title: Routine use of intravenous low-dose recombinant tissue plasminogen activator in Japanese patients: general outcomes and prognostic factors from the SAMURAI register.
abstract: OBJECTIVE
  A retrospective, multicenter, observational study was conducted to document clinical outcomes and to identify outcome predictors in patients treated with low-dose intravenous recombinant tissue plasminogen activator (0.6 mg/kg alteplase), which was approved in Japan in 2005, within 3 hours of stroke onset.
  
  
  METHODS
  Consecutive patients with stroke treated with recombinant tissue plasminogen activator in 10 Japanese stroke centers were included.
  
  
  RESULTS
  A total of 600 patients (377 men, 72+/-12 years old) were studied. Median National Institutes of Health Stroke Scale scores decreased from 13 before recombinant tissue plasminogen activator to 8 at 24 hours later. Symptomatic intracerebral hemorrhage within 36 hours with a >or=1-point increase from the baseline National Institutes of Health Stroke Scale score developed in 23 patients (3.8%; 95% CI, 2.6% to 5.7%). At 3 months, 43 patients had died (7.2%; 5.4% to 9.5%), and 199 patients (33.2%; 29.5% to 37.0%) had a modified Rankin Scale score <or=1. Analysis of 399 patients with a premorbid modified Rankin Scale score <or=1 who met the criteria of the European license (<or=80 years old, an initial National Institutes of Health Stroke Scale score <or=24, etc) showed that 40.6% (35.9% to 45.5%) had a 3-month modified Rankin Scale score <or=1. After multivariate adjustment, younger age, lower initial National Institutes of Health Stroke Scale score, absence of internal carotid artery occlusion, higher Alberta Stroke Program Early CT Score on CT, and absence of intravenous antihypertensives just before recombinant tissue plasminogen activator were independently related to a 3-month modified Rankin Scale score <or=1. Congestive heart failure and hyperglycemia were independently related to mortality.
  
  
  CONCLUSIONS
  Three-month outcomes of patients receiving low-dose intravenous recombinant tissue plasminogen activator therapy in the present study were similar to those from postmarketing surveys using 0.9 mg/kg alteplase.
authors.affiliation: Cerebrovascular Division, Department of Medicine, National Cardiovascular Center, Suita, Japan. toyoda@hsp.ncvc.go.jp
authors.forename: Kazunori
authors.initials: K
authors.lastname: Toyoda
authors.forename: Masatoshi
authors.initials: M
authors.lastname: Koga
authors.forename: Masaki
authors.initials: M
authors.lastname: Naganuma
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Shiokawa
authors.forename: Jyoji
authors.initials: J
authors.lastname: Nakagawara
authors.forename: Eisuke
authors.initials: E
authors.lastname: Furui
authors.forename: Kazumi
authors.initials: K
authors.lastname: Kimura
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Yamagami
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Okada
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Hasegawa
authors.forename: Kazuomi
authors.initials: K
authors.lastname: Kario
authors.forename: Satoshi
authors.initials: S
authors.lastname: Okuda
authors.forename: Kazutoshi
authors.initials: K
authors.lastname: Nishiyama
authors.forename: Kazuo
authors.initials: K
authors.lastname: Minematsu
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D044466:Asian People; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use; D012042:Registries; D012189:Retrospective Studies; D020521:Stroke / Q000175:diagnosis* / Q000188:drug therapy*; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D011994:Recombinant Proteins; D010959:Tissue Plasminogen Activator