PDF: ROADSTER 3
(2024)Objective
To evaluate the safety and effectiveness of transcarotid artery revascularization (TCAR) using the Enroute stent and neuroprotection system in standard surgical-risk patients with carotid stenosis.
Study Summary
• Cranial nerve injury occurred in 0.6% of patients, all resolved within 6 months
• Results support TCAR as safe and effective in standard-risk patients
Intervention
Single-arm prospective multicenter postapproval study of TCAR with Enroute transcarotid stent system and neuroprotection system.
Inclusion Criteria
Patients with carotid stenosis at standard surgical risk; 16.3% symptomatic; 75% <75 years old.
Study Design
Arms: Single-arm (TCAR with Enroute TSS + NPS)
Patients per Arm: 344 enrolled (320 per-protocol)
Outcome
• 30-day stroke rate: 0.9% ITT, 0.6% PP
• No deaths or MIs at 30 days
• CNI within 30 days: 0.6%, all resolved by 6 months
Bottom Line
TCAR using the ENROUTE system demonstrated excellent safety with 0.9% stroke/death/MI rate at 30 days and 0.6% cranial nerve injury rate in standard risk patients, representing the lowest reported stroke rate in this population.
Major Points
- First prospective multicenter trial of TCAR in standard surgical risk patients
- Primary endpoint of stroke/death/MI at 30 days was 0.9% (ITT) and 0.6% (PP)
- 30-day stroke rate was 0.9% (ITT) and 0.6% (PP) with no deaths or MIs
- Cranial nerve injury occurred in 0.6% and resolved within 6 months
- Study enrolled 344 ITT patients with 320 treated per-protocol across 53 US sites
- Mean lesion length was 23.3mm with 47.4% having Type II or III aortic arch
- Results demonstrate lowest reported stroke rate in standard surgical risk population
Study Design
- Study Type
- Prospective, multicenter, single-arm, post-approval study
- Randomization
- No
- Blinding
- Not specified
- Sample Size
- 344
- Follow-up
- 30 days (with planned 1-year follow-up)
- Centers
- 53
- Countries
- United States
Primary Outcome
Definition: Composite of major adverse events (stroke, death, or myocardial infarction) through 30 days post-procedure, plus ipsilateral stroke from day 31 to 365 post-procedure
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| 0.9% ITT (3/344), 0.6% PP (2/320) | - |
Limitations & Criticisms
- Single-arm study design without control group
- Short-term follow-up of only 30 days reported
- Post-approval study rather than randomized controlled trial
- Industry-sponsored study with potential bias
- Limited to standard risk patients only
- Conference presentation rather than peer-reviewed publication
Citation
Dermody, M. (2024). Prospective, Multicenter Evaluation of Transcarotid Artery Revascularization (TCAR) in Standard Risk Patients: 30-Day Outcomes of the ROADSTER 3 Study. Presented at VIVA Conference 2024.