Thrombectomy for Stroke at 6 to 16 Hours with Selection by Perfusion Imaging
Gregory W Albers, Michael P Marks, Stephanie Kemp, Soren Christensen, Jenny P Tsai, Santiago Ortega-Gutierrez, Ryan A McTaggart, Michel T Torbey, May Kim-Tenser, Thabele Leslie-Mazwi, Amrou Sarraj, Scott E Kasner, Sameer A Ansari, Sharon D Yeatts, Scott Hamilton, Michael Mlynash, Jeremy J Heit, Greg Zaharchuk, Sun Kim, Janice Carrozzella, Yuko Y Palesch, Andrew M Demchuk, Roland Bammer, Philip W Lavori, Joseph P Broderick, Maarten G Lansberg, DEFUSE 3 Investigators, Wade Smith, Helmi Lutsep, Colin Derdeyn, Peter Rasmussen, Osama Zaidat, Scott Janis, Joanna Vivalda, Claudia Moy, Jyoti Arora, Catherine Dillon, Jessica Griffin, Daniel Huang, Wenle Zhao, Amarnath Yennu, Tom Tomsick, E Clark Haley, Robert D Brown, Bryan H Curry, Stephanie Lowenhaupt, Michael K Parides, Arlene A Schmid, Jose-Miguel Yamal, Jason Davies, Alex Valadka, Enrique Leira, Edgar A Samaniego, Heena Olalde, Shadi Yaghi, Susan Foley, Ciarán J Powers, Muhammad Nasir, Matthew Tenser, Clare Binley, Emma Adair, Devin Qualls, Robert Hurst, Nichole Gallatti, Gary Spiegel, Chad Tremont, Shyam Prabhakaran, Ayesha Muzaffar, Dorothea Altschul, Kimberly Michel, Adam de Havenon, Min Park, Kinga Aitken, Johanna Fifi, Stanley Tuhrim, Jack Haslett, Robert Hoesch, Duane Blatter, Jeffrey Turner, Yasha Kayan, Mark Young, Jennifer Fease, Ray Stephens, Ira Finch, Parveen Sra, Arash Afshinnik, Robert Ryan, Rebekah Garcia, Neeraj Chaudhary, Devin Brown, Kelly Walter, Steven Feske, Ali Aziz-Sultan, Simone Renault, Daniel Cooke, Dominica Randazzo, Steven Warach, Jefferson Miley, Nathan Zuck, Azam Ahmed, Edward Bradbury, Stephanie Wilbrand, Hormozd Bozorgchami, Ryan Priest, Kelsey Nadeau, Toby Gropen, Mark Harrigan, April Sisson, Mary Kalafut, Giuseppe Ammirati, Linda Couts, Brett C Meyer, Alexander Khalessi, Brittney Lehmann, Gottfried Schlaug, Sarah Marchina, Souvik Sen, Roham Moftakhar, Evelyn Kennedy, Christopher Streib, Bharathi D Jagadeesan, Amanda Weller, Gabor Toth, Ken Uchino, Vikram Puvenna, Amie Hsia, Ai-Hsi Liu, Jamal Smith, Achala Vagal, Andrew J Ringer, Misty Wethington, Joshua Z Willey, Philip M Meyers, Alberto Canaan, Osama O Zaidat, Julie Goins-Whitmore, Michael Froehler, Jessica Collins, Dana Leifer, Athos Patsalides, Carla Sherman, Ted Lowenkopf, Vivek Deshmukh, Kristen Reid, David Tirschwell, Danial Hallam, Glenn Schubert, Gregory W Albers, Michael P Marks, Stephanie Kemp, Soren Christensen, Jenny P Tsai, Santiago Ortega-Gutierrez, Ryan A McTaggart, Michel T Torbey, May Kim-Tenser, Thabele Leslie-Mazwi, Amrou Sarraj, Scott E Kasner, Sameer A Ansari, Sharon D Yeatts, Scott Hamilton, Michael Mlynash, Jeremy J Heit, Greg Zaharchuk, Sun Kim, Janice Carrozzella, Yuko Y Palesch, Andrew M Demchuk, Roland Bammer, Philip W Lavori, Joseph P Broderick, Maarten G Lansberg, DEFUSE 3 Investigators, Wade Smith, Helmi Lutsep, Colin Derdeyn, Peter Rasmussen, Osama Zaidat, Scott Janis, Joanna Vivalda, Claudia Moy, Jyoti Arora, Catherine Dillon, Jessica Griffin, Daniel Huang, Wenle Zhao, Amarnath Yennu, Tom Tomsick, E Clark Haley, Robert D Brown, Bryan H Curry, Stephanie Lowenhaupt, Michael K Parides, Arlene A Schmid, Jose-Miguel Yamal, Jason Davies, Alex Valadka, Enrique Leira, Edgar A Samaniego, Heena Olalde, Shadi Yaghi, Susan Foley, Ciarán J Powers, Muhammad Nasir, Matthew Tenser, Clare Binley, Emma Adair, Devin Qualls, Robert Hurst, Nichole Gallatti, Gary Spiegel, Chad Tremont, Shyam Prabhakaran, Ayesha Muzaffar, Dorothea Altschul, Kimberly Michel, Adam de Havenon, Min Park, Kinga Aitken, Johanna Fifi, Stanley Tuhrim, Jack Haslett, Robert Hoesch, Duane Blatter, Jeffrey Turner, Yasha Kayan, Mark Young, Jennifer Fease, Ray Stephens, Ira Finch, Parveen Sra, Arash Afshinnik, Robert Ryan, Rebekah Garcia, Neeraj Chaudhary, Devin Brown, Kelly Walter, Steven Feske, Ali Aziz-Sultan, Simone Renault, Daniel Cooke, Dominica Randazzo, Steven Warach, Jefferson Miley, Nathan Zuck, Azam Ahmed, Edward Bradbury, Stephanie Wilbrand, Hormozd Bozorgchami, Ryan Priest, Kelsey Nadeau, Toby Gropen, Mark Harrigan, April Sisson, Mary Kalafut, Giuseppe Ammirati, Linda Couts, Brett C Meyer, Alexander Khalessi, Brittney Lehmann, Gottfried Schlaug, Sarah Marchina, Souvik Sen, Roham Moftakhar, Evelyn Kennedy, Christopher Streib, Bharathi D Jagadeesan, Amanda Weller, Gabor Toth, Ken Uchino, Vikram Puvenna, Amie Hsia, Ai-Hsi Liu, Jamal Smith, Achala Vagal, Andrew J Ringer, Misty Wethington, Joshua Z Willey, Philip M Meyers, Alberto Canaan, Osama O Zaidat, Julie Goins-Whitmore, Michael Froehler, Jessica Collins, Dana Leifer, Athos Patsalides, Carla Sherman, Ted Lowenkopf, Vivek Deshmukh, Kristen Reid, David Tirschwell, Danial Hallam, Glenn Schubert
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 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 .).
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Source: PubMed