Abstract
Objective
The aim of this trial was to compare the efficacy of closed-cell stents with Casper stents during carotid angioplasty stenting (CAS).
Methods
This was a randomized superiority trial in which 88 patients were enrolled. The primary end points were the incidence, number, and size of new ischemic brain lesions after CAS under distal embolic protection devices (EPD). The secondary end points included stroke, transient ischemic attack (TIA) and myocardial infarction (MI). Ischemic brain lesions were assessed by a diffusion-weighted magnetic resonance image (DW-MRI). Neurological outcomes were evaluated by means of the National Institutes of Health scale score (NIHSS) and the modified Rankin scale (mRS).
Results
Compared with closed-cell stents (n = 47), Casper stents (n = 41), resulted in no significant reduction in the incidence (44.7% versus 39%, P = 0.592), number (1.3 ± 1.8 versus 0.9 ± 1.5, p = 0.444), and size (3.9 ± 5.8 mm versus 2.8 ± 4.1 mm, p = 0.353) of new ischemic brain lesions. The global rate of stroke/TIA/MI was (2/88, 2.3%). Two TIA occurred during the hospitalization period, one in each group (1/41, 2.4% vs 1/47, 2.1%). One patient of the Casper group had an asymptomatic in-stent thrombosis. One patient of the control group had a MI (1/47, 2.1%) after discharge.
Conclusion
The Casper stents did not show superiority in the rate of incidence, number and size of new silent ischemic brain lesions detect by DW-MRI when compared to close cell stents during CAS under distal EPD.
Similar content being viewed by others
References
North American Symptomatic Carotid Endarterectomy Trial. Methods, patient characteristics, and progress. Stroke. 1991;22:711–20.
Mantese VA, Timaran CH, Chiu D, Begg RJ, Brott TG, CREST Investigators. The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST): stenting versus carotid endarterectomy for carotid disease. Stroke. 2010;41(10 Suppl):S31–4.
Jones MR, Howard G, Roubin GS, Blackshear JL, Cohen DJ, Cutlip DE, et al. Periprocedural stroke and myocardial infarction as risks for long-term mortality in CREST. Circ Cardiovasc Qual Outcomes. 2018;11:e004663.
Schnaudigel S, Groschel K, Pilgram SM, Kastrup A. New brain lesions after carotid stenting versus carotid endarterectomy: a systematic review of the literature. Stroke. 2008;39:1911–9.
Gensicke H, van der Worp HB, Nederkoorn PJ, Macdonald S, Gaines PA, van der Lugt A, et al. Ischemic brain lesions after carotid artery stenting increase future cerebrovascular risk. J Am Coll Cardiol. 2015;65:521–9.
Stabile E, Giugliano G, Cremonesi A, Bosiers M, Reimers B, Setacci C, et al. Impact on outcome of different types of carotid stent: results from the European Registry of Carotid Artery Stenting. EuroIntervention. 2016;12:e265–70.
Timaran CH, Rosero EB, Higuera A, Ilarraza A, Modrall JG, Clagett GP. Randomized clinical trial of open-cell vs closed-cell stents for carotid stenting and effects of stent design on cerebral embolization. J Vasc Surg. 2011;54:1310-1316. discussion 1316.
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.
Ruffino MA, Faletti R, Bergamasco L, Fonio P, Righi D. Incidence of new ischaemic brain lesions after carotid artery stenting with the micromesh roadsaver carotid artery stent: a prospective single-centre study. Cardiovasc Intervent Radiol. 2016;39:1541–9.
Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10:28–55.
Wahlund LO, Barkhof F, Fazekas F, Bronge L, Augustin M, Sjögren M, et al. A new rating scale for age-related white matter changes applicable to MRI and CT. Stroke. 2001;32:1318–22.
Adams HP Jr, Bendixen BH, Kappelle LJ, Biller J, Love BB, Gordon DL, et al. Classification of subtype of acute ischemic stroke. Definitions for use in a multicenter clinical trial. TOAST. Trial of Org 10172 in Acute Stroke Treatment. Stroke. 1993;24:35-41.
de Castro-Afonso LH, Nakiri GS, Monsignore LM, dos Santos AC, Leite JP, Fábio SR, et al. Early versus late carotid artery stenting for symptomatic carotid stenosis. J Neuroradiol. 2015;42:169–75.
Bonati LH, Jongen LM, Haller S, Flach HZ, Dobson J, Nederkoorn PJ, et al. New ischaemic brain lesions on MRI after stenting or endarterectomy for symptomatic carotid stenosis: a substudy of the International Carotid Stenting Study (ICSS). Lancet Neurol. 2010;9:353–62. Erratum in: Lancet Neurol. 2010;9:345.
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.
Wissgott C, Schmidt W, Brandt C, Behrens P, Andresen R. Preliminary clinical results and mechanical behavior of a new double-layer carotid stent. J Endovasc Ther. 2015;22:634–9.
American College of Cardiology Foundation; American Society of Interventional & Therapeutic Neuroradiology; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology, Bates ER, et al. ACCF/SCAI/SVMB/SIR/ASITN 2007 clinical expert consensus document on carotid stenting: a report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents (ACCF/SCAI/SVMB/SIR/ASITN Clinical Expert Consensus Document Committee on Carotid Stenting). J Am Coll Cardiol. 2007;49:126–70. Erratum in: J Am Coll Cardiol. 2007;49:924.
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.
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;42:812-9.
Mutzenbach SJ, Millesi K, Roesler C, Broussalis E, Pikija S, Sellner J, et al. The Casper Stent System for carotid artery stenosis. J Neurointerv Surg. 2018;10:869–73.
de Castro-Afonso LH, Abud LG, Rolo JG, Santos AC, Oliveira LD, Barreira CM, et al. Flow reversal versus filter protection: a pilot carotid artery stenting randomized trial. Circ Cardiovasc Interv. 2013;6:552–9.
Hauth EA, Jansen C, Drescher R, Schwartz M, Forsting M, Jaeger HJ, et al. MR and clinical follow-up of diffusion-weighted cerebral lesions after carotid artery stenting. AJNR Am J Neuroradiol. 2005;26:2336–41.
Abbott AL, Paraskevas KI, Kakkos SK, Golledge J, Eckstein HH, Diaz-Sandoval LJ, et al. Systematic Review of Guidelines for the Management of Asymptomatic and Symptomatic Carotid Stenosis. Stroke. 2015;46:3288–301.
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.
de Donato G, Setacci F, Sirignano P, Galzerano G, Cappelli A, Setacci C. Optical coherence tomography after carotid stenting: rate of stent malapposition, plaque prolapse and fibrous cap rupture according to stent design. Eur J Vasc Endovasc Surg. 2013;45:579–87.
Schillinger M, Gschwendtner M, Reimers B, Trenkler J, Stockx L, Mair J, et al. Does carotid stent cell design matter? Stroke. 2008;39:905–9.
Skjelland M, Krohg-Sørensen K, Tennøe B, Bakke SJ, Brucher R, Russell D. Cerebral microemboli and brain injury during carotid artery endarterectomy and stenting. Stroke. 2009;40:230–4.
Kotsugi M, Takayama K, Myouchin K, Wada T, Nakagawa I, Nakagawa H, et al. Carotid artery stenting: investigation of plaque protrusion incidence and prognosis. JACC Cardiovasc Interv. 2017;10:824–31.
Yamada K, Yoshimura S, Miura M, Kanamaru T, Shindo S, Uchida K, et al. Potential of new-generation double-layer micromesh stent for carotid artery stenting in patients with unstable plaque: a preliminary result using OFDI analysis. World Neurosurg. 2017;105:321–6.
Capodanno D, Patel A, Dharmashankar K, Ferreiro JL, Ueno M, Kodali M, et al. Pharmacodynamic effects of different aspirin dosing regimens in type 2 diabetes mellitus patients with coronary artery disease. Circ Cardiovasc Interv. 2011;4:180–7.
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;48:2171–5.
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;12:33–7.
Lamanna A, Maingard J, Kok HK, Barras C, Jhamb A, et al. Carotid artery stenting in acute stroke using a microporous stent device: a single-center experience. World Neurosurg. 2019;127:e1003–12.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of interest
J.R. Vanzin, L.H. de Castro-Afonso, M.N. Santos, L.B. Manzato, G.S. Nakiri, L.M. Monsignore, F.P. Trivelato, M.T.S. Rezende, O.M. Pontes-Neto and D.G. Abud declare that they have no competing interests.
Rights and permissions
About this article
Cite this article
Vanzin, J.R., de Castro-Afonso, L.H., Santos, M.N. et al. Casper vs. Closed-Cell Stent. Clin Neuroradiol 31, 843–852 (2021). https://doi.org/10.1007/s00062-020-00937-8
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00062-020-00937-8