Sonolysis during carotid endarterectomy: randomised controlled trial.

Area of Science:

• Neurology
• Vascular Surgery
• Medical Ultrasound

Background:

• Carotid endarterectomy (CEA) is a procedure to remove plaque from carotid arteries.
• Cerebrovascular events remain a risk following CEA.
• Novel therapeutic approaches are needed to improve CEA outcomes.

Purpose of the Study:

• To assess the efficacy and safety of sonolysis during CEA.
• To evaluate the impact of sonolysis on cerebrovascular events and brain lesions.

Main Methods:

• A multicentre, phase 3, double-blind, randomized controlled trial.
• 1004 patients undergoing CEA were randomized to sonolysis or sham procedure.
• Primary endpoint: composite of stroke, TIA, and death within 30 days.

Main Results:

• Sonolysis significantly reduced the primary endpoint (2.2% vs 7.6%, P<0.001).
• Reduced incidence of new ischemic lesions on MRI (8.5% vs 17.4%, P=0.004).
• Sonolysis demonstrated a favorable safety profile with 94.4% of patients free from serious adverse events.

Conclusions:

• Sonolysis is a safe and effective adjunct to CEA.
• Ultrasound therapy significantly lowers the risk of stroke, TIA, and death post-CEA.