使用Penumbra系统对卒中患者及治疗延迟患者进行抽吸血栓切除术：COMPLETE注册研究的亚组分析
Aspiration thrombectomy with the Penumbra System for patients with stroke and late onset to treatment: a subset analysis of the COMPLETE registry.
作者信息
Hassan Ameer E, Fifi Johanna T, Zaidat Osama O
机构信息
Department of Neurology, University of Texas Rio Grande Valley, Valley Baptist Medical Center, Harlingen, TX, United States.
Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, NY, United States.
出版信息
Front Neurol. 2023 Sep 14;14:1239640. doi: 10.3389/fneur.2023.1239640. eCollection 2023.
BACKGROUND
The purpose of this study was to report the safety and performance of aspiration thrombectomy with the Penumbra System for patients with acute ischemic stroke (AIS) due to anterior circulation large vessel occlusion (LVO) and late onset to treatment.
METHODS
This is a retrospective subset analysis of a global prospective multicenter registry (COMPLETE) that enrolled adults with AIS due to LVO and a pre-stroke modified Rankin Scale score (mRS) of 0 or 1 who were treated first-line with aspiration thrombectomy either alone (A Direct Aspiration First Pass Technique [ADAPT]) or in combination with the 3D Revascularization Device (ADAPT + 3D). This subset analysis included all patients in the registry who had anterior circulation LVO, an Alberta Stroke Program Early CT Score of at least 6, and late onset to treatment (>6 h from stroke onset to puncture).
RESULTS
Of the 650 patients in the COMPLETE registry, 167 were included in this subset analysis. The rate of successful revascularization (modified thrombolysis in cerebral infarction score 2b-3 achieved) at the end of the procedure was 83.2%, the rate of good functional outcome (mRS 0-2) at 90 days was 55.4%, and the all-cause mortality rate at 90 days was 14.4%. No device-related serious adverse events (SAEs) occurred. Procedure-related SAEs occurred in 9 patients (5.4%) within 24 h and in 12 patients (7.2%) overall. The rate of successful revascularization was higher for patients treated first-line with ADAPT (88.0%) than for patients treated first-line with ADAPT + 3D (75.0%; = 0.035); no significant difference was observed between the ADAPT and ADAPT + 3D groups for any other primary or secondary outcome.
CONCLUSION
For patients with AIS due to anterior circulation LVO and with late onset to treatment, aspiration thrombectomy with the Penumbra System appears to be safe and effective. The rates of good functional outcome and all-cause mortality from this study compared favorably with those rates from the medical management arms of the DAWN and DEFUSE-3 studies.
CLINICAL TRIAL REGISTRATION
https://www.clinicaltrials.gov, NCT03464565.
背景
本研究旨在报告使用Penumbra系统对因前循环大血管闭塞（LVO）导致急性缺血性卒中（AIS）且治疗延迟的患者进行取栓治疗的安全性和效果。
方法
这是一项对全球前瞻性多中心注册研究（COMPLETE）的回顾性子集分析，该研究纳入了因LVO导致AIS且卒中前改良Rankin量表评分（mRS）为0或1的成年人，这些患者接受了单独的取栓治疗（直接首次通过抽吸技术[ADAPT]）或与3D血管再通装置联合治疗（ADAPT + 3D）作为一线治疗。该子集分析包括注册研究中所有前循环LVO、阿尔伯塔卒中项目早期CT评分至少为6且治疗延迟（卒中发作至穿刺>6小时）的患者。
结果
在COMPLETE注册研究的650例患者中，167例被纳入该子集分析。手术结束时成功再通的比率（达到改良脑梗死溶栓评分2b - 3）为83.2%，90天时良好功能结局（mRS 0 - 2）的比率为55.4%，90天时全因死亡率为14.4%。未发生与器械相关的严重不良事件（SAE）。与手术相关的SAE在24小时内发生于9例患者（5.4%），总体发生于12例患者（7.2%）。一线接受ADAPT治疗的患者成功再通的比率（88.0%）高于一线接受ADAPT + 3D治疗的患者（75.0%；P = 0.035）；在任何其他主要或次要结局方面，ADAPT组和ADAPT + 3D组之间未观察到显著差异。
结论
对于因前循环LVO导致AIS且治疗延迟的患者，使用Penumbra系统进行取栓治疗似乎是安全有效的。本研究中良好功能结局和全因死亡率与DAWN和DEFUSE - 3研究中药物治疗组的比率相比具有优势。
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