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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: http://dx.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?

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, binomial test for primary endpoint, 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
Evolving stroke, spontaneous ICH <12 months, recent stroke <7 days
TIA or amaurosis fugax <48 hours
Bleeding disorders, life expectancy <12 months
Previous stent in target vessel, CCA/ICA occlusion
Previous intervention ipsilateral proximal CCA
CCA disease at entry site
<5 cm clavicle to bifurcation
Contralateral cranial 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 historical controls from other studies
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)