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Optical coherence tomography assessment of new-generation mesh-covered stents after carotid stenting.

Umemoto  et al.

Featured product: Roadsaver™ Carotid Artery Stent

9/11/2022 -  

​Objective

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 (RoadsaverTM  and CGuardTM)



Study Group

  • 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 RoadsaverTM ) 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.     


Methods

  • Embolic protection devices (EPD) use: 100% 
    • 56.3 % Proximal (Mo.Ma™ Ultra), 
      • 9 CGuardTM  (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 CGuardTM (36%) / 0 RoadsaverTM 
  • Nominal stent length: 32.4±6.2 mm,  
    • 35±5.2 mm CGuardTM  vs. 27.5±2.9 mm RoadsaverTM (p=0.02)
  • Postdilatation: 100%
  • Contrast volume: 82.8±34.1 ml, 
    • 93.5±38.7 ml CGuardTM vs. 55±13 ml RoadsaverTM (p=0.13)
  • Procedural time: 61.0 ± 24.9 min, 
    • 66.5±28.0 min CGuardTM  vs. 41.3±4.8 min RoadsaverTM  (p=0.04)


Results

  • 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% CGuardTM vs. 26.8% RoadsaverTM, (p=0.26)
    • Plaque prolapse: 
      • 10.8% CGuardTM vs. 20.7% RoadsaverTM (p=0.05)


Limitations

  • 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 


Conclusion

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.


Link to the full publication: https://doi.org/10.4244/eij-d-18-00230