Abstract
OBJECTIVE: To evaluate the real-world safety and efficacy for standard surgical risk patients with extracranial internal carotid artery disease undergoing transcarotid artery revascularization.
METHODS: ROADSTER 3 is a prospective, multicenter, single-arm post-approval study. Patients <80 years old without anatomic or physiologic high-risk factors were included. Thirty-day incidence of major adverse events (stroke, death, or myocardial infarction) and cranial nerve injury were assessed. An independent clinical events committee adjudicated events, and independent certified health care personnel performed neurological assessments.
RESULTS: Between 2022 and 2024, 344 patients (intent to treat population) were enrolled at 48 sites in the United States. Because of 24 major protocol deviations, 320 patients remained in the Food and Drug Administration's analysis population (per protocol). In the per protocol population, there were 136 (42.5%) females and 49 (15.3%) symptomatic patients. Among symptomatic patients, 12 (24.5%) were treated within 2 weeks of the prior event. Technical success was 100%. For the entire study population, there were strokes in 3 patients with no instances of death or myocardial infarction. The 2 instances of cranial nerve injury (0.6%; 95% CI, 0.1-2.2% in the per protocol population) both resolved within 6 months. The composite 30-day stroke/death/myocardial infarction rate was 0.6% (95% CI, 0.1-2.2%) for the per protocol population and 0.9% (95% CI, 0.2-2.5%) for the intent to treat population.
INTERPRETATION: The 30-day results of the ROADSTER 3 study confirm that transcarotid artery revascularization is safe and effective in the standard-risk population. Longer-term follow-up is pending to confirm durable stroke prevention for these patients. ANN NEUROL 2026;99:705-712.