Outcomes of thrombolytic therapy for acute ischemic stroke in Chinese patients: the Taiwan Thrombolytic Therapy for Acute Ischemic Stroke (TTT-AIS) study.
OBJECTIVE
The safety and efficacy of alteplase for ischemic stroke has not been examined in Chinese patients. We assessed the safety and efficacy of alteplase for acute ischemic stroke in daily clinical practice in Taiwan.


METHODS
A prospective, multicenter, observational study was conducted in Taiwan from December 2004 to July 2008. Eligible patients (241) receiving alteplase were recruited and divided into 2 groups: standard dose (0.90 + or - 0.02 mg/kg, n=125) and lower dose (0.72 + or - 0.07 mg/kg, n=116). Primary outcome measures were safety: symptomatic intracerebral hemorrhage and death within 3 months. The secondary outcome measure was efficacy a modified Rankin scale of 0 to 2 after 3 months.


RESULTS
The standard-dose group had higher rates of symptomatic intracerebral hemorrhage using National Institute of Neurological Diseases and Stroke, European Cooperative Acute Stroke Study, and Safe Implementation of Thrombolysis in Stroke-Monitoring Study definitions (10.4% versus 5.2%, 8.0% versus 2.6%, and 5.6% versus 1.7%, respectively) and mortality within 3 months (12.8% versus 6.9%), twice that of the lower-dose group. This pattern was more prominent in older patients. Significantly higher rates of symptomatic intracerebral hemorrhage per European Cooperative Acute Stroke Study (15.4% versus 3.3%, P=0.0257) and mortality (21.1% versus 5.0%, P=0.0099) and significantly lower independence rate (32.6% versus 53.6%, P=0.0311) were observed among patients > or = 70 years old receiving the standard dose than those receiving the lower dose.


CONCLUSIONS
This study suggests that the standard dose of 0.9 mg/kg alteplase may not be optimal for treating aged Chinese patients. However, the dose of recombinant tissue plasminogen activator for ischemic stroke in Chinese patients should be based on more broad and convincing evidences and randomized trials of lower versus higher doses are needed.
Department of Neurology, Taipei Veterans General Hospital, No. 201 Sec. 2, Shih-pai Road, Shih-pai, Taipei, Taiwan 11217.
A-Ching
AC
Chao
Hung-Yi
HY
Hsu
Chih-Ping
CP
Chung
Chung-Hsiang
CH
Liu
Chih-Hung
CH
Chen
Michael Mu-Huo
MM
Teng
Giia-Sheun
GS
Peng
Wen-Yung
WY
Sheng
Han Hwa
HH
Hu
D000368:Aged; D000369:Aged, 80 and over; D044466:Asian People; D002545:Brain Ischemia / Q000188:drug therapy* / Q000453:epidemiology / Q000235:genetics; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000627:therapeutic use; D020521:Stroke / Q000188:drug therapy* / Q000453:epidemiology / Q000235:genetics; D013624:Taiwan / Q000453:epidemiology; D015912:Thrombolytic Therapy / Q000639:trends*; D010959:Tissue Plasminogen Activator / Q000627:therapeutic use*; D016896:Treatment Outcome
D011994:Recombinant Proteins; D010959:Tissue Plasminogen Activator