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ROADSTER 2 Early Outcomes

Early Outcomes in the ROADSTER 2 Study of Transcarotid Artery Revascularization in Patients With Significant Carotid Artery Disease

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Year of Publication: 2020

Authors: Vikram S. Kashyap, Peter A. Schneider, Mazin Foteh, ..., Timothy Oskin

Journal: Stroke

Citation: Stroke. 2020;51:2620–2629

Link: https://doi.org/10.1161/STROKEAHA.120.030550

PDF: https://www.ahajournals.org/doi/epub/10....EAHA.120.030550

Clinical Question

What is the safety and efficacy of transcarotid artery revascularization (TCAR) performed by a broad group of physicians with variable TCAR experience using the ENROUTE Transcarotid Stent and Neuroprotection System?

Bottom Line

TCAR with the ENROUTE system demonstrates excellent early outcomes with high technical success (99.7%) and low stroke (0.6% per-protocol) and death rates (0.2% per-protocol) in high-risk patients, achieved by a majority of operators new to this technology.

Major Points

  • ROADSTER 2 is a prospective, open-label, single-arm, multicenter post-approval registry
  • 692 patients enrolled at 43 sites; 632 in per-protocol analysis
  • 81.2% of operators were TCAR naïve before study initiation
  • 26% had neurological symptoms; all patients had high-risk factors for CEA
  • Technical success: 99.7% in both ITT and per-protocol populations
  • Per-protocol outcomes: 0.6% stroke, 0.2% death, 0.9% MI
  • ITT outcomes: 1.9% stroke, 0.4% death, 0.9% MI
  • Composite 30-day stroke/death rate: 0.8% (per-protocol), 2.3% (ITT)
  • Procedural success rate: 97.9% (per-protocol), 96.5% (ITT)
  • Protocol adherence critical for optimal outcomes

Design

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

Randomization:

Blinding: Open-label design

Enrollment Period: 2015 - 2019

Follow-up Duration: 30 days

Centers: 43

Countries: United States, European Union

Sample Size: 632

Analysis: Intention-to-treat (ITT, n=692) and per-protocol (PP, n=632) populations analyzed using descriptive statistics

Inclusion Criteria

  • High risk for complications from carotid endarterectomy
  • Symptomatic stenosis ≥50% with stroke, TIA, or amaurosis fugax ≤180 days
  • Asymptomatic stenosis ≥80% without neurological symptoms ≤180 days
  • At least one clinical or anatomic high-risk criteria for CEA
  • Age ≥18 years
  • Signed informed consent
  • At least 5 cm of normal CCA below lesion for safe sheath placement

Exclusion Criteria

  • Alternative source of cerebral embolus (atrial fibrillation, heart valve)
  • Intracranial hemorrhage within 12 months
  • Evolving stroke or severe dementia
  • Major cardiovascular surgery within 30 days
  • Myocardial infarction within 72 hours
  • Carotid thrombus, occlusion, or string sign
  • Inflow disease or previous intervention in proximal ipsilateral carotid
  • Severe disease in common carotid artery
  • Entry site <5 cm to bifurcation
  • Open neck stoma

Baseline Characteristics

CharacteristicControlActive
Total ITT Population692 patients
Total Per-Protocol632 patients
Male67.8% (ITT), 67.7% (PP)
Age ≥8021.1% (ITT), 21.2% (PP)
Hypertension90.8% (ITT), 90.3% (PP)
Hyperlipidemia86.3% (ITT), 85.8% (PP)
Diabetes36.0% (ITT), 35.0% (PP)
Smoking History77.7% (ITT), 77.8% (PP)
Previous MI20.8% (ITT), 20.6% (PP)
Neurological Symptoms26.0% (ITT), 26.3% (PP)
TIA/Stroke16.0% (ITT), 16.1% (PP)
Age >75 years42.1% (ITT), 41.8% (PP)
Anatomic Risk Factors Only43.6% (ITT), 43.5% (PP)
Physiologic Risk Factors Only31.8% (ITT), 31.8% (PP)
Both Risk Factors24.6% (ITT), 24.7% (PP)

Arms

FieldTCAR with ENROUTE System
InterventionTranscarotid artery revascularization using ENROUTE Transcarotid Stent and Neuroprotection System with reversal of flow cerebral protection
DurationSingle procedure with 30-day follow-up

Outcomes

OutcomeTypeControlInterventionHR / OR / RRP-value
Procedural success (technical success plus absence of stroke, MI, or death within 30 days)Primary97.9% (PP), 96.5% (ITT)
Technical successSecondary99.7% (both ITT and PP)
Stroke at 30 daysSecondary0.6% (PP), 1.9% (ITT)
Death at 30 daysSecondary0.2% (PP), 0.4% (ITT)
Myocardial infarction at 30 daysSecondary0.9% (both PP and ITT)
Composite stroke/deathSecondary0.8% (PP), 2.3% (ITT)
Composite stroke/death/MISecondary1.7% (PP), 3.2% (ITT)
Cranial nerve injuryAdverse1.3% (PP), 1.4% (ITT)

Subgroup Analysis

Symptomatic patients (PP): 0.6% stroke, 0% death, 0.6% MI. Asymptomatic patients (PP): 0.6% stroke, 0.2% death, 1.1% MI. Protocol adherence crucial for optimal outcomes.

Criticisms

  • Single-arm design without randomized control group
  • 60 patients had major protocol violations (medication non-compliance)
  • Only early 30-day outcomes reported
  • Learning curve effects possible despite training
  • Selection bias inherent in registry design
  • No direct comparison to CEA in same time period
  • Majority of operators were TCAR naïve, limiting generalizability

Funding

Post-approval study was a condition of FDA approval for ENROUTE Stent

Based on: ROADSTER 2 Early Outcomes (Stroke, 2020)

Authors: Vikram S. Kashyap, Peter A. Schneider, Mazin Foteh, ..., Timothy Oskin

Citation: Stroke. 2020;51:2620–2629

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