Kahlberg et al.

Featured products: Roadsaver™ Carotid Artery Stent

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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.

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• 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 Roadsaver™
  • 88 patient patients treated with 1st-generations stents (Precise Pro Rx™, Xact, Carotid Wallstent™ & Cristallo Ideale™)
  • 15 patients treated with CGuard™

• 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.)

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• 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

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• No death, stroke or myocardial infarction in patients treated with the Roadsaver™ stent
• No significant differences in primary endpoint (stroke/TIA/death)

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(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 Roadsaver™ 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 Roadsaver™ dual layer vs single layer group, (p=0.51

• Roadsaver™ 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

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• 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 Roadsaver™ 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

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