Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2025 Mar 19:388:e082750.
doi: 10.1136/bmj-2024-082750.

Sonolysis during carotid endarterectomy: randomised controlled trial

David Školoudík  1 , Tomáš Hrbáč  2   3 , Martin Kovář  4 , Vladimír Beneš 3rd  5   6 , Jiří Fiedler  7   8 , Mattia Branca  9 , Jean-Benoit Rossel  9 , David Netuka  10 ; SONOBIRDIE Trial Investigators
Collaborators, Affiliations
Clinical Trial

Sonolysis during carotid endarterectomy: randomised controlled trial

David Školoudík et al. BMJ. .

Erratum in

Abstract

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.

PubMed Disclaimer

Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: support from the Czech Health Research Council for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

Figures

Fig 1
Fig 1
Cumulative incidence of primary outcome (composite of ischaemic stroke, transient ischaemic attack, or death within 30 days)
Fig 2
Fig 2
Cumulative incidence of death over one year of follow-up
See this image and copyright information in PMC

References

    1. Meng Y, Hynynen K, Lipsman N. Applications of focused ultrasound in the brain: from thermoablation to drug delivery. Nat Rev Neurol 2021;17:7-22. 10.1038/s41582-020-00418-z - DOI - PubMed
    1. Tharkar P, Varanasi R, Wong WSF, Jin CT, Chrzanowski W. Nano-Enhanced Drug Delivery and Therapeutic Ultrasound for Cancer Treatment and Beyond. Front Bioeng Biotechnol 2019;7:324. 10.3389/fbioe.2019.00324 - DOI - PMC - PubMed
    1. Yang C, Li Y, Du M, Chen Z. Recent advances in ultrasound-triggered therapy. J Drug Target 2019;27:33-50. 10.1080/1061186X.2018.1464012 - DOI - PubMed
    1. Tachibana S, Koga E. Ultrasonic vibration for boosting fibrinolytic effect of urokinase. Blood Vessels 1981;12:450-3 10.2491/jjsth1970.12.450 . - DOI
    1. Francis CW, Onundarson PT, Carstensen EL, et al. . Enhancement of fibrinolysis in vitro by ultrasound. J Clin Invest 1992;90:2063-8. 10.1172/JCI116088 - DOI - PMC - PubMed

Publication types

MeSH terms

Associated data

LinkOut - more resources