比较新型鲶鱼血流恢复装置与 Solitaire 支架取栓装置治疗急性大血管闭塞性卒中血管再通的前瞻性随机对照研究。

Comparing a novel Catfish flow restoration device and the Solitaire stent retriever for thrombectomy revascularisation in emergent largevessel occlusion stroke: a prospective randomised controlled study.

机构信息

Department of Intervention, Interventional Neuroradiology Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.

Department of Intervention, Interventional Neuroradiology Center, China National Clinical Research Center for Neurological Diseases, Beijing, China.

出版信息

Stroke Vasc Neurol. 2023 Dec 29;8(6):435-443. doi: 10.1136/svn-2022-002036.

DOI:10.1136/svn-2022-002036

PMID:37045544

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10800261/

Abstract

BACKGROUND

The Catfish stent retriever is a newly developed mechanical thrombectomy device for rapid recanalisation in emergent large vessel occlusion (ELVO) stroke. The current trial aimed to assess whether the Catfish stent retriever is non-inferior to the Solitaire stent retriever in terms of outcomes in ELVO stroke.

METHODS

This was a randomised, prospective, parallel-group, multicentre, open-label, non-inferiority study conducted at 18 sites in China. The primary outcome was the proportion of cases with successful recanalisation (modified thrombolysis in cerebral infarction score of 2b or 3) following the procedure. Secondary efficacy outcomes included the National Institutes of Health Stroke Scale scores at 24 hours and 7 days or discharge if earlier, time from artery puncture to successful recanalisation and good clinical outcome (modified Rankin scale score ≤2) at 90 days. Safety outcomes included symptomatic intracranial haemorrhage, all cause-death and severe adverse events at 90 days.

RESULTS

Between 3 March 2019 and 5 June 2021, 118 and 120 patients were randomly allocated to the Catfish and Solitaire groups, respectively. The primary endpoint after all endovascular procedures was non-inferior in the Catfish group (88.5%, 100/113) than in the Solitaire group (87.7%, 100/114), with a rate difference (RD) of 0.78% (95% CI -7.64 to -9.20; p=0.001). Sensitivity analysis only considering the per-protocol set also yielded similar results, with an RD of 0.83% (95% CI -7.03 to -8.70; p<0.001). Additionally, the proportions of cases with good clinical outcomes (47.8% vs 50.0%, p=0.739) and all-cause death rates (17.7% vs 18.8%, p=0.700) were similar in both groups at 90 days.

CONCLUSIONS

The Catfish stent retriever is an effective and safe device for endovascular recanalisation in ELVO stroke.

TRIAL REGISTRATION NUMBER

NCT03820882.

摘要

背景

Catfish 支架取栓器是一种新开发的机械血栓切除术装置，用于快速再通紧急大血管闭塞（ELVO）卒中。本研究旨在评估 Catfish 支架取栓器在 ELVO 卒中的再通结局方面是否不劣于 Solitaire 支架取栓器。

方法

这是一项在中国 18 个中心进行的随机、前瞻性、平行组、开放标签、非劣效性研究。主要结局是程序后成功再通（改良脑梗死溶栓评分 2b 或 3）的病例比例。次要疗效结局包括 24 小时和 7 天的国立卫生研究院卒中量表评分（如果更早则出院）、从动脉穿刺到成功再通的时间以及 90 天的良好临床结局（改良 Rankin 量表评分≤2）。安全性结局包括 90 天的症状性颅内出血、全因死亡和严重不良事件。

结果

2019 年 3 月 3 日至 2021 年 6 月 5 日，118 例和 120 例患者分别随机分配至 Catfish 组和 Solitaire 组。所有血管内手术后的主要终点在 Catfish 组（88.5%，110/113）优于 Solitaire 组（87.7%，100/114），差异率（RD）为 0.78%（95%CI-7.64 至-9.20；p=0.001）。仅考虑方案集的敏感性分析也得出了类似的结果，RD 为 0.83%（95%CI-7.03 至-8.70；p<0.001）。此外，两组 90 天时的良好临床结局（47.8% vs 50.0%，p=0.739）和全因死亡率（17.7% vs 18.8%，p=0.700）的比例相似。