Safety and efficacy of intravenous recombinant tissue plasminogen activator administered in the 3- to 4.5-hour window in Korea

Tai Hwan Park, Ji Sung Lee, Sang Soon Park, Youngchai Ko, Soo Joo Lee, Kyung Bok Lee, Jun Lee, Kyusik Kang, Jong Moo Park, Jay Chol Choi, Dong Eog Kim, Yong Jin Cho, Joon Tae Kim, Dae Hyun Kim, Jae Kwan Cha, Moon Ku Han, Juneyoung Lee, Mi Sun Oh, Kyung Ho Yu, Byung Chul LeeHee Joon Bae, Keun Sik Hong

Research output: Contribution to journalArticle

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Abstract

Background The safety and efficacy of intravenous tissue plasminogen activator (IV-TPA) in the 3- to 4.5-hour window were largely driven from Western populations, but have not been systematically explored in Korean population. Methods We compared outcomes of acute ischemic stroke patients treated in the 3- to 4.5-hour window versus those in the 0- to 3-hour window, using a prospective multicenter registry database. Safety outcomes included symptomatic intracranial hemorrhage (SICH) and 3-month mortality and efficacy outcomes were the proportions of modified Rankin Scale (mRS) 0-1 and mRS 0-2 and the overall mRS distribution at 3 months. Results Among 723 patients consecutively treated with IV-TPA alone, 616 were treated within 3 hours and 107 treated between 3 and 4.5 hours. The median onset-to-treatment time was 115 minutes for 0- to 3-hour group and 217 minutes for 3- to 4.5-hour group. The SICH rate was higher in the 3- to 4.5-hour group than in the 0- to 3-hour group (4.7% vs. 3.1%), but the difference was not significant (adjusted odds ratio [OR] [95% confidence interval {CI}],.81 [.20-3.35]). There were no significant differences between the 3- to 4.5-hour and 0- to 3-hour groups in the 3-month mortality (19.6% vs. 12.0%), mRS 0-1 (39.3% vs. 42.9%), mRS 0-2 (48.6% vs. 55.7%), and the overall mRS distribution (adjusted proportional OR [95% CI],.94 [.63-1.41]) after adjusting for covariates. Conclusions IV-TPA treatment can be safely and efficaciously administered to eligible Korean patients up to the extended time window of 4.5 hours. However, efforts to expedite the treatment should not be neglected.

Original languageEnglish
Pages (from-to)1805-1812
Number of pages8
JournalJournal of Stroke and Cerebrovascular Diseases
Volume23
Issue number7
DOIs
Publication statusPublished - 2014 Jan 1
Externally publishedYes

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Tissue Plasminogen Activator
Korea
Intracranial Hemorrhages
Safety
Odds Ratio
Confidence Intervals
Mortality
Population
Registries
Therapeutics
Stroke
Databases

Keywords

  • acute stroke
  • Intravenous recombinant tissue plasminogen activator
  • ischemic stroke
  • safety

ASJC Scopus subject areas

  • Surgery
  • Rehabilitation
  • Clinical Neurology
  • Cardiology and Cardiovascular Medicine

Cite this

Safety and efficacy of intravenous recombinant tissue plasminogen activator administered in the 3- to 4.5-hour window in Korea. / Park, Tai Hwan; Lee, Ji Sung; Park, Sang Soon; Ko, Youngchai; Lee, Soo Joo; Lee, Kyung Bok; Lee, Jun; Kang, Kyusik; Park, Jong Moo; Choi, Jay Chol; Kim, Dong Eog; Cho, Yong Jin; Kim, Joon Tae; Kim, Dae Hyun; Cha, Jae Kwan; Han, Moon Ku; Lee, Juneyoung; Oh, Mi Sun; Yu, Kyung Ho; Lee, Byung Chul; Bae, Hee Joon; Hong, Keun Sik.

In: Journal of Stroke and Cerebrovascular Diseases, Vol. 23, No. 7, 01.01.2014, p. 1805-1812.

Research output: Contribution to journalArticle

Park, TH, Lee, JS, Park, SS, Ko, Y, Lee, SJ, Lee, KB, Lee, J, Kang, K, Park, JM, Choi, JC, Kim, DE, Cho, YJ, Kim, JT, Kim, DH, Cha, JK, Han, MK, Lee, J, Oh, MS, Yu, KH, Lee, BC, Bae, HJ & Hong, KS 2014, 'Safety and efficacy of intravenous recombinant tissue plasminogen activator administered in the 3- to 4.5-hour window in Korea', Journal of Stroke and Cerebrovascular Diseases, vol. 23, no. 7, pp. 1805-1812. https://doi.org/10.1016/j.jstrokecerebrovasdis.2014.04.027
Park, Tai Hwan ; Lee, Ji Sung ; Park, Sang Soon ; Ko, Youngchai ; Lee, Soo Joo ; Lee, Kyung Bok ; Lee, Jun ; Kang, Kyusik ; Park, Jong Moo ; Choi, Jay Chol ; Kim, Dong Eog ; Cho, Yong Jin ; Kim, Joon Tae ; Kim, Dae Hyun ; Cha, Jae Kwan ; Han, Moon Ku ; Lee, Juneyoung ; Oh, Mi Sun ; Yu, Kyung Ho ; Lee, Byung Chul ; Bae, Hee Joon ; Hong, Keun Sik. / Safety and efficacy of intravenous recombinant tissue plasminogen activator administered in the 3- to 4.5-hour window in Korea. In: Journal of Stroke and Cerebrovascular Diseases. 2014 ; Vol. 23, No. 7. pp. 1805-1812.
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abstract = "Background The safety and efficacy of intravenous tissue plasminogen activator (IV-TPA) in the 3- to 4.5-hour window were largely driven from Western populations, but have not been systematically explored in Korean population. Methods We compared outcomes of acute ischemic stroke patients treated in the 3- to 4.5-hour window versus those in the 0- to 3-hour window, using a prospective multicenter registry database. Safety outcomes included symptomatic intracranial hemorrhage (SICH) and 3-month mortality and efficacy outcomes were the proportions of modified Rankin Scale (mRS) 0-1 and mRS 0-2 and the overall mRS distribution at 3 months. Results Among 723 patients consecutively treated with IV-TPA alone, 616 were treated within 3 hours and 107 treated between 3 and 4.5 hours. The median onset-to-treatment time was 115 minutes for 0- to 3-hour group and 217 minutes for 3- to 4.5-hour group. The SICH rate was higher in the 3- to 4.5-hour group than in the 0- to 3-hour group (4.7{\%} vs. 3.1{\%}), but the difference was not significant (adjusted odds ratio [OR] [95{\%} confidence interval {CI}],.81 [.20-3.35]). There were no significant differences between the 3- to 4.5-hour and 0- to 3-hour groups in the 3-month mortality (19.6{\%} vs. 12.0{\%}), mRS 0-1 (39.3{\%} vs. 42.9{\%}), mRS 0-2 (48.6{\%} vs. 55.7{\%}), and the overall mRS distribution (adjusted proportional OR [95{\%} CI],.94 [.63-1.41]) after adjusting for covariates. Conclusions IV-TPA treatment can be safely and efficaciously administered to eligible Korean patients up to the extended time window of 4.5 hours. However, efforts to expedite the treatment should not be neglected.",
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TY - JOUR

T1 - Safety and efficacy of intravenous recombinant tissue plasminogen activator administered in the 3- to 4.5-hour window in Korea

AU - Park, Tai Hwan

AU - Lee, Ji Sung

AU - Park, Sang Soon

AU - Ko, Youngchai

AU - Lee, Soo Joo

AU - Lee, Kyung Bok

AU - Lee, Jun

AU - Kang, Kyusik

AU - Park, Jong Moo

AU - Choi, Jay Chol

AU - Kim, Dong Eog

AU - Cho, Yong Jin

AU - Kim, Joon Tae

AU - Kim, Dae Hyun

AU - Cha, Jae Kwan

AU - Han, Moon Ku

AU - Lee, Juneyoung

AU - Oh, Mi Sun

AU - Yu, Kyung Ho

AU - Lee, Byung Chul

AU - Bae, Hee Joon

AU - Hong, Keun Sik

PY - 2014/1/1

Y1 - 2014/1/1

N2 - Background The safety and efficacy of intravenous tissue plasminogen activator (IV-TPA) in the 3- to 4.5-hour window were largely driven from Western populations, but have not been systematically explored in Korean population. Methods We compared outcomes of acute ischemic stroke patients treated in the 3- to 4.5-hour window versus those in the 0- to 3-hour window, using a prospective multicenter registry database. Safety outcomes included symptomatic intracranial hemorrhage (SICH) and 3-month mortality and efficacy outcomes were the proportions of modified Rankin Scale (mRS) 0-1 and mRS 0-2 and the overall mRS distribution at 3 months. Results Among 723 patients consecutively treated with IV-TPA alone, 616 were treated within 3 hours and 107 treated between 3 and 4.5 hours. The median onset-to-treatment time was 115 minutes for 0- to 3-hour group and 217 minutes for 3- to 4.5-hour group. The SICH rate was higher in the 3- to 4.5-hour group than in the 0- to 3-hour group (4.7% vs. 3.1%), but the difference was not significant (adjusted odds ratio [OR] [95% confidence interval {CI}],.81 [.20-3.35]). There were no significant differences between the 3- to 4.5-hour and 0- to 3-hour groups in the 3-month mortality (19.6% vs. 12.0%), mRS 0-1 (39.3% vs. 42.9%), mRS 0-2 (48.6% vs. 55.7%), and the overall mRS distribution (adjusted proportional OR [95% CI],.94 [.63-1.41]) after adjusting for covariates. Conclusions IV-TPA treatment can be safely and efficaciously administered to eligible Korean patients up to the extended time window of 4.5 hours. However, efforts to expedite the treatment should not be neglected.

AB - Background The safety and efficacy of intravenous tissue plasminogen activator (IV-TPA) in the 3- to 4.5-hour window were largely driven from Western populations, but have not been systematically explored in Korean population. Methods We compared outcomes of acute ischemic stroke patients treated in the 3- to 4.5-hour window versus those in the 0- to 3-hour window, using a prospective multicenter registry database. Safety outcomes included symptomatic intracranial hemorrhage (SICH) and 3-month mortality and efficacy outcomes were the proportions of modified Rankin Scale (mRS) 0-1 and mRS 0-2 and the overall mRS distribution at 3 months. Results Among 723 patients consecutively treated with IV-TPA alone, 616 were treated within 3 hours and 107 treated between 3 and 4.5 hours. The median onset-to-treatment time was 115 minutes for 0- to 3-hour group and 217 minutes for 3- to 4.5-hour group. The SICH rate was higher in the 3- to 4.5-hour group than in the 0- to 3-hour group (4.7% vs. 3.1%), but the difference was not significant (adjusted odds ratio [OR] [95% confidence interval {CI}],.81 [.20-3.35]). There were no significant differences between the 3- to 4.5-hour and 0- to 3-hour groups in the 3-month mortality (19.6% vs. 12.0%), mRS 0-1 (39.3% vs. 42.9%), mRS 0-2 (48.6% vs. 55.7%), and the overall mRS distribution (adjusted proportional OR [95% CI],.94 [.63-1.41]) after adjusting for covariates. Conclusions IV-TPA treatment can be safely and efficaciously administered to eligible Korean patients up to the extended time window of 4.5 hours. However, efforts to expedite the treatment should not be neglected.

KW - acute stroke

KW - Intravenous recombinant tissue plasminogen activator

KW - ischemic stroke

KW - safety

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