BACKGROUND: Increasing age is associated with poor outcome after stroke. The Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS) trial explored the augmentation of collateral circulation to the ischemic penumbra as a novel approach to stroke treatment. The aim of this post hoc analysis was to examine the effect of age on outcomes in the SENTIS trial. METHODS: Using data from the randomized controlled SENTIS trial, we explored outcomes of cerebral blood flow augmentation using the NeuroFlo™ device in patients categorized by age strata at 70 and 80 years. We evaluated outcomes of overall serious adverse event (SAE) and intracerebral hemorrhage (ICH) rates, freedom from all-cause and stroke-related mortality, and independent functional outcome as defined by the modified Rankin Scale score (mRS ≤2). RESULTS: The SENTIS as-treated cohort included 251 patients ≥70 years and 107 patients ≥80 years. Elderly SENTIS patients included a higher percentage of women and Caucasians than the younger group. Patients in the older group more frequently had vascular risk factors including hypertension, previous stroke, transient ischemic attacks and atrial fibrillation. However, baseline risk-factor profile, stroke severity, and time to randomization did not differ between the treated and nontreated elderly patients. The older patients treated with NeuroFlo had significantly higher chances for survival and for obtaining an independent functional state (mRS ≤2) compared with those who were not treated. Rates of SAEs and ICHs did not differ between the treatment groups. CONCLUSIONS:NeuroFlo treatment is safe and results in better outcomes for elderly patients. This may be the result of recruitment and support of already existing collateral systems in these patients.
RCT Entities:
BACKGROUND: Increasing age is associated with poor outcome after stroke. The Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS) trial explored the augmentation of collateral circulation to the ischemic penumbraas a novel approach to stroke treatment. The aim of this post hoc analysis was to examine the effect of age on outcomes in the SENTIS trial. METHODS: Using data from the randomized controlled SENTIS trial, we explored outcomes of cerebral blood flow augmentation using the NeuroFlo™ device in patients categorized by age strata at 70 and 80 years. We evaluated outcomes of overall serious adverse event (SAE) and intracerebral hemorrhage (ICH) rates, freedom from all-cause and stroke-related mortality, and independent functional outcome as defined by the modified Rankin Scale score (mRS ≤2). RESULTS: The SENTIS as-treated cohort included 251 patients ≥70 years and 107 patients ≥80 years. Elderly SENTIS patients included a higher percentage of women and Caucasians than the younger group. Patients in the older group more frequently had vascular risk factors including hypertension, previous stroke, transient ischemic attacks and atrial fibrillation. However, baseline risk-factor profile, stroke severity, and time to randomization did not differ between the treated and nontreated elderly patients. The older patients treated with NeuroFlo had significantly higher chances for survival and for obtaining an independent functional state (mRS ≤2) compared with those who were not treated. Rates of SAEs and ICHs did not differ between the treatment groups. CONCLUSIONS: NeuroFlo treatment is safe and results in better outcomes for elderly patients. This may be the result of recruitment and support of already existing collateral systems in these patients.
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