Abstract T P53: Implementation and Outcome of Intravenous Recombinant Tissue Plasminogen Activator Administered 3-4.5 hour after Stroke in Korea
Background: Although the benefit of intravenous recombinant tissue plasminogen activator (IV-TPA) has been proved in patients with 3-4.5 hour after stroke from a randomized trial and observational studies, in which most subjects were Western population. We aimed to determined the safety and efficacy of IV-TPA within the 3- to 4.5-hour window in Korean population.
Methods: Using a prospective, web-based registry of consecutive patients with acute stroke or transient ischemic attack (TIA) admitted to 12 academic hospitals in Korea, we enrolled 616 patients receiving IV-TPA therapy within 3 hours and 107 within 3-4.5 hours after stroke onset for this study. Functional outcome measured by modified Rankin scale (mRS) at 3 months after stroke was compared between the two time window cohorts. Symptomatic intracranial hemorrhage (SICH) defined as any apparently extravascular blood in the brain or within the cranium associated with 4 points or more increase in the National Institutes of Health Stroke Scale (NIHSS) score or leading to death was evaluated for safety. Odds ratios (OR) and 95% confidence intervals (CI) was calculated to present the probability of achieving each outcome for patients treated within 3-4.5 hours compared to those treated within 3 hours.
Results: The excellent outcome (mRS 0-1) was less often achieved in the 3-4.5 hours cohort than in the within 3 hours cohort (39.3% vs 42.9%), but the difference was not statistically significant after adjusting for age, sex, baseline NIHSS score, weight, glucose, center (adjusted OR [95% CI], 1.26 [0.60-2.65]). The proportion of mRS 0-2 at 3 months (48.6% vs55.7%) was not also different between two groups (adjusted OR [95% CI], 0.80 [0.41-1.54]). The rate of SICH was higher in the 3-4.5 hours cohort than in the within 3 hours cohort (4.7% vs 3.1%), but the difference was not statistically significant (adjusted OR [95% CI], 0.81 [0.20-3.35]).
Conclusion: This study shows that IV-TPA therapy within the 3- to 4.5-hour window after ischemic stroke is safe and effective in Korean patients.
Author Disclosures: T. Park: None. K. Hong: None. S. Park: None. Y. Ko: None. S. Lee: None. K. Kang: None. J. Park: None. J. Choi: None. D. Kim: None. Y. Cho: None. J. Kim: None. D. Kim: None. J. Cha: None. M. Han: None. K. Yu: None. B. Lee: None. J. Lee: None. J. Lee: None. K. Lee: None. J. Lee: None. H. Bae: None. B. Yoon: None.
- © 2014 by American Heart Association, Inc.