Publication
Title
Partial aortic occlusion for cerebral perfusion augmentation : safety and efficacy of neuroflo in acute ischemic stroke trial
Author
Institution/Organisation
SENTIS Trial Investigators
Abstract
Background and PurposeFewer than 5% of patients with acute ischemic stroke are currently treated, and there is need for additional treatment options. A novel catheter treatment (NeuroFlo) that increases cerebral blood flow was tested to 14 hours. MethodsThe Safety and Efficacy of NeuroFlo in Acute Ischemic Stroke trial is a randomized trial of the safety and efficacy of NeuroFlo treatment in improving neurological outcome versus standard medical management. The primary safety end point was the incidence of serious adverse events through 90 days. The primary efficacy end point on a modified intent-to-treat population was a global disability end point at 90 days. Secondary end points included mortality, intracranial hemorrhage, modified Rankin scale score outcome of 0 to 2, and modified Rankin scale shift analysis. ResultsBetween October 2005 and January 2010, 515 patients were enrolled at 68 centers in 9 countries. The primary efficacy end point did not reach statistical significance (OR, 1.17; CI, 0.811.67; P0.407). The primary safety end point did not show a difference in serious adverse events (P0.923). Ninety-day mortality was 11.3% (26/230) in treatment and 16.3% (42/257) in control (P0.087). Post hoc analyses showed that patients presenting within 5 hours (OR, 3.33; CI, 1.31 8.48), with NIHSS score 8 to 14 (OR, 1.80; CI, 0.99 3.30), or older than age 70 years (OR, 2.02; CI, 1.02 4.03) had better modified Rankin scale score outcomes of 0 to 2; additionally, there were fewer stroke-related deaths in treatment compared to control groups (7.4%17/230; 14.4%37/257). ConclusionsThe trial met its primary safety end point but not its primary efficacy end point. Signals of treatment effect were suggested on all-cause mortality, in patients presenting early, older than age 70 years, or with moderate strokes, but these require confirmation.
Language
English
Source (journal)
Stroke: a journal of cerebral circulation / American Heart Association. - New York, N.Y.
Publication
New York, N.Y. : 2011
ISSN
0039-2499
Volume/pages
42:6(2011), p. 1680-1690
ISI
000291032700050
Full text (Publisher's DOI)
UAntwerpen
Faculty/Department
Research group
Publication type
Subject
Affiliation
Publications with a UAntwerp address
External links
Web of Science
Record
Identification
Creation 15.09.2011
Last edited 20.09.2017
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