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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

Characteristic	Control	Active
Total Patients		155
Male		70%
Female		30%
Caucasian		89%
Age ≥80		23%
Hypertension		89%
Hyperlipidemia		82%
Diabetes		32%
Smoking History		73%
Previous MI		17%
Symptomatic		23%
Asymptomatic		77%
Anatomic High-Risk Only		43%
Physiologic High-Risk Only		32%
Both Anatomic and Physiologic		25%
High Lesion Location		26%
Age ≥75 years		44%

Arms

Field	TCAR with ENROUTE System
Intervention	Transcarotid artery revascularization using ENROUTE Transcarotid Stent and Neuroprotection System with dynamic flow reversal
Duration	Single procedure with 1-year follow-up

Outcomes

Outcome	Type	Intervention
Incidence of ipsilateral stroke at 1 year after treatment	Primary	0% (0/155)
Death at 1 year	Secondary	2.6% (4/155)
Neurological death	Secondary	0% (0/155)
Non-neurological death	Secondary	2.6% (4/155)
Composite stroke/death	Secondary	2.6% (4/155)
Technical success	Secondary	98.7% (153/155)
Perioperative myocardial infarction	Secondary	0% (0/155)
Cranial nerve injury	Adverse	1.3% (2/155)
Device-related adverse events	Adverse	1.3% (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)