Department of Neurology, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.
Stroke. 2010 Dec;41(12):2828-33. doi: 10.1161/STROKEAHA.110.594333. Epub 2010 Oct 28.
It remains unknown whether the effects of 0.6 mg/kg alteplase differ with occlusion site of the middle cerebral artery (MCA). We therefore evaluated the effects of 0.6 mg/kg intravenous alteplase in patients with different sites of MCA occlusion.
An exploratory analysis was made of 57 patients enrolled in the Japan Alteplase Clinical Trial II (J-ACT II), originally designed to evaluate 0.6 mg/kg alteplase in Japanese patients with unilateral occlusion of the MCA (M1 or M2 portion). The residual vessel length (in mm), determined by pretreatment magnetic resonance angiography, was used to reflect the occluded site. The proportions of patients with valid recanalization (modified Mori grade 2 to 3) at 6 and 24 hours and a modified Rankin Scale (mRS) score of 0 to 1 and of 0 to 2 at 3 months were compared between the groups dichotomized according to length of the residual vessel. Multiple logistic-regression models were generated to elucidate the predictors of valid recanalization, mRS 0 to 1, and mRS 0 to 2.
Receiver operating characteristics analysis revealed that 5 mm was the practical cutoff length for dichotomization. In patients with an M1 length < 5 mm (n = 12), the frequencies of valid recanalization at 6 and 24 hours (16.7% and 25.0%) were significantly lower compared with those (62.1% and 82.8%, respectively) of the 45 patients with a residual M1 length ≥ 5 mm and an M2 occlusion (P = 0.008 for 6 hours, P < 0.001 for 24 hours). The proportions of patients who achieved an mRS of 0 to 1 and an mRS of 0 to 2 were also lower for those with an M1 length < 5 mm (8.3% and 16.7%, respectively) compared with the other group (57.8% and 68.9%, respectively; P = 0.003 for mRS 0 to 1, P = 0.002 for mRS 0 to 2). In logistic-regression models, the site of MCA occlusion (< 5 mm) was a significant predictor of valid recanalization at 6 and 24 hours and of an mRS of 0 to 1 and of mRS of 0 to 2.
In patients with acute MCA occlusion, a residual vessel length < 5 mm on magnetic resonance angiography can identify poor responders to 0.6 mg/kg alteplase. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00412867.
目前尚不清楚 0.6mg/kg 阿替普酶的疗效是否因大脑中动脉(MCA)闭塞部位而异。因此,我们评估了 0.6mg/kg 静脉内阿替普酶在不同 MCA 闭塞部位患者中的疗效。
对原本旨在评估单侧 MCA(M1 或 M2 段)闭塞的 57 例日本阿替普酶临床试验 II(J-ACT II)患者进行了一项探索性分析。通过治疗前磁共振血管造影确定的残留血管长度(mm)反映闭塞部位。根据残留血管长度将患者分为两组,比较两组在 6 小时和 24 小时时有效再通(改良 Mori 分级 2 至 3)的比例、3 个月时改良 Rankin 量表(mRS)评分 0 至 1 和 0 至 2 的比例。采用多变量逻辑回归模型分析有效再通、mRS0 至 1 和 mRS0 至 2 的预测因素。
受试者工作特征分析显示,5mm 是实用的分界长度。在 M1 长度<5mm(n=12)的患者中,6 小时和 24 小时时有效再通的频率(分别为 16.7%和 25.0%)显著低于残留 M1 长度≥5mm 且 M2 闭塞的 45 例患者(6 小时时 P=0.008,24 小时时 P<0.001)。M1 长度<5mm 的患者 mRS0 至 1 和 mRS0 至 2 的比例也较低(分别为 8.3%和 16.7%),而其他患者为 57.8%和 68.9%(mRS0 至 1 时 P=0.003,mRS0 至 2 时 P=0.002)。在逻辑回归模型中,MCA 闭塞部位(<5mm)是 6 小时和 24 小时时有效再通以及 mRS0 至 1 和 mRS0 至 2 的显著预测因素。
在急性 MCA 闭塞患者中,磁共振血管造影上残留血管长度<5mm 可识别对 0.6mg/kg 阿替普酶反应不佳的患者。临床试验注册网址:http://www.clinicaltrials.gov。唯一标识符:NCT00412867。