Thrombectomy in DAWN- and DEFUSE-3-Ineligible Patients: A Subgroup Analysis From the BEST Prospective Cohort Study.

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.

[1]  S. Mayer,et al.  Blood Pressure after Endovascular Therapy for Ischemic Stroke (BEST): A Multicenter Prospective Cohort Study. , 2019, Stroke.

[2]  J. Grotta,et al.  Endovascular Thrombectomy for Mild Strokes: How Low Should We Go? A Multicenter Cohort Study , 2018, Stroke.

[3]  Renan Sales Barros,et al.  Imaging features and safety and efficacy of endovascular stroke treatment: a meta-analysis of individual patient-level data. , 2018, The Lancet. Neurology.

[4]  J. Desilles,et al.  Application of the DAWN clinical imaging mismatch and DEFUSE 3 selection criteria: benefit seems similar but restrictive volume cut‐offs might omit potential responders , 2018, European journal of neurology.

[5]  D. Haussen,et al.  Thrombectomy 24 hours after stroke: beyond DAWN , 2018, Journal of NeuroInterventional Surgery.

[6]  B. Molyneaux,et al.  Thrombectomy 6-24 hours after stroke in trial ineligible patients , 2018, Journal of NeuroInterventional Surgery.

[7]  A. Demchuk,et al.  Thrombectomy for Stroke at 6 to 16 Hours with Selection by Perfusion Imaging , 2018, The New England journal of medicine.

[8]  M. Chen,et al.  Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct , 2018, The New England journal of medicine.

[9]  K. Phan,et al.  Borderline Alberta Stroke Programme Early CT Score Patients with Acute Ischemic Stroke Due to Large Vessel Occlusion May Find Benefit with Endovascular Thrombectomy. , 2017, World neurosurgery.

[10]  W. Powers,et al.  2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association , 2018, Stroke.

[11]  K. Furie,et al.  Thrombectomy versus medical management for large vessel occlusion strokes with minimal symptoms: an analysis from STOPStroke and GESTOR cohorts , 2017, Journal of NeuroInterventional Surgery.

[12]  A. Demchuk,et al.  Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials , 2016, The Lancet.

[13]  H. Diener,et al.  Stent-retriever thrombectomy after intravenous t-PA vs. t-PA alone in stroke. , 2015, The New England journal of medicine.

[14]  Eric E. Smith,et al.  Randomized assessment of rapid endovascular treatment of ischemic stroke. , 2015, The New England journal of medicine.

[15]  M. Wintermark,et al.  Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association , 2013, Stroke.

[16]  M. Luby,et al.  Acute Stroke Imaging Research Roadmap II , 2008, Stroke.

[17]  P. Harris,et al.  Research electronic data capture (REDCap) - A metadata-driven methodology and workflow process for providing translational research informatics support , 2009, J. Biomed. Informatics.

[18]  Michael D. Hill,et al.  Thrombolysis for acute ischemic stroke: results of the Canadian Alteplase for Stroke Effectiveness Study , 2005, Canadian Medical Association Journal.