title: Safety and efficacy of intravenous recombinant tissue plasminogen activator administered in the 3- to 4.5-hour window in Korea.
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.
authors: Department of Neurology, Seoul Medical Center, Seoul, Korea.
authors: Tai Hwan
authors: TH
authors: Park
authors: Biostatistical Consulting Unit, Soonchunhyang University Medical Center, Korea.
authors: Ji Sung
authors: JS
authors: Lee
authors: Department of Neurology, Seoul Medical Center, Seoul, Korea.
authors: Sang-Soon
authors: SS
authors: Park
authors: Eulji University Hospital, Eulji University School of Medicine, Daejeon, Korea.
authors: Youngchai
authors: Y
authors: Ko
authors: Eulji University Hospital, Eulji University School of Medicine, Daejeon, Korea.
authors: Soo Joo
authors: SJ
authors: Lee
authors: Soonchunhyang University Hospital, Seoul, Korea.
authors: Kyung Bok
authors: KB
authors: Lee
authors: Yeungnam University Hospital, Daegu, Korea.
authors: Jun
authors: J
authors: Lee
authors: Eulji General Hospital, Eulji University, Seoul, Korea.
authors: Kyusik
authors: K
authors: Kang
authors: Eulji General Hospital, Eulji University, Seoul, Korea.
authors: Jong-Moo
authors: JM
authors: Park
authors: Jeju National University Hospital, Jeju National University College of Medicine, Jeju, Korea.
authors: Jay Chol
authors: JC
authors: Choi
authors: Dongguk University Ilsan Hospital, Ilsan, Korea.
authors: Dong-Eog
authors: DE
authors: Kim
authors: Ilsan Paik Hospital, Inje University, Ilsan, Korea.
authors: Yong-Jin
authors: YJ
authors: Cho
authors: Chonnam National University Hospital, Gwangju, Korea.
authors: Joon-Tae
authors: JT
authors: Kim
authors: Dong-A University Hospital, Pusan, Korea.
authors: Dae-Hyun
authors: DH
authors: Kim
authors: Dong-A University Hospital, Pusan, Korea.
authors: Jae-Kwan
authors: JK
authors: Cha
authors: Hallym University Sacred Heart Hospital, Anyang, Korea.
authors: Moon-Ku
authors: MK
authors: Han
authors: Stroke Center, Seoul National University Bundang Hospital, Seongnam, Korea.
authors: Juneyoung
authors: J
authors: Lee
authors: Department of Biostatistics, Korea University College of Medicine, Seoul, Korea.
authors: Mi Sun
authors: MS
authors: Oh
authors: Department of Biostatistics, Korea University College of Medicine, Seoul, Korea.
authors: Kyung-Ho
authors: KH
authors: Yu
authors: Department of Biostatistics, Korea University College of Medicine, Seoul, Korea.
authors: Byung-Chul
authors: BC
authors: Lee
authors: Hallym University Sacred Heart Hospital, Anyang, Korea.
authors: Hee-Joon
authors: HJ
authors: Bae
authors: Ilsan Paik Hospital, Inje University, Ilsan, Korea. Electronic address: nrhks455@gmail.com.
authors: Keun-Sik
authors: KS
authors: Hong
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D015331:Cohort Studies; D005260:Female; D006801:Humans; D020300:Intracranial Hemorrhages / Q000139:chemically induced / Q000453:epidemiology; D002546:Ischemic Attack, Transient / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011994:Recombinant Proteins; D012042:Registries; D056910:Republic of Korea; D012307:Risk Factors; D020521:Stroke / Q000188:drug therapy* / Q000453:epidemiology; D061665:Time-to-Treatment / Q000706:statistics & numerical data*; D010959:Tissue Plasminogen Activator / Q000009:adverse effects* / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D011994:Recombinant Proteins; D010959:Tissue Plasminogen Activator
keywords: Intravenous recombinant tissue plasminogen activator; acute stroke; ischemic stroke; safety