title: Sex-based differences in the effect of intra-arterial treatment of stroke: analysis of the PROACT-2 study.
abstract: OBJECTIVE
  Sex influences outcome after intravenous thrombolysis. In a combined analysis of the tissue plasminogen activator clinical trials, a sex-by-treatment interaction was observed. We sought to confirm that observation in an independent data set.
  
  
  METHODS
  Data were from the Pro-Urokinase for Acute Cerebral Thromboembolism-2 (PROACT-2) trial. Baseline factors were compared by sex. The primary outcome was an assessment of a sex-by-treatment interaction term within a logistic regression model, using a modified Rankin Scale score <or=2 at 90 days as the binary outcome. We also assessed whether there were differences in CT-scan appearance and recanalization at 2 hours post-treatment.
  
  
  RESULTS
  In the PROACT-2 study of intra-arterial stroke thrombolysis, in both women and men, prourokinase resulted in better outcomes than control. A sex by prourokinase treatment interaction was observed, with women showing a larger treatment effect (20% absolute benefit) compared with men (10% absolute benefit). The reason for this interaction is that thrombolytic treatment nullifies the worse outcome for untreated women compared with men. The reasons for effect modification do not include improved recanalization at 2 hours among women.
  
  
  CONCLUSIONS
  Women with middle cerebral artery ischemic stroke benefit more from intra-arterial therapy. Further study of how sex affects stroke outcome is needed.
authors.affiliation: Calgary Stroke Program, Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada. Michael.hill@calgaryhealthregion.ca
authors.forename: Michael D
authors.initials: MD
authors.lastname: Hill
authors.forename: David M
authors.initials: DM
authors.lastname: Kent
authors.forename: Judith
authors.initials: J
authors.lastname: Hinchey
authors.forename: Howard
authors.initials: H
authors.lastname: Rowley
authors.forename: Alastair M
authors.initials: AM
authors.lastname: Buchan
authors.forename: Lawrence R
authors.initials: LR
authors.lastname: Wechsler
authors.forename: Randall T
authors.initials: RT
authors.lastname: Higashida
authors.forename: Nancy J
authors.initials: NJ
authors.lastname: Fischbein
authors.forename: William P
authors.initials: WP
authors.lastname: Dillon
authors.forename: Michael
authors.initials: M
authors.lastname: Gent
authors.forename: Carolyn M
authors.initials: CM
authors.lastname: Firszt
authors.forename: Gregory A
authors.initials: GA
authors.lastname: Schulz
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Furlan
mesh_terms: D000368:Aged; D002545:Brain Ischemia / Q000150:complications; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D006801:Humans; D007269:Injections, Intra-Arterial; D008297:Male; D008875:Middle Aged; D020768:Middle Cerebral Artery; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use; D012727:Sex Characteristics; D020521:Stroke / Q000188:drug therapy* / Q000209:etiology; D016896:Treatment Outcome; D014568:Urokinase-Type Plasminogen Activator / Q000008:administration & dosage* / Q000627:therapeutic use
chemical_list: D005343:Fibrinolytic Agents; D011994:Recombinant Proteins; D014568:Urokinase-Type Plasminogen Activator; C067551:saruplase