Original Research ARTICLE
Intravenous Thrombolysis Administration 3 to 4.5 Hours after Acute Ischemic Stroke: A Retrospective, Multicenter Study
- 1Department of Neurology, Landseed Hospital, Taiwan
- 2National Taiwan University Hospital, Taiwan
- 3Ditmanson Medical Foundation Chia-Yi Christian Hospital, Taiwan
- 4National Cheng Kung University Hospital, Taiwan
- 5Chi Mei Medical Center, Taiwan
- 6China Medical University Hospital, Taiwan
- 7Mackay Memorial Hospital, Taiwan
- 8En Chu Kong Hospital, Taiwan
- 9Taichung Veterans General Hospital, Taiwan
- 10Shuang Ho Hospital, Taipei Medical University, Taiwan
- 11Chang Bing Show Chwan Memorial Hospital, Taiwan
- 12Tri-Service General Hospital, Taiwan
- 13Sin-Lau Christian Hospital, Taiwan
- 14Taipei Veterans General Hospital, Taiwan
- 15Cheng Hsin General Hospital, Taiwan
- 16Shin Kong Wu Ho-Su Memorial Hospital, Taiwan
Background and Objectives: Intravenous recombinant tissue plasminogen activator (rt-PA) has been approved for acute ischemic stroke (AIS) within 3 hours after onset, and was then extended to 4.5 hours. However, the Food and Drug Administration did not approve the indication in the expanded time window. This retrospective, matched cohort study aims to investigate the effectiveness and safety of rt-PA in AIS at 3-4.5 hours after onset.
Materials and methods: The treatment group included AIS patients receiving rt-PA at 3-4.5 hours after onset, otherwise complied with the regulation, in the stroke registries in 16 hospitals between 2008 and 2017. The control group included age- and sex-matched patients not receiving intravenous thrombolysis from the same registries, excluding those with contraindications. The primary outcome was modified Rankin Scale (mRS) 0-1 at day 90. The safety outcomes were any intracerebral hemorrhage (ICH), early neurological deterioration and 3-month mortality.
Results: Each group had 374 patients. There were 34.0% of patients with 3-month mRS 0-1 in the treatment group vs. 22.7% in the control group with an odds ratio of 1.75 (95% confidence intervals, 1.27 to 2.42, P=0.001). There was no difference in symptomatic ICH, early neurological deterioration and 3-month mortality rates between two groups. The 3-month mRS and symptomatic ICH did not differ significantly in patients receiving standard dose or low dose of rt-PA.
Conclusions: Our results support the prescription of rt-PA in AIS patients 3-4.5 hours after onset as an effective and tolerable treatment in their functional recovery.
Keywords: Acute ischemic stroke, intravenous thrombolysis, Tissue Plasminogen Activator, 3-4.5 hours after stroke onset, functional recovery
Received: 01 Jul 2019;
Accepted: 13 Sep 2019.
Copyright: © 2019 Chen, Sung, Chen, Tang, Tsai, Lin, Huang, Po, Sun, Chen, Chan, Wei, Lee, Hsieh, Lin, Yeh, Jeng and Lien. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Dr. Li-Ming Lien, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, 111, Taiwan, firstname.lastname@example.org