Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease

Abstract

Background: Coronary 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.

Objectives: The purpose of this study was to assess the safety and effectiveness of IVL in severely calcified de novo coronary lesions.

Methods: Disrupt 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 (cardiac death, myocardial infarction, or target vessel revascularization) at 30 days. The primary effectiveness endpoint was procedural success. Both endpoints were compared with a pre-specified performance goal (PG). The mechanism of calcium modification was assessed in an optical coherence tomography (OCT) substudy.

Results: Patients (n = 431) were enrolled at 47 sites in 4 countries. The primary safety endpoint of the 30-day freedom from major adverse cardiovascular events was 92.2%; the lower bound of the 95% confidence interval was 89.9%, which exceeded the PG of 84.4% (p < 0.0001). The primary effectiveness endpoint of procedural success was 92.4%; the lower bound of the 95% confidence interval was 90.2%, which exceeded the PG of 83.4% (p < 0.0001). Mean calcified segment length was 47.9 ± 18.8 mm, calcium angle was 292.5 ± 76.5°, and calcium thickness was 0.96 ± 0.25 mm at the site of maximum calcification. OCT demonstrated multiplane and longitudinal calcium fractures after IVL in 67.4% of lesions. Minimum stent area was 6.5 ± 2.1 mm2 and was similar regardless of demonstrable fractures on OCT.

Conclusions: Coronary IVL safely and effectively facilitated stent implantation in severely calcified lesions.

Keywords: calcification; coronary artery disease; optical coherence tomography.

Conflict of interest statement

Author Disclosures This study was supported by Shockwave Medical, Inc. Dr. Hill has received fees and grant support from Abbott Vascular, Boston Scientific, Abiomed, and Shockwave Medical; and is a stockholder in Shockwave Medical. Dr. Kereiakes has served as a consultant for SINO Medical Sciences Technologies, Inc., Boston Scientific, Elixir Medical, Svelte Medical Systems, Inc., Caliber Therapeutics/Orchestra Biomed, and Shockwave Medical; and is a stockholder in Ablative Solutions, Inc. Dr. Shlofmitz has served as a speaker for Shockwave Medical, Inc. Dr. Riley has received honoraria from Boston Scientific, Asahi Intecc, and Medtronic. Dr. Price has received personal fees from ACIST Medical, AstraZeneca, Abbott Vascular, Boston Scientific, Chiesi USA, Medtronic, and W.L. Gore. Dr. Herrmann has received research funding from Abbott, Boston Scientific, Medtronic, and Shockwave Medical; and is a consultant for Abbott, Medtronic, and Shockwave. Dr. Bachinsky has served as a consultant, served on the Speakers Bureau, and received research grant support from Abbott Vascular, Boston Scientific, BD Bard Vascular, Medtronic, and Shockwave Medical. Dr. Waksman has served on the Advisory Board of Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, and Pi-Cardia Ltd; has served as a consultant for Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, and Pi-Cardia Ltd.; has received grant support from AstraZeneca, Biotronik, Boston Scientific, Chiesi; has served as a speaker for AstraZeneca and Chiesi; and is a stockholder in MedAlliance. Dr. Stone has served as a speaker for Cook Medical; has served as a consultant for Valfix Medical, TherOx, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Miracor, Neovasc, V-Wave, Abiomed, Ancora, MAIA Pharmaceuticals, Vectorious, Reva, and Cardiomech; and has equity/options from Ancora, Qool Therapeutics, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, and Valfix.

Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.