Intravenous Thrombolysis Administration 3–4.5 h After Acute Ischemic Stroke: A Retrospective, Multicenter Study

Did the patients say they were 100% recovered?  I don't trust raters and the Rankin scale. What are you doing about the 66% of patients that did not get (mRS) 0–1? I'd say a 66% failure rate is failure.

Intravenous Thrombolysis Administration 3–4.5 h After Acute Ischemic Stroke: A Retrospective, Multicenter Study

Yu-Wei Chen^1,2, Sheng-Feng Sung³, Chih-Hung Chen⁴, Sung-Chun Tang², Li-Kai Tsai², Huey-Juan Lin⁵, Hung-Yu Huang⁶, Helen L. Po⁷, Yu Sun⁸, Po-Lin Chen⁹, Lung Chan^10,11,12, Cheng-Yu Wei¹³, Jiunn-Tay Lee¹⁴, Cheng-Yang Hsieh¹⁵, Yung-Yang Lin¹⁶, Shoou-Jeng Yeh¹⁷, Li-Ming Lien^12,18* and Jiann-Shing Jeng²

• ¹Department of Neurology, Landseed International Hospital, Taoyuan, Taiwan
• ²Stroke Center and Department of Neurology, National Taiwan University Hospital, Taipei, Taiwan
• ³Division of Neurology, Department of Internal Medicine, Ditmanson Medical Foundation Chiayi Christian Hospital, Chiayi, Taiwan
• ⁴Department of Neurology, National Cheng Kung University Hospital, Tainan, Taiwan
• ⁵Department of Neurology, Chi Mei Medical Center, Tainan, Taiwan
• ⁶Department of Neurology, China Medical University Hospital, Taichung, Taiwan
• ⁷Department of Neurology, Mackay Memorial Hospital, Taipei, Taiwan
• ⁸Department of Neurology, En Chu Kong Hospital, New Taipei City, Taiwan
• ⁹Department of Neurology, Taichung Veterans General Hospital, Taichung, Taiwan
• ¹⁰Department of Neurology and Stroke Center, Taipei Medical University–Shuang Ho Hospital, New Taipei City, Taiwan
• ¹¹Taipei Neuroscience Institute, Taipei Medical University, New Taipei City, Taiwan
• ¹²Department of Neurology, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan
• ¹³Department of Neurology, Chang Bing Show Chwan Memorial Hospital, Changhwa, Taiwan
• ¹⁴Department of Neurology, Tri Service General Hospital, Taipei, Taiwan
• ¹⁵Department of Neurology, Tainan Sin Lau Hospital, Tainan, Taiwan
• ¹⁶Department of Neurology and Department of Critical Care Medicine, Taipei Veterans General Hospital, Taipei, Taiwan
• ¹⁷Department of Neurology, Cheng Ching General Hospital, Taichung, Taiwan
• ¹⁸Department of Neurology, Shin Kong WHS Memorial Hospital, Taipei, Taiwan

Background and Objectives: Intravenous recombinant tissue plasminogen activator (rt-PA) has been approved for acute ischemic stroke (AIS) within 3 h after onset and the treatment was then extended to 4.5 h. 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 h after onset.

Materials and Methods: The treatment group included AIS patients receiving rt-PA at 3–4.5 h after onset, otherwise complying 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 h after onset as an effective and tolerable treatment in their functional recovery.