Bosiers et al. EuroIntervention 2018

Featured product: Roadsaver™ Carotid Artery Stent

November 20, 2018

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To evaluate the clinical outcomes of carotid artery stenting (CAS) using dual-layer micromesh Roadsaver^TM stent in patients at high risk for carotid endarterectomy (CEA) presenting lesions with significant stenosis with or without neurological symptoms. The present manuscript reports the 12-month results.

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• Prospective, Single-arm, Multi-centre, Multi-national, Investigator-initiated study

• 9 centers  (Belgium (N=3), Italy (N=1) & Germany (N=5))

  • Enrolment between July 2015 and February 2016

• 100 non-consecutive patients (Mean age: 73 ± 10 range: 48-89; 70 males)

  • 31 symptomatic cases (≥50% stenosis via angiography with neurological symptoms (i.e. transient ischemic attack (TIA) and/or (minor) stroke within 30 days before enrolment)
  • 69 asymptomatic cases (≥80% stenosis via angiography without neurological symptoms)

• 30-day, 6- and 12-month follow-up visits were predefined for:

  • Adverse event recording
  • Carotid duplex ultrasound (DUS) assessment
  • Independent neurological assessment by a certified physician (as per NIH Stroke Scale)
  • Physical examination and Concomitant medication registration

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• The CAS procedure was performed according to the physician’s standard of care.

• The recommended concomitant medication during the hospital stay and follow-up was as follows:

  • Aspirin 75-300 mg daily lifelong
  • Clopidogrel 75 mg daily for one month

• The use of embolic protection devices (EPDs) was not mandatory

  • EPD: 58/100

• Predilatation: 21/100

• Post-dilatation: 94/100

• Mean procedural time was 39 ± 12 minutes (range 18-72)

• Mean fluoroscopy time: 9 ± 5 minutes (range 0.3-38)

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• Successful stent implantation: 100/100

• The 30-day Major Adverse Event (MAE) rate was 2.1%

  • 1 patient experienced MI followed by death
  • 1 patient experienced a stroke within the first 14 days post-procedure due to inadequately medicated atrial fibrillation

• Between days 31-365 post-procedure:

  • 3 more patients experienced an ipsilateral stroke (all on DAPT for only a month and at the time of stroke on aspirin)

• At 12 months

  • 95.8 % of all patients were free of ipsilateral stroke

• At 12 months as per the DUS examination and NASCET guidelines

  • 92.5% of patients were free from patency loss (>50% In-Stent Restenosis (ISR))
  • 97.9% of patients were free from target lesion revascularization (TLR)

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The 12-month outcomes show that the Roadsaver^TM stent is a safe and effective device for endovascular treatment of subjects at high risk for CEA and may be considered a valid treatment alternative in both symptomatic and asymptomatic patients.

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