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Carotid artery stenting with a new-generation double-mesh stent in three high-volume Italian centres: clinical results of a multidisciplinary approach

Nerla  et al.

Featured product: Roadsaver™ Carotid Artery Stent

11/7/2022 -  

​Objective

The aim of this study was to assess the outcomes of carotid artery stenting (CAS) using dual-layer micromesh RoadsaverTM stent in a large real-world patient population. The present manuscript reports the 30-day results. 


Study Group

  • Prospective, Single-arm, Multi-center
  • 3 High-volume Italian centers 
    • Enrollment 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 substudy (n=26) with an independent Core Lab assessment 
  • All patients underwent DUS and an independent neurological evaluation at 24h and 30 days 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 inidications for RoadsaverTM 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%)


Results 

  • The final angiographic result was good in all patients, including those with ICA tortuosity. 
    • Mean diameter stenosis (pre-procedure): 81 ± 8 %
    • Mean (residual) diameter stenosis (post-procedure): 12 ± 5 %
  • No cerebrovascular event occurred during the procedure
  • No access-site vascular complications were reported. 
  • No patients had evidence of plaque prolapse at angiography
    • Mild plaque prolapse detected by OCT: 2/26 (7.7%)
  • No cerebrovascular events at 30 days
  • No In-Stent Restenosis (ISR) at 30 days
  • External carotid artery (ECA) patent: 100% at 30 days


Conclusion

  • The RoadsaverTM stent is safe and can be deployed easily in a wide variety of anatomies and lesions by expert operators performing CAS in high-volume centers. 
  • Plaque prolapse, as assessed by angiography and complementary OCT evaluation in a subset of patients, is relatively low with the dual-layer micromesh RoadsaverTM carotid stent. 
  • 30-day clinical outcomes are good after Roadsaver stenting with neuroprotection.

Link to the full publication: https://doi.org/10.4244/eijv12i5a109