ABSTRACT NUMBER: ESOC2026LT73 LT73 - RADIAL VERSUS FEMORAL ACCESS FOR CAROTID ARTERY STENTING IN PATIENTS WITH CAROTID-ARTERY STENOSIS: THE RACE-CAS TRIAL.

Abstract Background and aims Carotid artery stenting (CAS) is conventionally performed via transfemoral access (TFA). Transradial access (TRA) has emerged as an alternative to TFA. However, high-quality evidence directly comparing TRA and TFA for CAS in patients with carotid artery stenosis is still lacking. Methods RACE-CAS is a prospective, randomized, open label, blinded-endpoint, noninferiority, multicenter trial conducted across 70 centers in China. Participants will be randomly assigned in a 1:1 ratio to receive CAS treatment via either TRA or TFA. The primary end point is the incidence of death, or new-onset stroke, or myocardial infarction, or severe hemorrhage events within 30 days post-procedure. Assuming a 3% event rate in the control group and a 2% non-inferiority margin, a total of 3000 participants will be enrolled to achieve 80% power at a two-sided significance level of 0.05. Two planned interim analyses using the Pocock alpha-spending function were scheduled at 1/3 and 2/3 of the enrollment. Results From 2022-07-03 to 2025-02-24, 1207 participants are randomized to the TRA and TFA group. In the first interim analysis, the TRA group demonstrated non-inferiority to the TFA for the primary outcome in the full analysis set (1178 participants; risk difference [RD] = -0.48%; 95% confidence interval [CI]: -2.51% to 1.53%; P for non-inferiority = 0.0089) and the per-protocol set (1012 participants; RD = -0.65%; 95% CI = -2.85% to 1.49%; P for non-inferiority = 0.0086). The study successfully met the criteria for interim stopping for efficacy and non-inferiority. Conclusions TRA was non-inferior to TFA for CAS in carotid artery stenosis. (NCT05416853). Conflict of interest Figure 1 - belongs to Conclusions