Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD Studies

Abstract

Objectives: The aim of this pooled analysis was to assess the cumulative safety and effectiveness of coronary intravascular lithotripsy (IVL).

Background: The clinical outcomes of IVL to optimize target lesion preparation in severely calcified de novo coronary stenoses have been examined in 4 prospective studies (Disrupt CAD I [NCT02650128], Disrupt CAD II [NCT03328949], Disrupt CAD III [NCT03595176], and Disrupt CAD IV [NCT04151628]).

Methods: Patient data were pooled from the Disrupt CAD studies, which shared uniform study criteria, endpoint definitions and adjudication, and procedural follow-up. The primary safety endpoint was freedom from major adverse cardiovascular events (composite of cardiac death, all myocardial infarction, or target vessel revascularization) at 30 days. The primary effectiveness endpoint was procedural success, defined as stent delivery with a residual stenosis ≤30% by quantitative coronary angiography without in-hospital major adverse cardiovascular events. Secondary outcomes included serious angiographic complications, target lesion failure, cardiac death, and stent thrombosis at 30 days.

Results: Between December 2015 and April 2020, 628 patients were enrolled at 72 sites from 12 countries. Presence of severe calcification was confirmed in 97.0% of target lesions with an average calcified segment length of 41.5 ± 20.0 mm. The primary safety and effectiveness endpoints were achieved in 92.7% and 92.4% of patients, respectively. At 30 days, the rates of target lesion failure, cardiac death, and stent thrombosis were 7.2%, 0.5%, and 0.8%. Rates of post-IVL and final serious angiographic complications were 2.1% and 0.3%, with no IVL-associated perforations, abrupt closure, or episodes of no reflow.

Conclusions: In the largest cohort of patients treated with coronary IVL assessed to date, coronary IVL safely facilitated successful stent implantation in severely calcified coronary lesions with a high rate of procedural success.

Keywords: calcification; coronary artery disease; patient-level pooled analysis.

Conflict of interest statement

Funding Support and Author Disclosures Dr. Kereiakes is a consultant for SINO Medical Sciences Technologies, Boston Scientific, Elixir Medical, Svelte Medical Systems, Caliber Therapeutics/Orchestra BioMed, and Shockwave Medical; and is a stockholder in Ablative Solutions. Dr. Riley has received honoraria from Boston Scientific, Asahi Intecc, and Medtronic. Dr. Di Mario has received research grants from Amgen, Behring, Chiesi, Daiichi-Sanyo, Edwards Lifesciences, Medtronic, Shockwave, and Volcano Philips. Dr. Shlofmitz is a speaker for Shockwave Medical. Dr. Saito is a consultant for Terumo and Japan Lifeline. Dr. Ali has received grants from the National Heart, Lung, and Blood Institute, Abbott Vascular, and Cardiovascular Systems; has received personal fees from Amgen, AstraZeneca, and Boston Scientific; and holds equity in Shockwave Medical. Dr. Price has received consulting and speaker honoraria from Abbott Vascular, Boston Scientific, Biosense Webster, Medtronic, Shockwave Medical, and W.L. Gore. 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. Stone has received speaker honoraria from Cook Medical and Terumo; is 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 and options from Ancora, Qool Therapeutics, Cagent, Applied Therapeutics, the BioStar family of funds, SpectraWave, Orchestra BioMed, Aria, Cardiac Success, and Valfix. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.