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ROADSTER

Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure

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Year of Publication: 2015

Authors: Christopher J. Kwolek, Michael R. Jaff, J. Ignacio Leal, ..., Richard P. Cambria

Journal: Journal of Vascular Surgery

Citation: J Vasc Surg 2015;62:1227-35

Link: https://doi.org/10.1016/j.jvs.2015.04.460

PDF: https://www.jvascsurg.org/action/showPdf...%2815%2901147-7

Clinical Question

What is the safety and efficacy of ENROUTE Transcarotid NPS that provides direct surgical common carotid access and cerebral embolic protection via high-rate flow reversal during carotid artery stenting in high-risk patients?

Study Overview

Objective

Transcarotid carotid artery stenting with dynamic flow reversal in high-risk patients.

Study Summary

ROADSTER demonstrated excellent safety and efficacy for transcarotid carotid stenting with flow reversal in patients at high risk for CEA.

Intervention

ENROUTE Transcarotid Neuroprotection System providing direct surgical common carotid access and cerebral embolic protection via high-rate flow reversal during carotid artery stenting vs. standard medical care.

Patients per Arm

141 patients in the pivotal cohort (208 total including lead-in)

Bottom Line

Transcarotid carotid artery stenting with dynamic flow reversal using the ENROUTE system is safe and effective in high-risk patients, achieving the lowest stroke rate (1.4%) reported for any prospective multicenter CAS trial.

        Major Points
        ROADSTER was a prospective, single-arm, multicenter trial evaluating transcarotid CAS with flow reversal
208 patients enrolled at 18 sites; 141 in pivotal cohort, 67 in lead-in phase
26% were symptomatic, 75% were asymptomatic patients at high risk for CEA
Primary endpoint (stroke, death, MI at 30 days) occurred in 3.5% (5/141 patients)
Stroke rate was 1.4% (2/141) - lowest reported for any prospective CAS trial
Stroke and death rate was 2.8% (4/141)
Technical and device success rates were 99%
One cranial nerve injury (0.7%) with complete resolution at 6 months
Mean procedure time was 73.6 minutes
Flow reversal technique avoids aortic arch manipulation

      

Design

Study Type: Prospective, single-arm, multicenter clinical trial

Randomization:

Blinding: Open-label design, no blinding described

Enrollment Period: November 2012 - July 2014

Follow-up Duration: 30 days primary, extended follow-up for complications

Centers: 18

Countries: United States, Spain

Sample Size: 141

Analysis: Intention-to-treat analysis, two-sided binomial test for primary endpoint vs prespecified 11% OPC from CREATE, 95% confidence intervals

Inclusion Criteria

High risk for CEA complications
Asymptomatic stenosis ≥70% or symptomatic stenosis ≥50%
Stenosis confirmed by duplex ultrasound, MRA, CTA, or catheter angiography
Physiologic high-risk criteria (age ≥75, coronary disease, COPD, renal insufficiency, etc.)
Anatomic high-risk criteria (contralateral occlusion, high cervical lesion, hostile neck, restenosis post-CEA)
CCA length from clavicle to bifurcation ≥5 cm
CCA diameter ≥6 mm

Exclusion Criteria

Cardiac emboli, atrial fibrillation, MI <72 hours
Recently implanted heart valve; major surgery ≤30 days pre/postprocedure
Evolving stroke, spontaneous ICH <12 months, recent stroke <7 days, TIA or amaurosis fugax <48 hours, severe dementia, other neurologic disorders
Bleeding disorders
Life expectancy <12 months
Previous stent in target vessel, CCA/ICA occlusion or string sign
Ipsilateral intracranial or extracranial stenosis
Severe ostial lesion
Previous intervention ipsilateral proximal CCA
CCA disease at entry site
<5 cm clavicle to bifurcation
CCA <6 mm diameter
Contralateral recurrent laryngeal or vagus nerve injury

Baseline Characteristics

Characteristic	Control	Active
Mean Age		72.9 ± 9 years
Age ≥75		47%
Age ≥80		27.7%
Male		65%
Female		35%
Diabetes		36.9%
Hyperlipidemia		77.3%
Hypertension		86.5%
Coronary Artery Disease		41.8%
Peripheral Vascular Disease		29.1%
Current Smoker		22.7%
Symptomatic		25.5%
Asymptomatic		74.5%
Target Lesion Stenosis		85.9% ± 8.7%
Target Lesion Length		17.8 ± 12.51 mm
Distance Clavicle to Bifurcation		6.7 ± 1.21 cm

Arms

Field	Transcarotid Stenting Group
Intervention	ENROUTE Transcarotid Neuroprotection System with FDA-approved carotid stent, direct surgical CCA access, dynamic flow reversal for embolic protection
Duration	Single procedure

Outcomes

Outcome	Type	Intervention	P-value
Composite of all stroke, myocardial infarction, and death at 30 days	Primary	3.5% (5/141)	0.0047
All stroke at 30 days	Secondary	1.4% (2/141)
Stroke and death at 30 days	Secondary	2.8% (4/141)
Death at 30 days	Secondary	1.4% (2/141)
Myocardial infarction at 30 days	Secondary	0.7% (1/141)
Acute device success	Secondary	99% (140/141)
Technical success	Secondary	99% (140/141)
Procedural success	Secondary	96% (135/141)
Cranial nerve injury	Adverse	0.7% (1/141)
Arterial dissection requiring treatment	Adverse	2.1% (3/141)
Serious wound hematoma	Adverse	0.7% (1/141)
Limited surgical wound hematomas	Adverse	3.5% (5/141)

Subgroup Analysis

No strokes occurred in 36 symptomatic patients. Two minor strokes in 105 asymptomatic patients (1.9%). No strokes in patients aged ≥75 years.

Criticisms

Single-arm design without randomized control group
Comparison to prespecified 11% OPC from CREATE rather than concurrent CEA or TF CAS control
Relatively small sample size for rare event analysis
Limited follow-up duration (30 days primary endpoint)
Learning curve effects possible given lead-in phase design
Potential selection bias in high-risk patient population

Funding

Sponsored by Silk Road Medical, Inc., Sunnyvale, Calif

Based on: ROADSTER (Journal of Vascular Surgery, 2015)