Abstract
Background: Although most strokes present with mild symptoms, these have been poorly represented in clinical trials. The objective 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 TIA presenting with stroke symptoms and a baseline NIHSS 0-5 within 4.5 hours from symptom onset. The primary outcome was a 90-day modified Rankin Scale (mRS) 0-1; secondary outcomes included good outcomes in the Barthel Index, Stroke Impact Scale-16 (SIS-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 (GWTG)-Stroke participating hospitals (age 65 + 14, 42% women, final diagnosis ischemic stroke 90%, TIA 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, smokers, those with diabetes, atrial fibrillation, prior stroke, higher baseline NIHSS, visual field defects, arm and leg weakness. Similar outcomes were noted for the alteplase-treated and the untreated groups. Alteplase treated patients were younger (64 + 13 vs. 67 + 1.4) with a higher NIHSS (2.9 + 1.4 vs. 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 effect on SIS-16 in the restricted sample of baseline NIHSS 3-5. Very few symptomatic hemorrhages were recorded (3/999). Conclusions: A large proportion of stroke patients presenting with a 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 an indication of efficacy was noted in the NIHSS 3-5 subgroup.
