Advertisement
Clinical study| Volume 75, P117-121, May 2020

Download started.

Ok

Comparative analysis of CGUARD embolic prevention stent with Casper-RX and Wallstent for the treatment of carotid artery stenosis

Published:March 12, 2020DOI:https://doi.org/10.1016/j.jocn.2020.03.008

      Highlights

      • CGUARD stents is feasible and safe compared to one layer stents in symptomatic and asymptomatic patients.
      • The rate of thromboembolic complications compares favorably with Wallstent for emergent, urgent and elective cases.
      • No significant differences in the rate of acute in-stent occlusions among the 3 groups.
      • No significant differences in the rate of postinterventional symptomatic intracerebral hemorrhage among the 3 groups.

      Abstract

      Stent protected Angioplasty of extracranial carotid artery stenosis using the dual-layered CGUARD stent is a novel treatment option. In this study we evaluate the feasibility and the safety of the CGUARD in symptomatic and asymptomatic patients in comparison to Casper-RX and Wallstent. This is a multi-center study of consecutive patients treated with the CGUARD, Casper-RX and Wallstent at two German high volume neurovascular centers between April 2017 and May 2018. Patient characteristics, neuroimaging data and angiographic outcome were retrospectively analyzed. The primary end points of the study were acute occlusion of the carotid stent and symptomatic intracerebral hemorrhage (sICH). Carotid artery stenting was performed in 76 patients; of those 26 (34%) were treated with the CGUARD, 25 (33%) with Casper-RX, and 25 (33%) with Wallstent. In 58/76 (76%) cases carotid artery stenosis was symptomatic with a median baseline National Institutes of Health Stroke Scale of 4. Angioplasty and stenting as part of a mechanical thrombectomy for acute ischemic stroke was performed in 25/76 (33%) patients. Baseline patient characteristics were similar between the treatment groups, except for a higher portion of scheduled cases in the Casper-RX group. There were no significant differences in the rate of acute in stent occlusions (CGUARD, 2/26 (8%); Casper-RX, 1/25(4%); Wallstent, 1/25 (4%)) and postinterventional sICH (1/26 (4%), 0/25(0%), 0/25 (0%)). Clinical outcome at discharge did not differ between groups. Treatment of carotid artery stenosis using CGUARD is feasible with a good safety profile comparable to that of Casper-RX and Wallstent.

      Keywords

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Journal of Clinical Neuroscience
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Ovbiagele B.
        • Nguyen-Huynh M.N.
        Stroke epidemiology: advancing our understanding of disease mechanism and therapy.
        Neurotherapeutics. 2011; 8: 319-329
        • Authors Task Force
        • Members Aboyans V
        • Björck M.
        • Brodmann M.
        • Collet J.P.
        • Czerny M.
        • et al.
        Questions and answers on diagnosis and management of patients with peripheral arterial diseases: a companion document of the 2017 ESC guidelines for the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European Society fo.
        Eur J Vasc Endovasc Surg. 2018; 55: 457-464
        • Mantese V.A.
        • Timaran C.H.
        • Chiu D.
        • Begg R.J.
        • Brott T.G.
        The carotid revascularization endarterectomy versus stenting trial (CREST): stenting versus carotid endarterectomy for carotid disease.
        Stroke. 2010; 41: S31-S34
        • Voeks J.H.
        • Howard G.
        • Roubin G.S.
        • Malas M.B.
        • Cohen D.J.
        • Sternbergh W.C.
        • et al.
        Age and outcomes after carotid stenting and endarterectomy: the carotid revascularization endarterectomy versus stenting trial.
        Stroke. 2011; 42: 3484-3490
        • Al-Mubarak N.
        • Roubin G.S.
        • Vitek J.J.
        • Iyer S.S.
        • New G.
        • Leon M.B.
        Effect of the distal-balloon protection system on microembolization during carotid stenting.
        Circulation. 2001; 104: 1999-2002
        • Kim H.J.
        • Lee H.J.
        • Yang J.H.
        • Yeo I.S.
        • Yi J.S.
        • Lee I.W.
        • et al.
        The influence of carotid artery catheterization technique on the incidence of thromboembolism during carotid artery stenting.
        Am J Neuroradiol. 2010; 31: 1732-1736
        • Hopf-Jensen S.
        • Marques L.
        • Preiß M.
        • Müller-Hülsbeck S.
        Initial clinical experience with the micromesh roadsaver carotid artery stent for the treatment of patients with symptomatic carotid artery disease.
        J Endovasc Ther. 2015; 22: 220-225
        • Diaz O.
        • Lopez G.
        • Roehm J.O.F.
        • De La Rosa G.
        • Orozco F.
        • Almeida R.
        The Casper carotid artery stent: a unique all metal micromesh stent designed to prevent embolic release.
        J Neurointerv Surg. 2018; 10: 133-136
        • Schofer J.
        • Musiałek P.
        • Bijuklic K.
        • Kolvenbach R.
        • Trystula M.
        • Siudak Z.
        • et al.
        A prospective, multicenter study of a novel mesh-covered carotid stent the CGuard CARENET Trial (carotid embolic protection using MicroNet).
        JACC Cardiovasc Interv. 2015; 8: 1229-1234
        • Musialek P.
        • Mazurek A.
        • Trystula M.
        • Borratynska A.
        • Lesniak-Sobelga A.
        • Urbanczyk M.
        • et al.
        Novel PARADIGM in carotid revascularisation: prospective evaluation of all-comer percutaneous carotid revascularisation in symptomatic and increased-risk asymptomatic carotid artery stenosis using cguardTM micronet-covered embolic prevention stent system.
        EuroIntervention. 2016; 12: e658-e670
        • Capoccia L.
        • Sirignano P.
        • Mansour W.
        • d'Adamo A.
        • Sbarigia E.
        • Mariani P.
        • et al.
        Peri-procedural brain lesions prevention in CAS (3PCAS): randomized trial comparing CGuard™ stent vs. Wallstent™.
        Int J Cardiol. 2019; 279: 148-153
        • Ruffino M.A.
        • Faletti R.
        • Fronda M.
        • Gatti M.
        • Bergamasco L.
        • Gibello L.
        • et al.
        Early embolization after carotid artery stenting with mesh-covered stent: role of diffusion-weighted magnetic resonance imaging as pre-procedural predictor and discriminant between intra- and post-procedural events.
        Cardiovasc Intervent Radiol. 2019; 42: 812-819
        • Carnicelli A.P.
        • Stone J.J.
        • Doyle A.
        • Chowdhry A.K.
        • Mix D.
        • Ellis J.
        • et al.
        Cross-sectional area for the calculation of carotid artery stenosis on computed tomographic angiography.
        J Vasc Surg. 2013; 58: 659-665
        • Bosiers M.
        • Deloose K.
        • Verbist J.
        • Peeters P.
        What practical factors guide the choice of stent and protection device during carotid angioplasty?.
        Eur J Vasc Endovasc Surg. 2008; 35: 637-643
        • Jansen O.
        • Fiehler J.
        • Hartmann M.
        • Brückmann H.
        Protection or nonprotection in carotid stent angioplasty: the influence of interventional techniques on outcome data from the SPACE trial.
        Stroke. 2009; 40: 841-846
        • Bosiers M.
        • de Donato G.
        • Deloose K.
        • Verbist J.
        • Peeters P.
        • Castriota F.
        • et al.
        Does free cell area influence the outcome in carotid artery stenting?.
        Eur J Vasc Endovasc Surg. 2007; 33: 135-141
        • Doig D.
        • Turner E.L.
        • Dobson J.
        • Featherstone R.L.
        • Lo R.T.H.
        • Gaines P.A.
        • et al.
        Predictors of stroke, myocardial infarction or death within 30 days of carotid artery stenting: results from the international carotid stenting study.
        Eur J Vasc Endovasc Surg. 2016; 51: 327-334
      1. InspireMD. CGUARD Carotid Embolic Prevention System product brochure [Internet]. CGUARD Carotid Embolic Prev. Syst. Prod. Broch. 2015. Available from: http://www.inspiremd.com/en/product/cguard/.

        • Blasel S.
        • Hattingen E.
        • Berkefeld J.
        • Kurre W.
        • Morawe G.
        • Zanella F.
        • et al.
        Evaluation of angiographic and technical aspects of carotid stenting with diffusion-weighted magnetic resonance imaging.
        Cardiovasc Intervent Radiol. 2009; 32: 666-671
        • Schnaudigel S.
        • Gröschel K.
        • Pilgram S.M.
        • Kastrup A.
        New brain lesions after carotid stenting versus carotid endarterectomy: a systematic review of the literature.
        Stroke. 2008; 39: 1911-1919
        • Capoccia L.
        • Sirignano P.
        • Mansour W.
        • d’Adamo A.
        • Sbarigia E.
        • Mariani P.
        • et al.
        Peri-procedural brain lesions prevention in CAS (3PCAS): randomized trial comparing CGuardTM stent vs. WallstentTM.
        Int J Cardiol. 2018; 279: 148-153
        • Wissgott C.
        • Schmidt W.
        • Brandt-Wunderlich C.
        • Behrens P.
        • Andresen R.
        Clinical results and mechanical properties of the carotid CGUARD double-layered embolic prevention stent.
        J Endovasc Ther. 2017; 24: 130-137
        • Capoccia L.
        • Sirignano P.
        • Mansour W.
        • Sbarigia E.
        • Speziale F.
        Twelve-month results of the Italian registry on protected CAS with the mesh-covered CGuard stent: the IRON-Guard study.
        EuroIntervention. 2018; 14: 1150-1152
      2. The SIBERIA Trial (Acculink™ Versus CGuard™). https://clinicaltrials.gov/ct2/show/NCT03488199).

        • Yilmaz U.
        • Körner H.
        • Mühl-Benninghaus R.
        • Simgen A.
        • Kraus C.
        • Walter S.
        • et al.
        Acute occlusions of dual-layer carotid stents after endovascular emergency treatment of tandem lesions.
        Stroke. 2017; 48: 2171-2175
        • Yilmaz U.
        • Walter S.
        • Körner H.
        • Papanagiotou P.
        • Roth C.
        • Simgen A.
        • et al.
        Peri-interventional subarachnoid hemorrhage during mechanical thrombectomy with stent retrievers in acute stroke: a retrospective case-control study.
        Clin Neuroradiol. 2015; 2: 173-176
        • Stabile E.
        • de Donato G.
        • Musialek P.
        • De Loose K.
        • Nerla R.
        • Sirignano P.
        • et al.
        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; 11: 2405-2411