​Objective

The aim of this study was to assess the outcomes of carotid artery stenting (CAS) using dual-layer micromesh Roadsaver^TM stent in a large real-world patient population. The present manuscript reports the 12-month results. 

Study Group 

• Prospective, Single-arm, Multi-center
  
• 3 High-volume Italian centers 
  
• Enrolment between October 2014 - October 2015
• 150 consecutive patients (Mean age: 74 ± 8; 113 males )
• 29% symptomatic cases (≥50% stenosis via duplex ultrasound (DUS) with ipsilateral neurological symptoms (i.e. transient ischemic attack (TIA) and/or stroke within the previous 6 months)
• 71% asymptomatic cases (≥80% stenosis via duplex ultrasound (DUS) without ipsilateral neurological symptoms within the previous 6 months)
• The main exclusion criteria: (i) carotid obstruction or the presence of endoluminal thrombus, (ii) previous stenting in the same site, (iii) acute stroke within <30 days, (iv)myocardial infarction within 72 h, (v) intracranial hemorrhage in the last 12 months, (vi) bleeding or coagulative disorder and (vii) contraindication to antiplatelet therapy.
• Optical coherence tomography (OCT) imaging sub-study (n=26) with an independent Core Lab assessment 
• All patients underwent DUS evaluation at 24h, 30 days, 6- and 12 months post-procedure

Methods

• A “soft” plaque at baseline DUS assessment and/or a high-risk carotid plaque (symptomatic patient or angiographic evidence of complicated plaque) were indications for Roadsaver^TM implantation. A tailored approach to each patient’s lesion and anatomy was used in every center.
• All patients were on Dual Antiplatelet Therapy (DAPT; Aspirin 100 mg and Clopidogrel 75 mg/day) 3 days before and a minimum until 4 weeks after the procedure
• CAS was performed in a wide range of anatomic aortic arch variants 
• Type III: 11%
• Bovine: 21% 
• Severe vessel tortuosity was noted in 16/150 (11%), severe calcification in 13/150 (9%), plaque ulceration in 13/150 (9%), and dissection in 4/150 (3)
• Procedural success: 150/150 (100%) 
• Defined as successful stenting achieving residual stenosis of less than 20% by visual estimation.
• Access: Femoral: 140/150 (93%) / Radial: 9/150 (7%) (+1 Brachial)
  
• Pre-dilatation: 11/150 (7%) 
• Post-dilatation: 150/150 (100%) 
• Embolic protection device (EPD) use: 150/150
• Proximal EPD:  62/150 (41%)
• Proximal neuroprotection was preferred with symptomatic lesions
• Distal EPD: 88/150 (59%)

Results

• No cerebrovascular events at 12 months
• 3 asymptomatic In-Stent Restenosis (ISR) at 12 months (as per DUS: peak systolic velocity (PSV) >250 cm/s)
• 1 left on best medical therapy and 2 treated (1 with angioplasty (drug-coated balloon) and 1 with a stent) at the physician’s discretion.  
• 12-month target lesion revascularization  rate 2/150 (1.3%)
  
• External Carotid Artery (ECA) patent: 100% at 12 months       
• 3 deaths  (2%) at 12 months  (procedure-unrelated)

Conclusion

• The study notes favourable 12-month clinical outcomes with no cerebrovascular events reported.
• All deaths (n=3) not related to the stenting procedure
• ISR incidence seems comparable to rates detected with other stents, although no definite answer can be inferred due to the non-randomized study character.
• The dual-layer micromesh Roadsaver^TM carotid stent is a safe and efficient carotid stent with good 12-month treatment efficacy in terms of ipsilateral stroke prevention and low ISR.