Intravenous thrombolysis administration 3–4.5 h after acute ischemic stroke: A retrospective, multicenter study

Yu Wei Chen, Sheng Feng Sung, Chih Hung Chen, Sung Chun Tang, Li Kai Tsai, Huey Juan Lin, Hung Yu Huang, Helen L. Po, Yu Sun, Po Lin Chen, Lung Chan, Cheng Yu Wei, Jiunn Tay Lee, Cheng Yang Hsieh, Yung Yang Lin, Shoou Jeng Yeh, Li Ming Lien, Jiann Shing Jeng

Research output: Contribution to journalArticle

Abstract

Background and Objectives: Intravenous recombinant tissue plasminogen activator (rt-PA) has been approved for acute ischemic stroke (AIS) within 3 h after onset and the treatment was then extended to 4.5 h. However, the Food and Drug Administration did not approve the indication in the expanded time window. This retrospective, matched cohort study aims to investigate the effectiveness and safety of rt-PA in AIS at 3–4.5 h after onset. Materials and Methods: The treatment group included AIS patients receiving rt-PA at 3–4.5 h after onset, otherwise complying with the regulation, in the stroke registries in 16 hospitals between 2008 and 2017. The control group included age-and sex-matched patients not receiving intravenous thrombolysis from the same registries, excluding those with contraindications. The primary outcome was modified Rankin Scale (mRS) 0–1 at day 90. The safety outcomes were any intracerebral hemorrhage (ICH), early neurological deterioration and 3-month mortality. Results: Each group had 374 patients. There were 34.0%of patients with 3-month mRS 0-1 in the treatment group vs. 22.7% in the control group with an odds ratio of 1.75 (95% confidence intervals, 1.27 to 2.42, P = 0.001). There was no difference in symptomatic ICH, early neurological deterioration and 3-month mortality rates between two groups. The 3-month mRS and symptomatic ICH did not differ significantly in patients receiving standard dose or low dose of rt-PA. Conclusions: Our results support the prescription of rt-PA in AIS patients 3–4.5 h after onset as an effective and tolerable treatment in their functional recovery.

Original languageEnglish
Article number1038
JournalFrontiers in Neurology
Volume10
Issue numberOCT
DOIs
Publication statusPublished - 2019 Jan 1

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Intravenous Administration
Multicenter Studies
Tissue Plasminogen Activator
Retrospective Studies
Stroke
Cerebral Hemorrhage
Registries
Safety
Control Groups
Mortality
United States Food and Drug Administration
Therapeutics
Prescriptions
Cohort Studies
Odds Ratio
Confidence Intervals

All Science Journal Classification (ASJC) codes

  • Neurology
  • Clinical Neurology

Cite this

Chen, Yu Wei ; Sung, Sheng Feng ; Chen, Chih Hung ; Tang, Sung Chun ; Tsai, Li Kai ; Lin, Huey Juan ; Huang, Hung Yu ; Po, Helen L. ; Sun, Yu ; Chen, Po Lin ; Chan, Lung ; Wei, Cheng Yu ; Lee, Jiunn Tay ; Hsieh, Cheng Yang ; Lin, Yung Yang ; Yeh, Shoou Jeng ; Lien, Li Ming ; Jeng, Jiann Shing. / Intravenous thrombolysis administration 3–4.5 h after acute ischemic stroke : A retrospective, multicenter study. In: Frontiers in Neurology. 2019 ; Vol. 10, No. OCT.
@article{632069720e544b4b97b12feeeb95aa67,
title = "Intravenous thrombolysis administration 3–4.5 h after acute ischemic stroke: A retrospective, multicenter study",
abstract = "Background and Objectives: Intravenous recombinant tissue plasminogen activator (rt-PA) has been approved for acute ischemic stroke (AIS) within 3 h after onset and the treatment was then extended to 4.5 h. However, the Food and Drug Administration did not approve the indication in the expanded time window. This retrospective, matched cohort study aims to investigate the effectiveness and safety of rt-PA in AIS at 3–4.5 h after onset. Materials and Methods: The treatment group included AIS patients receiving rt-PA at 3–4.5 h after onset, otherwise complying with the regulation, in the stroke registries in 16 hospitals between 2008 and 2017. The control group included age-and sex-matched patients not receiving intravenous thrombolysis from the same registries, excluding those with contraindications. The primary outcome was modified Rankin Scale (mRS) 0–1 at day 90. The safety outcomes were any intracerebral hemorrhage (ICH), early neurological deterioration and 3-month mortality. Results: Each group had 374 patients. There were 34.0{\%}of patients with 3-month mRS 0-1 in the treatment group vs. 22.7{\%} in the control group with an odds ratio of 1.75 (95{\%} confidence intervals, 1.27 to 2.42, P = 0.001). There was no difference in symptomatic ICH, early neurological deterioration and 3-month mortality rates between two groups. The 3-month mRS and symptomatic ICH did not differ significantly in patients receiving standard dose or low dose of rt-PA. Conclusions: Our results support the prescription of rt-PA in AIS patients 3–4.5 h after onset as an effective and tolerable treatment in their functional recovery.",
author = "Chen, {Yu Wei} and Sung, {Sheng Feng} and Chen, {Chih Hung} and Tang, {Sung Chun} and Tsai, {Li Kai} and Lin, {Huey Juan} and Huang, {Hung Yu} and Po, {Helen L.} and Yu Sun and Chen, {Po Lin} and Lung Chan and Wei, {Cheng Yu} and Lee, {Jiunn Tay} and Hsieh, {Cheng Yang} and Lin, {Yung Yang} and Yeh, {Shoou Jeng} and Lien, {Li Ming} and Jeng, {Jiann Shing}",
year = "2019",
month = "1",
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doi = "10.3389/fneur.2019.01038",
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Chen, YW, Sung, SF, Chen, CH, Tang, SC, Tsai, LK, Lin, HJ, Huang, HY, Po, HL, Sun, Y, Chen, PL, Chan, L, Wei, CY, Lee, JT, Hsieh, CY, Lin, YY, Yeh, SJ, Lien, LM & Jeng, JS 2019, 'Intravenous thrombolysis administration 3–4.5 h after acute ischemic stroke: A retrospective, multicenter study', Frontiers in Neurology, vol. 10, no. OCT, 1038. https://doi.org/10.3389/fneur.2019.01038

Intravenous thrombolysis administration 3–4.5 h after acute ischemic stroke : A retrospective, multicenter study. / Chen, Yu Wei; Sung, Sheng Feng; Chen, Chih Hung; Tang, Sung Chun; Tsai, Li Kai; Lin, Huey Juan; Huang, Hung Yu; Po, Helen L.; Sun, Yu; Chen, Po Lin; Chan, Lung; Wei, Cheng Yu; Lee, Jiunn Tay; Hsieh, Cheng Yang; Lin, Yung Yang; Yeh, Shoou Jeng; Lien, Li Ming; Jeng, Jiann Shing.

In: Frontiers in Neurology, Vol. 10, No. OCT, 1038, 01.01.2019.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Intravenous thrombolysis administration 3–4.5 h after acute ischemic stroke

T2 - A retrospective, multicenter study

AU - Chen, Yu Wei

AU - Sung, Sheng Feng

AU - Chen, Chih Hung

AU - Tang, Sung Chun

AU - Tsai, Li Kai

AU - Lin, Huey Juan

AU - Huang, Hung Yu

AU - Po, Helen L.

AU - Sun, Yu

AU - Chen, Po Lin

AU - Chan, Lung

AU - Wei, Cheng Yu

AU - Lee, Jiunn Tay

AU - Hsieh, Cheng Yang

AU - Lin, Yung Yang

AU - Yeh, Shoou Jeng

AU - Lien, Li Ming

AU - Jeng, Jiann Shing

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background and Objectives: Intravenous recombinant tissue plasminogen activator (rt-PA) has been approved for acute ischemic stroke (AIS) within 3 h after onset and the treatment was then extended to 4.5 h. However, the Food and Drug Administration did not approve the indication in the expanded time window. This retrospective, matched cohort study aims to investigate the effectiveness and safety of rt-PA in AIS at 3–4.5 h after onset. Materials and Methods: The treatment group included AIS patients receiving rt-PA at 3–4.5 h after onset, otherwise complying with the regulation, in the stroke registries in 16 hospitals between 2008 and 2017. The control group included age-and sex-matched patients not receiving intravenous thrombolysis from the same registries, excluding those with contraindications. The primary outcome was modified Rankin Scale (mRS) 0–1 at day 90. The safety outcomes were any intracerebral hemorrhage (ICH), early neurological deterioration and 3-month mortality. Results: Each group had 374 patients. There were 34.0%of patients with 3-month mRS 0-1 in the treatment group vs. 22.7% in the control group with an odds ratio of 1.75 (95% confidence intervals, 1.27 to 2.42, P = 0.001). There was no difference in symptomatic ICH, early neurological deterioration and 3-month mortality rates between two groups. The 3-month mRS and symptomatic ICH did not differ significantly in patients receiving standard dose or low dose of rt-PA. Conclusions: Our results support the prescription of rt-PA in AIS patients 3–4.5 h after onset as an effective and tolerable treatment in their functional recovery.

AB - Background and Objectives: Intravenous recombinant tissue plasminogen activator (rt-PA) has been approved for acute ischemic stroke (AIS) within 3 h after onset and the treatment was then extended to 4.5 h. However, the Food and Drug Administration did not approve the indication in the expanded time window. This retrospective, matched cohort study aims to investigate the effectiveness and safety of rt-PA in AIS at 3–4.5 h after onset. Materials and Methods: The treatment group included AIS patients receiving rt-PA at 3–4.5 h after onset, otherwise complying with the regulation, in the stroke registries in 16 hospitals between 2008 and 2017. The control group included age-and sex-matched patients not receiving intravenous thrombolysis from the same registries, excluding those with contraindications. The primary outcome was modified Rankin Scale (mRS) 0–1 at day 90. The safety outcomes were any intracerebral hemorrhage (ICH), early neurological deterioration and 3-month mortality. Results: Each group had 374 patients. There were 34.0%of patients with 3-month mRS 0-1 in the treatment group vs. 22.7% in the control group with an odds ratio of 1.75 (95% confidence intervals, 1.27 to 2.42, P = 0.001). There was no difference in symptomatic ICH, early neurological deterioration and 3-month mortality rates between two groups. The 3-month mRS and symptomatic ICH did not differ significantly in patients receiving standard dose or low dose of rt-PA. Conclusions: Our results support the prescription of rt-PA in AIS patients 3–4.5 h after onset as an effective and tolerable treatment in their functional recovery.

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U2 - 10.3389/fneur.2019.01038

DO - 10.3389/fneur.2019.01038

M3 - Article

AN - SCOPUS:85074479360

VL - 10

JO - Frontiers in Neurology

JF - Frontiers in Neurology

SN - 1664-2295

IS - OCT

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ER -