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

• Kim B
• Lee JS
• Park HK
• Yung YB
• Oh KC
• Park JJ
• Cho YJ
• Kang K
• Lee SJ
• Kim JG
• Cha JK
• Kim DH
• Bae HJ
• Park TH
• Park SS
• Lee KB
• Lee J
• Lee BC
• Lee M
• Kim JT
• Choi KH
• Kim DE
• Choi JC
• Shin DI
• Kwon JH
• Kim WJ
• Sohn SI
• Hong JH
• Park HJ
• Jang SH
• Park KY
• Lee SH
• Park JM
• Hong KS

• KMID: 2542146
• DOI: http://doi.org/10.17340/jkna.2023.2.2

Abstract

Background
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.
Methods
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).
Results
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]).
Conclusions
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.

Keyword

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