SONOBIRDIE Trial

Description

Minimising perioperative vascular complications after carotid endarterectomy is essential for its safe use. We hypothesised that activation of the fibrinolytic system and a direct mechanical effect on flowing thrombi in intracranial arteries by use of sonolysis during carotid endarterectomy could reduce the risk of cerebrovascular events, such as ischaemic stroke, transient ischaemic attack, and silent brain infarction. We did a randomised controlled clinical trial to evaluate the effectiveness and safety of sonolysis during carotid endarterectomy. The Sonolysis in Prevention of Brain Infarctions During Internal Carotid Endarterectomy (SONOBIRDIE) trial is a randomised, double blind, sham controlled study designed to demonstrate the safety and effectiveness of sonolysis. The primary endpoint was a composite incidence of ischaemic stroke, transient ischaemic attack, and death over the course of 30 days after randomisation. Secondary efficacy endpoints included occurrence of any stroke within 30 days (including ischaemic stroke, intracerebral haemorrhage, subarachnoid haemorrhage, and unspecified stroke), myocardial infarction within 30 days, death within 30 days, and death within one year. Endpoints of the magnetic resonance imaging substudy were appearance of at least one new ischaemic lesion on a post-procedural brain scan, number of new ischaemic lesions on a post-procedural brain scan, appearance of at least one new ischaemic lesion ≥0.5 mL in volume on post-procedural diffusion weighted brain imaging, and appearance of at least one new ipsilateral ischaemic lesion on post-procedural diffusion weighted brain imaging. All endpoints of the magnetic resonance imaging substudy were assessed 24 hours (within four hours either side) after carotid endarterectomy. Safety endpoints included adverse events, serious adverse events, and incidence of haemorrhagic stroke, including subarachnoid haemorrhage, within 30 days after carotid endarterectomy and incidence of intracranial bleeding (including brain microbleeds) on a control T2* weighted gradient recalled echo sequence in the magnetic resonance imaging substudy. A total of 1004 patients from 16 centres in three European countries were enrolled between 20 AUG 2015 and 14 OCT 2020 until interim analysis in the randomised phase of the trial. Members of the DSMB evaluated the interim analysis results for the first 1000 enrolled patients and unanimously recommended stopping the SONOBIRDIE trial early owing to clear evidence of efficacy. The SONOBIRDIE trial showed that periprocedural sonolysis during carotid endarterectomy significantly reduced the risk of ischaemic stroke, transient ischaemic attack, and new brain infarction detected using magnetic resonance imaging of the brain, with no increase in the risk of any adverse events. The dataset includes ID data of patients and centers, data from initial (screening/randomization) visit, surgery data, data from visitafter 24 h, 30 d, and 1 year.

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Study detailes are available at: - Clinicaltrials.gov: NCT02398734 - Protocol was published at: Hrbáč T, Netuka D, Beneš V, et al. SONOlysis in prevention of Brain InfaRctions During Internal carotid Endarterectomy (SONOBIRDIE) trial - study protocol for a randomized controlled trial. Trials 2017;18:25. PubMed doi:10.1186/s13063-016-1754-x. - Study results are available at: Školoudík D, Hrbáč T, Kovář M, Beneš V 3rd, Fiedler J, Branca M, Rossel JB, Netuka D; SONOBIRDIE Trial Investigators. Sonolysis during carotid endarterectomy: randomised controlled trial. BMJ. 2025 Mar 19;388:e082750. doi: 10.1136/bmj-2024-082750.

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