Sonolysis during carotid endarterectomy: randomised controlled
trial

J 2025

Sonolysis during carotid endarterectomy: randomised controlled trial

SKOLOUDIK, David; Tomas HRBAC; Martin KOVAR; Benes III VLADIMIR; Jiří FIEDLER et al.

Základní údaje

Originální název

Sonolysis during carotid endarterectomy: randomised controlled trial

Autoři

SKOLOUDIK, David; Tomas HRBAC; Martin KOVAR; Benes III VLADIMIR; Jiří FIEDLER; Mattia BRANCA; Jean-Benoit ROSSEL a David NETUKA

Vydání

BMJ-BRITISH MEDICAL JOURNAL, LONDON, BMJ PUBLISHING GROUP, 2025, 0959-535X

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30212 Surgery

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 42.700 v roce 2024

Označené pro přenos do RIV

Ano

Organizační jednotka

Lékařská fakulta

Klíčová slova anglicky

carotid endarterectomy; sonolysis

Štítky

14110224, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 3. 6. 2025 13:24, Mgr. Tereza Miškechová

Anotace

V originále

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.

Citovat

SKOLOUDIK, David; Tomas HRBAC; Martin KOVAR; Benes III VLADIMIR; Jiří FIEDLER; Mattia BRANCA; Jean-Benoit ROSSEL a David NETUKA. Sonolysis during carotid endarterectomy: randomised controlled trial. BMJ-BRITISH MEDICAL JOURNAL. LONDON: BMJ PUBLISHING GROUP, 2025, roč. 388, č. 2025, s. 1-9. ISSN 0959-535X. Dostupné z: https://doi.org/10.1136/bmj-2024-082750.

@article{2501042,
   author = {Skoloudik, David and Hrbac, Tomas and Kovar, Martin and Vladimir, Benes III and Fiedler, Jiří and Branca, Mattia and Rossel, JeanandBenoit and Netuka, David},
   article_location = {LONDON},
   article_number = {2025},
   doi = {https://doi.org/10.1136/bmj-2024-082750},
   keywords = {carotid endarterectomy; sonolysis},
   language = {eng},
   issn = {0959-535X},
   journal = {BMJ-BRITISH MEDICAL JOURNAL},
   title = {Sonolysis during carotid endarterectomy: randomised controlled trial},
   url = {https://www.bmj.com/content/388/bmj-2024-082750},
   volume = {388},
   year = {2025}
}

TY  - JOUR
ID  - 2501042
AU  - Skoloudik, David - Hrbac, Tomas - Kovar, Martin - Vladimir, Benes III - Fiedler, Jiří - Branca, Mattia - Rossel, Jean-Benoit - Netuka, David
PY  - 2025
TI  - Sonolysis during carotid endarterectomy: randomised controlled trial
JF  - BMJ-BRITISH MEDICAL JOURNAL
VL  - 388
IS  - 2025
SP  - 1-9
EP  - 1-9
PB  - BMJ PUBLISHING GROUP
SN  - 0959535X
KW  - carotid endarterectomy
KW  - sonolysis
UR  - https://www.bmj.com/content/388/bmj-2024-082750
N2  - 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.
ER  -

SKOLOUDIK, David; Tomas HRBAC; Martin KOVAR; Benes III VLADIMIR; Jiří FIEDLER; Mattia BRANCA; Jean-Benoit ROSSEL a David NETUKA. Sonolysis during carotid endarterectomy: randomised controlled trial. \textit{BMJ-BRITISH MEDICAL JOURNAL}. LONDON: BMJ PUBLISHING GROUP, 2025, roč.~388, č.~2025, s.~1-9. ISSN~0959-535X. Dostupné z: https://doi.org/10.1136/bmj-2024-082750.

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