Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease: The Disrupt CAD III Study

• Published in: Journal of the American College of Cardiology 2020
• Main Authors: Hill, Jonathan M., MD, Kereiakes, Dean J., MD, Shlofmitz, Richard A., MD, Klein, Andrew J., MD, Riley, Robert F., MD, Price, Matthew J., MD, Herrmann, Howard C., MD, Bachinsky, William, MD, Waksman, Ron, MD, Stone, Gregg W., MD
• Format: Article
• Language: English
• Subjects: Cardiovascular; Internal Medicine
• ISSN: 0735-1097
• DOI: 10.1016/j.jacc.2020.09.603

AbstractBackgroundCoronary calcification hinders stent delivery and expansion and is associated with adverse outcomes. Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcium, enhancing vessel compliance and optimizing stent deployment. ObjectiveTo assess the safety and effectiveness of IVL in severely calcified de novo coronary lesions. MethodsDisrupt CAD III (NCT03595176) was a prospective, single-arm multicenter study designed for regulatory approval of coronary IVL. The primary safety endpoint was freedom from major adverse cardiovascular events (MACE: cardiac death, myocardial infarction or target vessel revascularization) at 30 days. The primary effectiveness endpoint was procedural success. Both endpoints were compared to a pre-specified performance goal (PG). The mechanism of calcium modification was assessed in an optical coherence tomography (OCT) sub-study. ResultsPatients (n=431) were enrolled at 47 sites in four countries. The primary safety endpoint of the 30-day freedom from MACE was 92.2%; the lower bound of the 95% confidence interval (CI) was 89.5% which exceeded the PG of 84.4% (P