Reduced Mortality and Severe Disability Rates in the SENTIS Trial

Overview

Journal AJNR Am J Neuroradiol

Specialty Neurology

Date 2013 Jul 6

PMID 23828106

Citations 4

Authors

P D Schellinger

A Shuaib

M Kohrmann

D S Liebeskind

T Jovin

M D Hammer

S Sen

D Y Huang

S Solander

R Gupta

R R Leker

J L Saver

Affiliations

Soon will be listed here.

Abstract

Background And Purpose: 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.

Materials And 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.

Citing Articles

Classification of Different Degrees of Disability Following Intracerebral Hemorrhage: A Decision Tree Analysis from VISTA-ICH Collaboration.

Phan T, Chen J, Beare R, Ma H, Clissold B, Ly J Front Neurol. 2017; 8:64.

PMID: 28293215 PMC: 5329022. DOI: 10.3389/fneur.2017.00064.

Sex Differences in the Cerebral Collateral Circulation.

Faber J, Moore S, Lucitti J, Aghajanian A, Zhang H Transl Stroke Res. 2016; 8(3):273-283.

PMID: 27844273 PMC: 5429998. DOI: 10.1007/s12975-016-0508-0.

Transient Aortic Occlusion Augments Collateral Blood Flow and Reduces Mortality During Severe Ischemia due to Proximal Middle Cerebral Artery Occlusion.

Ramakrishnan G, Dong B, Todd K, Shuaib A, Winship I Transl Stroke Res. 2015; 7(2):149-55.

PMID: 26706246 PMC: 4770060. DOI: 10.1007/s12975-015-0443-5.

Vascular remodeling after ischemic stroke: mechanisms and therapeutic potentials.

Liu J, Wang Y, Akamatsu Y, Lee C, Stetler R, Lawton M Prog Neurobiol. 2013; 115:138-56.

PMID: 24291532 PMC: 4295834. DOI: 10.1016/j.pneurobio.2013.11.004.

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