Data_Sheet_1_Safety and effectiveness of SOFIA/SOFIA PLUS for direct aspiration as first line treatment in patients with acute anterior ischemic stroke: results from the prospective, multicentric SESAME study.PDF

BackgroundMechanical thrombectomy is a cornerstone treatment for acute ischemic stroke (AIS) with large vessel occlusion (LVO), yet the optimal technique remains debated. The SOFIA/SOFIA PLUS catheter has emerged as a promising tool for direct aspiration thrombectomy.
PurposeThis prospective multi-center study, adhering Good-Clinical-Practice guidelines, aimed to evaluate the safety and efficacy of the SOFIA/SOFIA PLUS catheter for direct aspiration as a first-line treatment technique in patients with acute anterior circulation LVO.
Materials and methodsBetween 10/2017 and 12/2021, 246 consecutive patients presenting with AIS due to anterior circulation LVO were enrolled from 14 European centers. Primary treatment with SOFIA catheters was performed within 6 h of symptom onset. Clinical and radiological data were collected, and statistical analyses were conducted.
ResultsThe mean age of the included patients was 71.6 ± 13.9 years, with 44.7% being male. Primary aspiration achieved complete recanalization in 72.8% of patients, with functional independence observed in 63.8% after 90 days. Secondary outcomes included a median NIHSS of 4 at 24 h post-procedure, median ASPECTS of 7 on follow-up imaging, and a mortality rate of 24.4% at 90 days. No device malfunctions were observed, and the rate of symptomatic intracranial hemorrhage was 4.4%.
ConclusionPrimary aspiration with the SOFIA/SOFIA PLUS catheter demonstrates favorable safety and efficacy profiles in the treatment of anterior circulation LVO. These findings support the utilization of this technique as a first-line approach in mechanical thrombectomy for AIS, contributing to the growing body of evidence endorsing the effectiveness of direct aspiration thrombectomy in stroke management.

背景：机械取栓是伴大血管闭塞（large vessel occlusion, LVO）的急性缺血性卒中（acute ischemic stroke, AIS）的核心治疗手段，但最优术式仍存在争议。SOFIA/SOFIA PLUS取栓导管已成为直接抽吸取栓术的颇具前景的工具。
目的：本项遵循临床试验质量管理规范（Good Clinical Practice, GCP）的前瞻性多中心研究，旨在评估SOFIA/SOFIA PLUS导管作为一线治疗术式，用于急性前循环大血管闭塞患者的直接抽吸取栓的安全性与有效性。
材料与方法：2017年10月至2021年12月期间，研究从14家欧洲中心纳入246例因前循环大血管闭塞引发急性缺血性卒中的连续性入组患者。所有患者均在症状发作6小时内接受SOFIA导管作为初始治疗。研究收集了临床与影像学数据，并开展统计学分析。
结果：纳入患者的平均年龄为71.6±13.9岁，男性占比44.7%。初始抽吸取栓实现72.8%的患者完全再通，90天时63.8%的患者达到功能独立。次要结局指标包括术后24小时的美国国立卫生研究院卒中量表（National Institutes of Health Stroke Scale, NIHSS）中位数为4分，随访影像学的Alberta卒中项目早期CT评分（Alberta Stroke Program Early CT Score, ASPECTS）中位数为7分，以及90天死亡率为24.4%。研究未观察到器械故障，症状性颅内出血发生率为4.4%。
结论：采用SOFIA/SOFIA PLUS导管的初始抽吸取栓术，用于前循环大血管闭塞治疗时展现出良好的安全性与有效性特征。本研究结果支持将该术式作为急性缺血性卒中机械取栓的一线方案，为日益增多的、证实直接抽吸取栓术在卒中管理中有效性的证据体系增添了新的支持依据。