Beom Joon Kim1, Moon-Ku Han1, Tai Hwan Park1, Sang-Soon Park1, Kyung Bok Lee1, Byung-Chul Lee1, Kyung-Ho Yu1, Mi Sun Oh1, Jae Kwan Cha1, Dae-Hyun Kim1, Jun Lee1, Soo Joo Lee1, Youngchai Ko1, Jong-Moo Park1, Kyusik Kang1, Yong-Jin Cho1, Keun-Sik Hong1, Joon-Tae Kim1, Jay Chol Choi1, Dong-Eog Kim1, Dong-Ick Shin1, Wook-Joo Kim1, Juneyoung Lee1, Ji Sung Lee1, Byung-Woo Yoon1, Philip B Gorelick1, Hee-Joon Bae1. 1. From the Department of Neurology and Cerebrovascular Center, Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Republic of Korea (B.J.K., M.-K.H., H.-J.B.); Department of Neurology, Seoul Medical Center, Seoul, Republic of Korea (T.H.P., S.-S.P.); Department of Neurology, Soonchunhyang University Hospital Seoul, Seoul, Republic of Korea (K.B.L.); Department of Neurology, Hallym University Sacred Heart Hospital, Anyang-si Republic of Korea (B.-C.L., K.-H.Y., M.S.O.); Department of Neurology, Dong-A University Hospital, Busan, Republic of Korea (J.K.C., D.-H.K.); Department of Neurology, Yeungnam University Medical Center, Daegu, Republic of Korea (J.L.); Department of Neurology, Eulji University Hospital, Eulji University School of Medicine, Daejeon, Republic of Korea (S.J.L., Y.K.); Department of Neurology, Eulji General Hospital, Seoul, Republic of Korea (J.-M.P., K.K.); Department of Neurology, Inje University Ilsan Paik Hospital, Goyang-si, Gyeonggi-do, Republic of Korea (Y.-J.C., K.-S.H.); Department of Neurology, Chonnam National University Hospital, Gwangju, Republic of Korea (J.-T.K.); Department of Neurology, Jeju National University, Jeju, Republic of Korea (J.C.C.); Department of Neurology, Dongguk University Ilsan Hospital, Goyang-si, Gyeonggi-do, Republic of Korea (D.-E.K.); Department of Neurology, Chungbuk National University Hospital, Chungbuk National University School of Medicine, Cheongju, Republic of Korea (D.-I.S.); Department of Neurology, Ulsan University Hospital, Ulsan, Republic of Korea (W.-J.K.); Department of Biostatistics, Korea University College of Medicine, Seoul, Republic of Korea (J.L.); Clinical Trial Center, Asan Medical Center, Seoul, Republic of Korea (J.S.L.); Department of Neurology, Seoul National University Hospital, Seoul, Republic of Korea (B.-W.Y.); and Department of Translational Science and Molecular Medicine, Michigan State University College of Human Medicine, and Mercy Health Hauenstein Neuroscienc
Abstract
BACKGROUND AND PURPOSE: The low-dose (0.6 mg/kg) alteplase strategy to treat acute ischemic stroke patients became widespread in East Asian countries, without rigorous testing against standard-dose (0.9 mg/kg) alteplase treatment. Our aim was to investigate the comparative effectiveness and safety of the low-dose versus standard-dose intravenous alteplase strategy. METHODS: A total of 1526 acute ischemic stroke patients who qualified for intravenous alteplase and treated within 4.5 hours were identified from a prospective, multicenter, and nationwide stroke registry database. Primary outcomes were a modified Rankin scale score of 0 to 1 at 3 months after stroke and occurrence of symptomatic hemorrhagic transformation. Inverse probability of low-dose alteplase weighting by propensity scores was used to remove baseline imbalances between the 2 groups, and variation among centers were also accounted using generalized linear mixed models with a random intercept. RESULTS: Low-dose intravenous alteplase was given to 450 patients (29.5%) and standard-dose intravenous alteplase to 1076 patients (70.5%). Low-dose alteplase treatment was comparable to standard-dose therapy according to the following adjusted outcomes and odds ratios (95% confidence intervals): modified Rankin scale score 0 to 1 at 3 months and 0.95 (0.68-1.32); modified Rankin scale 0 to 2 at 3 months and 0.84 (0.62-1.15); symptomatic hemorrhagic transformation and 1.05 (0.65-1.70); and 3-month mortality and 0.54 (0.35-0.83). The associations were unchanged when the analysis was limited to those without endovascular recanalization. CONCLUSIONS: The low-dose alteplase strategy was comparable to the standard-dose treatment in terms of the effectiveness and safety.
BACKGROUND AND PURPOSE: The low-dose (0.6 mg/kg) alteplase strategy to treat acute ischemic strokepatients became widespread in East Asian countries, without rigorous testing against standard-dose (0.9 mg/kg) alteplase treatment. Our aim was to investigate the comparative effectiveness and safety of the low-dose versus standard-dose intravenous alteplase strategy. METHODS: A total of 1526 acute ischemic strokepatients who qualified for intravenous alteplase and treated within 4.5 hours were identified from a prospective, multicenter, and nationwide stroke registry database. Primary outcomes were a modified Rankin scale score of 0 to 1 at 3 months after stroke and occurrence of symptomatic hemorrhagic transformation. Inverse probability of low-dose alteplase weighting by propensity scores was used to remove baseline imbalances between the 2 groups, and variation among centers were also accounted using generalized linear mixed models with a random intercept. RESULTS: Low-dose intravenous alteplase was given to 450 patients (29.5%) and standard-dose intravenous alteplase to 1076 patients (70.5%). Low-dose alteplase treatment was comparable to standard-dose therapy according to the following adjusted outcomes and odds ratios (95% confidence intervals): modified Rankin scale score 0 to 1 at 3 months and 0.95 (0.68-1.32); modified Rankin scale 0 to 2 at 3 months and 0.84 (0.62-1.15); symptomatic hemorrhagic transformation and 1.05 (0.65-1.70); and 3-month mortality and 0.54 (0.35-0.83). The associations were unchanged when the analysis was limited to those without endovascular recanalization. CONCLUSIONS: The low-dose alteplase strategy was comparable to the standard-dose treatment in terms of the effectiveness and safety.
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