TY - JOUR
T1 - Fixed Dose IV rt-PA and Clinical Outcome in Ischemic Stroke Patients With Body Weight >100 kg
T2 - Pooled Data From 3 Randomized Clinical Trials
AU - Majidi, Shahram
AU - Leon Guerrero, Christopher R.
AU - Burger, Kathleen M.
AU - Sigounas, Dimitri
AU - Olan, Wayne J.
AU - Qureshi, Adnan I.
N1 - Publisher Copyright:
© 2018
PY - 2018/10
Y1 - 2018/10
N2 - Background and Purpose: The ASA/AHA guidelines recommend a fixed dose of 90 mg of intravenous (IV) recombinant tissue plasminogen activator (rt-PA) for acute stroke patients weighing more than 100 kg. We aimed to determine 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 clinical trials; NINDS IV rt-PA study, Interventional Management of Stroke 3 and ALIAS (part 1 and 2). Baseline characteristic, hospital course and 90-day mRS were compared between patients >100 kg and those ≤100 kg body weight. Multivariate logistic regression model was used to identify the independent effect of >100 kg body weight on favorable 90-day outcome (defined as mRS 0-2), the rate of symptomatic intracranial hemorrhage, and poor 90-day outcome (mRS 4-6). Results: Among 873 patients treated with IV rt-PA, a total of 105 (12%) subjects had body weight >100 kg. Compared with patients having ≤100 kg body weight, the rate of favorable outcome at 90 days was not significantly different among patients with >100 kg body weight (OR: 0.99; 95% CI: 0.91-1.01; p=0.91), after adjusting for potential confounders. The ordinal analysis did not show any significant shift in the distribution of 90-day mRS score in patients with >100 kg body weight (OR, 0.93; 95% CI, 0.64-1.37; P = 0.74) Conclusions: There was no reduction in the rate of favorable outcome in patients with acute ischemic stroke with body weight >100 kg who received <0.9 mg/kg dose of IV rt-PA. Our results support the current recommendations in the ASA/AHA guidelines.
AB - Background and Purpose: The ASA/AHA guidelines recommend a fixed dose of 90 mg of intravenous (IV) recombinant tissue plasminogen activator (rt-PA) for acute stroke patients weighing more than 100 kg. We aimed to determine 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 clinical trials; NINDS IV rt-PA study, Interventional Management of Stroke 3 and ALIAS (part 1 and 2). Baseline characteristic, hospital course and 90-day mRS were compared between patients >100 kg and those ≤100 kg body weight. Multivariate logistic regression model was used to identify the independent effect of >100 kg body weight on favorable 90-day outcome (defined as mRS 0-2), the rate of symptomatic intracranial hemorrhage, and poor 90-day outcome (mRS 4-6). Results: Among 873 patients treated with IV rt-PA, a total of 105 (12%) subjects had body weight >100 kg. Compared with patients having ≤100 kg body weight, the rate of favorable outcome at 90 days was not significantly different among patients with >100 kg body weight (OR: 0.99; 95% CI: 0.91-1.01; p=0.91), after adjusting for potential confounders. The ordinal analysis did not show any significant shift in the distribution of 90-day mRS score in patients with >100 kg body weight (OR, 0.93; 95% CI, 0.64-1.37; P = 0.74) Conclusions: There was no reduction in the rate of favorable outcome in patients with acute ischemic stroke with body weight >100 kg who received <0.9 mg/kg dose of IV rt-PA. Our results support the current recommendations in the ASA/AHA guidelines.
KW - Body weight
KW - acuteischemic stroke
KW - clinical outcome
KW - thrombolysis
KW - tissue plasminogen activator
UR - http://www.scopus.com/inward/record.url?scp=85050682683&partnerID=8YFLogxK
U2 - 10.1016/j.jstrokecerebrovasdis.2018.06.016
DO - 10.1016/j.jstrokecerebrovasdis.2018.06.016
M3 - Article
C2 - 30076113
AN - SCOPUS:85050682683
VL - 27
SP - 2843
EP - 2848
JO - Journal of Stroke and Cerebrovascular Diseases
JF - Journal of Stroke and Cerebrovascular Diseases
SN - 1052-3057
IS - 10
ER -