Bosiers  et al. EuroIntervention 2016

Featured product: Roadsaver™ Carotid Artery Stent

August 5, 2016

neutrals-100

To evaluate the clinical outcomes of carotid artery stenting (CAS) using the 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 30-day results.

neutrals-100

• 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, 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 National Institute of Stroke Scale (NIHSS))
  • Physical examination and Concomitant medication registration

neutrals-100

• The CAS procedure was performed according to the physician’s standard of care.
• The recommended concomitant medication during 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)

neutrals-100

• Successful stent implantation: 100/100

  • Mean diameter stenosis (pre-procedure): 85 ± 8 % (range 55-99%)
  • Mean (residual) diameter stenosis (post-procedure): 5 ± 7 % (range 0-40%)

• 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 fibrilation

• No notable differences in the 30-day MAE rate between symptomatic and asymptomatic patients, nor with or without EPD use.

• At 30-day DUS no restenosis (>50%) within the implanted dual-layer micromesh Roadsaver^TM carotid stent

  • No primary patency loss
  • No target lesion revascularization

neutrals-100

The 30-day 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 as a valid treatment alternative in both symptomatic and asymptomatic patients.

neutrals-100