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Contemporary Results of Carotid Artery Stenting Using Low-Profile Dual-Metal Layer Nitinol Micromesh Stents in Relation to Single-Layer Carotid Stents

Kahlberg et al.

Featured product: Roadsaver™ Carotid Artery Stent

11/21/2022 -  

​Objective

To compare patient characteristics, procedure, perioperative and mid-term results of the carotid artery stenting (CAS) with the dual-layer micromesh RoadsaverTM stent vs single-layer stents.


Study Group

  • Single-center, retrospective, non-randomized study 

  • 200 consecutive patients; n=205 elective CAS procedures performed between April 2015 and December 2018
    • 97 patients treated with RoadsaverTM
    • 88 patient patients treated with 1st-generations stents (Precise Pro RxTM, Xact, Carotid WallstentTM & Cristallo IdealeTM)
    • 15 patients treated with CGuardTM 
  • Primary endpoint: 
    • The occurrence rate of Major Adverse Cerebrovascular Events (MACE; including death, ipsilateral stroke, and TIA)
  • Secondary endpoints:
    • In-Stent Restenosis (ISR) rate
    • Re-intervention rate
    • Adverse cardiovascular events (i.e. including myocardial infarction, arrhythmias, and need for inotropic support.)

  
​
​Roadsaver
N = 100
​Single layer stents
N = 90
Symptomatic stenosis
​35%
​18%
​Asymptomatic stenosis​65%
​82%


Procedure

  • Patients treated with Roadsaver presented more «high-risk»* plaques 

    • Defined as SVS grade 2 (moderate risk) and 3 (severe risk), i.e. multi-fibrous plaque, ulcerated, thin capsule, multiple calcifying stenosis, or lipid / necrotic core
  • Roadsaver patients were more often symptomatic and had more frequently previous brain lesions as detected by pre-procedural CT scan
  • CAS with Roadsaver was performed more frequently through radial access (> 4x) and required less cervical cut-down
  • CAS procedures with Roadsaver were significantly shorter

​
​Roadsaver
N = 100
​Single layer stents
N = 90
​P
​ICA stenosis grade (%)
​75.6±8.0
​75.7±8.1
​0.931
​Peak systolic velocity (cm/s)
​312±119
​327±107
​0.364
​Contralateral ICA stenosis (%)
​40.6±25.5
​42.9±27.7
​0.552
​"High-risk" plaque type
​63 (63%)
​40 (44%)
​0.013
​Symptomatic stenosis
​35 (35%)
​16 (18%)
​0.008
​Reintervention
​41 (41%)
​49 (54%)
​0.080
​Neck irradiation
​19 (19%)
​9 (10%)
​0.101
​Carotid severe tortuosity
​10 (10%)
​4 (4%)
​0.171
​Aortic arch type 2 or 3
​3 (3%)
​2 (2%)
1.0​
​Bovine trunk
​5 (5%)
​2 (2%)
​0.449
​Ipsilaterally positive brain CT-scan
​28 (28%)
​10 (11%)
​0.003



​Roadsaver
N = 100		Single layer stents
N = 90		P
Radial access23 (23%)4 (5%)< 0.001
Cervical surgical access1 (1%)14 (16%)< 0.001
Use of embolic protection devices98 (98%)84 (93%)0.152
Need of predilatation2 (2%)3 (3%)0.669
Number of implanted stents1.1±0.31.1±0.31.0
Stent length (mm)31.0±5.536.8±5.5< 0.01
Stent post-dilatation92 (92%)70 (78%)0.007
Atropine administration16 (16%)12 (13%)0.684
Duration of procedure (min)40.7±16.949.4±27.30.008v


Results

  • No death, stroke or myocardial infarction in patients treated with the RoadsaverTM stent

  • No significant differences in primary endpoint (stroke/TIA/death)

30-day Outcomes 

​Roadsaver
N = 100
Single layer stents
N = 90
P
Length of stay (mean ± SD)2.25± .222.27±1.030.903
Access complications0 (0%)2 (2%)0.223
Cerebral hemorrhage0 (0%)0 (0%)1.0
Inotropic support3 (3%)3 (3%)1.0
Arrhythmias1 (1%)1 (1%)1.0
TIA3 (3%)1 (1%)0.623
Stroke0 (0%)0 (0%)1.0
MI0 (0%)0 (0%)1.0
Death0 (0%)0 (0%)1.0
Any complications6 (6%)6 (7%)1.0
Stroke/TIA/Death3 (3%)1 (1%)0.623


Follow-up 

(22.3 + 13.9 months)

  • No significant differences in primary patency (p=0.95) at 1 year (100% vs 99%) and 3 years (93.4% vs 94.3%), in RoadsaverTM dual layer vs single layer stent group.

  • No significant difference in long term survival (p=0.51) at 1 year (95% vs. 94%) and 3 years (92.6%  vs. 90.1%) in the RoadsaverTM dual layer vs single layer group, (p=0.51
  • RoadsaverTM group
    • 5 In-Stent Restenosis (ISR)
      • 3 asymptomatic (not treated) 
      • 1 ISR resulting in ipsilateral stroke (at 34 months) with a pre-occlusive lesion), 
      • 1 ipsilateral TIA with a calcified plaque and intimal hyperplasia treated by DCB)
    • no stent occlusion
  • Single layer stent group
    • 5 ISR
      • 2 not treated
      • 1 ipsilateral stroke (at 42 months) with intimal hyperplasia
      • 1 asymptomatic post-irradiation ISR with ulcerated plaque and irregular borders which required stenting
      • 1 pt refused reintervention
    • 1 stent occlusion


Conclusion

  • Due to its technical features, operators tend to select Roadsaver for use in high-risk cases (in symptomatic pts, with vulnerable plaques & difficult access) 
  • Despite expected higher rate of complications in these patients, CAS with RoadsaverTM resulted in very good clinical outcomes (early and late) 
  • Roadsaver low-profile and high deliverability allow more frequent use of radial access, avoid cervical surgical cut-down, reduce arch manipulation, and decrease procedural time


Link to the full publication: https://doi.org/10.1177/15266028211025046