School of Medicine and Health Sciences Poster Presentations
An analysis of fixed dose IV recombinant tissue plasminogen activator (rtPA) and clinical outcomes in acute ischemic stroke patients with body weight >100 kilograms: pooled data from three randomized clinical trials
Document Type
Poster
Keywords
Stroke; intravenous thrombolysis; body weight
Publication Date
Spring 2017
Abstract
BACKGROUND: The ASA/AHA guidelines recommend a fixed dose of 90 mg of intravenous recombinant tissue plasminogen activator (rt-PA) for acute stroke patients weighing more than 100 kilograms (kg). Previous analyses in small studies have suggested that the magnitude of benefit with IV rt-PA is lower in patients with body weight >100 kg. We determined if body weight >100 kg (and receiving <0.9 mg/kg dose) independently influence patient clinical outcomes following IV rt-PA treatment.
METHODS: We pooled data from IV rt-PA treatment arms from 3 randomized controlled trials; National Institutes of Neurological Disorders and Stroke (NINDS) IV tPA study, Interventional Management of Stroke 3 trial (IMS-III) and Albumin Treatment of Acute Ischemic Stroke (ALIAS part 1 and 2). Patients demographic, stroke severity, comorbidities, hospital outcome and 90-day modified Rankin Scale (mRS) were compared between patients >100 kg and those ≤100 kg body weight (defined by estimated weight). Multivariate logistic regression model was used to identify independent effect of >100 kg body weight on 90-day favorable outcome (defined as mRS 0-2). An ordinal analysis of the mRS was also performed.
RESULTS: Among 977 patients treated with IV rt-PA, total of 111 subjects had body weight >100 kg (11% of all patients). The mean age (±SD) for the patients with weight >100 Kg was significantly lower (60±11 versus 68±13, p<0.0001). The median admission National Institutes of Health Stroke Scale (NIHSS) score was not different between the two groups (12 versus 13, p=0.08). Patients with weight >100 kg had higher rates of history of hypertension, diabetes mellitus, and hyperlipidemia. Patients with body weight >100 kg had longer period (days±SD) of hospitalization (11±14 versus 8±7, p=0.04). Compared with patients with ≤100 kg body weight, the rate of favorable outcome at 90 days was not significantly different among patients with >100 kg body weight [OR; (95% CI): 0.99 (0.91-1.04)p=0.91, after adjusting for potential confounders. The ordinal analysis did not showed any significant shift in the distribution of scores on the mRS in patients with >100 kg body weight (OR, 0.93; 95% CI, 0.64 to 1.37; P = 0.74)
CONCLUSION: Body weight >100 kg (and receiving <0.9 mg/kg dose) did not reduce the benefit of IV rt-PA treatment in acute ischemic stroke patients. Our results support the current recommendations in the ASA/AHA guidelines.
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Open Access
1
An analysis of fixed dose IV recombinant tissue plasminogen activator (rtPA) and clinical outcomes in acute ischemic stroke patients with body weight >100 kilograms: pooled data from three randomized clinical trials
BACKGROUND: The ASA/AHA guidelines recommend a fixed dose of 90 mg of intravenous recombinant tissue plasminogen activator (rt-PA) for acute stroke patients weighing more than 100 kilograms (kg). Previous analyses in small studies have suggested that the magnitude of benefit with IV rt-PA is lower in patients with body weight >100 kg. We determined if body weight >100 kg (and receiving <0.9 mg/kg dose) independently influence patient clinical outcomes following IV rt-PA treatment.
METHODS: We pooled data from IV rt-PA treatment arms from 3 randomized controlled trials; National Institutes of Neurological Disorders and Stroke (NINDS) IV tPA study, Interventional Management of Stroke 3 trial (IMS-III) and Albumin Treatment of Acute Ischemic Stroke (ALIAS part 1 and 2). Patients demographic, stroke severity, comorbidities, hospital outcome and 90-day modified Rankin Scale (mRS) were compared between patients >100 kg and those ≤100 kg body weight (defined by estimated weight). Multivariate logistic regression model was used to identify independent effect of >100 kg body weight on 90-day favorable outcome (defined as mRS 0-2). An ordinal analysis of the mRS was also performed.
RESULTS: Among 977 patients treated with IV rt-PA, total of 111 subjects had body weight >100 kg (11% of all patients). The mean age (±SD) for the patients with weight >100 Kg was significantly lower (60±11 versus 68±13, p<0.0001). The median admission National Institutes of Health Stroke Scale (NIHSS) score was not different between the two groups (12 versus 13, p=0.08). Patients with weight >100 kg had higher rates of history of hypertension, diabetes mellitus, and hyperlipidemia. Patients with body weight >100 kg had longer period (days±SD) of hospitalization (11±14 versus 8±7, p=0.04). Compared with patients with ≤100 kg body weight, the rate of favorable outcome at 90 days was not significantly different among patients with >100 kg body weight [OR; (95% CI): 0.99 (0.91-1.04)p=0.91, after adjusting for potential confounders. The ordinal analysis did not showed any significant shift in the distribution of scores on the mRS in patients with >100 kg body weight (OR, 0.93; 95% CI, 0.64 to 1.37; P = 0.74)
CONCLUSION: Body weight >100 kg (and receiving <0.9 mg/kg dose) did not reduce the benefit of IV rt-PA treatment in acute ischemic stroke patients. Our results support the current recommendations in the ASA/AHA guidelines.
Comments
Poster to be presented at GW Annual Research Days 2017.