Document Detail


Endovascular treatment for acute ischemic stroke.
MedLine Citation:
PMID:  23387822     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: In patients with ischemic stroke, endovascular treatment results in a higher rate of recanalization of the affected cerebral artery than systemic intravenous thrombolytic therapy. However, comparison of the clinical efficacy of the two approaches is needed.
METHODS: We randomly assigned 362 patients with acute ischemic stroke, within 4.5 hours after onset, to endovascular therapy (intraarterial thrombolysis with recombinant tissue plasminogen activator [t-PA], mechanical clot disruption or retrieval, or a combination of these approaches) or intravenous t-PA. Treatments were to be given as soon as possible after randomization. The primary outcome was survival free of disability (defined as a modified Rankin score of 0 or 1 on a scale of 0 to 6, with 0 indicating no symptoms, 1 no clinically significant disability despite symptoms, and 6 death) at 3 months.
RESULTS: A total of 181 patients were assigned to receive endovascular therapy, and 181 intravenous t-PA. The median time from stroke onset to the start of treatment was 3.75 hours for endovascular therapy and 2.75 hours for intravenous t-PA (P<0.001). At 3 months, 55 patients in the endovascular-therapy group (30.4%) and 63 in the intravenous t-PA group (34.8%) were alive without disability (odds ratio adjusted for age, sex, stroke severity, and atrial fibrillation status at baseline, 0.71; 95% confidence interval, 0.44 to 1.14; P=0.16). Fatal or nonfatal symptomatic intracranial hemorrhage within 7 days occurred in 6% of the patients in each group, and there were no significant differences between groups in the rates of other serious adverse events or the case fatality rate.
CONCLUSIONS: The results of this trial in patients with acute ischemic stroke indicate that endovascular therapy is not superior to standard treatment with intravenous t-PA. (Funded by the Italian Medicines Agency, ClinicalTrials.gov number, NCT00640367.).
Authors:
Alfonso Ciccone; Luca Valvassori; Michele Nichelatti; Annalisa Sgoifo; Michela Ponzio; Roberto Sterzi; Edoardo Boccardi;
Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2013-02-06
Journal Detail:
Title:  The New England journal of medicine     Volume:  368     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2013 Mar 
Date Detail:
Created Date:  2013-03-07     Completed Date:  2013-03-14     Revised Date:  2013-10-18    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  904-13     Citation Subset:  AIM; IM    
Affiliation:
Stroke Unit and Department of Neurology, Niguarda Ca' Granda Hospital, Milan, Italy. alfonso.ciccone@aopoma.it
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00640367
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MeSH Terms
Descriptor/Qualifier:
Acute Disease
Adult
Aged
Brain Ischemia / drug therapy,  surgery
Cerebral Angiography
Cerebral Hemorrhage / etiology
Combined Modality Therapy
Endovascular Procedures / adverse effects,  methods*
Female
Fibrinolytic Agents / adverse effects,  therapeutic use*
Humans
Infusions, Intravenous
Male
Middle Aged
Single-Blind Method
Stroke / drug therapy*,  mortality,  surgery
Thrombectomy* / adverse effects
Tissue Plasminogen Activator / adverse effects,  therapeutic use*
Treatment Outcome
Grant Support
ID/Acronym/Agency:
R01 NS053716/NS/NINDS NIH HHS; R37 NS038710/NS/NINDS NIH HHS
Chemical
Reg. No./Substance:
0/Fibrinolytic Agents; EC 3.4.21.68/Tissue Plasminogen Activator
Investigator
Investigator/Affiliation:
A Ciccone / ; A Gatti / ; A Guccione / ; C Motto / ; I Santilli / ; R Tortorella / ; R Sterzi / ; E Ferrante / ; F Imbesi / ; R Marazzi / ; S Jann / ; A Protti / ; M Rizzone / ; P Tiraboschi / ; E Boccardi / ; L Valvassori / ; G Pero / ; L Quilici / ; M Piano / ; A Zini / ; F Casoni / ; M Cavazzuti / ; F Falzone / ; P Nichelli / ; S Vallone / ; P Carpeggiani / ; F Menetti / ; M Guidotti / ; N Checcarelli / ; F Muscia / ; A Martegani / ; G Torgano / ; C Mandelli / ; B Zecca / ; P Baron / ; A Bersano / ; V Branca / ; M Isalberti / ; R Papa / ; A Paolucci / ; M Magoni / ; A Costa / ; M Gamba / ; R Gasparotti / ; F Federico / ; M Petruzzellis / ; B Tartaglione / ; D Mezzapesa / ; L Chiumarulo / ; R De Blasi / ; E Agostoni / ; E Botto / ; M Longoni / ; V Ballarini / ; P Reganati / ; L Malfatto / ; D Rizzi / ; C Serrati / ; M Balestrino / ; C Gandolfo / ; L Castellan / ; N Mavilio / ; L Allegretti / ; M L Delodovici / ; F Carimati / ; E P Verrengia / ; G Bono / ; F Perlasca / ; G Craparo / ; A Giorgianni / ; C Azzini / ; A De Vito / ; M Tola / ; A Saletti / ; C Pozzessere / ; F Corsi / ; G Scifoni / ; S Anticoli / ; F R Pezzella / ; E Cotroneo / ; R Gigli / ; P Nencini / ; V Palumbo / ; L Pantoni / ; D Inzitari / ; S Mangiafico / ; M Chinaglia / ; M Russo / ; R L'Erario / ; P Amistà / ; G Malferrari / ; A Nucera / ; M L Zedde / ; A Dallari / ; G Deberti / ; F Falaschi / ; A Martignoni / ; F Zappoli / ; S Marcheselli / ; B Stival / ; P Presbitero / ; M L Rossi / ; G Belli / ; M Paciaroni / ; V Caso / ; G C Agnelli / ; M Hamam / ; P Bovi / ; E Piovan / ; M Sessa / ; F Scomazzoni / ; M Arnaboldi / ; L Tancredi / ; R Peroni / ; B Censori / ; M Poloni / ; S Lunghi / ; G Bonaldi / ; E Donati / ; E Magni / ; M Pavia / ; M Cobelli / ; E Bottacchi / ; G Corso / ; P Tosi / ; S Cordera / ; M Di Giovanni / ; G Giardini / ; T Meloni / ; M Cristoferi / ; M Natrella / ; L Ruiz / ; M L Dell'Acqua / ; G Rolandi / ; I Gallesio / ; A Ciccone / ; A Ciccone / ; L Valvassori / ; E Boccardi / ; R Sterzi / ; P Sandercock / ; L Candelise / ; G del Zoppo / ; M Nichelatti / ; M Ponzio / ; E Ciceri / ; P Doneda / ; C Motto / ; M Daolio / ; A Sgoifo / ; D Caputo / ; E del Zotto / ; E Botto / ; T Cantisani /
Comments/Corrections
Comment In:
N Engl J Med. 2013 Jun 20;368(25):2432   [PMID:  23782187 ]
N Engl J Med. 2013 Jun 20;368(25):2431   [PMID:  23782185 ]
N Engl J Med. 2013 Jun 20;368(25):2430-1   [PMID:  23782184 ]
Dtsch Med Wochenschr. 2013 Apr;138(17):874-5   [PMID:  23592341 ]
N Engl J Med. 2013 Mar 7;368(10):952-5   [PMID:  23394477 ]
N Engl J Med. 2013 Jun 20;368(25):2433-4   [PMID:  23802240 ]
Neurosurgery. 2013 Aug;73(2):E375-9   [PMID:  23632768 ]

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