Use of Dual-Layered Stents in Endovascular Treatment of Extracranial Stenosis of the Internal Carotid Artery: Results of a Patient-Based Meta-Analysis of 4 Clinical Studies

JACC Cardiovasc Interv. 2018 Dec 10;11(23):2405-2411. doi: 10.1016/j.jcin.2018.06.047.

Abstract

Objectives: The aim of this study was to evaluate the clinical efficacy of dual-layered mesh-covered carotid stent systems (DLS) for carotid artery stenting (CAS).

Background: The need to minimize the risk for plaque debris prolapsing between stent struts following CAS has resulted in the development of DLS. Small clinical studies evaluating 2 available devices, Roadsaver and CGuard, have been recently published; none of these studies is sufficiently powered to test the role of common risk factors on the occurrence of stroke at 30 days post-CAS.

Methods: A search was performed of multiple electronic databases for studies larger than 100 cases of CAS with DLS. Four single-arm prospective studies were identified, and individual patient data were collected. The primary endpoint was the occurrence of stroke at 30 days; secondary endpoints were technical and procedural success, periprocedural stroke, and in-hospital and 30-day rates of death.

Results: The Roadsaver and CGuard stents were used in similar proportions, and technical success was achieved in all procedures (100% [n = 556]). There were 6 periprocedural strokes (1.08%; all minor). During 30-day follow-up, there was 1 death (0.17%) from myocardial infarction and 1 additional minor stroke (0.17%). The cumulative 30-day mortality rate was 0.17%, and the incidence of stroke at 30 days was 1.25%. No predictors of stroke at 30 days could be identified.

Conclusions: This meta-analysis suggests that DLS can be safely used for CAS, and their use minimizes the incremental risk related to symptomatic status and other risk factors.

Keywords: carotid artery disease; carotid artery stenting; stroke.

Publication types

  • Meta-Analysis
  • Systematic Review

MeSH terms

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