RT Journal Article
SR Electronic
T1 Sonolysis during carotid endarterectomy: randomised controlled trial
JF BMJ
JO BMJ
FD British Medical Journal Publishing Group
SP e082750
DO 10.1136/bmj-2024-082750
VO 388
A1 Školoudík, David
A1 Hrbáč, Tomáš
A1 Kovář, Martin
A1 Beneš, Vladimír
A1 Fiedler, Jiří
A1 Branca, Mattia
A1 Rossel, Jean-Benoit
A1 Netuka, David
A1 
YR 2025
UL https://www.bmj.com/content/388/bmj-2024-082750.abstract
AB Objective To evaluate the effectiveness and safety of sonolysis using a low intensity 2 MHz pulsed wave ultrasound beam during carotid endarterectomy.Design Multicentre, phase 3, double blind, randomised controlled trial.Setting 16 European centres.Participants 1004 patients (mean age 68 years; 312 (31%) female) were enrolled in the study between 20 August 2015 and 14 October 2020 until the interim analysis was performed.Interventions Sonolysis (n=507) versus sham procedure (n=497).Main outcome measures The primary endpoint was the composite incidence of ischaemic stroke, transient ischaemic attack, and death within 30 days. 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.Conclusion 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.Trial registration Clinicaltrials.gov NCT02398734.Data will become available to interested investigators on submission of a reasonable research request by email to the corresponding author (skoloudik@email.cz) and approval by the steering committee of the trial.