title: Reduced mortality and severe disability rates in the SENTIS trial.
abstract: OBJECTIVE
  The Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke trial showed a trend for reduced all-cause mortality and positive secondary safety end point outcomes. We present further analyses of the mortality and severe disability data from the Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke trial.
  
  
  METHODS
  The Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke trial was a multicenter, randomized, controlled trial that evaluated the safety and effectiveness of the NeuroFlo catheter in patients with stroke. The current analysis was performed on the as-treated population. All-cause and stroke-related mortality rates at 90 days were compared between groups, and logistic regression models were fit to obtain ORs and 95% CIs for the treated versus not-treated groups. We categorized death-associated serious adverse events as neurologic versus non-neurologic events and performed multiple logistic regression analyses. We analyzed severe disability and mortality by outcomes of the mRS. Patient allocation was gathered by use of a poststudy survey.
  
  
  RESULTS
  All-cause mortality trended in favor of treated patients (11.5% versus 16.1%; P = .079) and stroke-related mortality was significantly reduced in treated patients (7.5% versus 14.2%; P = .009). Logistic regression analysis for freedom from stroke-related mortality favored treatment (OR, 2.41; 95% CI, 1.22, 4.77; P = .012). Treated patients had numerically fewer neurologic causes of stroke-related deaths (52.9% versus 73.0%; P = .214). Among the 90-day survivors, nominally fewer treated patients were severely disabled (mRS 5) (5.6% versus 7.5%; OR, 1.72; 95% CI, 0.72, 4.14; P = .223). Differences in allocation of care did not account for the reduced mortality rates.
  
  
  CONCLUSIONS
  There were consistent reductions in all-cause and stroke-related mortality in the NeuroFlo-treated patients. This reduction in mortality did not result in an increase in severe disability.
authors.affiliation: From JW Klinikum, Minden, Germany.
authors.forename: P D
authors.initials: PD
authors.lastname: Schellinger
authors.forename: A
authors.initials: A
authors.lastname: Shuaib
authors.forename: M
authors.initials: M
authors.lastname: Köhrmann
authors.forename: D S
authors.initials: DS
authors.lastname: Liebeskind
authors.forename: T
authors.initials: T
authors.lastname: Jovin
authors.forename: M D
authors.initials: MD
authors.lastname: Hammer
authors.forename: S
authors.initials: S
authors.lastname: Sen
authors.forename: D Y
authors.initials: DY
authors.lastname: Huang
authors.forename: S
authors.initials: S
authors.lastname: Solander
authors.forename: R
authors.initials: R
authors.lastname: Gupta
authors.forename: R R
authors.initials: RR
authors.lastname: Leker
authors.forename: J L
authors.initials: JL
authors.lastname: Saver
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002545:Brain Ischemia / Q000175:diagnosis / Q000401:mortality* / Q000628:therapy*; D004185:Disability Evaluation; D005260:Female; D006801:Humans; D015994:Incidence; D038622:Internationality; D008297:Male; D008875:Middle Aged; D009422:Nervous System Diseases / Q000175:diagnosis / Q000401:mortality* / Q000517:prevention & control*; D018570:Risk Assessment; D020521:Stroke / Q000175:diagnosis / Q000401:mortality* / Q000628:therapy*; D015996:Survival Rate; D060205:Therapeutic Occlusion / Q000379:methods / Q000401:mortality*; D016896:Treatment Outcome; D055815:Young Adult