Abstract W P63: Comparison of the Efficacy and Safety of the Acute Stroke Patients Receiving Different Dose Intravenous Tissue Plasminogen Activator
Background and Purpose: In consideration of the racial differences, distinctly reduced cost of treatment and anticipated lower rates of symptomatic intracranial hemorrhage(SICH) coupled with the comparable efficacy, many Asian centers adopted the low dose intravenous tissue plasminogen activator (tPA). We aimed to examine whether lower dose tPA is comparable to standard dose by comparing the efficacy and safety of different doses of tPA in Chinese acute stroke patients.
Methods: We analyzed data from the Thrombolysis Implementation and Monitor of Acute Ischemic Stroke in China(TIMS-China)- a prospective, multicentric cohort study of intravenous alteplase treatment with patient enrollment from 67 centres across China. Patients who were fully compliant with Chinese product characteristics criteria of alteplase within 4.5 h after symptom onset were included. And these patients were divided into 5 group according to dose regimens of tPA (<0.5, 0.5-0.7, 0.7-0.85 , 0.85-0.95 and >=0.95 mg/kg). The SICH, mortality and 90-day outcome of patients were compared.
Results: A total of 919 patients were included (<0.5 n=9, 0.5-0.7 n=75, 0.7-0.85 n=131, 0.85-0.95 n=678,and >=0.95 n=26). In consideration of sample size, only 0.5-0.7, 0.7-0.85 and 0.85-0.95 mg/kg group were compared. Median tPA dose were 0.90, 0.79 and 0.64mg/kg.Median Stroke onset to treatment time were 2.79h,2.86h and 2.90h (p=0.941). Median NIHSS score were 11,10 and 10(p=0.252). After adjustment for the baseline variables, there were no significant differences for mortality(5.41% vs 8.66% vs 7.36%, p=0.695) and SICH(0% vs 3.82% vs 1.46%, p=0.106). For excellent recovery outcome defined as modified Ranking Scale(mRS) 0-1 at 3 month, 0.5-0.7 mg/kg group were significantly worse than 0.85-0.95 mg/kg group(OR=0.58,p=0.031). For functional independence outcome defined as mRS 0-2 at 3 month, 0.70-0.85 mg/kg group were significantly worse than 0.85-0.95 mg/kg group(OR=0.66,p=0.036)
Conclusion: Our study suggests that stoke patients receiving standard dose tPA may have more favorable outcome than those receiving lower dose tPA. For Asian people, 0.9mg/kg is also the most optimal dose for intravenous alteplase treatment.
Author Disclosures: X. Liao: None. Y. Wang: None. Y. Pan: None. C. Wang: None. X. Zhao: None. X. Zhao: None. C. Wang: None. L. Liu: None. Y. Wang: None.
- © 2014 by American Heart Association, Inc.