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.

Background

Mechanical 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.

Purpose

This 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 methods

Between 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.

Results

The 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%.

Conclusion

Primary 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.

Informations de copyright

Copyright © 2024 Neuberger, Marnat, Barreau, Pitrone, Caragliano, Killer-Oberpfalzer, Pfaff, Maurer, Berlis, Bokkers, Uyttenboogaart, Sourour, Clarençon, Wodarg, Cognard, Bohner, Trenkler, Spelle, Weber, Nouri, Bonekamp, Thomalla, Fiehler, Bendszus and Möhlenbruch.

Déclaration de conflit d'intérêts

GT has received compensation by the University Heidelberg for activities as member of the CEC within the study, and fees as consultant or lecturer from Acandis, Alexion, Amarin, Astra Zeneca, Bayer, Boehringer Ingelheim, BristolMyersSquibb, Daiichi Sankyo, Portoly, Stryker outside this study. GM reports consulting fees from Microvention Europe, Stryker Neurovascular, Balt SAS, Sim and Cure and paid lectures from Medtronic, Phenox, Cerenovus, Bracco. All of these were outside this study. AP is the principal investigator of the SEALANT study sponsored by Microvention. MM received research grants from Acandis, Balt, Medtronic, Microvention, Phenox, Stryker* (*industry payments are made to the research fund of the institution), receives payment or honoraria for lectures from Balt, Medtronic, Stryker* (*industry payments are made to the research fund of the institution). SESAME was an investigator-initiated study (IIT). A grant for conducting the study was provided by Microvention. However, Microvention did not exert any influence on the study’ design. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.