Safety and effectiveness of coronary intravascular lithotripsy in eccentric calcified coronary lesions: a patient-level pooled analysis from the Disrupt CAD I and CAD II Studies

Clin Res Cardiol. 2021 Feb;110(2):228-236. doi: 10.1007/s00392-020-01737-3. Epub 2020 Sep 18.

Abstract

Background: The aim of this study was to assess the safety and effectiveness of intravascular lithotripsy (IVL) in treating eccentric calcified coronary lesions.

Methods: Between December 2015 and March 2019, 180 patients were enrolled in the Disrupt CAD I and CAD II studies across 19 sites in 10 countries. Patient-level data were pooled from these two studies (n = 180), within which 47 eccentric lesions (26%) and 133 concentric lesions were identified.

Results: Clinical success, defined as residual stenosis < 50% after stenting and no in-hospital MACE, was similar between the eccentric and concentric cohorts (93.6% vs. 93.2%, p = 1.0). There were no perforations, abrupt closure, slow flow or no reflow events observed in either group, and there were low rates of flow-limiting dissections (Grade D-F: 0% eccentric, 1.7% concentric; p = 0.54). Final acute gain and percent residual stenosis were similar between the two groups. Final residual stenosis of 8.6 ± 9.8% in eccentric and 10.0 ± 9.0% (p = 0.56) in concentric stenosis confirms the significant effect of IVL in calcified coronary lesions.

Conclusion: In this first report from a pooled patient-level analysis of coronary IVL from the Disrupt CAD I and CAD II studies, IVL use was associated with consistent improvement in procedural and clinical outcomes in both eccentric and concentric calcified lesions.

Keywords: Calcified lesions; Clinical research; Lithotripsy; Percutaneous coronary intervention.

Publication types

  • Multicenter Study

MeSH terms

  • Aged
  • Coronary Angiography
  • Coronary Stenosis / diagnosis
  • Coronary Stenosis / etiology
  • Coronary Stenosis / therapy*
  • Coronary Vessels / diagnostic imaging*
  • Endovascular Procedures / methods*
  • Female
  • Follow-Up Studies
  • Humans
  • Lithotripsy / methods*
  • Male
  • Prospective Studies
  • Stents*
  • Treatment Outcome
  • Vascular Calcification / complications
  • Vascular Calcification / diagnosis
  • Vascular Calcification / surgery*