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Original research
Importance of proper patient selection and endpoint selection in evaluation of new therapies in acute stroke: further analysis of the SENTIS trial
  1. Ashfaq Shuaib1,
  2. Stefan Schwab2,
  3. J Neal Rutledge3,
  4. Sidney Starkman4,
  5. David S Liebeskind4,
  6. Gary L Bernardini5,
  7. Alan Boulos5,
  8. Alex Abou-Chebl6,
  9. David Y Huang7,
  10. Geert Vanhooren8,
  11. Salvador Cruz-Flores9,
  12. Richard Paul Klucznik10,
  13. Jeffrey L Saver4,
  14. for the SENTIS trial investigators
  1. 1Department of Neurology, University of Alberta, Edmonton, Alberta Canada
  2. 2Department of Neurology, University Clinic Erlangen, Erlangen, Germany
  3. 3Brackenridge Medical Center, Austin, Texas, USA
  4. 4Department of Neurology, UCLA, Los Angeles,California, USA
  5. 5Department of Neurology, Albany Medical Center, Albany, New York, USA
  6. 6Department of Neurology, University of Louisville, Louisville, Kentucky, USA
  7. 7Department of Neurology, University of North Carolina, Chapel Hill, North Carolina, USA
  8. 8Department of Neurology, AZ Sint-Jan AV Hospital, Brugge, Belgium
  9. 9Department of Neurology and Psychiatry, St Louis University, St Louis, Missouri, USA
  10. 10Department of Neuroradiology, The Methodist Hospital, Houston, Texas, USA
  1. Correspondence to Dr Ashfaq Shuaib, Department of Neurology, University of Alberta, 2E3.13 WMC, 8440-112 Street, Edmonton, AB, Canada T6G 2B7; ashfaq.shuaib{at}


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.

Clinical trial registration URL:// identifier: NCT00119717.

  • Stroke
  • Brain
  • Blood Flow
  • Flow Diverter
  • Intervention

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