Carotid Stenting in Patients With High Risk Versus Standard Risk for Open Carotid Endarterectomy (REAL-1 Trial)

Area of Science:

• Vascular Surgery
• Interventional Cardiology
• Medical Devices

Background:

• Carotid stenting (CAS) is typically reserved for high-risk patients undergoing carotid endarterectomy.
• Recent studies question the strict definition of
• high-risk
• criteria for CAS indication.

Purpose of the Study:

• To evaluate the safety and effectiveness of CAS with a proximal protection device (MOMA) in patients with significant carotid artery stenosis.
• To compare outcomes between "high-risk" and "standard-risk" patients undergoing CAS.

Main Methods:

• Nonrandomized, double-arm registry study (REAL-1 trial) including 125 patients.
• Patients were categorized into "standard-risk" (n=71) and "high-risk" (n=54) groups.
• Primary endpoint: composite of major adverse events (stroke, myocardial infarction, death) within 30 days, and ipsilateral stroke up to 4 years.

Main Results:

• No significant difference in the 30-day primary endpoint rate between standard-risk (1.4%) and high-risk (1.9%) groups.
• No significant difference in the estimated 4-year rate of ipsilateral stroke between standard-risk (1.3%) and high-risk (1.8%) groups.
• Hazard ratio for standard risk was 1.1 (95% CI 0.8 to 1.2, p=0.77) at 30 days and 1.05 (95% CI 0.86 to 1.14, p=0.9) at 4 years.

Conclusions:

• CAS with the MOMA proximal device is safe and effective for patients with and without high-risk criteria for carotid endarterectomy.
• Four-year follow-up data support the use of CAS in a broader patient population.
• The study challenges traditional indications for CAS based on surgical risk stratification.