Sonolysis during carotid endarterectomy: randomised controlled trial
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61383082%3A_____%2F25%3A00001511" target="_blank" >RIV/61383082:_____/25:00001511 - isvavai.cz</a>
Alternative codes found
RIV/00216224:14110/25:00141299 RIV/00216208:11130/25:10496396 RIV/00064203:_____/25:10496396 RIV/00023884:_____/25:00010065 and 2 more
Result on the web
<a href="https://pubmed.ncbi.nlm.nih.gov/40107675/" target="_blank" >https://pubmed.ncbi.nlm.nih.gov/40107675/</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1136/bmj-2024-082750" target="_blank" >10.1136/bmj-2024-082750</a>
Alternative languages
Result language
angličtina
Original language name
Sonolysis during carotid endarterectomy: randomised controlled trial
Original language description
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.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30103 - Neurosciences (including psychophysiology)
Result continuities
Project
Result was created during the realization of more than one project. More information in the Projects tab.
Continuities
P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)
Others
Publication year
2025
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
BMJ-BRITISH MEDICAL JOURNAL
ISSN
0959-535X
e-ISSN
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Volume of the periodical
388
Issue of the periodical within the volume
Mar 19 2025
Country of publishing house
GB - UNITED KINGDOM
Number of pages
9
Pages from-to
1-9
UT code for WoS article
001460104500005
EID of the result in the Scopus database
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