Thrombectomy for Stroke With Large Infarct on Noncontrast CT: The TESLA Randomized Clinical Trial.

Autor:	Yoo AJ; Division of Neurointervention, Texas Stroke Institute, Dallas-Fort Worth., Zaidat OO; Bon Secours Mercy Health Neuroscience Institute, Toledo, Ohio., Sheth SA; Department of Neurology, UT Health McGovern Medical School, Houston., Rai AT; Department of Neuroradiology, Rockefeller Neuroscience Institute, West Virginia University, Morgantown., Ortega-Gutierrez S; Departments of Neurology, Radiology, and Neurosurgery, University of Iowa Hospitals and Clinics, Iowa City., Given CA 2nd; Department of Radiology and Neurosurgery, Baptist Health Lexington, Lexington, Kentucky., Zaidi SF; University of Toledo, ProMedica Toledo Hospital, Toledo, Ohio., Grandhi R; Department of Neurosurgery, University of Utah School of Medicine, Salt Lake City., Cuellar H; LSU Health Shreveport, Departments of Radiology and Neurology, Shreveport, Louisiana., Mokin M; University of South Florida, Department of Neurosurgery and Brain Repair, Tampa., Katz JM; Donald and Barbara Zucker School of Medicine at Hostra, Northwell Health, Department of Neurology, Uniondale, New York., Alshekhlee A; SSM Health DePaul Hospital St Louis, Bridgeton, Missouri., Taqi MA; Department of Neurosciences, Vascular Neurology of Southern California, Thousand Oaks., Ansari SA; Departments of Radiology, Neurology, and Neurological Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois., Siddiqui AH; Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York., Barazangi N; California Pacific Medical Center and Mills Peninsula Medical Center, Sutter Health, Department of Neuroscience, San Francisco., English JD; California Pacific Medical Center and Mills Peninsula Medical Center, Sutter Health, Department of Neuroscience, San Francisco., Maud A; Department of Neurology, Texas Tech University Health Science Center, El Paso., Kirmani J; Department of Neurology, JFK University Medical Center, Hackensack Meridian Health, Edison, New Jersey., Gupta R; Department of Neurosurgery, WellStar Health System, Marietta, Georgia., Yavagal DR; Departments of Neurology and Neurosurgery, University of Miami Miller School of Medicine, Miami, Florida., Tarpley J; Providence Little Company of Mary Medical Center, Pacific Neuroscience Institute, Torrance, California., Pandya DJ; Departments of Neurology and Neurointerventional Radiology, Northwestern Medicine Central DuPage Hospital and Delnor Hospital, Winfield, Illinois., Cress MC; Department of Neurosurgery, Orlando Health Neuroscience Institute, Orlando, Florida., Dharmadhikari S; Department of Neurosurgery, Baptist Health Medical Center-Little Rock, Little Rock, Arkansas., Asif KS; Division of Neuroendovascular Surgery, University of Illinois at Chicago, Ascension Health, Chicago., Kass-Hout T; Departments of Neurology and Neurosurgery, University of Chicago, Chicago, Illinois., Puri AS; Departments of Radiology, Neurosurgery, and Neurology, University of Massachusetts Memorial Medical Center, Worcester, Massachusetts., Janjua N; Pomona Valley Hospital Medical Center, Asia Pacific Comprehensive Stroke Institute, Pomona, California., Majjhoo AQ; McLaren Flint and McLaren Macomb, Flint/Mount Clemens, Michigan., Badruddin A; Department of Neuroscience, Munster Community Hospital, Munster, Indiana., Edgell RC; Departments of Neurology and Surgery, SSM Health Saint Louis University Hospital, St Louis, Missouri., Khatri R; Neurovascular Department, Lutheran Hospital, Fort Wayne, Indiana., Morgan L; Bronson Neuroscience Center, Kalamazoo, Michigan., Razak A; Department of Neurology, Michigan State University/Sparrow Health, Lansing, Michigan., Zha A; Department of Neurology, Ohio State University Wexner Medical Center, Columbus., Khandelwal P; Departments of Neurosurgery and Neurology, Rutgers New Jersey Medical School, Newark, New Jersey., Mueller-Kronast N; Advanced Neuroscience Network/Tenet South Florida, Delray Beach., Rivet DJ; Department of Neurosurgery, Virginia Commonwealth University, Richmond., Wolfe T; Department of Neurosciences, Aurora St Luke's Hospital, Milwaukee, Wisconsin., Snelling B; Marcus Neuroscience Institute, Boca Raton Regional Hospital, Boca Raton, Florida., Sultan-Qurraie A; Valley Medical Center, Neuroscience Institute, University of Washington, Renton, Washington., Lin SP; Department of Radiology, PIH Health Good Samaritan Hospital, Los Angeles, California., Khangura R; Sutter Medical Center, Neuroscience Institute, Division of Diagnostic Imaging, Sacramento, California., Spiotta AM; Department of Neurosurgery, Medical University of South Carolina, Charleston., Bhuva P; Division of Neurointervention, Texas Stroke Institute, Dallas-Fort Worth., Salazar-Marioni S; Department of Neurology, UT Health McGovern Medical School, Houston., Lin E; Bon Secours Mercy Health Neuroscience Institute, Toledo, Ohio., Tarabishy AR; Department of Neuroradiology, Rockefeller Neuroscience Institute, West Virginia University, Morgantown., Samaniego EA; Departments of Neurology, Radiology, and Neurosurgery, University of Iowa Hospitals and Clinics, Iowa City., Kolikonda MK; Department of Radiology and Neurosurgery, Baptist Health Lexington, Lexington, Kentucky., Jumaa MA; University of Toledo, ProMedica Toledo Hospital, Toledo, Ohio., Reddy VK; Department of Neurosurgery, University of Utah School of Medicine, Salt Lake City., Sharma P; LSU Health Shreveport, Departments of Radiology and Neurology, Shreveport, Louisiana., Berkhemer OA; Departments of Radiology and Nuclear Medicine, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands., van Doormaal PJ; Departments of Radiology, Erasmus University Medical Center, Rotterdam, the Netherlands., van Es ACGM; Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands., van Zwam WH; Departments of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, the Netherlands., Emmer BJ; Departments of Radiology and Nuclear Medicine, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands., Beenen LF; Departments of Radiology and Nuclear Medicine, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands., Majoie CBLM; Departments of Radiology and Nuclear Medicine, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands., Buderer N; Nancy Buderer Consulting, Toledo, Ohio., Detry MA; Berry Consultants, Austin, Texas., Bosse A; Berry Consultants, Austin, Texas., Graves TL; Berry Consultants, Austin, Texas., Saunders C; Berry Consultants, Austin, Texas., Elijovich L; Department of Neurology, University of Tennessee Health Science Center-Semmes Murphey Clinic, Memphis., Jadhav A; Department of Neurosurgery, Barrow Neurological Institute, Phoenix, Arizona., Patterson M; Bon Secours Mercy Health Neuroscience Institute, Toledo, Ohio., Slight H; Bon Secours Mercy Health Neuroscience Institute, Toledo, Ohio., Below K; Bon Secours Mercy Health Neuroscience Institute, Toledo, Ohio., Al Kasab S; Department of Neurosurgery, Medical University of South Carolina, Charleston.
Jazyk:	angličtina
Zdroj:	JAMA [JAMA] 2024 Sep 23. Date of Electronic Publication: 2024 Sep 23.
DOI:	10.1001/jama.2024.13933
Abstrakt:	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.
Databáze:	MEDLINE
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