Remote ischemic conditioning plus stenting for symptomatic carotid artery stenosis (RICSICAS): rationale and design.

BACKGROUND

Remote ischemic conditioning (RIC) has emerged as a promising non-invasive strategy to protect the brain, with evidence suggesting its benefit in patients with carotid artery stenting (CAS). However, the long-term benefit and safety of chronic RIC in this population remain unknown.

OBJECTIVE

To evaluate whether chronic RIC reduces the incidence of major vascular events in high-risk patients with carotid artery stenosis who received CAS.

METHODS

RICSICAS is a prospective, randomized, open-label, blinded endpoint evaluation (PROBE), single-center trial. We plan to enroll 450 high-risk patients with symptomatic carotid artery stenosis (Essen score ≥ 3) scheduled for CAS. Participants will be randomly assigned (1:1) to receive either standard medical therapy plus RIC or standard medical therapy alone. The RIC protocol involves bilateral upper-arm cuff inflation to 200 mmHg (5-min inflation/5-min deflation, 5 cycles) performed 1-2 times daily, starting 3 days before CAS and continuing for 12 months post-procedure, thus constituting a combined peri-procedural and chronic RIC strategy. The primary efficacy endpoint is the composite of stroke, myocardial infarction, TIA, and vascular death within 12 months. Safety endpoints include any RIC-related adverse event (e.g., limb pain, petechiae, peripheral nerve injury), and any serious adverse event.

SAMPLE SIZE: Assuming a 12-month event rate of 20% in the control group and a 40% relative risk reduction with RIC, with 80% power and a two-sided α of 0.05, 355 patients are required. Accounting for a 20% dropout rate/loss-to-follow-up, as well as the consumption of the interim analysis, the total sample size is set as 450.

DISCUSSION: This trial will provide high-level evidence on the role of long-term RIC as an adjunctive therapy for high-risk patients with symptomatic carotid artery stenosis undergoing CAS.

CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, identifier: NCT07412249.