Umemoto  et al. EuroIntervention  2017

Featured product: Roadsaver™ Carotid Artery Stent

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The aim of this study was to identify the findings (by optical coherence tomography [OCT]) after carotid artery stenting (CAS) with two different types of new-generation dual-layer micromesh stents (Roadsaver^TM  and CGuard^TM)

• Prospective, 2-arms, 2 Italian centers

  • CAS procedures performed between October 2014 and July 2015

• 16 consecutive patients (15 males, mean age: 75.0±7.5) undergoing CAS using the dual-layer micromesh stents (11 CGuardTM / 5 Roadsaver^TM) with OCT

  • 3 Symptomatic  > 50% stenosis (19%)
  • 13 Asymptomatic >80% stenosis   (81%)

• The primary endpoints were the incidences of Stent Malapposition and Plaque prolapse as detected by OCT (according to the implanted stent).

• Secondary endpoints included the presence of either stroke or death at 30 days and any in-hospital adverse events.

• Independent neurological examinations of all patients were performed before the intervention, at discharge, and at 30 days after the procedure.

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• Embolic protection devices (EPD) use: 100%

  • 56.3 % Proximal (Mo.Ma™ Ultra),
    • 9 CGuard^TM  (81.8%) / 0 Roadsaver™ (0%) (p=0.005)
  • 43.8% Distal protection (5 Spider FX™ (%) / 2 FilterWire EZ™ (%))
    • 2 CGuard™ (18.2%) / 5 Roadsaver™ (100%) (p=0.005)

• Stent size selection

  • The stent diameter was selected according to the common carotid artery (CCA)  diameter (mean oversize of 1 mm),
  • The stent length was calculated to cover the entire carotid lesion (at least 0.5 cm below and 0.5 cm above the target lesion).

• Predilatation: 4 (25%), 4 CGuard^TM (36%) / 0 Roadsaver^TM

• Nominal stent length: 32.4±6.2 mm,

  • 35±5.2 mm CGuard^TM  vs. 27.5±2.9 mm Roadsaver^TM (p=0.02)

• Postdilatation: 100%

• Contrast volume: 82.8±34.1 ml,

  • 93.5±38.7 ml CGuard^TM vs. 55±13 ml Roadsaver^TM (p=0.13)

• Procedural time: 61.0 ± 24.9 min,

  • 66.5±28.0 min CGuard^TM  vs. 41.3±4.8 min Roadsaver^TM  (p=0.04)

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• Technical success (i.e. CAS procedure achieving <30% residual stenosis): 100%

• No major complications (any TIA / stroke / death up to 6 months post-procedure)

• Incidence of Stent Malapposition and Plaque prolapse

  • Stent Malposition:
    • 20.5% CGuard^TM vs. 26.8% Roadsaver^TM, (p=0.26)
  • Plaque prolapse:
    • 10.8% CGuard^TM vs. 20.7% Roadsaver^TM (p=0.05)

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• A small number of patients (unequal groups)
• Stent selection depended on the physician's discretion
• Although DW-MRI imaging at 30 days would be the final demonstrator of the relevance of OCT-detected it was not performed

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This work indicates that dual-layer micromesh stents may show differences in Stent Malposition and Plaque prolapse. The effect of stent design and implantation technique on OCT findings post CAS, and their relation to long-term clinical outcomes, however, require more meticulous evaluation.

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