Objective
To evaluate the clinical outcomes of carotid artery stenting (CAS) using the dual-layer micromesh RoadsaverTM 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.
Study Group
- 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
Methods
- 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)
Results
- 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 RoadsaverTM carotid stent
- No primary patency loss
- No target lesion revascularization
Conclusion
The 30-day outcomes show that the RoadsaverTM 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.
