Carotid Artery Stenting With Double-Layer Stent: A Systematic Review and Meta-Analysis

Abstract

Background: Carotid artery stenting (CAS) in the treatment of significant stenosis is a cause of stroke due to both plaque prolapse and cerebral embolization. New types of stents with a double-layer structure have been designed to minimize plaque prolapse and embolization; these double-layer stents (DLSs) should be able to reduce the stroke risk; however, definite data on their performance are scarce in the literature.

Methods: A systematic search was performed through PubMed, Scopus, and Cochrane Library, according to PRISMA guidelines; all studies on CAS with DLS (Roadsaver/Casper or CGuard) up to January 1, 2022, with a cohort of at least 20 patients were considered eligible. The present meta-analysis was approved and registered on PROSPERO register (CRD42022297512). Patients with tandem lesions or complete carotid occlusion were excluded from the study. The 30-day stroke rate after CAS was analyzed evaluating the preoperative symptomatic status and DLS occlusion. The estimated pooled rate of events was calculated by random effect model and moderators were evaluated.

Results: A total of 14 studies were included in the meta-analysis for a total of 1955 patients. The estimated overall (95% confidence interval [CI]) stroke rate was 1.4% (0.9%-2.2%, I² = 0%), which was not influenced by the type of DLS used: CGuard 0.8% (0.4%-1.8%, I² = 0%) versus Roadsaver/Casper 1.5% (0.7%-3.2%, I² = 0%), p=0.30. The 30-day estimated stroke rate was 1.5% (0.8%-2.9%, I² = 0%) in asymptomatic and 1.9% (1.0%-3.6%, I² = 0%) in symptomatic patients, with no influence by moderators. The 30-day DLS occlusion rate was 0.8% (0.4%-1.8%, I² = 0%). The publication bias assessment identified asymmetry in the asymptomatic populations.

Conclusion: The overall 30-day stroke rate in CAS with DLS is low (1.4%), with similar results in symptomatic and asymptomatic patients. Acute occlusion of DLS is rare (0.8%). Further studies are necessary to reduce the publication bias for asymptomatic patients.

Clinical impact: CAS with DLS is associated to a low rate of 30-day stroke in both symptomatic (1.9%) and asymptomatic (1.5%) patients. The type of DLS (CGuard or Roadsaver/Casper) did not affect the 30-day stroke rate.

Keywords: carotid artery stenosis; double-layer stent; double-layer structure; stroke.

Figure 1.

Flow-chart of selected studies.

Figure 2.

Forest plot of the pooled estimate rate of 30-day stroke after double-layer carotid stent. Heterogeneity analysis: Q=12.9; df=13; Sig.=0.45; I² = 0%. CI, confidence interval; ES, effect size; W, weight; N, number.

Figure 3.

Forest-plot of the pooled estimate rate of 30-day stroke after double-layer carotid stent with Roadsaver/Casper and CGuard. ANOVA Q-Test Random Effect with pooled estimate of T2: P = .30. CI, confidence interval; ES, effect size; W, weight; N, number.

Figure 4.

Forest plot of the pooled estimate rate of 30-day stent occlusion after double-layer carotid stent. Heterogeneity analysis: Q = 1.84; df = 9; Sig. = 0.99; I² = 0%. CI, confidence interval; ES, effect size; W, weight; N, number.

Figure 5.

Funnel plot for overall stroke (A), stroke in asymptomatic patients (B), stroke in symptomatic patients (C), and occlusion (D) at 30-day after dual-layer carotid stent.