Shockwave balloon or atherectomy with rotablation in calcified coronary artery lesions: Design and rationale of the SONAR trial

Johan Bennett*, Keir McCutcheon, Koen Ameloot, Maarten Vanhaverbeke, Pierluigi Lesizza, Gianluca Castaldi, Tom Adriaenssens, Lennert Minten, Pieter Jan Palmers, Quentin de Hemptinne, Willem de Wilde, Claudiu Ungureanu, Bert Vandeloo, Giuseppe Colletti, Patrick Coussement, Nicolas M. Van Mieghem, Jo Dens

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Background: 

The percutaneous treatment of calcified coronary lesions remains challenging and is associated with worse clinical outcomes. In addition, coronary artery calcification is associated with more frequent peri-procedural myocardial infarction. 

Study design and objectives: 

The ShOckwave ballooN or Atherectomy with Rotablation in calcified coronary artery lesions (SONAR) study is an investigator-initiated, prospective, randomized, international, multicenter, open label trial (NCT05208749) comparing a lesion preparation strategy with either shockwave intravascular lithotripsy (IVL) or rotational atherectomy (RA) before drug-eluting stent implantation in 170 patients with moderate to severe calcified coronary lesions. The primary endpoint is difference in the rate of peri-procedural myocardial infarction. Key secondary endpoints include rate of peri-procedural microvascular dysfunction, peri-procedural myocardial injury, descriptive study of IMR measurements in calcified lesions, technical and procedural success, interaction between OCT calcium score and primary endpoint, 30-day and 1-year major adverse clinical events. 

Conclusions: 

The SONAR trial is the first randomized controlled trial comparing the incidence of peri-procedural myocardial infarction between 2 contemporary calcium modification strategies (Shockwave IVL and RA) in patients with calcified coronary artery lesions. Furthermore, for the first time, the incidence of peri-procedural microvascular dysfunction after Shockwave IVL and RA will be evaluated and compared.

Original languageEnglish
Pages (from-to)82-86
Number of pages5
JournalCardiovascular Revascularization Medicine
Volume60
Early online date9 Sept 2023
DOIs
Publication statusPublished - Mar 2024

Bibliographical note

Funding Information:
This study is an investigator-initiated clinical trial sponsored by the Department of Cardiovascular Medicine, University Hospitals Leuven, Belgium and supported by an unrestricted research grant from Shockwave Medical Santa Clara, CA, USA. The steering committee (JB, JD and KA) has the task of overseeing the good execution and administrative progress of the trial protocol. The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper, and its final contents. Shockwave Medical provided an unrestricted grant to execute the study but is not involved in data acquisition, analysis or any study related activity.

Publisher Copyright:
© 2023 Elsevier Inc.

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