title: Thrombectomy within 8 hours after symptom onset in ischemic stroke.
abstract: 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. (Funded by Fundació Ictus Malaltia Vascular through an unrestricted grant from Covidien and others; REVASCAT ClinicalTrials.gov number, NCT01692379.).
authors.affiliation: The authors' affiliations are listed in the Appendix.
authors.forename: Tudor G
authors.initials: TG
authors.lastname: Jovin
authors.forename: Angel
authors.initials: A
authors.lastname: Chamorro
authors.forename: Erik
authors.initials: E
authors.lastname: Cobo
authors.forename: María A
authors.initials: MA
authors.lastname: de Miquel
authors.forename: Carlos A
authors.initials: CA
authors.lastname: Molina
authors.forename: Alex
authors.initials: A
authors.lastname: Rovira
authors.forename: Luis
authors.initials: L
authors.lastname: San Román
authors.forename: Joaquín
authors.initials: J
authors.lastname: Serena
authors.forename: Sonia
authors.initials: S
authors.lastname: Abilleira
authors.forename: Marc
authors.initials: M
authors.lastname: Ribó
authors.forename: Mònica
authors.initials: M
authors.lastname: Millán
authors.forename: Xabier
authors.initials: X
authors.lastname: Urra
authors.forename: Pere
authors.initials: P
authors.lastname: Cardona
authors.forename: Elena
authors.initials: E
authors.lastname: López-Cancio
authors.forename: Alejandro
authors.initials: A
authors.lastname: Tomasello
authors.forename: Carlos
authors.initials: C
authors.lastname: Castaño
authors.forename: Jordi
authors.initials: J
authors.lastname: Blasco
authors.forename: Lucía
authors.initials: L
authors.lastname: Aja
authors.forename: Laura
authors.initials: L
authors.lastname: Dorado
authors.forename: Helena
authors.initials: H
authors.lastname: Quesada
authors.forename: Marta
authors.initials: M
authors.lastname: Rubiera
authors.forename: María
authors.initials: M
authors.lastname: Hernandez-Pérez
authors.forename: Mayank
authors.initials: M
authors.lastname: Goyal
authors.forename: Andrew M
authors.initials: AM
authors.lastname: Demchuk
authors.forename: Rüdiger
authors.initials: R
authors.lastname: von Kummer
authors.forename: Miquel
authors.initials: M
authors.lastname: Gallofré
authors.forename: Antoni
authors.initials: A
authors.lastname: Dávalos
mesh_terms: D000208:Acute Disease; D061605:Administration, Intravenous; D000368:Aged; D002545:Brain Ischemia / Q000628:therapy; D003131:Combined Modality Therapy; D000075202:Contraindications; D057510:Endovascular Procedures; D005260:Female; D005343:Fibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015607:Stents; D020521:Stroke / Q000188:drug therapy / Q000628:therapy*; D017131:Thrombectomy / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D061665:Time-to-Treatment; D010959:Tissue Plasminogen Activator / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator