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Who will benefit more from low-dose alteplase in acute ischemic stroke?
International Journal of Stroke ( IF 6.7 ) Pub Date : 2019-06-21 , DOI: 10.1177/1747493019858775
Xia Wang 1 , Keon-Joo Lee 2 , Tom J Moullaali 1, 3 , Beom Joon Kim 2 , Qiang Li 1 , Hee-Joon Bae 2 , Cheryl Carcel 1 , Candice Delcourt 1, 4, 5 , Hisatomi Arima 6 , Shoichiro Sato 7 , Thompson G Robinson 8 , Lili Song 9 , Guofang Chen 10 , Jie Yang 11 , John Chalmers 1 , Craig S Anderson 1, 5, 9 , Richard Lindley 1, 12 , Mark Woodward 1, 13 ,
Affiliation  

Objectives

Controversy persists over the benefits of low-dose versus standard-dose intravenous alteplase for the treatment of acute ischemic stroke. We sought to determine individual patient factors that contribute to the risk–benefit balance of low-dose alteplase treatment.

Methods

Observational study using data from the Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED), an international, randomized, open-label, blinded-endpoint trial that assessed low-dose (0.6 mg/kg) versus standard-dose (0.9 mg/kg) intravenous alteplase in acute ischemic stroke patients. Logistic regression models were used to estimate the benefit of good functional outcome (scores 0 or 1 on the modified Rankin scale at 90 days) and risk (symptomatic intracerebral hemorrhage), under both regimens for individual patients. The net advantage for low-dose, relative to standard-dose, alteplase was calculated by dividing excess benefit by excess risk according to a combination of patient characteristics. The algorithms were externally validated in a nationwide acute stroke registry database in South Korea.

Results

Patients with an estimated net advantage from low-dose alteplase, compared with without, were younger (mean age of 66 vs. 75 years), had lower systolic blood pressure (148 vs. 160 mm Hg), lower National Institute of Health Stroke Scale score (median of 8 vs. 16), and no atrial fibrillation (10.3% vs. 97.4%), diabetes mellitus (19.2% vs. 22.4%), or premorbid symptoms (defined by modified Rankin scale = 1) (16.3% vs. 37.8%).

Conclusion

Use of low-dose alteplase may be preferable in acute ischemic stroke patients with a combination of favorable characteristics, including younger age, lower systolic blood pressure, mild neurological impairment, and no atrial fibrillation, diabetes mellitus, or premorbid symptoms.



中文翻译:

谁将在急性缺血性中风中从低剂量阿替普酶中受益?

目标

低剂量静脉注射阿替普酶与标准剂量静脉注射阿替普酶在治疗急性缺血性中风方面的优势之间存在争议。我们试图确定导致低剂量阿替普酶治疗风险与收益平衡的个体患者因素。

方法

一项观察性研究,使用了一项增强的高血压和溶栓性卒中控制研究(ENCHANTED)中的数据,这是一项国际性,随机,开放标签,盲目的试验,评估了低剂量(0.6 mg / kg)与标准剂量(0.9 mg / kg)公斤)静脉注射阿替普酶治疗急性缺血性中风患者。在个别患者的两种治疗方案下,均使用逻辑回归模型来评估良好的功能结局(改良的兰金评分在90天时得分为0或1)和风险(有症状的脑出血)的益处。通过根据患者特征的组合将超额收益除以超额风险,可以计算出低剂量(相对于标准剂量)阿替普酶的净收益。该算法在韩国的全国性急性卒中注册数据库中进行了外部验证。

结果

与未服用低剂量阿替普酶相比,低剂量阿替普酶具有预计净获益的患者较年轻(平均年龄为66岁vs. 75岁),收缩压较低(148 vs. 160 mm Hg),美国国立卫生研究院卒中量表较低评分(中位数为8 vs. 16),无房颤(10.3%vs. 97.4%),糖尿病(19.2%vs. 22.4%)或病前症状(由改良的兰金评分= 1定义)(16.3%vs 37.8%)。

结论

低剂量阿替普酶可能在急性缺血性中风患者中具有较好的综合特征,包括年龄小,收缩压降低,轻度神经功能缺损,无房颤,糖尿病或病前症状,可能更可取。

更新日期:2020-02-04
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