Department of Neurology, Stroke Unit, 'Niguarda Ca' Granda' Hospital, Milan, Italy.
J Neurointerv Surg. 2010 Mar;2(1):74-9. doi: 10.1136/jnis.2009.001388. Epub 2009 Oct 30.
OBJECTIVE To assess the feasibility, safety and preliminary efficacy of intra-arterial thrombolysis (IAT) compared with standard intravenous thrombolysis (IVT) for acute ischemic stroke. METHODS Eligible patients with ischemic stroke, who were devoid of contraindications, started IVT within 3 h or IAT as soon as possible within 6 h. Patients were randomized within 3 h of onset to receive either intravenous alteplase, in accordance with the current European labeling, or up to 0.9 mg/kg intra-arterial alteplase (maximum 90 mg), over 60 min into the thrombus, if necessary with mechanical clot disruption and/or retrieval. The purpose of the study was to determine the proportion of favorable outcome at 90 days. Safety endpoints included symptomatic intracranial hemorrhage (SICH), death and other serious adverse events. RESULTS 54 patients (25 IAT) were enrolled. Median time from stroke onset to start to treatment was 3 h 15 min for IAT and 2 h 35 min for IVT (p<0.001). Almost twice as many patients on IAT as those on IVT survived without residual disability (12/25 vs 8/29; OR 3.2; 95% CI 0.9 to 11.4; p=0.067). SICH occurred in 2/25 patients on IAT and in 4/29 on IVT (OR 0.5; CI 0.1 to 3.3; p=0.675). Mortality at day 7 was 5/25 (IAT) compared with 4/29 (IVT) (OR 1.6; CI 0.4 to 6.7; p=0.718). There was no significant difference in the rate of other serious adverse events. CONCLUSIONS Rapid initiation of IAT is a safe and feasible alternative to IVT in acute ischemic stroke.
目的 评估动脉内溶栓（IAT）与标准静脉内溶栓（IVT）治疗急性缺血性脑卒中的可行性、安全性和初步疗效。
方法 符合条件的缺血性脑卒中患者，无禁忌证，在发病 3 小时内开始 IVT 或在发病 6 小时内尽快开始 IAT。发病 3 小时内，患者根据目前的欧洲标签随机接受静脉内阿替普酶，或在血栓内 60 分钟内给予高达 0.9 mg/kg 的动脉内阿替普酶（最大 90 mg），如有必要进行机械血栓破碎和/或取栓。本研究的目的是确定 90 天的良好结局比例。安全性终点包括症状性颅内出血（SICH）、死亡和其他严重不良事件。
结果 54 例患者（25 例 IAT）入组。IAT 的发病至开始治疗的中位时间为 3 小时 15 分钟，IVT 为 2 小时 35 分钟（p<0.001）。IAT 组无残障存活的患者几乎是 IVT 组的两倍（12/25 比 8/29；OR 3.2；95%CI 0.9 至 11.4；p=0.067）。2 例 IAT 患者发生 SICH，4 例 IVT 患者发生 SICH（OR 0.5；CI 0.1 至 3.3；p=0.675）。第 7 天死亡率为 IAT 组 5/25（IAT）与 IVT 组 4/29（IVT）（OR 1.6；CI 0.4 至 6.7；p=0.718）。其他严重不良事件的发生率无显著差异。
结论 在急性缺血性脑卒中患者中，快速启动 IAT 是 IVT 的一种安全可行的替代方法。
