J Korean Neurol Assoc.  2023 May;41(2):112-120. 10.17340/jkna.2023.2.2.

Safety and Efficacy of Intravenous Thrombolysis in the 3- to 4.5-hour Window in Acute Ischemic Stroke Patients Who Have Both Diabetes Mellitus and History of Prior Stroke

  • 1Department of Neurology, Inje University Ilsan Paik Hospital, Goyang, Korea
  • 2Clinical Research Center, Asan Medical Center, Seoul, Korea
  • 3Department of Neurology, Nowon Eulji Medical Center, Seoul, Korea
  • 4Department of Neurology, Daejeon Eulji Medical Center, Daejeon, Korea
  • 5Department of Neurology, Dong-A University Hospital, Busan, Korea
  • 6Department of Neurology, Seoul National University Bundang Hospital, Seongnam, Korea
  • 7Department of Neurology, Seoul Medical Center, Seoul, Korea
  • 8Department of Neurology, Soonchunhyang University Hospital Seoul, Seoul, Korea
  • 9Department of Neurology, Yeungnam University Hospital, Daegu, Korea
  • 10Department of Neurology, Hallym University Sacred Heart Hospital, Anyang, Korea
  • 11Department of Neurology, Chonnam National University Hospital, Gwangju, Korea
  • 12Department of Neurology, Dongguk University Ilsan Hospital, Goyang, Korea
  • 13Department of Neurology, Jeju National University Hospital, Jeju, Korea
  • 14Department of Neurology, Chungbuk National University Hospital, Cheongju, Korea
  • 15Department of Neurology, Ulsan University Hospital, Ulsan, Korea
  • 16Department of Neurology, Keimyung University Dongsan Hospital, Daegu, Korea
  • 17Department of Neurology, Chung-Ang University Hospital, Seoul, Korea
  • 18Department of Neurology, Hallym University Chuncheon Sacred Heart Hospital, Chuncheon, Korea
  • 19Department of Neurology, Uijeongbu Eulji Medical Center, Uijeongbu, Korea


For acute ischemic stroke (AIS) patients with history of prior stroke (PS) and diabetes mellitus (DM), intravenous recombinant tissue plasminogen activator (IV-tPA) therapy in the 3- to 4.5-hour window is off-label in Korea. This study aimed to assess the safety and efficacy of IV-tPA in these patients.
Using data from a prospective multicenter stroke registry between January 2009 and March 2021, we identified AIS patients who received IV-tPA in the 3- to 4.5-hour window, and compared the outcomes of symptomatic intracranial hemorrhage (SICH), 3-month mortality, 3-month modified Rankin Scale (mRS) score 0-1 and 3-month mRS distribution between patients with both PS and DM (PS/DM, n=56) versus those with neither PS nor DM, or with only one (non-PS/DM, n=927).
The PS/DM group versus the non-PS/DM group was more likely to have a prior disability, hypertension, hyperlipidemia, coronary heart disease and less likely to have atrial fibrillation. The PS/DM and the non-PS/DM groups had comparable rates of SICH (0% vs. 1.7%; p>0.999) and 3-month mortality (10.7% vs. 10.2%; p=0.9112). The rate of 3-month mRS 0-1 was non-significantly lower in the PS/DM group than in the non-PS/DM group (30.4% vs. 40.7%; adjusted odds ratio [95% confidence interval], 0.81 [0.41-1.59]).
In the 3- to 4.5-hour window, AIS patients with PS/DM, as compared to those with non-PS/DM, might benefit less from IV-tPA. However, given the similar risks of SICH and mortality, IV-tPA in the late time window could be considered in patients with both PS and DM.


Diabetes mellitus; Stroke; Thrombolytic therapy; Tissue plasminogen activator; 3- to 4.5-hour time window
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