PURPOSE: The aim of this study was to report intermediate-term results of duplex ultrasound follow-up of carotid artery stenting performed with the dual-layer stent as compared to concurrent patients treated with other commercially available single-layer carotid stents. MATERIALS AND METHODS: A single centre, retrospective, nonrandomized study including 162 non-consecutive patients with 199 implanted carotid stents treated over a 7-year period was conducted. Patients with at least one ultrasound examination after treatment were included. Procedural and follow-up data for patients treated with the dual-layer stent implantation (83 stents) vs first-generation carotid stents implantations (116 stents) were compared. RESULTS: The median follow-up time was 24.0 months (IQR 10-32 months) for dual-layer stents and 27.5 months (IQR 10.3-59 months) for single-layer stents. The rate of severe restenosis was significantly higher in the dual-layer stent group than in the single-layer group (13.3% [11/83] vs 3.4% [4/116], p = 0.01). Seven reinterventions were performed in 5 patients with dual-layer stents. The rate of reintervention was significantly higher compared to no reinterventions in single-layer stents (6% [5/83] vs 0% [0/116], p = 0.012). Patients with restenosis had significantly higher presence of dyslipidaemia (100% [12/12] vs 63.3% [95/150], p = 0.009). CONCLUSIONS: In this real-world cohort of patients undergoing carotid artery stenting, the patients treated with low-profile dual-layer micromesh stent showed higher rates of restenosis and reinterventions compared to first-generation single-layer stents.

Clinic of Neurology University Hospital Kollárova 2 036 59 Martin Slovakia

Clinic of Radiology Comenius University's Jessenius Faculty of Medicine and University Hospital Kollárova 2 036 59 Martin Slovakia

Department of Geotechnics Faculty of Civil Engineering University of Žilina Univerzitná 8215 1 010 26 Žilina Slovakia

Department of Medical Biophysics Faculty of Medicine and Dentistry Palacký University Olomouc Hněvotínská 976 3 775 15 Olomouc Czech Republic

Department of Radiology Faculty of Medicine and Dentistry Palacky University Olomouc 1 P Pavlova 185 6 77520 Olomouc Czech Republic

Department of Vascular Surgery University Hospital Kollárova 2 036 59 Martin Slovakia

Diagnostic and Interventional Neuroradiology University Medical Center Hamburg Eppendorf 20251 Hamburg Germany

Middle Slovak Institute of Cardiovascular Diseases Cesta k nemocnici 1 974 01 Banská Bystrica Slovakia

Orthopedic Clinic Comenius University's Jessenius Faculty of Medicine and University Hospital Kollárova 2 036 59 Martin Slovakia

Vaša Ambulancia s r o Prieložtek 1 036 01 Martin Slovakia

Zobrazit více v PubMed

Kammler J, Blessberger H, Lambert T, Kellermair J, Grund M, Nahler A, et al. In-stent restenosis after interventional treatment of carotid artery stenoses: a long-term follow-up of a single center cohort. Clin Res Cardiol. 2017;106:493–500. https://doi.org/10.1007/s00392-017-1078-1 . PubMed DOI

Stabile E, Garg P, Cremonesi A, Bosiers M, Reimers B, Setacci C, et al. European registry of carotid artery stenting: results from a prospective registry of eight high volume EUROPEAN institutions. Catheter Cardiovasc Interv. 2012;80:329–34. https://doi.org/10.1002/ccd.24348 . PubMed DOI

Zeleňák K, Nosáľ V, Zeleňáková J, Kurča E, Šinák I, Sivák Š, et al. CAS-complications rate and relation to risk factors. Open J Radiol. 2013;3(1):26–32. https://doi.org/10.4236/ojrad.2013.31004 . DOI

Aboyans V, Ricco JB, Bartelink MLEL, Björck M, Brodmann M, Cohnert T, et al. 2017 ESC Guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the european society for vascular surgery (ESVS). Eur Heart J. 2018;39:763–816. https://doi.org/10.1093/eurheartj/ehx095 . PubMed DOI

Brott TG, Halperin JL, Abbara S, Bacharach JM, Barr JD, Bush RL, et al. ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS guideline on the management of patients with extracranial carotid and vertebral artery disease: executive summary. a report of the American college of cardiology foundation/American heart association task force on practice guidelines, and the American stroke association, American association of neuroscience nurses, American association of neurological surgeons, American college of radiology, American society of neuroradiology, congress of neurological surgeons, society of atherosclerosis imaging and prevention, society for cardiovascular angiography and interventions, society of interventional radiology, society of neurointerventional surgery, society for vascular medicine, and society for vascular surgery. Circulation. 2011;124:489–532. https://doi.org/10.1161/CIR.0b013e31820d8d78 . PubMed DOI

Goode SD, Cleveland TJ, Gaines PA. United Kingdom carotid artery stent registry: short- and long-term outcomes. Cardiovasc Intervent Radiol. 2013 Oct;36(5):1221–31. doi: https://doi.org/10.1007/s00270-013-0573-7 . Epub 2013 Mar 8. Erratum in: Cardiovasc Intervent Radiol. 2013 Oct;36(5):1440–1. DOI: https://doi.org/10.1007/s00270-013-0573-7 .

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;8:1229–34. https://doi.org/10.1016/j.jcin.2015.04.016 . PubMed DOI

Nerla R, Micari A, Castriota F, Miccichè E, Ruffino MA, de Donato G, et al. Carotid artery stenting with a new-generation double-mesh stent in three high-volume Italian centres: 12-month follow-up results. EuroIntervention. 2018;14:1147–9. https://doi.org/10.4244/EIJ-D-18-00513 . PubMed DOI

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;279:148–53. https://doi.org/10.1016/j.ijcard.2018.09.066 . PubMed DOI

Ruffino MA, 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(6):812–9. https://doi.org/10.1007/s00270-019-02173-1 . PubMed DOI

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(8):2171–5. https://doi.org/10.1161/STROKEAHA.116.015965 . PubMed DOI

Machnik R, Paluszek P, Tekieli Ł, Dzierwa K, Maciejewski D, Trystuła M, et al. Mesh-covered (roadsaver) stent as a new treatment modality for symptomatic or high-risk carotid stenosis. Postepy Kardiol Interwencyjnej. 2017;13:130–4. https://doi.org/10.5114/pwki.2017.68139 . PubMed DOI PMC

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;22:220–5. https://doi.org/10.1177/1526602815576337 . PubMed DOI

Bosiers M, Deloose K, Torsello G, Scheinert D, Maene L, Peeters P, et al. The CLEAR-ROAD study: evaluation of a new dual layer micromesh stent system for the carotid artery. EuroIntervention. 2016;12:e671-6. https://doi.org/10.4244/EIJY16M05_04 . PubMed DOI

Stabile E, de Donato G, Musialek P, Deloose K, Nerla R, Sirignano P, et al. Use of dual-layered stents for carotid artery angioplasty: 1-year results of a patient based meta-analysis. JACC Cardiovasc Interv. 2020;13:1709–15. https://doi.org/10.1016/j.jcin.2020.03.048 . PubMed DOI

Imamura H, Sakai N, Matsumoto Y, Yamagami H, Terada T, Fujinaka T, et al. Clinical trial of carotid artery stenting using dual-layer CASPER stent for carotid endarterectomy in patients at high and normal risk in the Japanese population. J Neurointerv Surg. 2021;13:524–9. https://doi.org/10.1136/neurintsurg-2020-016250 . PubMed DOI

Vanzin JR, de Castro-Afonso LH, Santos MN, Manzato LB, Nakiri GS, Monsignore LM, et al. Casper vs closed-cell stent: carotid artery stenting randomized trial. Clin Neuroradiol. 2020. https://doi.org/10.1007/s00062-020-00937-8 . PubMed DOI

Economopoulos KP, Sergentanis TN, Tsivgoulis G, Mariolis AD, Stefanadis C. Carotid artery stenting versus carotid endarterectomy: a comprehensive meta-analysis of short-term and long-term outcomes. Stroke. 2011;42:687–92. https://doi.org/10.1161/STROKEAHA.110.606079 . PubMed DOI

Wasser K, Schnaudigel S, Wohlfahrt J, Psychogios MN, Schramm P, Knauth M, et al. Clinical impact and predictors of carotid artery in-stent restenosis. J Neurol. 2012;259:1896–902. https://doi.org/10.1007/s00415-012-6436-3 . PubMed DOI PMC

Lal BK, Beach KW, Roubin GS, Lutsep HL, Moore WS, Malas MB, et al. Restenosis after carotid artery stenting and endarterectomy: a secondary analysis of CREST, a randomised controlled trial. Lancet Neurol. 2012;11:755–63. https://doi.org/10.1016/S1474-4422(12)70159-X . PubMed DOI PMC

Bonati LH, Ederle J, McCabe DJH, Dobson J, Featherstone RL, Gaines PA, et al. Long-term risk of carotid restenosis in patients randomly assigned to endovascular treatment or endarterectomy in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): long-term follow-up of a randomised trial. Lancet Neurol. 2009;8:908–17. https://doi.org/10.1016/S1474-4422(09)70227-3 . PubMed DOI PMC

Bonati LH, Gregson J, Dobson J, McCabe DJH, Nederkoorn PJ, van der Worp HB, et al. Restenosis and risk of stroke after stenting or endarterectomy for symptomatic carotid stenosis in the International Carotid Stenting Study (ICSS): secondary analysis of a randomised trial. Lancet Neurol. 2018;17(7):587–96. https://doi.org/10.1016/S1474-4422(18)30195-9 . PubMed DOI PMC

Maleux G, Bernaerts P, Thijs V, Daenens K, Vaninbroukx J, Fourneau I, et al. Extracranial carotid artery stenting in surgically high-risk patients using the carotid wallstent endoprosthesis: midterm clinical and ultrasound follow-up results. Cardiovasc Intervent Radiol. 2003;26:340–6. https://doi.org/10.1007/s00270-003-0039-4 . PubMed DOI

Eckstein H-H, Ringleb P, Allenberg J-R, Berger J, Fraedrich G, Hacke W, et al. Results of the Stent-protected Angioplasty versus Carotid Endarterectomy (SPACE) study to treat symptomatic stenoses at 2 years: a multinational, prospective, randomised trial. Lancet Neurol. 2008;7:893–902. https://doi.org/10.1016/S1474-4422(08)70196-0 . PubMed DOI

Arquizan C, Trinquart L, Touboul P-J, Long A, Feasson S, Terriat B, et al. Restenosis is more frequent after carotid stenting than after endarterectomy. Stroke. 2011;42:1015–20. https://doi.org/10.1161/STROKEAHA.110.589309 . PubMed DOI

Bosiers M, Scheinert D, Mathias K, Langhoff R, Mudra H, Diaz-Cartelle J. Carotid stenting with distal protection in high-surgical-risk patients: one-year results of the ASTI trial. Cardiovasc Intervent Radiol. 2015;38(2):295–303. https://doi.org/10.1007/s00270-014-1000-4 . PubMed DOI

Zeleňák K, Zeleňáková J, DeRiggo J, Kurča E, Kantorová E, Poláček H. Treatment of cervical internal carotid artery spontaneous dissection with pseudoaneurysm and unilateral lower cranial nerves palsy by two silk flow diverters. Cardiovasc Intervent Radiol. 2013;36(4):1147–50. https://doi.org/10.1007/s00270-012-0472-3 . PubMed DOI

Nosáľ V, Zeleňák K, Sivák S, Michalík J, Kantorová E, Péčová R, et al. One session bilateral carotid stenting-experience from slovakian center. Acta Medica Martiniana. 2016;16(1):30–5. DOI

Tao Y, Hua Y, Jia L, Jiao L, Liu B. Risk factors for residual stenosis after carotid artery stenting. Front Neurol. 2021;11: 606924. https://doi.org/10.3389/fneur.2020.606924 . PubMed DOI PMC

Köcher M, Šaňák D, Zapletalová J, Černá M, Veverka T, Prášil V, et al. Stenting of cervical internal carotid artery in patients with acute ischemic stroke due to tandem occlusion Is antegrade approach safe? Ces Radiol. 2019;73(1):7–12.

Černík D, Šaňák D, Divišová P, Köcher M, Cihlář F, Zapletalová J, et al. Mechanical thrombectomy in patients with acute ischemic stroke on anticoagulation therapy. Cardiovasc Intervent Radiol. 2018;41(5):706–11. https://doi.org/10.1007/s00270-018-1902-7 . PubMed DOI

Černá M, Roček M, Peregrin JH, Köcher M, Krajina A, Pádr R, et al. Czech society of interventions CLS JEP guidelines for periprocedural medication in endovascular procedures. Ces Radiol. 2018;72(2):71–5.

Mutzenbach JS, Griessenauer CJ, Broussalis E, Pikija S, Moscote-Salazar LR, Millesi K, et al. Follow-up after carotid stenting with the CASPER stent system: a duplex ultrasound evaluation. J Vasc Surg. 2020;72(6):2054–60. https://doi.org/10.1016/j.jvs.2020.03.048 . PubMed DOI

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: journal of Europcr in collaboration with the working group on interventional cardiology of the European. Soc Cardiol. 2018;14(10):1150–2. https://doi.org/10.4244/eij-d-18-00241 . DOI

Chi Y-W, White CJ, Woods TC. Ultrasound velocity criteria for carotid in-stent restenosis. Catheter Cardiovasc Interv. 2007;69:349–54. https://doi.org/10.1002/ccd.21032 . PubMed DOI

Lal BK, Hobson RW 2nd, Tofighi B, Kapadia I, Cuadra S, Jamil Z. Duplex ultrasound velocity criteria for the stented carotid artery. J Vasc Surg. 2008;47:63–73. https://doi.org/10.1016/j.jvs.2007.09.038 . PubMed DOI

AbuRahma AF, Abu-Halimah S, Bensenhaver J, Dean LS, Keiffer T, Emmett M, et al. Optimal carotid duplex velocity criteria for defining the severity of carotid in-stent restenosis. J Vasc Surg. 2008;48:589–94. https://doi.org/10.1016/j.jvs.2008.04.004 . PubMed DOI

Zhou W, Felkai DD, Evans M, McCoy SA, Lin PH, Kougias P, et al. Ultrasound criteria for severe in-stent restenosis following carotid artery stenting. J Vasc Surg. 2008;47:74–80. https://doi.org/10.1016/j.jvs.2007.09.031 . PubMed DOI

Brott TG, Hobson RW, Howard G, Roubin GS, Clark WM, Brooks W, et al. Stenting versus endarterectomy for treatment of carotid-artery stenosis. N Engl J Med. 2010;363:11–23. https://doi.org/10.1056/nejmoa0912321 . PubMed DOI PMC

Naylor AR, Ricco JB, de Borst GJ, Debus S, de Haro J, Halliday A, et al. Editor’s choice - management of atherosclerotic carotid and vertebral artery disease: 2017 clinical practice guidelines of the European society for vascular surgery (ESVS). Eur J Vasc Endovasc Surg. 2018;55:3–81. https://doi.org/10.1016/j.ejvs.2018.03.023 . PubMed DOI

de Donato G, Setacci C, Deloose K, Peeters P, Cremonesi A, Bosiers M. Long-term results of carotid artery stenting. J Vasc Surg. 2008;48:1431–40. https://doi.org/10.1016/j.jvs.2008.07.012 . PubMed DOI

Arning C, Widder B, von Reutern GM, Stiegler H, Görtler M. Revision of DEGUM ultrasound criteria for grading internal carotid artery stenoses and transfer to NASCET measurement. Ultraschall Med Stuttg Ger. 2010;31:251–7. https://doi.org/10.1055/s-0029-1245336 . DOI

Lal BK, Hobson RW 2nd, Goldstein J, Chakhtoura EY, Durán WN. Carotid artery stenting: is there a need to revise ultrasound velocity criteria? J Vasc Surg. 2004;39:58–66. https://doi.org/10.1016/j.jvs.2003.10.043 . PubMed DOI

Stanziale SF, Wholey MH, Boules TN, Selzer F, Makaroun MS. Determining in-stent stenosis of carotid arteries by duplex ultrasound criteria. J Endovasc Ther. 2005;12:346–53. https://doi.org/10.1583/04-1527.1 . PubMed DOI

Levy EI, Hanel RA, Lau T, Koebbe CJ, Levy N, Padalino DJ, et al. Frequency and management of recurrent stenosis after carotid artery stent implantation. J Neurosurg. 2005;102:29–37. https://doi.org/10.3171/jns.2005.102.1.0029 . PubMed DOI

Machnik R, Pieniążek P, Misztal M, Plens K, Kazibudzki M, Tomaszewski T, et al. Carotid artery stenting with Roadsaver stent. early and four-year results from a single-center registry. Adv Interventional Cardiol/Postępy w Kardiologii Interwencyjnej. 2020;16(4):444–51. https://doi.org/10.5114/aic.2020.101770 . DOI

Bosiers M, Deloose K, Torsello G, Scheinert D, Maene L, Peeters P, et al. Evaluation of a new dual-layer micromesh stent system for the carotid artery: 12-month results from the CLEAR-ROAD study. EuroIntervention. 2018;14(10):1144–6. https://doi.org/10.4244/EIJ-D-18-00230 . PubMed DOI

Kahlberg A, Bilman V, Ardita V, Mascia D, Bertoglio L, Rinaldi E, et al. Contemporary results of carotid artery stenting using low-profile dual-metal layer nitinol micromesh stents in relation to single-layer carotid stents. J Endovasc Ther. 2021;28(5):726–36. https://doi.org/10.1177/15266028211025046 . PubMed DOI

Bartolini B, Puccinelli F, Mosimann PJ, Hajdu SD, Veunac L, Michel P, et al. Evaluating the effectiveness and safety of the carotid Casper-RX stent for tandem lesions in acute ischemic stroke. J Neurointerv Surg. 2019;11(8):772–4. https://doi.org/10.1136/neurintsurg-2018-014425 . PubMed DOI

Pfaff JAR, Maurer C, Broussalis E, Janssen H, Blanc R, Dargazanli C, et al. Acute thromboses and occlusions of dual layer carotid stents in endovascular treatment of tandem occlusions. J Neurointerv Surg. 2020;12(1):33–7. https://doi.org/10.1136/neurintsurg-2019-015032 . PubMed DOI

Müller MD, Gregson J, McCabe DJH, Nederkoorn PJ, van der Worp HB, de Borst GJ, et al. Stent design, restenosis and recurrent stroke after carotid artery stenting in the international carotid stenting study. Stroke. 2019;50(11):3013–20. https://doi.org/10.1161/STROKEAHA.118.024076 . PubMed DOI

Texakalidis P, Giannopoulos S, Kokkinidis DG, Lanzino G. Effect of open- vs closed-cell stent design on periprocedural outcomes and restenosis after carotid artery stenting: a systematic review and comprehensive meta-analysis. J Endovasc Ther. 2018;25(4):523–33. https://doi.org/10.1177/1526602818783505 . PubMed DOI

Broussalis E, Griessenauer C, Mutzenbach S, Pikija S, Jansen H, Stevanovic V, et al. Reduction of cerebral DWI lesion burden after carotid artery stenting using the Casper stent system. J Neurointerv Surg. 2019;11:62–7. https://doi.org/10.1136/neurintsurg-2018-013869 . PubMed DOI