James E Siegler1, Steven R Messé1, Heidi Sucharew2,3, Scott E Kasner1, Tapan Mehta4,5,6,7,8,9, Niraj Arora10, Amy K Starosciak11, Felipe De Los Rios La Rosa11, Natasha R Barnhill12, Akshitkumar M Mistry13, Kishan Patel14, Salman Assad15, Amjad Tarboosh15, Katarina Dakay16, Sanjana Salwi17, Jeff Wagner18, Alicia Bennett18, Bharathi D Jagadeesan4,5,6,7,8,9, Christopher Streib4,5,6,7,8,9, Stewart A Weber12, Rohan Chitale13, John J Volpi14, Stephan A Mayer15, Shadi Yaghi16, Mahesh Jayaraman17, Pooja Khatri19, Eva A Mistry20. 1. Department of Neurology, Hospital of the University of Pennsylvania, University of Pennsylvania, Philadelphia, Pennsylvania. 2. Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio. 3. Department of Pediatrics, College of Medicine, University of Cincinnati, Cincinnati, Ohio. 4. Department of Neurology, University of Minnesota Medical Center, School of Medicine, University of Minnesota, Minneapolis, Minnesota. 5. Department of Neurosurgery, University of Minnesota Medical Center, School of Medicine, University of Minnesota, Minneapolis, Minnesota. 6. Department of Radiology, University of Minnesota Medical Center, School of Medicine, University of Minnesota, Minneapolis, Minnesota. 7. Department of Neurology, Hennepin County Medical Center, Minneapolis, Minnesota. 8. Department of Neurosurgery, Hennepin County Medical Center, Minneapolis, Minnesota. 9. Department of Radiology, Hennepin County Medical Center, Minneapolis, Minnesota. 10. Department of Neurology, Jackson Memorial Hospital, Miami, Florida. 11. Baptist Health Neuroscience Center, Miami, Florida. 12. Department of Neurology, Oregon Health and Science University, Portland, Oregon. 13. Department of Neurosurgery, Vanderbilt University Medical Center, Nashville, Tennessee. 14. Department of Neurology, Houston Methodist Medical Center, Houston, Texas. 15. Department of Neurology, Henry Ford Health System, Detroit, Michigan. 16. Department of Neurology, Brown University, Providence, Rhode Island. 17. School of Medicine, Vanderbilt University, Nashville, Tennessee. 18. Department of Neurology, Blue Sky Neurology, Englewood, Colorado. 19. Department of Neurology, University of Cincinnati, Cincinnati, Ohio. 20. Department of Neurology, Vanderbilt University Medical Center, Nashville, Tennessee.
Abstract
BACKGROUND: Because of the overwhelming benefit of thrombectomy for highly selected trial patients with large vessel occlusion (LVO), some trial-ineligible patients are being treated in practice. OBJECTIVE: To determine the safety and efficacy of thrombectomy in DAWN/DEFUSE-3-ineligible patients. METHODS: Using a multicenter prospective observational study of consecutive patients with anterior circulation LVO who underwent late thrombectomy, we compared symptomatic intracerebral hemorrhage (sICH) and good outcome (90-d mRS 0-2) among DAWN/DEFUSE-3-ineligible patients to trial-eligible patients and to untreated DAWN/DEFUSE-3 controls. RESULTS: Ninety-eight patients had perfusion imaging and underwent thrombectomy >6 h; 46 (47%) were trial ineligible (41% M2 occlusions, 39% mild deficits, 28% ASPECTS <6). In multivariable regression, the odds of a good outcome (aOR 0.76, 95% CI 0.49-1.19) and sICH (aOR 3.33, 95% CI 0.42-26.12) were not different among trial-ineligible vs eligible patients. Patients with mild deficits were more likely to achieve a good outcome (aOR 3.62, 95% CI 1.48-8.86) and less sICH (0% vs 10%, P = .16), whereas patients with ASPECTS <6 had poorer outcomes (aOR 0.14, 95% CI 0.05-0.44) and more sICH (aOR 24, 95% CI 5.7-103). Compared to untreated DAWN/DEFUSE-3 controls, trial-ineligible patients had more sICH (13%BEST vs 3%DAWN [P = .02] vs 4%DEFUSE [P = .05]), but were more likely to achieve a good outcome at 90 d (36%BEST vs 13%DAWN [P < .01] vs 17%DEFUSE [P = .01]). CONCLUSION: Thrombectomy is used in practice for some patients ineligible for the DAWN/DEFUSE-3 trials with potentially favorable outcomes. Additional trials are needed to confirm the safety and efficacy of thrombectomy in broader populations, such as large core infarction and M2 occlusions.
BACKGROUND: Because of the overwhelming benefit of thrombectomy for highly selected trial patients with large vessel occlusion (LVO), some trial-ineligible patients are being treated in practice. OBJECTIVE: To determine the safety and efficacy of thrombectomy in DAWN/DEFUSE-3-ineligible patients. METHODS: Using a multicenter prospective observational study of consecutive patients with anterior circulation LVO who underwent late thrombectomy, we compared symptomatic intracerebral hemorrhage (sICH) and good outcome (90-d mRS 0-2) among DAWN/DEFUSE-3-ineligible patients to trial-eligible patients and to untreated DAWN/DEFUSE-3 controls. RESULTS: Ninety-eight patients had perfusion imaging and underwent thrombectomy >6 h; 46 (47%) were trial ineligible (41% M2 occlusions, 39% mild deficits, 28% ASPECTS <6). In multivariable regression, the odds of a good outcome (aOR 0.76, 95% CI 0.49-1.19) and sICH (aOR 3.33, 95% CI 0.42-26.12) were not different among trial-ineligible vs eligible patients. Patients with mild deficits were more likely to achieve a good outcome (aOR 3.62, 95% CI 1.48-8.86) and less sICH (0% vs 10%, P = .16), whereas patients with ASPECTS <6 had poorer outcomes (aOR 0.14, 95% CI 0.05-0.44) and more sICH (aOR 24, 95% CI 5.7-103). Compared to untreated DAWN/DEFUSE-3 controls, trial-ineligible patients had more sICH (13%BEST vs 3%DAWN [P = .02] vs 4%DEFUSE [P = .05]), but were more likely to achieve a good outcome at 90 d (36%BEST vs 13%DAWN [P < .01] vs 17%DEFUSE [P = .01]). CONCLUSION: Thrombectomy is used in practice for some patients ineligible for the DAWN/DEFUSE-3 trials with potentially favorable outcomes. Additional trials are needed to confirm the safety and efficacy of thrombectomy in broader populations, such as large core infarction and M2 occlusions.
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