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日本 Trevo 注册研究:日本急性缺血性脑卒中支架取栓术或与抽吸导管联合治疗的真实世界注册研究。

Japan Trevo Registry: Real-world Registry of Stent Retriever Alone or in Combined Therapy with Aspiration Catheter for Acute Ischemic Stroke in Japan.

机构信息

Department of Neurosurgery, Hyogo Medical University.

Department of Neurovascular Research, Kobe City Medical Center General Hospital.

出版信息

Neurol Med Chir (Tokyo). 2023 Nov 15;63(11):503-511. doi: 10.2176/jns-nmc.2023-0069. Epub 2023 Oct 18.

Abstract

Endovascular therapy (EVT) for real-world patients after extended time frames is associated with concerns about its efficacy and safety. We conducted a prospective registry at 77 centers between November 2019 and October 2020. The registry criteria included patients treated with Trevo Retriever alone or in combined therapy with an aspiration catheter. The primary outcome was effective reperfusion (thrombolysis in cerebral infarction grade ≥ 2b), the secondary outcome was a modified Rankin scale 0-2 at 90 days, and the safety outcomes were worsening of neurologic symptoms within 24 h postoperatively, intracranial hemorrhage (ICH) within 24 h after EVT and mortality. We also exlpored the difference between patients whose last known well time (LKWT) to a puncture was less than 6 h (0-6 h) and those whose LKWT was 6 h or more but less than 24 h (6-24 h). Among the 1041 patients registered, 1025 patients were analyzed. The mean age was 76.9 years, and 53.6% of the participants were males. The 6-24 h group was 206/998 (20.6%), the median National Institute of Health Stroke Scale (NIHSS) score at admission was 18, and the median Alberta Stroke Program Early CT score was 8. Combined technique as the first pass was used on 817 (79.7%) patients. The primary outcome was 934 (91.1%). The secondary outcome was 433/1021 (42.4%). Symptomatic ICH, any ICH, and mortality were 10/1019 (1.0%), 311/1019 (30.5%), and 75 (7.3%). In the subanalysis, the 6-24 h group was lower in NIHSS (median;18 vs 16), and the secondary outcome was not significantly different in the <6 h group. Even after treatment time expansion, this result was comparable to other Trevo-based trials and nationwide registries.

摘要

对于时间延长后的真实世界患者,血管内治疗(EVT)的疗效和安全性令人担忧。我们在 2019 年 11 月至 2020 年 10 月在 77 个中心进行了一项前瞻性登记研究。登记标准包括单独使用 Trevo Retriever 或与抽吸导管联合治疗的患者。主要结局是有效的再灌注(脑梗死溶栓分级≥2b),次要结局是 90 天时改良 Rankin 量表评分为 0-2 分,安全性结局是术后 24 小时内神经症状恶化、EVT 后 24 小时内颅内出血(ICH)和死亡率。我们还探讨了最后一次已知良好时间(LKWT)至穿刺时间<6 小时(0-6 小时)的患者与 LKWT 为 6 小时或更长但<24 小时(6-24 小时)的患者之间的差异。在登记的 1041 例患者中,1025 例进行了分析。患者的平均年龄为 76.9 岁,53.6%为男性。6-24 小时组为 206/998(20.6%),入院时的中位国立卫生研究院卒中量表(NIHSS)评分为 18 分,中位 Alberta 卒中计划早期 CT 评分(ASPECTS)为 8 分。817 例(79.7%)患者采用联合技术作为第一次通过。主要结局为 934 例(91.1%)。次要结局为 433/1021(42.4%)。症状性 ICH、任何 ICH 和死亡率分别为 10/1019(1.0%)、311/1019(30.5%)和 75 例(7.3%)。在亚组分析中,6-24 小时组 NIHSS 评分较低(中位数为 18 分比 16 分),<6 小时组的次要结局无显著差异。即使治疗时间延长,这一结果与其他基于 Trevo 的试验和全国登记研究相当。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1bb0/10725828/cf8eb888bf1d/1349-8029-63-0503-g001.jpg

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