title: A randomized trial of intraarterial treatment for acute ischemic stroke.
abstract: BACKGROUND
  In patients with acute ischemic stroke caused by a proximal intracranial arterial occlusion, intraarterial treatment is highly effective for emergency revascularization. However, proof of a beneficial effect on functional outcome is lacking.
  
  
  METHODS
  We randomly assigned eligible patients to either intraarterial treatment plus usual care or usual care alone. Eligible patients had a proximal arterial occlusion in the anterior cerebral circulation that was confirmed on vessel imaging and that could be treated intraarterially within 6 hours after symptom onset. The primary outcome was the modified Rankin scale score at 90 days; this categorical scale measures functional outcome, with scores ranging from 0 (no symptoms) to 6 (death). The treatment effect was estimated with ordinal logistic regression as a common odds ratio, adjusted for prespecified prognostic factors. The adjusted common odds ratio measured the likelihood that intraarterial treatment would lead to lower modified Rankin scores, as compared with usual care alone (shift analysis).
  
  
  RESULTS
  We enrolled 500 patients at 16 medical centers in The Netherlands (233 assigned to intraarterial treatment and 267 to usual care alone). The mean age was 65 years (range, 23 to 96), and 445 patients (89.0%) were treated with intravenous alteplase before randomization. Retrievable stents were used in 190 of the 233 patients (81.5%) assigned to intraarterial treatment. The adjusted common odds ratio was 1.67 (95% confidence interval [CI], 1.21 to 2.30). There was an absolute difference of 13.5 percentage points (95% CI, 5.9 to 21.2) in the rate of functional independence (modified Rankin score, 0 to 2) in favor of the intervention (32.6% vs. 19.1%). There were no significant differences in mortality or the occurrence of symptomatic intracerebral hemorrhage.
  
  
  CONCLUSIONS
  In patients with acute ischemic stroke caused by a proximal intracranial occlusion of the anterior circulation, intraarterial treatment administered within 6 hours after stroke onset was effective and safe. (Funded by the Dutch Heart Foundation and others; MR CLEAN Netherlands Trial Registry number, NTR1804, and Current Controlled Trials number, ISRCTN10888758.).
authors.affiliation: The authors' affiliations are listed in the Appendix.
authors.forename: Olvert A
authors.initials: OA
authors.lastname: Berkhemer
authors.forename: Puck S S
authors.initials: PS
authors.lastname: Fransen
authors.forename: Debbie
authors.initials: D
authors.lastname: Beumer
authors.forename: Lucie A
authors.initials: LA
authors.lastname: van den Berg
authors.forename: Hester F
authors.initials: HF
authors.lastname: Lingsma
authors.forename: Albert J
authors.initials: AJ
authors.lastname: Yoo
authors.forename: Wouter J
authors.initials: WJ
authors.lastname: Schonewille
authors.forename: Jan Albert
authors.initials: JA
authors.lastname: Vos
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Nederkoorn
authors.forename: Marieke J H
authors.initials: MJ
authors.lastname: Wermer
authors.forename: Marianne A A
authors.initials: MA
authors.lastname: van Walderveen
authors.forename: Julie
authors.initials: J
authors.lastname: Staals
authors.forename: Jeannette
authors.initials: J
authors.lastname: Hofmeijer
authors.forename: Jacques A
authors.initials: JA
authors.lastname: van Oostayen
authors.forename: Geert J
authors.initials: GJ
authors.lastname: Lycklama à Nijeholt
authors.forename: Jelis
authors.initials: J
authors.lastname: Boiten
authors.forename: Patrick A
authors.initials: PA
authors.lastname: Brouwer
authors.forename: Bart J
authors.initials: BJ
authors.lastname: Emmer
authors.forename: Sebastiaan F
authors.initials: SF
authors.lastname: de Bruijn
authors.forename: Lukas C
authors.initials: LC
authors.lastname: van Dijk
authors.forename: L Jaap
authors.initials: LJ
authors.lastname: Kappelle
authors.forename: Rob H
authors.initials: RH
authors.lastname: Lo
authors.forename: Ewoud J
authors.initials: EJ
authors.lastname: van Dijk
authors.forename: Joost
authors.initials: J
authors.lastname: de Vries
authors.forename: Paul L M
authors.initials: PL
authors.lastname: de Kort
authors.forename: Willem Jan J
authors.initials: WJ
authors.lastname: van Rooij
authors.forename: Jan S P
authors.initials: JS
authors.lastname: van den Berg
authors.forename: Boudewijn A A M
authors.initials: BA
authors.lastname: van Hasselt
authors.forename: Leo A M
authors.initials: LA
authors.lastname: Aerden
authors.forename: René J
authors.initials: RJ
authors.lastname: Dallinga
authors.forename: Marieke C
authors.initials: MC
authors.lastname: Visser
authors.forename: Joseph C J
authors.initials: JC
authors.lastname: Bot
authors.forename: Patrick C
authors.initials: PC
authors.lastname: Vroomen
authors.forename: Omid
authors.initials: O
authors.lastname: Eshghi
authors.forename: Tobien H C M L
authors.initials: TH
authors.lastname: Schreuder
authors.forename: Roel J J
authors.initials: RJ
authors.lastname: Heijboer
authors.forename: Koos
authors.initials: K
authors.lastname: Keizer
authors.forename: Alexander V
authors.initials: AV
authors.lastname: Tielbeek
authors.forename: Heleen M
authors.initials: HM
authors.lastname: den Hertog
authors.forename: Dick G
authors.initials: DG
authors.lastname: Gerrits
authors.forename: Renske M
authors.initials: RM
authors.lastname: van den Berg-Vos
authors.forename: Giorgos B
authors.initials: GB
authors.lastname: Karas
authors.forename: Ewout W
authors.initials: EW
authors.lastname: Steyerberg
authors.forename: H Zwenneke
authors.initials: HZ
authors.lastname: Flach
authors.forename: Henk A
authors.initials: HA
authors.lastname: Marquering
authors.forename: Marieke E S
authors.initials: ME
authors.lastname: Sprengers
authors.forename: Sjoerd F M
authors.initials: SF
authors.lastname: Jenniskens
authors.forename: Ludo F M
authors.initials: LF
authors.lastname: Beenen
authors.forename: René
authors.initials: R
authors.lastname: van den Berg
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Koudstaal
authors.forename: Wim H
authors.initials: WH
authors.lastname: van Zwam
authors.forename: Yvo B W E M
authors.initials: YB
authors.lastname: Roos
authors.forename: Aad
authors.initials: A
authors.lastname: van der Lugt
authors.forename: Robert J
authors.initials: RJ
authors.lastname: van Oostenbrugge
authors.forename: Charles B L M
authors.initials: CB
authors.lastname: Majoie
authors.forename: Diederik W J
authors.initials: DW
authors.lastname: Dippel
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002545:Brain Ischemia / Q000188:drug therapy / Q000628:therapy*; D002404:Catheterization; D003131:Combined Modality Therapy; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D006801:Humans; D016015:Logistic Models; D008297:Male; D061185:Mechanical Thrombolysis; D008875:Middle Aged; D016017:Odds Ratio; D016037:Single-Blind Method; D020521:Stroke / Q000188:drug therapy / Q000628:therapy*; D010959:Tissue Plasminogen Activator / Q000627:therapeutic use*; D014568:Urokinase-Type Plasminogen Activator / Q000627:therapeutic use*
chemical_list: D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator; D014568:Urokinase-Type Plasminogen Activator