1-Year Results From a Prospective Experience on CAS Using the CGuard Stent System

Sirignano, Pasqualino; Stabile, Eugenio; Mansour, Wassim; Capoccia, Laura; Faccenna, Federico; Intrieri, Francesco; Ferri, Michelangelo; Saccà, Salvatore; Sponza, Massimo; Mortola, Paolo; Ronchey, Silvia; Praquin, Barbara; Grillo, Placido; Chiappa, Roberto; Losa, Sergio; Setacci, Francesco; Pirrelli, Stefano; Taurino, Maurizio; Ruffino, Maria Antonella; Udini, M; Palombo, Domenico; Ippoliti, Arnaldo; Montelione, Nunzio; Setacci, Carlo; Donato, Gianmarco de; Ruggeri, Massimo; Speziale, Francesco

doi:10.1016/j.jcin.2021.05.045

Cited by 18 publications

(15 citation statements)

References 16 publications

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“…There were 6 incidences of ISR; however, no DM status was provided for these patients [44]. Overall, the IRONGUARD-1 [42,43] and IRONGUARD-2 [10,44] clinical results are in concordance with our present findings.…”

Section: Journal Of Diabetes Researchsupporting

confidence: 90%

“…It is unclear, however, whether the affected patients were diabetic or nondiabetic, and evaluation of any potential impact of DM on ISR in dual-metallic layer stents is warranted. Regarding MCS, two large-scale Italian registries have been recently published: IRONGUARD-1 [ 42 , 43 ] and IRONGUARD-2 [ 10 , 44 ]. The IRONGUARD-1 study population of 200 patients included 28% diabetics.…”

Section: Discussionmentioning

confidence: 99%

“…Also 12-month data IRONGUARD-2 showed no difference in death/stroke/MI between DM vs. non-DM patients. There were 6 incidences of ISR; however, no DM status was provided for these patients [ 44 ]. Overall, the IRONGUARD-1 [ 42 , 43 ] and IRONGUARD-2 [ 10 , 44 ] clinical results are in concordance with our present findings.…”

Section: Discussionmentioning

confidence: 99%

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Diabetes Mellitus and Clinical Outcomes in Carotid Artery Revascularization Using Second-Generation, MicroNet-Covered Stents: Analysis from the PARADIGM Study

Mazurek

Borratyńska

Gancarczyk

et al. 2022

Journal of Diabetes Research

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Introduction. Carotid artery stenting (CAS) using conventional (single-layer) stents is associated with worse clinical outcomes in diabetes mellitus (DM) vs. non-DM patients: an effect driven largely by lesion-related adverse events. CAS outcomes with MicroNet-covered stents (MCS) in diabetic patients have not been evaluated. Aim. To compare short- and long-term clinical outcomes and restenosis rate in DM vs. non-DM patients with carotid stenosis treated using MCS. Materials and Methods. In a prospective study in all-comer symptomatic and increased-stroke-risk asymptomatic carotid stenosis, 101 consecutive patients (age 51-86 years, 41% diabetics) underwent 106 MCS-CAS. Clinical outcomes and duplex ultrasound velocities were assessed periprocedurally and at 30 days/12 months. Results. Baseline characteristics of DM vs. non-DM patients were similar except for a higher prevalence of recent cerebral symptoms in DM. Type 1 and type 1+2 plaques were more prevalent in DM patients (26.7% vs. 9.8%, p = 0.02 ; 62.2% vs. 37.7%, p = 0.01 ). Proximal embolic protection was more prevalent in DM (60% vs. 36%; p = 0.015 ). 30-day clinical complications were limited to a single periprocedural minor stroke in DM (2.4% vs. 0%, p = 0.22 ). 12-month in-stent velocities and clinical outcomes were not different (death rate 4.8% vs. 3.3%; p = 0.69 ; no new strokes). Restenosis rate was not different (0% vs. 1.7%, p = 0.22 ). Conclusions. MCS may offset the adverse impact of DM on periprocedural, 30-day, and 12-month clinical complications of CAS and minimize the risk of in-stent restenosis. In this increased-stroke-risk cohort, adverse event rate was low both in DM and non-DM. Further larger-scale clinical datasets including extended follow-ups are warranted.

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Section: Journal Of Diabetes Researchsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 99%

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Diabetes Mellitus and Clinical Outcomes in Carotid Artery Revascularization Using Second-Generation, MicroNet-Covered Stents: Analysis from the PARADIGM Study

Mazurek

Borratyńska

Gancarczyk

et al. 2022

Journal of Diabetes Research

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“…In 103 patients recently treated with CGuard, no DSM occurred by 30 days [ 230 ]. A very recent 733-patient multicentric (20 centers) CGuard study in Italy showed three strokes by 30 days (0.4%, cumulative DSM rate of 0.95%) [ 231 ] and a 12-month ISR rate of 0.82% [ 232 ]. These outcomes are consistent with those indicated by the meta-analytic model ( Table 2 ).…”

Section: Discussionmentioning

confidence: 99%

Clinical Outcomes of Second- versus First-Generation Carotid Stents: A Systematic Review and Meta-Analysis

Mazurek

Malinowski

Rosenfield

et al. 2022

JCM

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Background: Single-cohort studies suggest that second-generation stents (SGS; “mesh stents”) may improve carotid artery stenting (CAS) outcomes by limiting peri- and postprocedural cerebral embolism. SGS differ in the stent frame construction, mesh material, and design, as well as in mesh-to-frame position (inside/outside). Objectives: To compare clinical outcomes of SGS in relation to first-generation stents (FGSs; single-layer) in CAS. Methods: We performed a systematic review and meta-analysis of clinical studies with FGSs and SGS (PRISMA methodology, 3302 records). Endpoints were 30-day death, stroke, myocardial infarction (DSM), and 12-month ipsilateral stroke (IS) and restenosis (ISR). A random-effect model was applied. Results: Data of 68,422 patients from 112 eligible studies (68.2% men, 44.9% symptomatic) were meta-analyzed. Thirty-day DSM was 1.30% vs. 4.11% (p < 0.01, data for SGS vs. FGS). Among SGS, both Casper/Roadsaver and CGuard reduced 30-day DSM (by 2.78 and 3.03 absolute percent, p = 0.02 and p < 0.001), whereas the Gore stent was neutral. SGSs significantly improved outcomes compared with closed-cell FGS (30-day stroke 0.6% vs. 2.32%, p = 0.014; DSM 1.3% vs. 3.15%, p < 0.01). At 12 months, in relation to FGS, Casper/Roadsaver reduced IS (−3.25%, p < 0.05) but increased ISR (+3.19%, p = 0.04), CGuard showed a reduction in both IS and ISR (−3.13%, −3.63%; p = 0.01, p < 0.01), whereas the Gore stent was neutral. Conclusions: Pooled SGS use was associated with improved short- and long-term clinical results of CAS. Individual SGS types, however, differed significantly in their outcomes, indicating a lack of a “mesh stent” class effect. Findings from this meta-analysis may provide clinically relevant information in anticipation of large-scale randomized trials.

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“…For example, the ISR rate in coronary artery stenting is 5–35% using uncoated stents, and the risk is lower with drug-eluting stents (DES),7 and even lower in carotid artery stenting. A large-scale registry using a dual-layered stent reported its ISR rate at 12 months to be 0.82%,8 and a recent meta-analysis revealed the pooled cumulative incidence of ISR at 12 months was 5.7% 9. This discrepancy between VAOS and other artery stenosis is alarming, and emphasizes the role of prediction of ISR and risk stratification for patients with VAOS.…”

Section: Introductionmentioning

confidence: 99%

In-stent restenosis after vertebral artery origin stenosis stenting: a nomogram for risk assessment

Yang

Fang

Zhang

et al. 2022

J NeuroIntervent Surg

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ObjectiveTo propose a nomogram for individual risk assessment of in-stent restenosis (ISR) after vertebral artery origin stenosis (VAOS) stenting.MethodsWe included 793 patients with VAOS treated with stenting from October 2006 to May 2013, with a median follow-up of 27.8 months. Cox regression and the least absolute shrinkage and selection operator (LASSO) regression were adopted for variable selection. The nomogram was formulated and validated by concordance indexes (C-indexes) and calibration curves. An in-stent restenosis risk table (ISR-RT) was subsequently generated for risk stratification. Differences between low-, intermediate-, and high-risk levels were shown by Kaplan-Meier curves and compared by log-rank test.ResultsThe training and validation set included 594 and 199 patients, with a mean ISR rate of 37.2% and 35.2%, respectively. Stent type (HR=1.64, 95% CI 1.26 to 2.14), stent diameter (HR=2.48, 95% CI 1.77 to 3.48), history of peripheral vascular disease (HR=2.17, 95% CI 1.17 to 4.00), history of transit ischemic attack (HR=1.45, 95% CI 1.05 to 2.14), and left-side involvement (HR=1.33, 95% CI 1.04 to 1.69) were included in the nomogram. The C-indexes at 6 and 12 months were 0.650 and 0.611 in the training set, and 0.713 and 0.603 in the validation set, respectively. Compared with low-risk patients, the intermediate- and high-level group had 1.46 (95% CI 1.05 to 2.04; p=0.0235) and 2.28 (95% CI 1.64 to 3.17; p<0.0001) higher chances of developing ISR in 2 years, respectively.ConclusionsA nomogram and a risk evaluation table were developed with good predictive ability for in-stent restenosis among patients with VAOS, which could serve as a practical approach for individualized risk evaluation.

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1-Year Results From a Prospective Experience on CAS Using the CGuard Stent System

Cited by 18 publications

References 16 publications

Diabetes Mellitus and Clinical Outcomes in Carotid Artery Revascularization Using Second-Generation, MicroNet-Covered Stents: Analysis from the PARADIGM Study

Diabetes Mellitus and Clinical Outcomes in Carotid Artery Revascularization Using Second-Generation, MicroNet-Covered Stents: Analysis from the PARADIGM Study

Clinical Outcomes of Second- versus First-Generation Carotid Stents: A Systematic Review and Meta-Analysis

In-stent restenosis after vertebral artery origin stenosis stenting: a nomogram for risk assessment

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