Original Investigation
Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease

https://doi.org/10.1016/j.jacc.2020.09.603Get rights and content
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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.

Key Words

calcification
coronary artery disease
optical coherence tomography

Abbreviations and Acronyms

DES
drug-eluting stent
FDA
U.S. Food and Drug Administration
IDE
investigational device exemption
IVL
intravascular lithotripsy
MACE
major adverse cardiovascular events
OCT
optical coherence tomography
PCI
percutaneous coronary intervention
PG
performance goal

Cited by (0)

Philippe Genereux, MD, served as Guest Associate Editor for this paper. Deepak L. Bhatt, MD, MPH, served as Guest Editor-in-Chief for this paper.

The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC author instructions page.

Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.

Drs. Hill and Kereiakes contributed equally to this work.