Comparative analysis of safety and efficacy of flow diversion with and without surface modification technology, FRED-X, FRED, PED shield and PED in 386 patients: A single center experience with systematic review and network meta analysis.

Abstract

Introduction: The FRED-X is a newer generation flow diverting stent (FDS) with surface modification that has demonstrated favorable efficacy in treating intracranial aneurysms. Our study provides an analysis of patients treated using FRED-X compared to FRED, PED Shield and PED.

Materials and methods: This was a retrospective single center study and a systematic review with network meta analysis of patients who underwent flow diversion using FRED-X, FRED, PED Shield or PED. Multivariate logistic regression was used to assess long-term outcomes of interest- angiographic occlusion, in-stent stenosis and functional outcome at 6- and 12-month follow up.

Results: 386 patients with 386 aneurysms were included. The average age of the cohort was 56.2 years, and 81 % was female. PED had significantly higher aneurysm occlusion rates compared to FRED-X at 6- and 12-months (OR: 3.03, 95 % CI: 1.36-6.62 and OR: 4.01, 95 % CI: 1.26-12.2), with higher odds of absent in-stent stenosis (OR: 9.03, 95 % CI: 3.63-23.3 and OR: 9.58, 95 % CI: 2.56-33.8) at 6- and 12-months, respectively. Rates of stroke, TIA, ICH and mortality were not significantly different across cohorts. All patients were functionally independent on follow-up. A network meta-analysis revealed no significant difference in occlusion rates among each of the included FDS.

Conclusion: Our study revealed comparable 12-month occlusion rates and in-stent stenosis between surface modified devices, FRED-X and PED Shield. In addition, angiographic results were comparable between FRED-X and the first generation FRED, however classic PED demonstrated higher rates of angiographic occlusion with lower in-stent stenosis.