Purpose: Intravenous Thrombolysis (IV rt-PA) is administered in <10% of ischemic stroke patients. In rare cases, patients or caregivers refuse IV rt-PA treatment even when recommended by stroke practitioners. We sought to assess the characteristics and outcomes of patients who refuse IV rt-PA for acute ischemic stroke, and to compare outcomes between those who were treated with IV rt-PA and those who refused.
Methods: We examined data from the prospectively collected, IRB approved UC San Diego Stroke Registry who presented as a "stroke code" from July 2004 to July 2019 at two academic facilities and five community hospitals. Patients were included if they presented within 4.5 hours of symptom onset or last seen normal, had a "stroke code" alert activated, and were either treated with IV rt-PA or the reason for exclusion was patient/family refusal. Patients were considered "refusers" if IV rt-PA was recommended by the provider during the stroke code and the patient and/or legally authorized representative declined treatment. Baseline demographics, baseline National Institutes of Health Stroke Scale (NIHSS), treatment times and 90-day Modified Rankin Scale (mRS) were collected. Patients who refused IV rt-PA were compared to those that were treated with IV rt-PA. Data was examined for frequencies and distribution. Chi squared was used to evaluate nominal variables. Continuous variables were assessed by Pearson correlation and t test. Kruskal-Wallis or ANOVA were used to evaluate group differences.
Results: A total of 1056 patients were included in the analysis. Forty-seven patients (4.5%) refused IV rt-PA. There were no significant socio-demographic differences between patients who were treated with IV rt-PA and those who refused. Compared to patients who were treated with IV rt-PA, patients who refused IV rt-PA had a significantly lower baseline NIHSS (4 vs 9, p < 0.0001) and higher baseline mRS (IQR 0-1.0 vs 0-2.8, p < 0.001). The time from arrival to treatment decision was significantly longer in patients who refused IV rt-PA (group mean 57.9 min vs 48.8 min, p = 0.03). Data for 90-day outcome was available for 556 (55.1%) patients treated with IV rt-PA and 20 (42.5%) patients who refused IV rt-PA. There was no difference in 90-day mRS between groups (p = 0.68).
Conclusions: There is a low rate of IV rt-PA refusal in our registry population which is similar to what previous studies have shown. We found that patients who refuse IV rt-PA have significantly milder deficits and significantly worse pre-morbid disability. We speculate that the longer "arrival to decision" time in the refuse IV rt-PA group is due to longer informed consent discussions. This analysis furthers the body of literature regarding rt-PA refusals.
Keywords: Ischemic stroke; TPA; cerebrovascular disease; refusal; thrombolysis; tissue plasminogen activator.
Copyright © 2020 Elsevier Inc. All rights reserved.