Gregory W Albers1, Michael P Marks1, Stephanie Kemp1, Soren Christensen1, Jenny P Tsai1, Santiago Ortega-Gutierrez1, Ryan A McTaggart1, Michel T Torbey1, May Kim-Tenser1, Thabele Leslie-Mazwi1, Amrou Sarraj1, Scott E Kasner1, Sameer A Ansari1, Sharon D Yeatts1, Scott Hamilton1, Michael Mlynash1, Jeremy J Heit1, Greg Zaharchuk1, Sun Kim1, Janice Carrozzella1, Yuko Y Palesch1, Andrew M Demchuk1, Roland Bammer1, Philip W Lavori1, Joseph P Broderick1, Maarten G Lansberg1. 1. From the Departments of Neurology and Neurological Sciences (G.W.A., S. Kemp, S.C., J.P.T., S.H., M.M., M.G.L.), Diagnostic Radiology (M.P.M., J.J.H., G.Z.), Radiology (R.B.), and Biomedical Data Science (P.W.L.), Stanford University School of Medicine, Stanford, and the Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles (M.K.-T.) - both in California; the Departments of Neurology, Anesthesia, Neurosurgery, and Radiology, University of Iowa, Ames (S.O.-G.); the Departments of Diagnostic Imaging, Neurology, and Neurosurgery, Warren Alpert School of Medicine at Brown University and Rhode Island Hospital, Providence (R.A.M.); the Departments of Neurology and Neurosurgery, Ohio State University, Columbus (M.T.T.), and the University of Cincinnati Gardner Neuroscience Institute and the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.C., J.P.B.) - both in Ohio; the Departments of Neurosurgery and Neurology, Massachusetts General Hospital, Boston (T.L.-M.); the Department of Neurology, University of Texas Health Science Center, Houston (A.S.); the Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia (S.E.K.); the Departments of Radiology, Neurology, and Neurological Surgery, Northwestern University, Feinberg School of Medicine, Chicago (S.A.A.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (S.D.Y., Y.Y.P.); the Department of Neurology, New York University School of Medicine, New York (S. Kim); and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary Cumming School of Medicine, Calgary, AB, Canada (A.M.D.).
Abstract
BACKGROUND: Thrombectomy is currently recommended for eligible patients with stroke who are treated within 6 hours after the onset of symptoms. METHODS: We conducted a multicenter, randomized, open-label trial, with blinded outcome assessment, of thrombectomy in patients 6 to 16 hours after they were last known to be well and who had remaining ischemic brain tissue that was not yet infarcted. Patients with proximal middle-cerebral-artery or internal-carotid-artery occlusion, an initial infarct size of less than 70 ml, and a ratio of the volume of ischemic tissue on perfusion imaging to infarct volume of 1.8 or more were randomly assigned toendovascular therapy (thrombectomy) plus standard medical therapy (endovascular-therapy group) or standard medical therapy alone (medical-therapy group). The primary outcome was the ordinal score on the modified Rankin scale (range, 0 to 6, with higher scores indicating greater disability) at day 90. RESULTS: The trial was conducted at 38 U.S. centers and terminated early for efficacy after 182 patients had undergone randomization (92 to the endovascular-therapy group and 90 to the medical-therapy group). Endovascular therapy plus medical therapy, as compared with medical therapy alone, was associated with a favorable shift in the distribution of functional outcomes on the modified Rankin scale at 90 days (odds ratio, 2.77; P<0.001) and a higher percentage of patients who were functionally independent, defined as a score on the modified Rankin scale of 0 to 2 (45% vs. 17%, P<0.001). The 90-day mortality rate was 14% in the endovascular-therapy group and 26% in the medical-therapy group (P=0.05), and there was no significant between-group difference in the frequency of symptomatic intracranial hemorrhage (7% and 4%, respectively; P=0.75) or of serious adverse events (43% and 53%, respectively; P=0.18). CONCLUSIONS:Endovascular thrombectomy for ischemic stroke 6 to 16 hours after a patient was last known to be well plus standard medical therapy resulted in better functional outcomes than standard medical therapy alone among patients with proximal middle-cerebral-artery or internal-carotid-artery occlusion and a region of tissue that was ischemic but not yet infarcted. (Funded by the National Institute of Neurological Disorders and Stroke; DEFUSE 3 ClinicalTrials.gov number, NCT02586415 .).
RCT Entities:
BACKGROUND: Thrombectomy is currently recommended for eligible patients with stroke who are treated within 6 hours after the onset of symptoms. METHODS: We conducted a multicenter, randomized, open-label trial, with blinded outcome assessment, of thrombectomy in patients 6 to 16 hours after they were last known to be well and who had remaining ischemic brain tissue that was not yet infarcted. Patients with proximal middle-cerebral-artery or internal-carotid-artery occlusion, an initial infarct size of less than 70 ml, and a ratio of the volume of ischemic tissue on perfusion imaging to infarct volume of 1.8 or more were randomly assigned to endovascular therapy (thrombectomy) plus standard medical therapy (endovascular-therapy group) or standard medical therapy alone (medical-therapy group). The primary outcome was the ordinal score on the modified Rankin scale (range, 0 to 6, with higher scores indicating greater disability) at day 90. RESULTS: The trial was conducted at 38 U.S. centers and terminated early for efficacy after 182 patients had undergone randomization (92 to the endovascular-therapy group and 90 to the medical-therapy group). Endovascular therapy plus medical therapy, as compared with medical therapy alone, was associated with a favorable shift in the distribution of functional outcomes on the modified Rankin scale at 90 days (odds ratio, 2.77; P<0.001) and a higher percentage of patients who were functionally independent, defined as a score on the modified Rankin scale of 0 to 2 (45% vs. 17%, P<0.001). The 90-day mortality rate was 14% in the endovascular-therapy group and 26% in the medical-therapy group (P=0.05), and there was no significant between-group difference in the frequency of symptomatic intracranial hemorrhage (7% and 4%, respectively; P=0.75) or of serious adverse events (43% and 53%, respectively; P=0.18). CONCLUSIONS: Endovascular thrombectomy for ischemic stroke 6 to 16 hours after a patient was last known to be well plus standard medical therapy resulted in better functional outcomes than standard medical therapy alone among patients with proximal middle-cerebral-artery or internal-carotid-artery occlusion and a region of tissue that was ischemic but not yet infarcted. (Funded by the National Institute of Neurological Disorders and Stroke; DEFUSE 3 ClinicalTrials.gov number, NCT02586415 .).
Authors: Maarten G Lansberg; Matus Straka; Stephanie Kemp; Michael Mlynash; Lawrence R Wechsler; Tudor G Jovin; Michael J Wilder; Helmi L Lutsep; Todd J Czartoski; Richard A Bernstein; Cherylee W J Chang; Steven Warach; Franz Fazekas; Manabu Inoue; Aaryani Tipirneni; Scott A Hamilton; Greg Zaharchuk; Michael P Marks; Roland Bammer; Gregory W Albers Journal: Lancet Neurol Date: 2012-09-04 Impact factor: 44.182
Authors: Hayley M Wheeler; Michael Mlynash; Manabu Inoue; Aaryani Tipirnini; John Liggins; Roland Bammer; Maarten G Lansberg; Stephanie Kemp; Greg Zaharchuk; Matus Straka; Gregory W Albers Journal: Int J Stroke Date: 2015-01-12 Impact factor: 5.266
Authors: Pooja Khatri; Sharon D Yeatts; Mikael Mazighi; Joseph P Broderick; David S Liebeskind; Andrew M Demchuk; Pierre Amarenco; Janice Carrozzella; Judith Spilker; Lydia D Foster; Mayank Goyal; Michael D Hill; Yuko Y Palesch; Edward C Jauch; E Clarke Haley; Achala Vagal; Thomas A Tomsick Journal: Lancet Neurol Date: 2014-04-27 Impact factor: 44.182
Authors: Jeffrey L Saver; Mayank Goyal; Alain Bonafe; Hans-Christoph Diener; Elad I Levy; Vitor M Pereira; Gregory W Albers; Christophe Cognard; David J Cohen; Werner Hacke; Olav Jansen; Tudor G Jovin; Heinrich P Mattle; Raul G Nogueira; Adnan H Siddiqui; Dileep R Yavagal; Blaise W Baxter; Thomas G Devlin; Demetrius K Lopes; Vivek K Reddy; Richard du Mesnil de Rochemont; Oliver C Singer; Reza Jahan Journal: N Engl J Med Date: 2015-04-17 Impact factor: 91.245
Authors: Bruce C V Campbell; Peter J Mitchell; Timothy J Kleinig; Helen M Dewey; Leonid Churilov; Nawaf Yassi; Bernard Yan; Richard J Dowling; Mark W Parsons; Thomas J Oxley; Teddy Y Wu; Mark Brooks; Marion A Simpson; Ferdinand Miteff; Christopher R Levi; Martin Krause; Timothy J Harrington; Kenneth C Faulder; Brendan S Steinfort; Miriam Priglinger; Timothy Ang; Rebecca Scroop; P Alan Barber; Ben McGuinness; Tissa Wijeratne; Thanh G Phan; Winston Chong; Ronil V Chandra; Christopher F Bladin; Monica Badve; Henry Rice; Laetitia de Villiers; Henry Ma; Patricia M Desmond; Geoffrey A Donnan; Stephen M Davis Journal: N Engl J Med Date: 2015-02-11 Impact factor: 91.245
Authors: Edward C Jauch; Jeffrey L Saver; Harold P Adams; Askiel Bruno; J J Buddy Connors; Bart M Demaerschalk; Pooja Khatri; Paul W McMullan; Adnan I Qureshi; Kenneth Rosenfield; Phillip A Scott; Debbie R Summers; David Z Wang; Max Wintermark; Howard Yonas Journal: Stroke Date: 2013-01-31 Impact factor: 7.914
Authors: Osama O Zaidat; Albert J Yoo; Pooja Khatri; Thomas A Tomsick; Rüdiger von Kummer; Jeffrey L Saver; Michael P Marks; Shyam Prabhakaran; David F Kallmes; Brian-Fred M Fitzsimmons; J Mocco; Joanna M Wardlaw; Stanley L Barnwell; Tudor G Jovin; Italo Linfante; Adnan H Siddiqui; Michael J Alexander; Joshua A Hirsch; Max Wintermark; Gregory Albers; Henry H Woo; Donald V Heck; Michael Lev; Richard Aviv; Werner Hacke; Steven Warach; Joseph Broderick; Colin P Derdeyn; Anthony Furlan; Raul G Nogueira; Dileep R Yavagal; Mayank Goyal; Andrew M Demchuk; Martin Bendszus; David S Liebeskind Journal: Stroke Date: 2013-08-06 Impact factor: 7.914
Authors: James E Siegler; Steven R Messé; Heidi Sucharew; Scott E Kasner; Tapan Mehta; Niraj Arora; Amy K Starosciak; Felipe De Los Rios La Rosa; Natasha R Barnhill; Akshitkumar M Mistry; Kishan Patel; Salman Assad; Amjad Tarboosh; Katarina Dakay; Jeff Wagner; Alicia Bennett; Bharathi Jagadeesan; Christopher Streib; Stewart A Weber; Rohan Chitale; John J Volpi; Stephan A Mayer; Shadi Yaghi; Mahesh V Jayaraman; Pooja Khatri; Eva A Mistry Journal: J Neuroimaging Date: 2019-11-24 Impact factor: 2.486