Sonolysis during carotid endarterectomy: randomised controlled trial
Language English Country England, Great Britain Media electronic
Document type Journal Article, Randomized Controlled Trial, Multicenter Study, Clinical Trial, Phase III
PubMed
40107675
PubMed Central
PMC11921150
DOI
10.1136/bmj-2024-082750
Knihovny.cz E-resources
- MeSH
- Double-Blind Method MeSH
- Ischemic Stroke epidemiology prevention & control etiology MeSH
- Endarterectomy, Carotid * methods adverse effects MeSH
- Middle Aged MeSH
- Humans MeSH
- Magnetic Resonance Imaging MeSH
- Aged MeSH
- Carotid Stenosis * surgery therapy MeSH
- Ischemic Attack, Transient epidemiology etiology prevention & control MeSH
- Ultrasonic Therapy * methods adverse effects MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
- Geographicals
- Europe epidemiology MeSH
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.
Centre for Health Research Faculty of Medicine University of Ostrava Ostrava Czech Republic
CTU Bern Department of Clinical Research University of Bern Bern Switzerland
Department of Neurology Na Homolce Hospital Prague Czech Republic
Department of Neurosurgery České Budějovice Hospital České Budějovice Czech Republic
Department of Neurosurgery Faculty Military Hospital Praha Praha Czech Republic
Department of Neurosurgery Medical Faculty Masaryk University Brno Brno Czech Republic
Department of Neurosurgery Regional Hospital Liberec Liberec Czech Republic
Department of Neurosurgery University Hospital Ostrava Ostrava Czech Republic
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ClinicalTrials.gov
NCT02398734
