Ierardi et al. Vascular and Interventional Radiology 2019

Featured product: Roadsaver™ Carotid Artery Stent

March 02, 2019

neutrals-100

To assess ISR rate in patients treated with the Roadsaver^TM dual-layer micromesh stent.

neutrals-100

• 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)

neutrals-100

• 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.

neutrals-100

• 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

neutrals-100

Roadsaver^TM 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.

neutrals-100