ShOckwave ballooN or Atherectomy with Rotablation in calcified coronary artery lesions: Design and rationale of the SONAR trial

Cardiovasc Revasc Med. 2024 Mar:60:82-86. doi: 10.1016/j.carrev.2023.08.019. Epub 2023 Sep 9.

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.

Keywords: Coronary artery calcification; Intravascular lithotripsy; Microvascular obstruction; Periprocedural myocardial infarction; Randomized clinical trial; Rotablation.

Publication types

  • Randomized Controlled Trial
  • Multicenter Study

MeSH terms

  • Atherectomy
  • Atherectomy, Coronary* / adverse effects
  • Calcium
  • Coronary Angiography
  • Coronary Artery Disease* / diagnostic imaging
  • Coronary Artery Disease* / etiology
  • Coronary Artery Disease* / therapy
  • Coronary Vessels / diagnostic imaging
  • Coronary Vessels / surgery
  • Drug-Eluting Stents*
  • Humans
  • Myocardial Infarction* / etiology
  • Percutaneous Coronary Intervention* / adverse effects
  • Prospective Studies
  • Treatment Outcome
  • Vascular Calcification* / diagnostic imaging
  • Vascular Calcification* / etiology
  • Vascular Calcification* / therapy

Substances

  • Calcium