Nerla et al. EuroIntervention 2018

Featured product: Roadsaver™ Carotid Artery Stent

November 20, 2018

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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.

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• 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

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• 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 Cloidogrel 75 mg/day) 3 days before and 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%) of patients

• Procedural success: 150/150 (100%)

  • Defined as successful stenting under proximal or distal neuroprotection, achieving <20% residual stenosis by visual estimation

• Access:

  • Femoral: 140/150 (93%)
  • Radial access: 9/150 (7%) (+1 Brachial access)

• Pre-dilation: 11/150 (7%)

• Post-dilatation: 150/150 (100%)

• Embolic protection device (EPD) use: 150/150 (100%)

  • Proximal EPD: 62/150 (41%)
    • Proximal neuroprotection was preferred with symptomatic lesions
  • Distal EPD: 88/150 (59%)

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• 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)

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• 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.

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