Thrombectomy within 8 hours after symptom onset in ischemic stroke

BACKGROUND: We aimed to assess the safety and efficacy of thrombectomy for the treatment of stroke in a trial embedded within a population-based stroke reperfusion registry. METHODS: During a 2-year period at four centers in Catalonia, Spain, we randomly assigned 206 patients who could be treated wi...

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Authors: Jovin, Tudor G., Chamorro Sánchez, Ángel, Cobo, Erik, Miquel, Maria Angels de, Molina, Carlos A., Rovira, Alex, San Román, Luis, Serena, Joaquín, Abilleira, Sònia, Ribó Jacobi, Marc, Millán, Mónica, Urra, Xabier, Cardona Portela, Pere, López Cancio, Elena, Tomasello, Alejandro, Castaño, Carlos, Blasco, Jordi, Aja, Lucía, Dorado, Laura, Quesada, Helena, Rubiera, Marta, Hernández Pérez, María, Goyal, Mayank, Demchuk, Andrew M., Kummer, Rüdiger von, Gallofré, Miquel, Dávalos, Antoni, REVASCAT Trial Investigators
Format: article
Status:Published version
Publication Date:2015
Country:España
Institution:Universidad de Barcelona
Repository:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/125710
Online Access:https://hdl.handle.net/2445/125710
Access Level:Open access
Keyword:Malalties cerebrovasculars
Isquèmia cerebral
Cerebrovascular disease
Cerebral ischemia
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spelling Thrombectomy within 8 hours after symptom onset in ischemic strokeJovin, Tudor G.Chamorro Sánchez, ÁngelCobo, ErikMiquel, Maria Angels de Molina, Carlos A.Rovira, AlexSan Román, LuisSerena, JoaquínAbilleira, SòniaRibó Jacobi, MarcMillán, MónicaUrra, XabierCardona Portela, PereLópez Cancio, ElenaTomasello, AlejandroCastaño, CarlosBlasco, JordiAja, LucíaDorado, LauraQuesada, HelenaRubiera, MartaHernández Pérez, MaríaGoyal, MayankDemchuk, Andrew M.Kummer, Rüdiger vonGallofré, MiquelDávalos, AntoniREVASCAT Trial InvestigatorsMalalties cerebrovascularsIsquèmia cerebralCerebrovascular diseaseCerebral ischemiaBACKGROUND: We aimed to assess the safety and efficacy of thrombectomy for the treatment of stroke in a trial embedded within a population-based stroke reperfusion registry. METHODS: During a 2-year period at four centers in Catalonia, Spain, we randomly assigned 206 patients who could be treated within 8 hours after the onset of symptoms of acute ischemic stroke to receive either medical therapy (including intravenous alteplase when eligible) and endovascular therapy with the Solitaire stent retriever (thrombectomy group) or medical therapy alone (control group). All patients had confirmed proximal anterior circulation occlusion and the absence of a large infarct on neuroimaging. In all study patients, the use of alteplase either did not achieve revascularization or was contraindicated. The primary outcome was the severity of global disability at 90 days, as measured on the modified Rankin scale (ranging from 0 [no symptoms] to 6 [death]). Although the maximum planned sample size was 690, enrollment was halted early because of loss of equipoise after positive results for thrombectomy were reported from other similar trials. RESULTS Thrombectomy reduced the severity of disability over the range of the modified Rankin scale (adjusted odds ratio for improvement of 1 point, 1.7; 95% confidence interval [CI], 1.05 to 2.8) and led to higher rates of functional independence (a score of 0 to 2) at 90 days (43.7% vs. 28.2%; adjusted odds ratio, 2.1; 95% CI, 1.1 to 4.0). At 90 days, the rates of symptomatic intracranial hemorrhage were 1.9% in both the thrombectomy group and the control group (P = 1.00), and rates of death were 18.4% and 15.5%, respectively (P = 0.60). Registry data indicated that only eight patients who met the eligibility criteria were treated outside the trial at participating hospitals. CONCLUSIONS: Among patients with anterior circulation stroke who could be treated within 8 hours after symptom onset, stent retriever thrombectomy reduced the severity of post-stroke disability and increased the rate of functional independence.Massachusetts Medical Society2015info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/2445/125710Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésReproducció del document publicat a: https://doi.org/10.1056/NEJMoa1503780New England Journal of Medicine, 2015, vol. 372, num. 24, p. 2296-2306https://doi.org/10.1056/NEJMoa1503780(c) Massachusetts Medical Society, 2015info:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/1257102026-05-27T06:46:51Z
dc.title.none.fl_str_mv Thrombectomy within 8 hours after symptom onset in ischemic stroke
title Thrombectomy within 8 hours after symptom onset in ischemic stroke
spellingShingle Thrombectomy within 8 hours after symptom onset in ischemic stroke
Jovin, Tudor G.
Malalties cerebrovasculars
Isquèmia cerebral
Cerebrovascular disease
Cerebral ischemia
title_short Thrombectomy within 8 hours after symptom onset in ischemic stroke
title_full Thrombectomy within 8 hours after symptom onset in ischemic stroke
title_fullStr Thrombectomy within 8 hours after symptom onset in ischemic stroke
title_full_unstemmed Thrombectomy within 8 hours after symptom onset in ischemic stroke
title_sort Thrombectomy within 8 hours after symptom onset in ischemic stroke
dc.creator.none.fl_str_mv Jovin, Tudor G.
Chamorro Sánchez, Ángel
Cobo, Erik
Miquel, Maria Angels de
Molina, Carlos A.
Rovira, Alex
San Román, Luis
Serena, Joaquín
Abilleira, Sònia
Ribó Jacobi, Marc
Millán, Mónica
Urra, Xabier
Cardona Portela, Pere
López Cancio, Elena
Tomasello, Alejandro
Castaño, Carlos
Blasco, Jordi
Aja, Lucía
Dorado, Laura
Quesada, Helena
Rubiera, Marta
Hernández Pérez, María
Goyal, Mayank
Demchuk, Andrew M.
Kummer, Rüdiger von
Gallofré, Miquel
Dávalos, Antoni
REVASCAT Trial Investigators
author Jovin, Tudor G.
author_facet Jovin, Tudor G.
Chamorro Sánchez, Ángel
Cobo, Erik
Miquel, Maria Angels de
Molina, Carlos A.
Rovira, Alex
San Román, Luis
Serena, Joaquín
Abilleira, Sònia
Ribó Jacobi, Marc
Millán, Mónica
Urra, Xabier
Cardona Portela, Pere
López Cancio, Elena
Tomasello, Alejandro
Castaño, Carlos
Blasco, Jordi
Aja, Lucía
Dorado, Laura
Quesada, Helena
Rubiera, Marta
Hernández Pérez, María
Goyal, Mayank
Demchuk, Andrew M.
Kummer, Rüdiger von
Gallofré, Miquel
Dávalos, Antoni
REVASCAT Trial Investigators
author_role author
author2 Chamorro Sánchez, Ángel
Cobo, Erik
Miquel, Maria Angels de
Molina, Carlos A.
Rovira, Alex
San Román, Luis
Serena, Joaquín
Abilleira, Sònia
Ribó Jacobi, Marc
Millán, Mónica
Urra, Xabier
Cardona Portela, Pere
López Cancio, Elena
Tomasello, Alejandro
Castaño, Carlos
Blasco, Jordi
Aja, Lucía
Dorado, Laura
Quesada, Helena
Rubiera, Marta
Hernández Pérez, María
Goyal, Mayank
Demchuk, Andrew M.
Kummer, Rüdiger von
Gallofré, Miquel
Dávalos, Antoni
REVASCAT Trial Investigators
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Malalties cerebrovasculars
Isquèmia cerebral
Cerebrovascular disease
Cerebral ischemia
topic Malalties cerebrovasculars
Isquèmia cerebral
Cerebrovascular disease
Cerebral ischemia
description BACKGROUND: We aimed to assess the safety and efficacy of thrombectomy for the treatment of stroke in a trial embedded within a population-based stroke reperfusion registry. METHODS: During a 2-year period at four centers in Catalonia, Spain, we randomly assigned 206 patients who could be treated within 8 hours after the onset of symptoms of acute ischemic stroke to receive either medical therapy (including intravenous alteplase when eligible) and endovascular therapy with the Solitaire stent retriever (thrombectomy group) or medical therapy alone (control group). All patients had confirmed proximal anterior circulation occlusion and the absence of a large infarct on neuroimaging. In all study patients, the use of alteplase either did not achieve revascularization or was contraindicated. The primary outcome was the severity of global disability at 90 days, as measured on the modified Rankin scale (ranging from 0 [no symptoms] to 6 [death]). Although the maximum planned sample size was 690, enrollment was halted early because of loss of equipoise after positive results for thrombectomy were reported from other similar trials. RESULTS Thrombectomy reduced the severity of disability over the range of the modified Rankin scale (adjusted odds ratio for improvement of 1 point, 1.7; 95% confidence interval [CI], 1.05 to 2.8) and led to higher rates of functional independence (a score of 0 to 2) at 90 days (43.7% vs. 28.2%; adjusted odds ratio, 2.1; 95% CI, 1.1 to 4.0). At 90 days, the rates of symptomatic intracranial hemorrhage were 1.9% in both the thrombectomy group and the control group (P = 1.00), and rates of death were 18.4% and 15.5%, respectively (P = 0.60). Registry data indicated that only eight patients who met the eligibility criteria were treated outside the trial at participating hospitals. CONCLUSIONS: Among patients with anterior circulation stroke who could be treated within 8 hours after symptom onset, stent retriever thrombectomy reduced the severity of post-stroke disability and increased the rate of functional independence.
publishDate 2015
dc.date.none.fl_str_mv 2015
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/125710
url https://hdl.handle.net/2445/125710
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: https://doi.org/10.1056/NEJMoa1503780
New England Journal of Medicine, 2015, vol. 372, num. 24, p. 2296-2306
https://doi.org/10.1056/NEJMoa1503780
dc.rights.none.fl_str_mv (c) Massachusetts Medical Society, 2015
info:eu-repo/semantics/openAccess
rights_invalid_str_mv (c) Massachusetts Medical Society, 2015
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Massachusetts Medical Society
publisher.none.fl_str_mv Massachusetts Medical Society
dc.source.none.fl_str_mv Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))
reponame:Dipòsit Digital de la UB
instname:Universidad de Barcelona
instname_str Universidad de Barcelona
reponame_str Dipòsit Digital de la UB
collection Dipòsit Digital de la UB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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