Year: 2025
Type: article
Study design: Clinical Trial
Abstract: Importance: It remains uncertain whether surgical evacuation improves functional outcomes in patients with supratentorial intracerebral hemorrhage (ICH). Objective: To compare the safety and efficacy of minimally invasive surgery with the Artemis Neuro Evacuation Device to guideline-based medical management alone for spontaneous supratentorial ICH. Design, Setting, and Participants: The MIND open-label, multicenter randomized clinical trial randomized patients with spontaneous supratentorial ICH in a 2:1 ratio to either minimally invasive surgery or medical management alone. Participants were enrolled at 32 participating global sites between February 6, 2018, and August 28, 2023. This article reports on the primary trial outcome. Of 4066 eligible adult patients (aged 18-80 years) with moderate- to large-volume supratentorial ICH (20-80 mL), baseline National Institutes of Health Stroke Scale score of 6 or higher, and Glasgow Coma Scale score between 5 and 15, 154 were randomized to minimally invasive surgery and 82 to medical management. Data were analyzed from February to September 2024. Intervention: Minimally invasive surgery (within 72 hours of symptom onset) plus medical management or medical management alone. Main Outcomes and Measures: The primary efficacy outcome was 180-day combined death and disability via ordinal modified Rankin Scale score (range, 0 [no symptoms] to 6 [death]). The primary safety outcome was 30-day mortality. Results: Following an independent feasibility analysis prompted by the publication of positive results of a contemporaneous ICH trial, enrollment was stopped early at 236 participants. Overall median (IQR) participant age was 60 (50-70) years, 87 participants (36.9%) were female, 164 (69.5%) had primarily deep bleeds, and 72 (30.5%) had primarily lobar bleeds. Efficacy results of the primary model analysis suggested lack of evidence for the superiority of minimally invasive surgery over medical management (odds ratio [OR], 1.03; 96% CI, 0.62-1.72; P = .45). The adjusted model's mean OR was also nonsignificantly greater than 1 (OR, 1.10; 96% CI, 0.66-1.85; P = .35). By 30 days, 11 participants (7.2%) in the surgery group and 8 (9.8%) in the medical management group died (difference, -2.5%; 95% CI, -11.7% to 4.8%). Conclusions and Relevance: In the MIND randomized clinical trial, minimally invasive surgery within 72 hours did not significantly reduce 30-day mortality or improve 180-day disability in patients with supratentorial ICH compared to medical management alone. Trial Registration: ClinicalTrials.gov Identifier: NCT03342664.
Source: JAMA Neurology
Authors: Adam S. Arthur, Babak S. Jahromi, Paul S. Saphier, Christopher M. Nickele, Robert W. Ryan, Peter Vajkoczy, Clemens M. Schirmer, Christopher P. Kellner, Charles C. Matouk, Eric J. Arias, Jamie S. Ullman, Michael R. Levitt, Ziad A. Hage, David J. Fiorella, MIND Study Investigators and Collaborators, Giorgio Paulon, Melanie Quintana, Michelle A. Detry, Anna Bosse, Alexander Norbash, Colin P. Derdeyn, Lee H. Schwamm, Scott Hamilton, Philip M. Meyers, Andrew Ducruet, Rishi Gupta, Keith B. Woodward, Padmaja Gutti, William Metcalf-Doetsch, Matthew Potts, Kapil Sachdeva, Ronald Benitez, Reza Dashti, Eugene Gu, Elzbieta Wirkowski, Khalid Alsherbini, Demi Dawkins, David Dornbos, Lucas Elijovich, Nitin Goyal, Daniel Heiferman, Daniel Hoit, Violiza Inoa, Kendrick Johnson, Nickalus Khan, Kenneth Moore, Bhageeradh Mulpur, Vincent Nguyen, Jeremy Peterson, Radmehr Torabi, Mario Zamora, Mike Mercurio, Fatima Milfred, Steven O’Donnell, Viren Patel, Rene Sanchez-Mejia, Sami Czabanka, Kiarash Ferdowssian, Nils Hecht, Christoph Leithner, Lars Wessels, Oded Goren, Christoph Griessenauer, Philipp Hendrix, Yasser Khorchid, Matthew Kole, Itay Melamed, Gregory Weiner, J Mocco, Branden Cord, Ryan Hebert, Andrew Koo, Andrew Bauerschmidt, Amir Dehdashti, Jason Ellis, Shahab Khazanehdari, Jung-Min Kim, David Langer, David LeDoux, Zachary Levy, Krista Lim-Hing, Ashesh Mehta, Aashish Patel, Tania Rebeiz, Kenia Samuel, Heustein Sy, Richard Temes, David Weintraub, Gregory Imbarrato, Sami Al Kasab, Charles Andrews, Elizabeth Callan, Michael Casey, Guilherme Bastos Ferreira Porto, Ryan Kellogg, Kimberly Kicielinski, Jonathan Lena, Suhas Pai, Danuel Snelgrove, Alejandro Spiotta, Raymond Turner, Ifeanyi Iwuchukwu, Joseph Keen, Harold McGrade, Basit Rahim, Vikas Rao, Courtney Strifler, Justin Fraser, Benjamin Carroll, Paul Clark, Nicholas Derrico, Daniel Duran, Patrick Kim, Rebekah Kimball, Christa O. Nobleza, Christopher Seward, Zachary Smalley, Andrew Smith, Allison Strickland, Kelsey Walsh, Chad Washington, Michael Ziemke, Adnan Qureshi, Farhan Siddiq, Cian O'Kelly, Maximilian-Niklas Bonk, Micol Colosimo, Hauke Schneider, Ehab Shiban, Bjoern Sommer, Christina Wolfert, Theodore Bowen, Trisha R Dickey, Stefan A Dupont, Alan Hoffer, Yin Hu, Abhishek Ray, Warren Selman, Berje Shammassian, Wei Xiong, Michael Schneck, Joseph Serrone, Ilya Levin, Daniel Zumofen, Kai Bansemir, Jens Lehmberg, Manuel Buitrago Blanco, Geoffrey Colby, Paul Vespa, Anthony Wang, Constantin Hecker, Helmut Novak, Slaven Pikija, Sohum Desai, Ameer Hassan, Emun Abdu, Mark Baker, Fernando Mayor Basto, Kathleen Burger, Chris Leon-Guerrero, Dimitri Sigounas, Ramy Amirah, Katerina Argiti, Jürgen Beck, Panagiotis Fistouris, Christian Fung, Benedikt Haupt, Mukesch Shah, Isaac Abecassis, Dale Ding, Robert James
Institutions: University of Tennessee Health Science Center, Northwestern University, Northwestern Memorial Hospital, Overlook Medical Center, Virginia Mason Medical Center, Charité - Universitätsmedizin Berlin, Geisinger College of Health Sciences, Mount Sinai Hospital, Yale University, HealthONE, Donald & Barbara Zucker School of Medicine at Hofstra/Northwell, University of Washington, Novant Health Presbyterian Medical Center, Stony Brook University Hospital
Language: English
Subfield: Neurology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W4413914635