Fahad S Al-Ajlan1, Mayank Goyal1, Andrew M Demchuk1, Priyanka Minhas1, Farahna Sabiq1, Zarina Assis1, Robert Willinsky1, Walter J Montanera1, Jeremy L Rempel1, Ashfaq Shuaib1, John Thornton1, David Williams1, Daniel Roy1, Alexandre Y Poppe1, Tudor G Jovin1, Biggya L Sapkota1, Blaise W Baxter1, Timo Krings1, Frank L Silver1, Donald F Frei1, Christopher Fanale1, Donatella Tampieri1, Jeanne Teitelbaum1, Cheemun Lum1, Dar Dowlatshahi1, Jai J Shankar1, Philip A Barber1, Michael D Hill1, Bijoy K Menon2. 1. From the Department of Clinical Neurosciences and Department of Radiology, Cumming School of Medicine, University of Calgary, Calgary (F.S.A.-A., M.G., A.M.D., P.M., F.S., Z.A., P.A.B., M.D.H., B.K.M.); Department of Community Health Sciences and Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary (M.D.H., B.K.M.); Department of Medical Imaging, UHN, Toronto Western Hospital, Toronto (R.W., W.J.M.); Department of Surgery (Neurosurgery), University of Alberta, Edmonton (J.L.R.); Department of Medicine (Neurology), University of Alberta, Edmonton (A.S.); Department of Neuroradiology, Beaumont Hospital and the Royal College of Surgeons in Ireland (J. Thornton); Department of Geriatric and Stroke Medicine, Beaumont Hospital and the Royal College of Surgeons in Ireland (D.W.); Department of Radiology, CHUM, University of Montreal, Montreal (D.R.); Department of Neurosciences, CHUM, University of Montreal, Montreal (A.Y.P.); Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh (T.G.J.); Division of Neurology, University of Tennessee, Chattanooga (B.L.S.); Department of Radiology, Erlanger Hospital, University of Tennessee, Chattanooga (B.W.B.); Division of Radiology, UHN, Toronto Western Hospital, Toronto (T.K.); Division of Neurology, Department of Medicine, UHN, Toronto Western Hospital, Toronto (F.L.S., C.F.); Colorado Neurological Institute, Engelwood (D.F.F., D.T.); Montreal Neurological Institute, McGill University, Montreal (J. Teitelbaum); Department of Radiology, The Ottawa Hospital, University of Ottawa, Ottawa (C.L.); Department of Neurology, The Ottawa Hospital Research Institute, University of Ottawa, Ottawa (D.D.); Department of Neuroradiology, Dalhousie University, Halifax (J.J.S.); and Hotchkiss Brain Institute, University of Calgary (M.G., A.M.D., P.A.B., M.D.H., B.K.M.). 2. From the Department of Clinical Neurosciences and Department of Radiology, Cumming School of Medicine, University of Calgary, Calgary (F.S.A.-A., M.G., A.M.D., P.M., F.S., Z.A., P.A.B., M.D.H., B.K.M.); Department of Community Health Sciences and Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary (M.D.H., B.K.M.); Department of Medical Imaging, UHN, Toronto Western Hospital, Toronto (R.W., W.J.M.); Department of Surgery (Neurosurgery), University of Alberta, Edmonton (J.L.R.); Department of Medicine (Neurology), University of Alberta, Edmonton (A.S.); Department of Neuroradiology, Beaumont Hospital and the Royal College of Surgeons in Ireland (J. Thornton); Department of Geriatric and Stroke Medicine, Beaumont Hospital and the Royal College of Surgeons in Ireland (D.W.); Department of Radiology, CHUM, University of Montreal, Montreal (D.R.); Department of Neurosciences, CHUM, University of Montreal, Montreal (A.Y.P.); Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh (T.G.J.); Division of Neurology, University of Tennessee, Chattanooga (B.L.S.); Department of Radiology, Erlanger Hospital, University of Tennessee, Chattanooga (B.W.B.); Division of Radiology, UHN, Toronto Western Hospital, Toronto (T.K.); Division of Neurology, Department of Medicine, UHN, Toronto Western Hospital, Toronto (F.L.S., C.F.); Colorado Neurological Institute, Engelwood (D.F.F., D.T.); Montreal Neurological Institute, McGill University, Montreal (J. Teitelbaum); Department of Radiology, The Ottawa Hospital, University of Ottawa, Ottawa (C.L.); Department of Neurology, The Ottawa Hospital Research Institute, University of Ottawa, Ottawa (D.D.); Department of Neuroradiology, Dalhousie University, Halifax (J.J.S.); and Hotchkiss Brain Institute, University of Calgary (M.G., A.M.D., P.A.B., M.D.H., B.K.M.). docbijoymenon@gmail.com.
Abstract
BACKGROUND AND PURPOSE: The goal of reperfusion therapy in acute ischemic stroke is to limit brain infarction. The objective of this study was to investigate whether the beneficial effect of endovascular treatment on functional outcome could be explained by a reduction in post-treatment infarct volume. METHODS: The Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times (ESCAPE) trial was a multicenter randomized open-label trial with blinded outcome evaluation. Among 315 enrolled subjects (endovascular treatment n=165; control n=150), 314 subject's infarct volumes at 24 to 48 hours onmagnetic resonance imaging (n=254) or computed tomography (n=60) were measured. Post-treatment infarct volumes were compared by treatment assignment and recanalization/reperfusion status. Appropriate statistical models were used to assess relationship between baseline clinical and imaging variables, post-treatment infarct volume, and functional status at 90 days (modified Rankin Scale). RESULTS: Median post-treatment infarct volume in all subjects was 21 mL (interquartile range =65 mL), in the intervention arm, 15.5 mL (interquartile range =41.5 mL), and in the control arm, 33.5 mL (interquartile range =84 mL; P<0.01). Baseline National Institute of Health Stroke Scale (P<0.01), site of occlusion (P<0.01), baseline noncontrast computed tomographic scan Alberta Stroke Program Early CT score (ASPECTS) (P<0.01), and recanalization (P<0.01) were independently associated with post-treatment infarct volume, whereas age, sex, treatment type, intravenous alteplase, and time from onset to randomization were not (P>0.05). Post-treatment infarct volume (P<0.01) and delta National Institute of Health Stroke Scale (P<0.01) were independently associated with 90-day modified Rankin Scale, whereas laterality (left versus right) was not. CONCLUSIONS: These results support the primary results of the ESCAPE trial and show that the biological underpinning of the success of endovascular therapy is a reduction in infarct volume. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01778335.
RCT Entities:
BACKGROUND AND PURPOSE: The goal of reperfusion therapy in acute ischemic stroke is to limit brain infarction. The objective of this study was to investigate whether the beneficial effect of endovascular treatment on functional outcome could be explained by a reduction in post-treatment infarct volume. METHODS: The Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times (ESCAPE) trial was a multicenter randomized open-label trial with blinded outcome evaluation. Among 315 enrolled subjects (endovascular treatment n=165; control n=150), 314 subject's infarct volumes at 24 to 48 hours on magnetic resonance imaging (n=254) or computed tomography (n=60) were measured. Post-treatment infarct volumes were compared by treatment assignment and recanalization/reperfusion status. Appropriate statistical models were used to assess relationship between baseline clinical and imaging variables, post-treatment infarct volume, and functional status at 90 days (modified Rankin Scale). RESULTS: Median post-treatment infarct volume in all subjects was 21 mL (interquartile range =65 mL), in the intervention arm, 15.5 mL (interquartile range =41.5 mL), and in the control arm, 33.5 mL (interquartile range =84 mL; P<0.01). Baseline National Institute of Health Stroke Scale (P<0.01), site of occlusion (P<0.01), baseline noncontrast computed tomographic scan Alberta Stroke Program Early CT score (ASPECTS) (P<0.01), and recanalization (P<0.01) were independently associated with post-treatment infarct volume, whereas age, sex, treatment type, intravenous alteplase, and time from onset to randomization were not (P>0.05). Post-treatment infarct volume (P<0.01) and delta National Institute of Health Stroke Scale (P<0.01) were independently associated with 90-day modified Rankin Scale, whereas laterality (left versus right) was not. CONCLUSIONS: These results support the primary results of the ESCAPE trial and show that the biological underpinning of the success of endovascular therapy is a reduction in infarct volume. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01778335.
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