Navigating complexity with low-crossing profile dual-layer micromesh carotid stent: implications for contemporary carotid artery stenting outcomes (ROADSAVER study insights)

J Cardiovasc Surg (Torino). 2024 Jun;65(3):205-212. doi: 10.23736/S0021-9509.24.13068-6.

Abstract

Background: The safety and efficacy of carotid artery stenting (CAS) can be affected by certain technical and anatomical factors. However, it is not known whether the use of a dual-layer micromesh stent (DLMS) with a low-crossing profile could reduce the risks associated with complex vascular anatomies during CAS.

Methods: This study involved 1965 asymptomatic or symptomatic carotid artery stenosis patients who received the Roadsaver DLMS during CAS, as part of a prospective, multicenter observational ROADSAVER study, conducted from January 2018 to February 2021. The primary outcome was the 30-day rate of major adverse events (MAE; i.e. any death or stroke) after CAS. Procedural details and outcomes were compared between patients with complex anatomical features and those without.

Results: One or more complex anatomical characteristics were identified in 1639 (83.4%) patents. Patients with complex anatomies were older and had a higher prevalence of arterial hypertension, cardiovascular disease, and prior stroke. Between patients with or without complex anatomical features, no significant differences were found either in procedural techniques, or in 30-day MAE (age-adjusted odds ratio (95% CI) for complexities vs. no complexities: 0.76 (0.35, 1.66); p=0.4905) and any stroke (age-adjusted odds ratio (95% CI) for complexities vs. no complexities: 0.89 (0.37, 2.17); p=0.8032) incidence. Furthermore, neither the presence of specific types of anatomic complexity nor their number (per patient) markedly influenced the 30-day MAE and any stroke incidence.

Conclusions: In this real-world cohort of patients undergoing CAS with the Roadsaver DLMS, no significant difference in the occurrence of 30-day MAE and any stroke was observed between patients with or without high-risk anatomical features.

Publication types

  • Observational Study
  • Multicenter Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Carotid Stenosis* / complications
  • Carotid Stenosis* / diagnostic imaging
  • Carotid Stenosis* / mortality
  • Carotid Stenosis* / surgery
  • Carotid Stenosis* / therapy
  • Endovascular Procedures* / adverse effects
  • Endovascular Procedures* / instrumentation
  • Female
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Prosthesis Design*
  • Risk Assessment
  • Risk Factors
  • Stents*
  • Stroke* / etiology
  • Stroke* / prevention & control
  • Time Factors
  • Treatment Outcome