Randomized Controlled Trial of Conventional Versus MicroNet-Covered Stent in Carotid Artery Revascularization

Karpenko, Andrey; Bugurov, Savr; Ignatenko, Pavel; Starodubtsev, Vladimir; Popova, Irina; Malinowski, Krzysztof Piotr; Musiałek, Piotr

doi:10.1016/j.jcin.2021.08.005

Cited by 38 publications

(41 citation statements)

References 43 publications

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“…Today, clinicians are exposed to often contradictory data regarding strategies in carotid revascularization in primary and secondary stroke prevention. Within the limitations that need to be taken into account (see below), the data from this systematic review and meta-analysis may play a role in informing clinical decisions until larger sets of randomized evidence [ 27 ] become available.…”

Section: Discussionmentioning

confidence: 99%

“…Severe bias presence led to study exclusion from further analysis. Finally, CAS data from103 observational and 9 randomized studies were included [ 4 , 21 , 22 , 23 , 26 , 27 , 30 , 35 , 39 , 41 , 44 , 45 , 56 , 58 , 65 , 66 , 84 , 89 , 91 , 92 , 97 , 104 , 111 , 112 , 113 , 114 , 115 , 116 , 117 , 118 , 119 , 120 , 121 , 122 , 123 , 124 , 125 , 126 , 127 , 128 , 129 , 130 , 131 , 132 , 133 , 134 , 135 , 136 , 137 , 138 , 139 , 140 , 141 , 142 , 143 , 144 ,…”

Section: Methodsmentioning

confidence: 99%

“…Recently, several single-cohort studies [ 20 , 23 , 24 , 25 ] and two randomized studies [ 26 , 27 ] indicated that SGS may improve CAS outcomes by limiting peri- and postprocedural embolism. However, a pilot analysis suggested that SGS may differ in their clinical outcomes [ 28 , 29 ].…”

Section: Introductionmentioning

confidence: 99%

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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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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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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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“… 12 FGS implantation for in-FGS (neo)atherosclerosis may result in (continued) plaque prolapse-related distal embolism 12 that, in contrast, is inhibited by MCS. 6 , 13 , 14…”

Section: Discussionmentioning

confidence: 99%

“…Evidence is accumulating that the MCS may eliminate—by insulation the plaque—the periprocedural and long-term plaque-related problems. 6 , 13 , 14…”

Section: Discussionmentioning

confidence: 99%

Symptomatic atherosclerotic plaque progression in a first-generation carotid stent: management and 5-year clinical and imaging outcome—a case report

Tekieli

Mazurek

Pienia̦żek

et al. 2021

European Heart Journal - Case Reports

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Background Restenosis in first-generation (single-layer, nitinol) carotid stents (FGS) is believed to represent an exaggerated healing response of (neo)intimal hyperplasia (NIH) formation. Rather than NIH, we describe symptomatic in-FGS unstable plaque (neo)atherosclerosis mandating re-revascularization. To halt continued plaque evolution, we propose a novel treatment strategy involving a micronet-covered stent to sequestrate the plaque from the vessel lumen. A durable long-term result is documented using multi-modal imaging. Case summary With a seemingly optimal result of FGS (Precise) symptomatic carotid lesion revascularization followed by optimal medical therapy, a late (≥3 years) progressive ISR arose. At year 11, crescendo ipsilateral transient ischaemic attacks occurred. Angiography showed an ulcerated tight lesion throughout stent length. Intravascular ultrasound (IVUS) revealed thin-cap fibroatheroma. Re-intervention was performed under distal protection. Undersized balloon predilatation caused symptomatic no-flow, and aspiration catheter was used to reduce the filter load. A micronet-covered stent (CGuard) was implanted and post-dilated to ensure full lumen gain; IVUS confirmed complete plaque sequestration. The optimal anatomic result remained unchanged throughout 5 years (ultrasound and computed tomography verification); this was accompanied by clinical cure. Discussion This is the first demonstration of in-FGS (neo)atherosclerosis resolution using a micronet-covered stent to sequestrate and insulate the atherosclerotic plaque. We show that ISR may be underlined by late atherosclerotic plaque progression via the FGS single-layer stent struts that may show vulnerable plaque phenotype and may be associated with cerebral ischaemia. The anatomically and clinically effective exclusion of the atherosclerotic plaque by a micronet-covered stent enabled lasting, optimal endovascular reconstruction and clinical cure.

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Extracranial Atherosclerotic Arterial Disease

Harrigan,

Deveikis

2023

Contemporary Medical Imaging

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Randomized Controlled Trial of Conventional Versus MicroNet-Covered Stent in Carotid Artery Revascularization

Cited by 38 publications

References 43 publications

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

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

Symptomatic atherosclerotic plaque progression in a first-generation carotid stent: management and 5-year clinical and imaging outcome—a case report

Extracranial Atherosclerotic Arterial Disease

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