KMID : 0359720230410020112
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Journal of the Korean Neurological Association 2023 Volume.41 No. 2 p.112 ~ p.120
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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
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Kim Bo-Young
Lee Ji-Sung Park Hong-Kyunr Yung Young-Bok Park Jeong-Joo Cho Yong-Jin Kang Kyu-Sik Lee Soo-Joo Kim Jae-Guk Cha Jae-Kwan Kim Dae-Hyun Bae Hee-Joon Park Tai-Hwan Park Sang-Soon Lee Kyung-Bok Lee Jun Lee Byung-Chul Lee Min-Woo Kim Joon-Tae Choi Kang-Ho Kim Dong-Eog Choi Jay-Chol Shin Dong-Ick Kwon Jee-Hyun Kim Wook-Joo Sohn Sung-Il Hong Jeong-Ho Park Hyung-Jong Jang Seong-Hwa Park Kwang-Yeol Lee Sang-Hwa Park Jong-Moo Hong Keun-Sik
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Abstract
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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.
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KEYWORD
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Diabetes mellitus, Stroke, Thrombolytic therapy, Tissue plasminogen activator, 3- to 4.5-hour time window
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