Low-Versus Standard-Dose Alteplase for Ischemic Strokes Within 4.5 Hours A Comparative Effectiveness and Safety Study

被引:63
作者
Kim, Beom Joon [1 ,2 ]
Han, Moon-Ku [1 ,2 ]
Park, Tai Hwan [3 ]
Park, Sang-Soon [3 ]
Lee, Kyung Bok [4 ]
Lee, Byung-Chul [5 ]
Yu, Kyung-Ho [5 ]
Oh, Mi Sun [5 ]
Cha, Jae Kwan [6 ]
Kim, Dae-Hyun [6 ]
Lee, Jun [7 ]
Lee, Soo Joo [8 ]
Ko, Youngchai [8 ]
Park, Jong-Moo [9 ]
Kang, Kyusik [9 ]
Cho, Yong-Jin [10 ]
Hong, Keun-Sik [10 ]
Kim, Joon-Tae [11 ]
Choi, Jay Chol [12 ]
Kim, Dong-Eog [13 ]
Shin, Dong-Ick [14 ]
Kim, Wook-Joo [15 ]
Lee, Juneyoung [16 ]
Lee, Ji Sung [17 ]
Yoon, Byung-Woo [18 ]
Gorelick, Philip B. [19 ,20 ]
Bae, Hee-Joon [1 ,2 ]
机构
[1] Seoul Natl Univ, Bundang Hosp, Dept Neurol, Songnam 463707, Gyeonggi Do, South Korea
[2] Seoul Natl Univ, Bundang Hosp, Cerebrovasc Ctr, Songnam 463707, Gyeonggi Do, South Korea
[3] Seoul Med Ctr, Dept Neurol, Seoul, South Korea
[4] Soonchunhyang Univ Hosp Seoul, Dept Neurol, Seoul, South Korea
[5] Hallym Univ, Sacred Heart Hosp, Dept Neurol, Anyang Si, South Korea
[6] Dong A Univ, Dept Neurol, Busan, South Korea
[7] Yeungnam Univ, Med Ctr, Dept Neurol, Daegu, South Korea
[8] Eulji Univ, Sch Med, Eulji Univ Hosp, Dept Neurol, Taejon, South Korea
[9] Eulji Gen Hosp, Dept Neurol, Seoul, South Korea
[10] Inje Univ, Ilsan Paik Hosp, Dept Neurol, Goyang Si, Gyeonggi Do, South Korea
[11] Chonnam Natl Univ Hosp, Dept Neurol, Gwangju, South Korea
[12] Jeju Natl Univ, Dept Neurol, Jeju, South Korea
[13] Dongguk Univ, Ilsan Hosp, Dept Neurol, Goyang Si, Gyeonggi Do, South Korea
[14] Chungbuk Natl Univ, Sch Med, Chungbuk Natl Univ Hosp, Dept Neurol, Cheongju, South Korea
[15] Ulsan Univ Hosp, Dept Neurol, Ulsan, South Korea
[16] Korea Univ, Coll Med, Dept Biostat, Seoul 136705, South Korea
[17] Asan Med Ctr, Clin Trial Ctr, Seoul, South Korea
[18] Seoul Natl Univ Hosp, Dept Neurol, Seoul 110744, South Korea
[19] Michigan State Univ, Coll Human Med, Dept Translat Sci & Mol Med, Grand Rapids, MI USA
[20] Mercy Hlth Hauenstein Neurosci, Grand Rapids, MI USA
关键词
acute ischemic stroke; hemorrhage; low-dose tPA; thrombolysis; tissue-type plasminogen activator; TISSUE-PLASMINOGEN ACTIVATOR; MG/KG INTRAVENOUS ALTEPLASE; MARGINAL STRUCTURAL MODELS; PROPENSITY SCORE; CHINESE PATIENTS; RT-PA; J-ACT; THROMBOLYSIS; TRIAL; REGISTRY;
D O I
10.1161/STROKEAHA.115.010180
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
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.
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收藏
页码:2541 / 2548
页数:8
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