Shockwave balloon or atherectomy with rotablation in calcified coronary artery lesions: Design and rationale of the SONAR trial.
Coronary artery calcification
Intravascular lithotripsy
Microvascular obstruction
Periprocedural myocardial infarction
Randomized clinical trial
Rotablation
Journal
Cardiovascular revascularization medicine : including molecular interventions
ISSN: 1878-0938
Titre abrégé: Cardiovasc Revasc Med
Pays: United States
ID NLM: 101238551
Informations de publication
Date de publication:
09 Sep 2023
09 Sep 2023
Historique:
received:
22
06
2023
accepted:
31
08
2023
medline:
16
9
2023
pubmed:
16
9
2023
entrez:
15
9
2023
Statut:
aheadofprint
Résumé
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. 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. 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.
Sections du résumé
BACKGROUND
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
OBJECTIVE
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
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.
Identifiants
pubmed: 37714726
pii: S1553-8389(23)00801-1
doi: 10.1016/j.carrev.2023.08.019
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © 2023 Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of competing interest JB reports research grants and speaking fees from Abbott Vascular and Biotronik AG, and consulting fees from Biotronik AG, Boston Scientific and Elixir. NMVM reports research grant support from Abbott Vascular, Medtronic, Boston Scientific, Daiichi Sankyo, Astra Zeneca and advisory fees from Abbott Vascular, Medtronic, Boston Scientific, Daiichi Sankyo, Amgen, Anteris, JenaValve, Siemens, and Teleflex. JD reports consulting fees from Topmedical and Boston Scientific.