Author + information
- Received August 17, 2020
- Revision received September 28, 2020
- Accepted September 28, 2020
- Published online October 15, 2020.
- Jonathan M. Hill, MDa,∗,
- Dean J. Kereiakes, MDb,∗∗∗ (, )
- Richard A. Shlofmitz, MDc,
- Andrew J. Klein, MDd,
- Robert F. Riley, MDb,
- Matthew J. Price, MDe,
- Howard C. Herrmann, MDf,
- William Bachinsky, MDg,
- Ron Waksman, MDh and
- Gregg W. Stone, MDi
- aRoyal Brompton Hospital, London, United Kingdom
- bThe Christ Hospital and Lindner Research Center, Cincinnati, OH
- cSt. Francis Hospital, Roslyn, NY
- dPiedmont Heart Interventional Cardiology, Atlanta, GA
- eScripps Clinic,, La Jolla, CA
- fUniversity of Pennsylvania Medical Center, Philadelphia, PA
- gUPMC Pinnacle Health, Harrisburg, PA
- hMedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Washington, DC
- iThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY
- ↵∗∗Address for correspondence: Dean J. Kereiakes MD FACC FSCAI, The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital2123 Auburn Avenue Suite 424, Cincinnati, OH 45219, USA. Telephone: 513.585.0576 Fax: 513.585.4857 mailto:
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.
Objective 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 (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.
Results Patients (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<0.0001). The primary effectiveness endpoint of procedural success was 92.4%; the lower bound of the 95% CI 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 multi-plane and longitudinal calcium fractures after IVL in 67.4% of lesions. Minimum stent area was 6.5 ± 2.1mm2 and was similar regardless of demonstrable fractures on OCT.
Conclusions Coronary IVL safely and effectively facilitated stent implantation in severely calcified lesions.
↵∗ Drs. Hill and Kereiakes contributed equally to study oversight, analysis and manuscript preparation
Funding support: Shockwave Medical, Inc. (Santa Clara, CA)
Disclosures: Dr. Hill reports fees and grant support from Abbott Vascular, Boston Scientific, Abiomed, Shockwave Medical and is a stockholder in Shockwave Medical. Dr. Kereiakes is a consultant for SINO Medical Sciences Technologies, Inc., Boston Scientific, Elixir Medical, Svelte Medical Systems, Inc., Caliber Therapeutics/Orchestra Biomed, Shockwave Medical and is a stockholder in Ablative Solutions, Inc. Dr. Shlofmitz is a speaker for Shockwave Medical, Inc. Dr. Klein reports no relationships with industry. Dr. Riley reports honoraria from Boston Scientific, Asahi Intecc, and Medtronic. Dr. Price reports personal fees from ACIST Medical, AstraZeneca, Abbott Vascular, Boston Scientific, Chiesi USA, Medtronic, and W.L. Gore. Dr. Herrmann reports research funding from Abbott, Boston Scientific, Medtronic, Shockwave Medical and is a consultant for Abbott, Medtronic, and Shockwave. Dr. Bachinsky reports consultant, speakers bureau and research grant support from Abbott Vascular, Boston Scientific, BD Bard Vascular, Medtronic, Shockwave Medical. Dr. Waksman is on the Advisory Board of Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd; is a consultant for Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; has received grant support from AstraZeneca, Biotronik, Boston Scientific, Chiesi; is a speaker for AstraZeneca, Chiesi; and is a stockholder in MedAlliance; Dr. Stone is a speaker for Cook Medical; is a consultant for Valfix Medical, TherOx, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Miracor, Neovasc, V-Wave, Abiomed, Ancora, MAIA Pharmaceuticals, Vectorious, Reva, Cardiomech; and has equity/options from Ancora, Qool Therapeutics, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, and Valfix.
Twitter summary: Disrupt CAD III demonstrates safety and efficacy of intravascular lithotripsy to optimize stent expansion in severely calcified coronary artery disease
- Received August 17, 2020.
- Revision received September 28, 2020.
- Accepted September 28, 2020.
- 2020 The Authors