Abstract 1911: Recanalization of Proximal Arterial Occlusion in the SENTIS Trial

Abstract

Background: Collateral circulation may enhance recanalization in acute ischemic stroke. Augmentation of collaterals with partial aortic occlusion may promote recanalization and thereby influence outcomes in the SENTIS randomized controlled trial of the NeuroFlo device. We conducted a post hoc analysis of angiography acquired in SENTIS to evaluate potential differences in recanalization rates between NeuroFlo-treated and non-treated arms, accounting for site of arterial occlusion. Methods: Blinded imaging expert review of baseline and 6-hour follow-up angiography (CTA, MRA, or DSA) from the core lab was conducted for evaluation of recanalization. Recanalization was defined as TIMI 2-3 in the arterial segment distal to baseline occlusion. Baseline demographics, stroke presentation characteristics, and medical history variables were analyzed with respect to recanalization in univariate and subsequent multivariable logistic regression models after adjusting by treatment arm. Results: Serial angiography was available in 109/515 SENTIS subjects, including 56 in the treatment arm and 53 in the non-treated arm. Baseline demographics, stroke presentation characteristics, and medical history variables did not differ statistically between arms. Across all sites of arterial occlusion, recanalization occurred in 25.7% of cases, with similar rates between device (25.0%) and medical therapy (26.4%) arms. Age and baseline stroke severity (NIHSS score) were significant predictors of recanalization in univariate analyses. Multivariable logistic regression analyses confirmed that baseline NIHSS score was the sole predictor of recanalization (OR 0.90, p=0.0458) per one unit increase, with decreased recanalization in more severe strokes. Device treatment was not associated with significant increases in recanalization rates (p=NS). Recanalization of terminal internal carotid artery (12.5%), proximal MCA or M1 (17.9%) and M2 (46.7%) occlusions was not different between arms (all p=NS). Recanalization of proximal arterial occlusion in acute ischemic stroke cases enrolled in SENTIS was more frequent in M2 occlusions. Conclusions: More severe strokes at baseline were less likely to recanalize and device therapy did not increase recanalization rates. Treatment with the NeuroFlo device may invoke mechanisms of collateral perfusion distinct from direct arterial recanalization.