title: Endovascular treatment for acute ischemic stroke.
abstract: 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: Stroke Unit and Department of Neurology, Niguarda Ca' Granda Hospital, Milan, Italy. alfonso.ciccone@aopoma.it
authors: Alfonso
authors: A
authors: Ciccone
authors: Luca
authors: L
authors: Valvassori
authors: Michele
authors: M
authors: Nichelatti
authors: Annalisa
authors: A
authors: Sgoifo
authors: Michela
authors: M
authors: Ponzio
authors: Roberto
authors: R
authors: Sterzi
authors: Edoardo
authors: E
authors: Boccardi
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D002545:Brain Ischemia / Q000188:drug therapy / Q000601:surgery; D002533:Cerebral Angiography; D002543:Cerebral Hemorrhage / Q000209:etiology; D003131:Combined Modality Therapy; D057510:Endovascular Procedures / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005343:Fibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D016037:Single-Blind Method; D020521:Stroke / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D017131:Thrombectomy / Q000009:adverse effects; D010959:Tissue Plasminogen Activator / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator
references: Stroke. 2008 Apr;39(4):1205-12
references: 18309168
references: Lancet. 2012 Oct 6;380(9849):1231-40
references: 22932714
references: Lancet. 2012 Oct 6;380(9849):1241-9
references: 22932715
references: Int J Stroke. 2011 Jun;6(3):259-65
references: 21557814
references: AJNR Am J Neuroradiol. 2002 Oct;23(9):1596-9
references: 12372754
references: Lancet Neurol. 2009 Sep;8(9):802-9
references: 19647488
references: Int J Stroke. 2008 May;3(2):130-7
references: 18706007
references: AJNR Am J Neuroradiol. 1996 Jan;17(1):79-85
references: 8770253
references: AJNR Am J Neuroradiol. 1998 Jun-Jul;19(6):1169-75
references: 9672034
references: Stroke. 2007 Oct;38(10):2633-9
references: 17702958
references: Stroke. 1989 Jul;20(7):864-70
references: 2749846
references: J Neurointerv Surg. 2010 Mar;2(1):74-9
references: 21990564
references: Stroke. 2008 Feb;39(2):379-83
references: 18096842
references: Stroke. 2007 Mar;38(3):948-54
references: 17290031
references: AJNR Am J Neuroradiol. 2010 Mar;31(3):454-8
references: 20075087
references: Lancet. 2012 Jun 23;379(9834):2364-72
references: 22632907
references: Stroke. 2012 May;43(5):1309-14
references: 22382160
references: JAMA. 1999 Dec 1;282(21):2003-11
references: 10591382
references: Stroke. 2007 Jul;38(7):2191-5
references: 17540973
references: Stroke. 2012 Sep;43(9):2350-5
references: 22811451
references: Stroke. 1998 Jan;29(1):4-11
references: 9445320
references: Stroke. 2007 Mar;38(3):967-73
references: 17272772
references: Stroke. 1988 May;19(5):604-7
references: 3363593
references: Ann Neurol. 1992 Jul;32(1):78-86
references: 1642475
references: Stroke. 2009 Aug;40(8):2761-8
references: 19590057
references: Stroke. 2010 May;41(5):842-3
references: 20378862
references: Lancet Neurol. 2003 Jun;2(6):375-8
references: 12849154