For patients undergoing carotid endarterectomy, sonolysis is safe and results in a significant reduction in the composite incidence of ischemic stroke, transient ischemic attack, and death within 30 days, according to a study published online March 19 in The BMJ.

David Školoudík, Ph.D., from the University of Ostrava in the Czech Republic, and colleagues examined the effectiveness and safety of sonolysis using a low-intensity 2-MHz pulsed wave ultrasound beam during carotid endarterectomy in a phase 3 trial involving 1,004 patients from 16 European centers. Participants were randomly assigned to receive sonolysis or sham procedure (507 and 497 individuals, respectively). The composite incidence of ischemic stroke, transient ischemic attack, and death within 30 days was the primary end point.

The researchers found that the results favored sonolysis for the primary end point (2.2 versus 7.6%) and in the substudy for magnetic resonance imaging-detected new ischemic lesions (8.5 versus 17.4%). In a sensitivity analysis, the risk ratios for sonolysis were 0.25 and 0.23 for ischemic stroke and transient ischemic stroke, respectively, within 30 days. Sonolysis was safe; 30 days after the procedure, 94.4% of patients were free from serious adverse events.

“Sonolysis should be used to reduce the risk of periprocedural cerebrovascular events during carotid endarterectomy in all patients with sufficient temporal bone window for transcranial Doppler,” the authors write. “It has the potential to make carotid endarterectomy safer with a higher benefit for patients with carotid stenosis compared with the best medical treatment, especially in patients with asymptomatic carotid stenosis.”

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