School of Medicine and Health Sciences Poster Presentations

Title

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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Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.

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Poster to be presented at GW Annual Research Days 2017.

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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.