Objective
To assess ISR rate in patients treated with the RoadsaverTM dual-layer micromesh stent.
Study Group
- Retrospective, single arm, single center study
- CAS procedures performed between February 2017 and July 2018
- 13 patients (8 Men and 5 women (mean age: 75.8))
- Symptomatic (≥50% by NASCET): 11
- 8 with Ipsilateral TIA or Amaurosis Fugax (within <6 months)
- 3 with ipsilateral strokes (within <6 months))
- Asymptomatic (≥70% by NASCET & suitable for treatment): 2
- 7 lipidic (echoluscent) / 5 heterogenous lesions
- All patients presented at least 1 anatomic and comorbid clinical criteria that potentially increased risk posed by surgery (as per the SAPHIRE study)
- Exclusion criteria
- Carotid obstruction, previous stenting at the same site, acute stroke within last 30 days, myocardial infarction within 72 hours and intracranial hemorrhage within last 12 months.
- Follow up at 12 months
- Neurological examinations of all patients were performed before the intervention, by an independent neurologist using the National Institute of Health Stroke Scale (NIHSS)
- Plaque morphology assessment by Doppler Ultrasound (DUS): categorizing all the plaques into lipidic (echoluscent), fibrotic (echogenic), and those with heterogenous texture (heterogenous plaque)
Methods
- Each patient was on Dual antiplatelet therapy (DAPT; aspirin 100 mg and clopidogrel 75mg daily for at least 3 days before the procedures on loading doses of 300 mg of aspirin and clopidogrel the day before the procedure.
- All patients received 3000 – 5000 units of intravenous heparin after the establishment of endovascular access.
- Neurological examination was performed in all patients.
- Carotid stenosis was revealed by Doppler ultrasound (DUS) and multidetector CT (MDCT) scan.
- 4 patients had a peak systolic velocity (PSV) between 130 and 150 cm/s (50-69% stenosis),
- 6 a PSV between 150 and 180 cm/s (70-79%),
- 3 a PSV > 180 cm/s (≥80% (severe) stenosis).
- EPD was used in 12/13 patients (11 Filter Wire EZ & 1 Spider FX)
- Direct stenting: 11 (84.6%) cases,
- Predilatation: 2 (15.4%) cases
- In all cases postdilatation was performed.
- Stent patency was evaluated at 12-month follow-up.
- Patients were discharged 1-2 days after the procedure with the recommendation to take aspirin indefinitely and clopidogrel 75 mg for 3 months.
Results
- Technical success (<30% residual stenosis): all (100%) cases.
- In 3 patients a nonsignificant residual stenosis <30% has been reported
- No major complications during or after the procedure occurred
- 1 patient (7.7%) showed a transitory bradycardia during angioplasty
- 1 patient (7.7%) showed local bleeding at the puncture site
- All the neurological examinations performed 24 h and 30 days after the procedure were negative
- No significant ISR was registered up to 12 months
- In 2 patients, < 30% ISR was revealed at DUS performed after 6 months and confirmed at 12 months
- In both patients contrast enhanced ultrasound (CEUS) and MDCT denied the presence of significant stenosis
- One of the two patients already had insignificant (<30%) residua stenosis on the post-procedural angiogram
Conclusion
RoadsaverTM stent seems to be durable up to 12 months in terms of freedom from ISR. Further studies with larger populations and longer-term follow up are necessary to confirm these results.
