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Stroke & Vascular Neurology(SVN)最新上线文章“Comparing a novel Catfish flow restoration device and the Solitaire stent retriever for thrombectomy revascularisation in emergent large vessel occlusion stroke: a prospective randomised controlled study”,来自首都医科大学附属北京天坛医院神经病学中心介入神经病学科缪中荣教授团队等。
Catfish取栓支架是一种新近发展的机械取栓装置,用于急性大血管闭塞(emergent large vessel occlusion, ELVO)卒中的快速再通。该试验旨在评估Catfish取栓支架在ELVO卒中的结局方面的效果是否非劣效于Solitaire取栓支架。
该试验是一项在全国18家中心进行的随机、前瞻性、平行对照、多中心、开放标签、非劣效性研究。主要结局是术后成功再通(改良脑梗死溶栓分级mTICI为2b或3)的病例比例。次要疗效结局包括24小时和第7天或出院时(如果更早)的NIHSS评分,从动脉穿刺到成功再通的时间以及90天良好临床结局(改良Rankin量表评分mRS≤2)。安全性结局包括症状性颅内出血、全因死亡和90天时的严重不良事件。
研究结果显示,2019年3月3日至2021年6月5日期间,分别有118例和120例患者被随机分配至Catfish组和Solitaire组。Catfish组所有血管内手术后的主要终点(88.5%, 100/113)不劣于Solitaire组(87.7%, 100/114),率差(rate difference, RD)为0.78%(95%CI -7.64至-9.20;p=0.001)。对仅考虑每个方案集的敏感性分析也得到了类似的结果,RD为0.83% (95%CI -7.03至-8.70;p<0.001)。此外,两组患者90天临床结局良好的病例比例(47.8% vs 50.0%,p=0.739)和全因死亡率(17.7% vs 18.8%,p=0.700)相似。
Figure 1. Illustration of the Catfish stent-retriever device. (A) The thinner strut of the proximal-third segment and distal-third segment which was equal to the 0.7-fold diameter of the strut at the middle-third segment, three distal radio-opaque markers. A2: large clot-catching cell. A3: radiopaque platinum wire integration into the stent strut. A4: One Proximal radio-opaque marker. (B) The Catfish (B2) has a larger stent cell compared to the competitive stent (B1). (C) The Catfish have optimal coverage and wall apposition peculiarity in the tortuous anatomical model. (D) Fluoroscopic visibility of the deployed Catfish stent retriever device.
Figure 3. Treatment outcomes. (A) Immediately mTICI grade after first pass thrombectomy; (B) mTICI grade at the end of the procedure, the successful recanalization rate at the end of the precedure in the Catfish group was non-inferior to that in the Solitaire group for per-protocol population analysis (rate difference, 0.83; 95% CI –7.03 to 8.70;). (C) and (D) Modified Rankin Scale at 3 months.
Figure 4. Categorised whisker plots of mean NIHSS scores at admission, at 24 hours, and at 7 days or discharge in both groups.
研究结论:Catfish取栓支架是一种有效、安全的ELVO卒中血管内再通装置。
来源:SVN俱乐部
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