O23/195 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

Introduction

Despite the proven efficacy of mechanical thrombectomy, there is still ongoing debate regarding the optimal technique and devices to use.

Aim of Study

In this prospective, multi-center study, we aimed to assess the safety and efficacy of the SOFIA/SOFIA PLUS catheter for direct aspiration as a first line treatment technique (SESAME).

Methods

N=246 patients with acute ischemic stroke due to large or medium vessel occlusion in the anterior circulation between October 2017 and December 2021 were enrolled from 14 European centers. First-line treatment was performed using the SOFIA catheters within 6 hours from onset (NIHSS≥2 and ≤30). Safety and imaging results were independently reviewed by a Core Laboratory and a Clinical Events Committee. The primary outcome was defined as attaining functional independence (mRS of 0–2 after 90 days). Secondary outcomes included angiographic (mTICI) and imaging parameters (ASPECTS) as well as clinical outcomes (NIHSS, mRS).

Results

Mean age of included patients was 71.6±13.9 years with a median NIHSS of 14 (IQR 10–18) on admission. After first-line therapy using only SOFIA/SOFIA PLUS for aspiration, 15.9%/23.6%/35.0% mTICI 2b/2c/3 could be attained after 33.4±24.6min. In n=47, stent-retrievers had to be used as second-line therapy, leading to 13.8%/29.7%/48.4% mTICI 2b/2c/3 overall after 38.73±27.3min. No device malfunctions were observed. Symptomatic intracranial haemorrhages occurred in 2.8%, while embolization in a new territory occurred in 4.1%.

Conclusion

Primary aspiration with SOFIA catheter offers a safe and effective choice of therapy for the treatment of large vessel occlusions of the anterior circulation.

Disclosure of Interest

MM: grants/grants pending from MicroVention, money paid to the institution; SB: nothing to disclose; JF: nothing to disclose; GM: nothing to disclose; AP: nothing to disclose; AB: nothing to disclose; MS: nothing to disclose; RB: nothing to disclose; FC: nothing to disclose; MB: nothing to disclose; UN: nothing to disclose.