Bruce Ovbiagele1, Mathew J Reeves2, Mojdeh Nasiri2, S Claiborne Johnston3, Philip M Bath4, Gustavo Saposnik5. 1. Department of Neurosciences, Medical University of South Carolina, Charleston. 2. Department of Epidemiology and Biostatistics, Michigan State University, East Lansing. 3. Clinical and Translational Science Institute, University of California, San Francisco. 4. Stroke Trials Unit, University of Nottingham, Nottingham, England. 5. Stroke Outcomes Research Unit, Division of Neurology, University of Toronto, Toronto, Ontario, Canada.
Abstract
IMPORTANCE: The Stroke Prognostication using Age and the NIH Stroke Scale index, created by combining age in years plus a National Institutes of Health (NIH) Stroke Scale score of 100 or higher (and hereafter referred to as the SPAN-100 index), is a simple risk score for estimating clinical outcomes for patients with acute ischemic stroke (AIS). The association between this index and response to intravenous thrombolysis for AIS has not been properly evaluated. OBJECTIVE: To assess the relationship between SPAN-100 index status and outcome following treatment with intravenous thrombolysis for AIS. DESIGN, SETTING, AND PARTICIPANTS: Using the Virtual International Stroke Trials Archive (VISTA) database, an international repository of clinical trials data, we assessed the SPAN-100 index among 7093 patients with AIS who participated in 4 clinical trials from 2000 to 2006. The SPAN-100 index is considered positive if the sum of the age and the NIH Stroke Scale (a 15-item neurological examination scale with scores ranging from 0 to 42, with higher scores indicating more severe strokes) score is greater than or equal to 100. Multivariable logistic regression analyses were used to determine the independent association between SPAN-100 index status and 90-day outcomes. MAIN OUTCOMES AND MEASURES: The primary outcome was a composite of severe disability or death measured 90 days after stroke, and the secondary outcomes were death alone and a composite of no disability/modest disability. RESULTS: Of 7093 patients, 743 (10.5%) were SPAN-100 positive, and 2731 (38.5%) received intravenous thrombolysis. Compared with SPAN-100-negative patients, SPAN-100-positive patients were more likely to experience a catastrophic outcome (adjusted odds ratio [AOR], 9.03 [95% CI, 6.68-12.21]) or death alone (AOR, 5.03 [95% CI, 4.06-6.23]) and less likely to experience a favorable outcome (AOR, 0.08 [95% CI, 0.06-0.13]). However, there was an interaction between SPAN-100 index status and thrombolysis treatment (P < .001) revealing a reduction in the likelihood of severe disability/death with thrombolytic treatment for SPAN-100-positive (AOR, 0.46 [95% CI, 0.29-0.71]) but not SPAN-100-negative patients (AOR, 0.96 [95% CI, 0.85-1.07]). Similar interactions between SPAN-100 index status and thrombolysis treatment were observed for the 2 secondary outcomes. CONCLUSION AND RELEVANCE: Compared with the SPAN-100-negative patients with AIS, the SPAN-100-positive patients with AIS seem to have poorer 3-month outcomes but may derive greater benefit when treated with intravenous thrombolysis. The SPAN-100-positive patients are often excluded from AIS clinical trials but should probably not be denied thrombolysis treatment on the basis of such a profile alone.
IMPORTANCE: The Stroke Prognostication using Age and the NIH Stroke Scale index, created by combining age in years plus a National Institutes of Health (NIH) Stroke Scale score of 100 or higher (and hereafter referred to as the SPAN-100 index), is a simple risk score for estimating clinical outcomes for patients with acute ischemic stroke (AIS). The association between this index and response to intravenous thrombolysis for AIS has not been properly evaluated. OBJECTIVE: To assess the relationship between SPAN-100 index status and outcome following treatment with intravenous thrombolysis for AIS. DESIGN, SETTING, AND PARTICIPANTS: Using the Virtual International Stroke Trials Archive (VISTA) database, an international repository of clinical trials data, we assessed the SPAN-100 index among 7093 patients with AIS who participated in 4 clinical trials from 2000 to 2006. The SPAN-100 index is considered positive if the sum of the age and the NIH Stroke Scale (a 15-item neurological examination scale with scores ranging from 0 to 42, with higher scores indicating more severe strokes) score is greater than or equal to 100. Multivariable logistic regression analyses were used to determine the independent association between SPAN-100 index status and 90-day outcomes. MAIN OUTCOMES AND MEASURES: The primary outcome was a composite of severe disability or death measured 90 days after stroke, and the secondary outcomes were death alone and a composite of no disability/modest disability. RESULTS: Of 7093 patients, 743 (10.5%) were SPAN-100 positive, and 2731 (38.5%) received intravenous thrombolysis. Compared with SPAN-100-negative patients, SPAN-100-positive patients were more likely to experience a catastrophic outcome (adjusted odds ratio [AOR], 9.03 [95% CI, 6.68-12.21]) or death alone (AOR, 5.03 [95% CI, 4.06-6.23]) and less likely to experience a favorable outcome (AOR, 0.08 [95% CI, 0.06-0.13]). However, there was an interaction between SPAN-100 index status and thrombolysis treatment (P < .001) revealing a reduction in the likelihood of severe disability/death with thrombolytic treatment for SPAN-100-positive (AOR, 0.46 [95% CI, 0.29-0.71]) but not SPAN-100-negative patients (AOR, 0.96 [95% CI, 0.85-1.07]). Similar interactions between SPAN-100 index status and thrombolysis treatment were observed for the 2 secondary outcomes. CONCLUSION AND RELEVANCE: Compared with the SPAN-100-negative patients with AIS, the SPAN-100-positive patients with AIS seem to have poorer 3-month outcomes but may derive greater benefit when treated with intravenous thrombolysis. The SPAN-100-positive patients are often excluded from AIS clinical trials but should probably not be denied thrombolysis treatment on the basis of such a profile alone.
Authors: Fergus N Doubal; Myzoon Ali; G David Batty; Andreas Charidimou; Maria Eriksdotter; Martin Hofmann-Apitius; Yun-Hee Kim; Deborah A Levine; Gillian Mead; Hermann A M Mucke; Craig W Ritchie; Charlotte J Roberts; Tom C Russ; Robert Stewart; William Whiteley; Terence J Quinn Journal: BMC Neurol Date: 2017-04-17 Impact factor: 2.474