Flow diverter stents for endovascular treatment of aneurysms: a comparative study of efficacy and safety between FREDX and FRED

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• dc.contributor.author Guimaraens, Leopoldo
• dc.contributor.author Saldaña, Jesus
• dc.contributor.author Vivas, Elio
• dc.contributor.author Cifuentes, Sebastián
• dc.contributor.author Balaguer, Ernest
• dc.contributor.author Mon, Dunia
• dc.contributor.author Macias-Gómez, Adrià
• dc.contributor.author Ois Santiago, Angel Javier
• dc.contributor.author Guisado-Alonso, Daniel
• dc.contributor.author Cuadrado-Godia, Elisa
• dc.contributor.author Jiménez-Balado, Joan
• dc.date.accessioned 2024-10-25T06:09:46Z
• dc.date.available 2024-10-25T06:09:46Z
• dc.date.issued 2024
• dc.description Data de publicació electrònica: 16-01-2024
• dc.description.abstract Background: The FRED X flow diverter (FREDX), as the second generation in the FRED series, aims to improve the treatment of cerebral aneurysms. This study compares the efficacy and safety of FREDX with its predecessor, FRED. Methods: This prospective registry included patients treated with FRED and FREDX devices. Efficacy was assessed using digital subtraction angiography with 3D volumetric reconstruction at immediate and 1 year follow-ups. Safety was evaluated by recording complications, analyzed through univariate contrasts, generalized mixed models, and Bayesian network analyses. Results: We treated 287 patients with 385 aneurysms, with 77.9% receiving FRED and 22.1% FREDX. The median age was 55 years (IQR 47-65) and 78.4% were women. The FREDX group showed a higher prevalence of saccular-like aneurysms (70.6% vs 52.7%, P=0.012) and a higher rate of complete occlusion compared with FRED interventions (79.4% vs 59.3%, P=0.022). After adjusting for confounders, these differences represented a 3.04-fold increased likelihood (95% CI 1.44 to 6.41, P=0.003) of achieving complete occlusion at 1 year with FREDX interventions. Regarding safety, two (3.5%) complications (both non-symptomatic) were observed in the FREDX group and 23 (10.4%) in the FRED group (P=0.166). Bayesian network analysis suggested a trend towards fewer complications for FREDX, with a median reduction of 5.5% in the posterior distribution of the prevalence of complications compared with FRED interventions. Conclusions: The FREDX device shows improved complete occlusion rates at 1 year compared with the FRED device while maintaining a favourable safety profile, indicating its potential advantage in the treatment of cerebral aneurysms.
• dc.format.mimetype application/pdf
• dc.identifier.citation Guimaraens L, Saldaña J, Vivas E, Cifuentes S, Balaguer E, Mon D, et al. Flow diverter stents for endovascular treatment of aneurysms: a comparative study of efficacy and safety between FREDX and FRED. J Neurointerv Surg. 2024 Jan 16:jnis-2023-021103. DOI: 10.1136/jnis-2023-021103
• dc.identifier.doi http://dx.doi.org/10.1136/jnis-2023-021103
• dc.identifier.issn 1759-8478
• dc.identifier.uri http://hdl.handle.net/10230/68348
• dc.language.iso eng
• dc.publisher BMJ Publishing Group
• dc.relation.ispartof J Neurointerv Surg. 2024 Jan 16:jnis-2023-021103
• dc.rights © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.rights.uri http://creativecommons.org/licenses/by-nc/4.0/
• dc.subject.keyword Aneurysm
• dc.subject.keyword Angiography
• dc.subject.keyword Device
• dc.subject.keyword Flow diverter
• dc.subject.keyword Stent
• dc.title Flow diverter stents for endovascular treatment of aneurysms: a comparative study of efficacy and safety between FREDX and FRED
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/publishedVersion