Sonolysis Reduces CV Events During Carotid Endarterectomy: Insights from the SONOBIRDIE Trial

The incidence of new ischaemic lesions on follow-up brain magnetic resonance imaging was the main substudy endpoint, and incidence of intracranial bleeding was the main safety endpoint. Results The results favoured the sonolysis group for the primary endpoint (11 (2.2%) v 38 (7.6%); risk difference −5.5%, 95% confidence interval (CI) −8.3% to −2.8%; P<0.001), as well as in the substudy for magnetic resonance imaging detected new ischaemic lesions (20/236 (8.5%) v 39/224 (17.4%); risk difference −8.9%, −15% to −2.8%; P=0.004).

Sensitivity analysis resulted in a risk ratio for sonolysis of 0.25 (95% CI 0.11 to 0.56) for ischaemic stroke and 0.23 (0.07 to 0.73) for transient ischaemic attack within 30 days. Sonolysis was found to be safe, and 94.4% of patients in the sonolysis group were free from serious adverse events 30 days after the procedure. Sonolysis was safe for patients undergoing carotid endarterectomy and resulted in a significant reduction in the composite incidence of ischaemic stroke, transient ischaemic attack, and death within 30 days.

Reference:

Školoudík D, et al "Sonolysis during carotid endarterectomy: randomised controlled trial" BMJ 2025; DOI: 10.1136/bmj-2024-082750.