Roadsaver versus Wallstent for carotid artery stenting: a retrospective cohort study
Authors: Achim A , Lacko D , Huttl A , Csobay-Novak C , Csavajda A , Sotonyi P , Merkely B , Nemes B , Ruzsa Z 
Published: October 2022

Abstract

Introduction
Carotid artery stenting (CAS) is an established alternative option to surgical treatment for carotid artery stenosis, 3 main contemporary types of stent design being used for this purpose (open-, closed-cell, mesh-covered stents). So far, no definite conclusions have been reached on the superiority of any of those devices for CAS. With its new double-mesh design, the Roadsaver stent has emerged as an attractive option for use in CAS, aiming to further reduce neurological events. However, its efficacy as compared to other stents, such as Wallstent, has not been thoroughly explored. We thus aimed to compare the clinical outcomes of Roadsaver and Wallstent for use in CAS.

Methods
This retrospective cohort study included patients who underwent CAS and received either Wallstent or Roadsaver stent at a tertiary centre (centre A) in a Central European country during 2009–2021, and another tertiary centre (centre B) in the same country during 2016–2019. Patients with incomplete baseline clinical records were excluded. Patients were followed up for one year at centre A, and for 30 days at centre B. The primary outcomes were 30-day and 1-year major adverse cardiac or cerebrovascular events (MACCE), defined as a composite of myocardial infarction, stroke, and cardiovascular mortality. The secondary outcome was 30-day bradycardia. Baseline covariates were balanced between groups using inverse probability treatment weighting. Thirty-day outcomes were compared using logistic regression with odds ratio (OR) as the summary statistic, and 1-year MACCE was compared using Cox regression with hazard ratio (HR) as the summary statistic.

Results
In total, 982 patients were identified. After applying the exclusion criterion, 770 patients were included in the analysis (482 patients from centre A and 288 patients from centre B; 287 (37.3%) females, mean age 68±8 years old), of which 589 (76.5%) received Wallstent and 181 (23.5%) received Roadsaver. There was no loss to follow-up. Twenty-three (3%) patients had MACCE by 30 days, and 16 (3.3%) of those who completed one-year follow-up had MACCE by one year. No significant differences in MACCE were observed between the two stents at 30 days (OR 0.697 [0.374, 1.300], p=0.256) and one year (HR 0.512 [0.126, 2.073], p=0.348). Roadsaver was associated with significantly higher odds of 30-day bradycardia (OR 5.391 [4.089, 7.108], p&lt;0.0001), which remained significant after adjusting for the number of post-dilatations performed (p&lt;0.0001). Additionally, Roadsaver was associated with significantly lower risk of one-year MACCE among symptomatic patients (N=184; HR 0.131 [0.024, 0.723], p=0.020; Figure 1), but not among asymptomatic patients (N=298; HR 1.774 [0.332, 9.490], p=0.503).

Conclusion
There was no short- and long-term hazard difference between the 2 types of stent designs, however Roadsaver may be superior to Wallstent among symptomatic patients.

Funding Acknowledgement
Type of funding sources: None.