Abstract 2549: Favorable Vascular Profile Is An Independent Predictor Of Outcome: A Post Hoc Analysis Of The Sentis Trial
Background: The Safety and Efficacy of NeuroFloTM Technology in Acute Ischemic Stroke (SENTIS) trial was the first randomized interventional stroke study for hemodynamic augmentation by partial aortic occlusion to improve neurological outcome versus standard medical management. We hypothesized that a favourable vascular profile (FVP) defined as anatomical intactness of the Circle of Willis (CoW, including visualization of the communicators) combined with a stable cerebral perfusion pressure (CPP) is a prerequisite for collateral recruitment and maintenance. We performed post hoc analyses to identify whether a favorable vascular profile (FVP) is associated with independent outcome.
Methods: We identified all patients from the primary dataset (n=515 patients) with available intracranial vascular imaging (MRA, CTA, or conventional angiography) at baseline. Two independent readers evaluated the vascular imaging blind to clinical and treatment data. CPP compromise was assumed in critical hypotension defined as mean arterial blood pressure (MAP) drop below 65mmHg. FVP was scored, when CoW was intact and MAP >65mmHg at all timepoints within the first 12h of the NeuroFlo procedure. We performed univariate and multivariate analyses to identify predictors of independent outcome (mRS 0-2) at 90 days.
Results: 192/515 SENTIS subjects had available baseline vascular imaging (91 treated / 101 controls). Baseline characteristics did not differ between groups (age, weight, infarct side, NIHSS, race, time from symptom onset, vital parameters, cardiovascular risk factors including atrial fibrillation (AF), medical history). Overall, FVP was seen in 89.6% of patients with a trend in favor of treated patients (94.5% vs 85.2%, p=0.0562). Nevertheless, presence of FVP predicted independent outcome in univariate (OR=7.46, 1.68-33.18, p=0.0082) and multiple logistic regression analyses after adjustment for all variables (OR=10.22, 1.78-58.57, p=0.0091). Aside from FVP, only baseline NIHSS (OR=0.74, 95% CI 0.67-0.82, p<0.0001) and presence of atrial fibrillation (OR=0.48, 95% CI 0.21-1.12, p=0.0909) entered the predictive model. There was no interaction with randomization to treatment or control.
Conclusion: FVP and baseline NIHSS independently predicted outcome in this subset of the SENTIS population. FVP is a novel parameter to predict outcome of acute stroke patients and further studies will establish its potential role for selection of optimal candidates for hemodynamic augmentation.
- © 2012 by American Heart Association, Inc.