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Mesh-covered (RoadsaverTM) stent as a new treatment modality for symptomatic or high-risk carotid stenosis

Machnik  et al.

Featured product: Roadsaver™ Carotid Artery Stent

9/11/2022 -  

​Objective

To assess the 30-day safety and effectiveness of the dual-layer micromesh RoadsaverTM stent in symptomatic or high-risk carotid artery stenosis treatment.


Study Group

  • Retrospective, Single-arm, Single-centre (High-volume Polish centre)
  • 41 non-consecutive CAS procedures (31 men & 9 women (67.8 ± 7.9) with >50% carotid artery stenosis
    • 21 Symptomatic (51.2%): 18 ipsilateral-stroke (44%), 1 ipsilateral TIA (2.4%), 2 ipsilateral amaurosis fugax (4.8%) within 6 months of the procedure
    • 20 Asymptomatic (high-risk) (48.7%)
  • One patient with severe, bilateral ICA stenosis underwent a sequential CAS procedure of both ICA. 


Methods

  • Carotid stenosis grade was assessed on carotid DUS and subsequently verified by quantitative carotid angiography (QCA) just before CAS.
  • All patients on DAPT (aspirin 75 mg and clopidogrel 75 mg daily for at least 3 days before the procedure or loading doses of 300 mg of aspirin and clopidogrel the day before the procedure). 
  • During CAS unfractionated heparin (100 IU/kg) was used.
  • Embolic protection device (EPD) use: 
    • 27 Proximal (66%) 
    • 14 distal (34%)
  • Direct stenting: 24 (58.5%) cases
  • Predilatation 17 (41.4%) cases
  • Postdilatation all (100%) cases 
  • Patients were discharged 1–2 days after the procedure with the recommendation to take aspirin indefinitely and clopidogrel 75 mg for 3 months. 
    • In 4 patients with atrial fibrillation, vitamin K antagonists were continued after CAS.

Results

  • Successful implantation: 100%
  • Carotid stenosis was reduced from 82.9 ± 9.1% (61-97%) to 19.3 ± 7.3% (0-33%) (p < 0.05) 
  • Mean fluoroscopy time was 9.8 ± 1.1 (8.1–11.7) min
  • Mean procedure time: 
    • With proximal EPD: 26 ± 6 (18–32) min
    • With distal EPD: 25 ± 2 (17–30) min
  • 1 minor stroke before stent deployment 
  • 1 ipsilateral transient ischemic attack (TIA)
  • DUS at 24-48h post-procedure 
    • PSV: 1.1 ±0.4 m/s (0.5–2.1 m/s) vs 3.9 ±1.0 m/s (range: 2.0–7.0 m/s) pre-procedure (p < 0.05)
    • EDV: 0.3 ±0.1 m/s (range: 0.17–0.6) vs 1.4 ±0.5 m/s (range: 0.85–3.5 m/s) pre-procedure (p < 0.05)
  • DUS at 30 days post-procedure 
    • PSV: 1.1 ±0.3 m/s (range: 0.7–2.7 m/s)  vs 3.9 ±1.0 m/s (range: 2.0–7.0 m/s) pre-procedure (p < 0.05)
    • EDV: 0.4 ±0.1 m/s (range: 0.2–0.6) vs 1.4 ±0.5 m/s (range: 0.85–3.5 m/s) pre-procedure (p < 0.05)
  • No stent thrombosis or significant In-Stent Restenosis occurred for up to 30 days. 


Conclusion

CAS with the dual-layer micromesh RoadsaverTM stent appears safe and effective. Additional prospective studies with larger patient populations and longer-term follow up are needed to confirm these promising findings.


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