano, Colleen Lechtenberg, Sabreena Slavin, Latih Maali, Ernest Madarang, Aparna Pendurthi, Abid Qureshi, Alan Reeves, Lee Rosterman, Yunxia Wang, Tiffany Barkley, Husitha Reddy Vanguru, Jeremy Paterson, Carissa Walters, Peyton Ackerman, Ricardó A. Hanel, Amin N. Aghaebrahim, Eric Sauvageau, Gina Munden, Muhammad Shazam Hussain, Mohammad A Abdulrazzak, Ken Uchino, Irene Katzan, Mei Lü, Gábor Tóth, Andrew Russman, Dolora Wisco, Jayashree Sundararajan, Andrew Buletko, Mark Bain, Nina Z. Moore, Alex M Witek, Marek Čierny, Ashutosh Mahapatra, Ghulum Kharal, Denice Limbert, Tina Resser, Laura J Sweeney, Michael Chen, Stephan A. Munich, R. Webster Crowley, Elizabeth McLaughlin, Sarah Song, Rebecca McWilliams, Bartosz Jacher, Steven Warach, Truman J. Milling, Jefferson T. Miley, Kent Ellington, Aliaksandra Regan, J. Erfán, Manzure Mawla, Lisa Davis, Nathan D. Zuck, Ron F Budzik, William J. Hicks, Nirav Vora, Peter Pema, Abdulnasser Alhajeri, Aaron Loochtan, Vivek Rai, Brian Katz, Adam Koss, Nikita Dedhia, Katy Groezinger, Megan Heckathorn, Heather Bartelt, Navdeep Sangha, Duy Le, Lei Feng, Kuo Chao, Pamela Cheng, Zahra Ajani, Catherine L Lui, Ashima Sharma, Osman Kozak, Larami Mackenzie, Hana Choe, Patricia Bussinger, Ashley L. DePalmo, Ameer E Hassan, Wondwossen Tekle, Alexandros Georgiadis, Olive Sanchez, Pualani Smith, Daniel Gibson, Adam N. Wallace, Tracy Mente, Margaret D. Wilson, Santiago Ortega-Gutierrez, Edgar A. Samaniego, Colin P. Derdeyn, Kathleen Dlouhy, David Hasan, M. Hayakawa, Enrique C. Leira, Kaustubh Limaye, Amir Shaban, Hyung Sub Shim, Malik Ghannam, Cynthia Zeballos, Jason Maljaars, Prateeka Koul, Mohammad Almajali, Heena Olalde, Harika A Kekinagath, Lucas Elijovich, Adam S Arthur, Daniel Hoit, Christopher Nickele, Violiza Inoa, Nitin Goyal, Stephanie R. Wilson, Kaushik Parsha, A. Nolte, Nabeel Herial, Pascal Jabbour, Stavropoula Tjoumakaris, M. Reid Gooch, Thana Theofanis, Robert H. Rosenwasser, Victoria Schunemann, Rizwan Tahir, Mohamed S Eldin, Roland Jabre, J. Chen, Nadirah Jones, Scott E. Kasner, Brett Cucchiara, Steven R. Messé, Jens Witsch, Donna L. George, Christopher G. Favilla, Qingyang Yuan, Laura A Stein, Paul Novello, Aaron Rothstein, Daniel Cristancho, Kelly L. Sloane, Kelley Humbert, Jonah P. Zuflacht, Arooshi Kumar, Farhan Khan, Michael T. Mullen, Judy Dawod, Jan‐Karl Burkhardt, Brian T. Jankowitz, Bryan Pukenas, Omar Choudhri, Preethi Ramchand, Sahily Reyes‐Esteves, Gbambele Kone, Nino Kvantaliani, Michela Rosso, Sydni Cole, Ossama Khazaal, Nichole Gallatti, Jenny P. Tsai, Jiangyong Min, Nabil Wees, Amjad Abdallah, Muhib Khan, Nadeem Khan, Asad Ahrar, Paul Mazaris, M M Maciorowska Malgorzata, Justin Singer, Ryan S. Groseclose, Beenish I. Sultan, Daniel H. Sahlein, Krishna Amuluru, John A. Scott, Andrew DeNardo, David Rosenbaum, Kati Campbell, Chirag D. Gandhi, Fawaz Al‐Mufti, Gurmeen Kaur, Justin Santarelli, Nicole Lemrick, Heather Cero, Kevin Clare, Bridget Nolan, Joanna D. Schaafsma, Tim Stewart, Anne Cayley, Cheryl Jaigobin, Leanne K. Casaubon, Patrick Nicholson, Ronit Agid, Frank L. Silver, Aleksandra Pikula, William Wing Kee To, Lisa Crellin, Ashfaq Shuaib, Nina Sobreira, Bruce Campbell, Bernard Yan, Vignan Yogendrakumar, Felix Ng, Peter Mitchell, Richard Dowling, Steven Bush, Cameron Williams, Nawaf Yassi, Davor Pavlin‐Premrl, James Beharry, Anna Balabanski, Angela Dos Santos, Angelos Sharobeam, Michael Valente, Ashley Park, Joseph K. Wong, Amy McDonald, David M. Jackson, Gagan Sharma, Prodipta Guha, Birendra Rokaha, Timothy Kleinig, Rebecca Scroop, Craig Kurunawai, Joshua Mahadevan, Rudy Goh, Roy Drew, Dennis Cordato, Nathan Manning, Mark Parsons, Alex McQuinn, Jason Wenderoth, Andrew Cheung, Alan McDougall, James Thomas, Cecilia Cappelen‐Smith, Christopher Blair, Leon Edwards, Justin Whitely, Jacob Helou, Megan Miller, Teddy Y. Wu, Wayne Collecutt, Frances Colgan, Martin Krauß, Andrew Laing, Duncan Wilson, John Fink, Campbell LeHeron, Deborah Mason, Rosemary Green, K.C. Bremner, Marc Ribo, Alejandro Tomasello, Manuel Requena Ruiz, Marta Olive Gadea, Estela Sanjuán, Judith Cendrero, Jordi Blasco, Arturo Renú, Luís San Román, Xabier Urra, Daniel Santana, José-María Cabrera, Laura Llull, Antonio López‐Rueda, Andrea Cabero, Elena Serrano, Natàlia Pérez de la Ossa, María Hernández‐Pérez, Monica A. Millan, Meritxell Gomis, Alejandro Bustamante, Laura Dorado, Manuel Gómez‐Choco, Sebastián Remollo, Carlos Castaño, Mariano Werner, Lucía Muñoz-Narbona, Pere Cardona, Helena Quesada, Blanca Lara, Andrés Paipa, Anna Nuñez, Víctor Cuba, Óscar Chirife, Lucía Aja, María Ángeles de Miquel, Juan F. Arenillas, Mercedes de Lera Alfonso, María Esther Ramos Araque, Ana Calleja, Elisa Cortijo, Mario Martínez‐Galdámez, Miguel Schüller, Jorge Galván, Javier Reyes Muñoz, Beatriz Gómez Vicente, Marios Psychogios, Alex Brehm

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Abstract

Importance: Whether endovascular thrombectomy (EVT) efficacy for patients with acute ischemic stroke and large cores varies depending on the extent of ischemic injury is uncertain. Objective: To describe the relationship between imaging estimates of irreversibly injured brain (core) and at-risk regions (mismatch) and clinical outcomes and EVT treatment effect. Design, Setting, and Participants: An exploratory analysis of the SELECT2 trial, which randomized 352 adults (18-85 years) with acute ischemic stroke due to occlusion of the internal carotid or middle cerebral artery (M1 segment) and large ischemic core to EVT vs medical management (MM), across 31 global centers between October 2019 and September 2022. Intervention: EVT vs MM. Main Outcomes and Measures: Primary outcome was functional outcome-90-day mRS score (0, no symptoms, to 6, death) assessed by adjusted generalized OR (aGenOR; values >1 represent more favorable outcomes). Benefit of EVT vs MM was assessed across levels of ischemic injury defined by noncontrast CT using ASPECTS score and by the volume of brain with severely reduced blood flow on CT perfusion or restricted diffusion on MRI. Results: Among 352 patients randomized, 336 were analyzed (median age, 67 years; 139 [41.4%] female); of these, 168 (50%) were randomized to EVT, and 2 additional crossover MM patients received EVT. In an ordinal analysis of mRS at 90 days, EVT improved functional outcomes compared with MM within ASPECTS categories of 3 (aGenOR, 1.71 [95% CI, 1.04-2.81]), 4 (aGenOR, 2.01 [95% CI, 1.19-3.40]), and 5 (aGenOR, 1.85 [95% CI, 1.22-2.79]). Across strata for CT perfusion/MRI ischemic core volumes, aGenOR for EVT vs MM was 1.63 (95% CI, 1.23-2.16) for volumes ≥70 mL, 1.41 (95% CI, 0.99-2.02) for ≥100 mL, and 1.47 (95% CI, 0.84-2.56) for ≥150 mL. In the EVT group, outcomes worsened as ASPECTS decreased (aGenOR, 0.91 [95% CI, 0.82-1.00] per 1-point decrease) and as CT perfusion/MRI ischemic core volume increased (aGenOR, 0.92 [95% CI, 0.89-0.95] per 10-mL increase). No heterogeneity of EVT treatment effect was observed with or without mismatch, although few patients without mismatch were enrolled. Conclusion and Relevance: In this exploratory analysis of a randomized clinical trial of patients with extensive ischemic stroke, EVT improved clinical outcomes across a wide spectrum of infarct volumes, although enrollment of patients with minimal penumbra volume was low. In EVT-treated patients, clinical outcomes worsened as presenting ischemic injury estimates increased. Trial Registration: ClinicalTrials.gov Identifier: NCT03876457.

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What this paper is about

Importance: Whether endovascular thrombectomy (EVT) efficacy for patients with acute ischemic stroke and large cores varies depending on the extent of ischemic injury is uncertain. Objective: To describe the relationship between imaging estimates of irreversibly injured brain (core) and at-risk regions (mismatch) and clinical outcomes and EVT treatment effect. Design, Setting, and Participants: An exploratory analysis of the SELECT2 trial, which randomized 352 adults (18-85 years) with acute ischemic stroke due to occlusion of the internal carotid or middle cerebral artery (M1 segment) and large ischemic core to EVT vs medical management (MM), across 31 global centers between October 2019 and September 2022. Intervention: EVT vs MM. Main Outcomes and Measures: Primary outcome was functional outcome-90-day mRS score (0, no symptoms, to 6, death) assessed by adjusted generalized OR (aGenOR; values >1 represent more favorable outcomes). Benefit of EVT vs MM was assessed across levels of ischemic injury defined by noncontrast CT using ASPECTS score and by the volume of brain with severely reduced blood flow on CT perfusion or restricted diffusion on MRI. Results: Among 352 patients randomized, 336 were analyzed (median age, 67 years; 139 [41.4%] female); of these, 168 (50%) were randomized to EVT, and 2 additional crossover MM patients received EVT. In an ordinal analysis of mRS at 90 days, EVT improved functional outcomes compared with MM within ASPECTS categories of 3 (aGenOR, 1.71 [95% CI, 1.04-2.81]), 4 (aGenOR, 2.01 [95% CI, 1.19-3.40]), and 5 (aGenOR, 1.85 [95% CI, 1.22-2.79]). Across strata for CT perfusion/MRI ischemic core volumes, aGenOR for EVT vs MM was 1.63 (95% CI, 1.23-2.16) for volumes ≥70 mL, 1.41 (95% CI, 0.99-2.02) for ≥100 mL, and 1.47 (95% CI, 0.84-2.56) for ≥150 mL. In the EVT group, outcomes worsened as ASPECTS decreased (aGenOR, 0.91 [95% CI, 0.82-1.00] per 1-point decrease) and as CT perfusion/MRI ischemic core volume increased (aGenOR, 0.92 [95% CI, 0.89-0.95] per 10-mL increase). No heterogeneity of EVT treatment effect was observed with or without mismatch, although few patients without mismatch were enrolled. Conclusion and Relevance: In this exploratory analysis of a randomized clinical trial of patients with extensive ischemic stroke, EVT improved clinical outcomes across a wide spectrum of infarct volumes, although enrollment of patients with minimal penumbra volume was low. In EVT-treated patients, clinical outcomes worsened as presenting ischemic injury estimates increased. Trial Registration: ClinicalTrials.gov Identifier: NCT03876457.

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Available abstract

Importance: Whether endovascular thrombectomy (EVT) efficacy for patients with acute ischemic stroke and large cores varies depending on the extent of ischemic injury is uncertain. Objective: To describe the relationship between imaging estimates of irreversibly injured brain (core) and at-risk regions (mismatch) and clinical outcomes and EVT treatment effect. Design, Setting, and Participants: An exploratory analysis of the SELECT2 trial, which randomized 352 adults (18-85 years) with acute ischemic stroke due to occlusion of the internal carotid or middle cerebral artery (M1 segment) and large ischemic core to EVT vs medical management (MM), across 31 global centers between October 2019 and September 2022. Intervention: EVT vs MM. Main Outcomes and Measures: Primary outcome was functional outcome-90-day mRS score (0, no symptoms, to 6, death) assessed by adjusted generalized OR (aGenOR; values >1 represent more favorable outcomes). Benefit of EVT vs MM was assessed across levels of ischemic injury defined by noncontrast CT using ASPECTS score and by the volume of brain with severely reduced blood flow on CT perfusion or restricted diffusion on MRI. Results: Among 352 patients randomized, 336 were analyzed (median age, 67 years; 139 [41.4%] female); of these, 168 (50%) were randomized to EVT, and 2 additional crossover MM patients received EVT. In an ordinal analysis of mRS at 90 days, EVT improved functional outcomes compared with MM within ASPECTS categories of 3 (aGenOR, 1.71 [95% CI, 1.04-2.81]), 4 (aGenOR, 2.01 [95% CI, 1.19-3.40]), and 5 (aGenOR, 1.85 [95% CI, 1.22-2.79]). Across strata for CT perfusion/MRI ischemic core volumes, aGenOR for EVT vs MM was 1.63 (95% CI, 1.23-2.16) for volumes ≥70 mL, 1.41 (95% CI, 0.99-2.02) for ≥100 mL, and 1.47 (95% CI, 0.84-2.56) for ≥150 mL. In the EVT group, outcomes worsened as ASPECTS decreased (aGenOR, 0.91 [95% CI, 0.82-1.00] per 1-point decrease) and as CT perfusion/MRI ischemic core volume increased (aGenOR, 0.92 [95% CI, 0.89-0.95] per 10-mL increase). No heterogeneity of EVT treatment effect was observed with or without mismatch, although few patients without mismatch were enrolled. Conclusion and Relevance: In this exploratory analysis of a randomized clinical trial of patients with extensive ischemic stroke, EVT improved clinical outcomes across a wide spectrum of infarct volumes, although enrollment of patients with minimal penumbra volume was low. In EVT-treated patients, clinical outcomes worsened as presenting ischemic injury estimates increased. Trial Registration: ClinicalTrials.gov Identifier: NCT03876457.

Key concepts: Medicine, Penumbra, Randomized controlled trial, Stroke (engine), Internal medicine, Cardiology, Perfusion scanning, Ischemic stroke

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Endovascular Thrombectomy for Large Ischemic Stroke Across Ischemic Injury and Penumbra Profiles — Research Paper | ScholarLens