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Published on: September 20, 2020
Radial Versus Femoral Access for Carotid Artery Stenting in Patients With Carotid Artery Stenosis: Protocol of the
Rui Liu1,2, Kang Yuan2, Xuehan Liu1
1Division of Life Sciences and Medicine, Department of Neurology, The First Affiliated Hospital of University of Science and Technology of China (USTC), USTC, Hefei (R.L., Xuehan Liu, W.S., Xinfeng Liu).
Background:
Carotid artery stenting (CAS) is conventionally performed via transfemoral access (TFA), which requires prolonged postoperative immobilization and is associated with access-site complications. Transradial access (TRA) has emerged as an alternative to TFA for suitable vessel caliber and improved patient comfort. However, high-quality evidence directly comparing TRA and TFA for CAS in patients with carotid artery stenosis is still lacking. This trial aims to determine whether TRA is noninferior to TFA in patients treated with CAS due to carotid artery stenosis.
Methods:
The RACE-CAS (Radial Versus Femoral Access for Carotid Artery Stenting in Patients With Carotid-Artery Stenosis) is a prospective, randomized, open-label, blinded-end point, multicenter trial. Up to 3000 patients with carotid artery stenosis will be randomly assigned in a 1:1 ratio to receive CAS treatment via either TRA or TFA across 70 centers in China.
Results:
The primary end point is the incidence of death, new-onset stroke, myocardial infarction, or severe hemorrhage events within 30 days post-procedure, analyzed in the full analysis set using risk differences with 2-sided 95% CIs for noninferiority testing. Key secondary outcomes include the successful rate of CAS and angiography, patient comfort, and each individual component of the primary end point within 48 hours or 30 days post-procedure. Safety outcomes include all adverse events and severe adverse events. The RACE-CAS trial enrolled its first patient on July 3, 2022, and recruitment is ongoing. At the time of manuscript submission, the sample size required for the first planned interim analysis had been completed.
Conclusions:
The RACE-CAS trial will provide definitive, high-level evidence on the comparative efficacy and safety of TRA versus TFA for carotid artery stenting in patients with carotid artery stenosis, with the goal of guiding clinical practice.
Registration:
URL: https://www.clinicaltrials.gov; Unique identifier: NCT05416853.
