title: Importance of proper patient selection and endpoint selection in evaluation of new therapies in acute stroke: further analysis of the SENTIS trial.
abstract: BACKGROUND
  The magnitude of treatment effect in acute stroke depends on several factors, including time from symptom onset (TFSO) to treatment and severity of the initial insult.
  
  
  OBJECTIVE
  To report further evaluation of NeuroFlo therapy, focusing on the effect of time and stroke severity.
  
  
  METHODS
  SENTIS was a prospective randomized trial (N=515) comparing standard medical therapy with/without NeuroFlo therapy. For this analysis, we evaluated outcomes in groups of patients based on TFSO and stroke severity: patients randomized <6 h, 6-10 h, and >10 h with mild (NIHSS<8), moderate (8-14), and severe (>14) symptoms at randomization. 90-Day mRS (modified Rankin Scale) scores and stroke-related death rates were compared between treatment groups.
  
  
  RESULTS
  For patients randomized <6 h TFSO (n=128), the OR for mRS 0-2 was 3.11 (CI 1.30 to 7.46, p=0.011) for treated versus non-treated patients. In patients with disease of moderate severity (NIHSS 8-14, n=214), NeuroFlo-treated patients were more likely to have a good outcome (mRS 0-2; OR=1.84, CI 1.02 to 3.33, p=0.043). The stroke-related death rate was better in the treated group with TFSO >10 h and NIHSS >14 (n=42) (OR=7.10, CI 1.13 to 44.55, p=0.036).
  
  
  CONCLUSIONS
  The results of our analysis support the importance of careful selection of outcome measures and the impact that rapid treatment and initial stroke severity have on outcome.
authors.affiliation: Department of Neurology, University of Alberta, Edmonton, Alberta Canada. hfaq.shuaib@ualberta.ca
authors.forename: Ashfaq
authors.initials: A
authors.lastname: Shuaib
authors.forename: Stefan
authors.initials: S
authors.lastname: Schwab
authors.forename: J Neal
authors.initials: JN
authors.lastname: Rutledge
authors.forename: Sidney
authors.initials: S
authors.lastname: Starkman
authors.forename: David S
authors.initials: DS
authors.lastname: Liebeskind
authors.forename: Gary L
authors.initials: GL
authors.lastname: Bernardini
authors.forename: Alan
authors.initials: A
authors.lastname: Boulos
authors.forename: Alex
authors.initials: A
authors.lastname: Abou-Chebl
authors.forename: David Y
authors.initials: DY
authors.lastname: Huang
authors.forename: Geert
authors.initials: G
authors.lastname: Vanhooren
authors.forename: Salvador
authors.initials: S
authors.lastname: Cruz-Flores
authors.forename: Richard Paul
authors.initials: RP
authors.lastname: Klucznik
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Saver
mesh_terms: D015331:Cohort Studies; D023381:Endpoint Determination; D005500:Follow-Up Studies; D006801:Humans; D018579:Patient Selection; D011446:Prospective Studies; D012189:Retrospective Studies; D020521:Stroke / Q000175:diagnosis* / Q000453:epidemiology / Q000628:therapy*; D016896:Treatment Outcome