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ROADSTER 2

One-year outcomes after transcarotid artery revascularization (TCAR) in the ROADSTER 2 trial

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Year of Publication: 2022

Authors: Vikram S. Kashyap, Kristine L. So, Peter A. Schneider, ..., James G. Melton

Journal: Journal of Vascular Surgery

Citation: J Vasc Surg 2022;76:466-73

Link: https://doi.org/10.1016/j.jvs.2022.03.872

PDF: https://www.jvascsurg.org/action/showPdf...%2822%2901366-0

Clinical Question

What are the 1-year safety and efficacy outcomes of transcarotid artery revascularization (TCAR) using the ENROUTE Transcarotid Stent System in high-risk patients?

Bottom Line

TCAR with the ENROUTE system demonstrates excellent 1-year safety with 0% ipsilateral stroke rate and low mortality (2.6%) in high-risk patients, supporting its use as a safe alternative to CEA in this population.

Major Points

  • ROADSTER 2 LTFU was a prospective, open-label, single-arm, multicenter post-approval registry
  • 155 patients from 21 centers with 1-year follow-up (subset of 632 total ROADSTER 2 enrollment)
  • 77% asymptomatic, 23% symptomatic patients, all high-risk for CEA
  • Primary endpoint: 0% ipsilateral stroke at 1 year (0/155 patients)
  • Overall mortality: 2.6% (4/155), all from non-neurological causes
  • Technical success rate: 98.7%
  • Cranial nerve injury rate: 1.3% (2/155)
  • No perioperative myocardial infarctions occurred
  • Composite stroke/death rate: 2.6%
  • Results demonstrate superior outcomes compared to transfemoral carotid stenting trials

Design

Study Type: Prospective, open-label, single-arm, multicenter, post-approval registry

Randomization:

Blinding: Open-label, no blinding

Enrollment Period: June 2016 - November 2018

Follow-up Duration: 1 year (365 days)

Centers: 21

Countries: United States, European Union

Sample Size: 155

Analysis: Per-protocol analysis with descriptive statistics and Fisher exact test for categorical variables

Inclusion Criteria

  • Participation in ROADSTER 2 parent trial
  • High risk for CEA complications
  • Completion of 30-day follow-up visit
  • Consent for 1-year clinical follow-up visit
  • Age >18 years
  • Treatment with ENROUTE Transcarotid Stent and Neuroprotection System

Exclusion Criteria

  • Major protocol deviations in parent trial
  • Inclusion/exclusion criteria violations
  • Medication noncompliance
  • Failure to complete required follow-up visits

Baseline Characteristics

CharacteristicControlActive
Total Patients155
Male70%
Female30%
Caucasian89%
Age ≥8023%
Hypertension89%
Hyperlipidemia82%
Diabetes32%
Smoking History73%
Previous MI17%
Symptomatic23%
Asymptomatic77%
Anatomic High-Risk Only43%
Physiologic High-Risk Only32%
Both Anatomic and Physiologic25%
High Lesion Location26%
Age ≥75 years44%

Arms

FieldTCAR with ENROUTE System
InterventionTranscarotid artery revascularization using ENROUTE Transcarotid Stent and Neuroprotection System with dynamic flow reversal
DurationSingle procedure with 1-year follow-up

Outcomes

OutcomeTypeControlInterventionHR / OR / RRP-value
Incidence of ipsilateral stroke at 1 year after treatmentPrimary0% (0/155)
Death at 1 yearSecondary2.6% (4/155)
Neurological deathSecondary0% (0/155)
Non-neurological deathSecondary2.6% (4/155)
Composite stroke/deathSecondary2.6% (4/155)
Technical successSecondary98.7% (153/155)
Perioperative myocardial infarctionSecondary0% (0/155)
Cranial nerve injuryAdverse1.3% (2/155)
Device-related adverse eventsAdverse1.3% (2/155 - carotid artery dissections)

Subgroup Analysis

Symptomatic patients: 1 death (2.8%), 0 strokes. Asymptomatic patients: 3 deaths (2.5%), 0 strokes. All deaths were non-neurological.

Criticisms

  • Single-arm design without randomized control group
  • Subset analysis of larger parent trial (155 of 632 patients)
  • Potential selection bias - only patients consenting to long-term follow-up included
  • 11 patients excluded due to protocol deviations
  • Limited follow-up duration (1 year)
  • Investigators had prior TCAR experience, limiting generalizability to learning curve
  • No comparison to CEA in same time period

Funding

Funded by Silk Road Medical Inc

Based on: ROADSTER 2 (Journal of Vascular Surgery, 2022)

Authors: Vikram S. Kashyap, Kristine L. So, Peter A. Schneider, ..., James G. Melton

Citation: J Vasc Surg 2022;76:466-73

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