Jose G Romano1, Hannah Gardener1, Iszet Campo-Bustillo1, Yosef Khan2, Sofie Tai2, Nikesha Riley2, Eric E Smith3, Ralph L Sacco1, Pooja Khatri4, Heather M Alger2, Brian Mac Grory5, Deepak Gulati6, Navdeep S Sangha7, Jeffrey M Craig8, Karin E Olds9, Curtis G Benesch10, Adam G Kelly10, Scott S Brehaut11, Amit C Kansara12, Lee H Schwamm13. 1. Department of Neurology, University of Miami Miller School of Medicine, FL (J.G.R., H.G., I.C.-B., R.L.S.). 2. American Heart Association, Dallas, TX (Y.K., S.T., N.R., H.M.A.). 3. Hotchkiss Brain Institute, University of Calgary, Alberta, Canada (E.E.S.). 4. Department of Neurology and Rehabilitation Medicine, University of Cincinnati, OH (P.K.). 5. Department of Neurology, Duke University School of Medicine, Durham, NC (B.M.G.). 6. Department of Neurology, Ohio State University Wexner Medical Center, Columbus (D.G.). 7. Kaiser Permanente/Los Angeles Medical Center, CA (N.S.S.). 8. Mercy Hospital, Oklahoma City, OK (J.M.C.). 9. Department of Neurology, St. Luke's Hospital, Kansas City, MO (K.E.O.). 10. Department of Neurology, University of Rochester Medical Center, NY (C.G.B., A.G.K.). 11. Faxton St. Luke's Healthcare, Utica, NY (S.S.B.). 12. Providence St. Vincent Medical Center, Portland, OR (A.C.K.). 13. Department of Neurology, Massachusetts General Hospital/Harvard Medical School, Boston (L.H.S.).
Abstract
Background and Purpose: Although most strokes present with mild symptoms, these have been poorly represented in clinical trials. The objective of this study is to describe multidimensional outcomes, identify predictors of worse outcomes, and explore the effect of thrombolysis in this population. Methods: This prospective observational study included patients with ischemic stroke or transient ischemic attack, a baseline National Institutes of Health Stroke Scale (NIHSS) score 0 to 5, presenting within 4.5 hours from symptom onset. The primary outcome was a 90-day modified Rankin Scale score of 0 to 1; secondary outcomes included good outcomes in the Barthel Index, Stroke Impact Scale-16, and European Quality of Life. Multivariable models were created to determine predictors of outcomes and the effect of alteplase. Results: A total of 1765 participants were included from 100 Get With The Guidelines-Stroke participating hospitals (age, 65±14; 42% women; final diagnosis of ischemic stroke, 90%; transient ischemic attack, 10%; 57% received alteplase). At 90 days, 37% were disabled and 25% not independent. Worse outcomes were noted for older individuals, women, non-Hispanic Blacks and Hispanics, Medicaid recipients, smokers, those with diabetes, atrial fibrillation, prior stroke, higher baseline NIHSS, visual field defects, and extremity weakness. Similar outcomes were noted for the alteplase-treated and untreated groups. Alteplase-treated patients were younger (64±13 versus 67±1.4) with higher NIHSS (2.9±1.4 versus 1.7±1.4). After adjusting for age, sex, race/ethnicity, and baseline NIHSS, we did not identify an effect of alteplase on the primary outcome but did find an association with Stroke Impact Scale-16 in the restricted sample of baseline NIHSS score 3–5. Few symptomatic intracerebral hemorrhages were recorded (<1%). Conclusions: A large proportion of stroke patients presenting with low NIHSS have a disabled outcome. Baseline predictors of worse outcomes are described. An effect of alteplase on outcomes was not identified in the overall cohort, but a suggestion of efficacy was noted in the NIHSS 3–5 subgroup. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02072681.
Background and Purpose: Although most strokes present with mild symptoms, these have been poorly represented in clinical trials. The objective of this study is to describe multidimensional outcomes, identify predictors of worse outcomes, and explore the effect of thrombolysis in this population. Methods: This prospective observational study included patients with ischemic stroke or transient ischemic attack, a baseline National Institutes of Health Stroke Scale (NIHSS) score 0 to 5, presenting within 4.5 hours from symptom onset. The primary outcome was a 90-day modified Rankin Scale score of 0 to 1; secondary outcomes included good outcomes in the Barthel Index, Stroke Impact Scale-16, and European Quality of Life. Multivariable models were created to determine predictors of outcomes and the effect of alteplase. Results: A total of 1765 participants were included from 100 Get With The Guidelines-Stroke participating hospitals (age, 65±14; 42% women; final diagnosis of ischemic stroke, 90%; transient ischemic attack, 10%; 57% received alteplase). At 90 days, 37% were disabled and 25% not independent. Worse outcomes were noted for older individuals, women, non-Hispanic Blacks and Hispanics, Medicaid recipients, smokers, those with diabetes, atrial fibrillation, prior stroke, higher baseline NIHSS, visual field defects, and extremity weakness. Similar outcomes were noted for the alteplase-treated and untreated groups. Alteplase-treated patients were younger (64±13 versus 67±1.4) with higher NIHSS (2.9±1.4 versus 1.7±1.4). After adjusting for age, sex, race/ethnicity, and baseline NIHSS, we did not identify an effect of alteplase on the primary outcome but did find an association with Stroke Impact Scale-16 in the restricted sample of baseline NIHSS score 3–5. Few symptomatic intracerebral hemorrhages were recorded (<1%). Conclusions: A large proportion of stroke patients presenting with low NIHSS have a disabled outcome. Baseline predictors of worse outcomes are described. An effect of alteplase on outcomes was not identified in the overall cohort, but a suggestion of efficacy was noted in the NIHSS 3–5 subgroup. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02072681.
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