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Publications

Journal Article Multicenter Study Clinical Trial Ppublish 1 citation

PubMed: 42933913 DOI: 10.1016/j.jcin.2026.08.018

Safety and Effectiveness of a Novel Laser-Based Intravascular Lithotripsy System for Coronary Calcium: FRACTURE Study.

JACC Cardiovasc Interv 19(20):2710-2722

Authors: Margaret McEntegart, Povilas Budrys, Samin Sharma, James C Spratt, Holger Nef, Brian Jefferson, Niels Verouden, Frank E Corrigan, Kalpa De Silva, Dhananjay Chatterjee, Matthew Price, Ian Webb, Louis Verreault-Julien, Jan-Malte Sinning, Helge Mollmann, Jeffrey Chambers, Azeem Latib, Ajay J Kirtane, Briahnna Austin, Timothy E Meyer, John TsungYing Tsai, Rafael Cavalcante, Nicolas M Van Mieghem

Affiliations

  • Columbia University Irving Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York, USA.
  • Klaipeda University Hospital/Clinic of Cardiac and Vascular Diseases, Vilnius University, Vilnius, Lithuania.
  • The Mount Sinai Hospital, New York, New York, USA.
  • City St George's University of London, London, United Kingdom.
  • University of Giessen, Giessen, Germany.
  • HCA Healthcare Tristar Centennial Medical Center, Nashville, Tennessee, USA.
  • Amsterdam UMC, Amsterdam, the Netherlands.
  • Wellstar Center for Cardiovascular Care, Hiram, Georgia, USA.
  • St Thomas' Hospital, London, United Kingdom.
  • University of California, Los Angeles, California, USA.
  • Scripp's Clinic, La Jolla, California, USA.
  • King's College Hospital, London, United Kingdom.
  • Montefiore Medical Center, Bronx, New York, USA.
  • St. Vinzenz-Hospital GmbH, Nippes, Germany.
  • Klinik für Augenheilkunde, St.-Johannes-Hospital Dortmund, Innenstadt-West, Germany.
  • Metropolitan Heart & Vascular Institute, Coon Rapids, Minnesota, USA.
  • Columbia University Irving Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York, USA.
  • Boston Scientific Corporation, Marlborough, Massachusetts, USA.
  • Erasmus MC, Rotterdam, the Netherlands.

Abstract

BACKGROUND

Intravascular lithotripsy (IVL) has emerged as a promising option to modify calcium.

OBJECTIVES

This study evaluated the safety and effectiveness of a novel laser- and optic-based quad-emitter IVL system in severely calcified de novo coronary lesions.

METHODS

FRACTURE was a prospective, multicenter, single-arm trial. The primary safety endpoint was 30-day freedom from major adverse cardiac events (MACE; composite of cardiac death, myocardial infarction, or target vessel revascularization). The primary effectiveness endpoint was procedural success (successful stent delivery with a final residual stenosis <50% and freedom from in-hospital MACE). Both endpoints were evaluated against prespecified performance goals. An optical coherence tomography (OCT) substudy was performed.

RESULTS

A total of 420 patients (mean age: 71.2 ± 9.01 years; 74.0% male) were enrolled. Median calcified length was 34.4 mm (Q1-Q3: 21.3-52.5 mm). Among 106 patients with OCT, at the site of maximum calcification, the calcium arc was 271.89° ± 77.35° and the median thickness was 0.88 mm (Q1-Q3: 0.72-1.11 mm). OCT confirmed calcium fracture in 67% of lesions; the median minimal stent area was 6.51 mm 2 (Q1-Q3: 4.85-7.78 mm 2), and stent expansion was 94.2% ± 19.4% at the site of maximum calcification. The primary safety endpoint of 30-day freedom from MACE was 93.3% (373/400; with lower bound of 95% CI of 90.8%, exceeding the 86.2% performance goal [P < 0.0001]). The primary effectiveness endpoint of procedural success was 93.7% (374/399; with lower bound of 95% CI of 91.3%, exceeding the 85.8% performance goal [P < 0.0001]).

CONCLUSIONS

The quad-emitter IVL system is a safe and effective option to modify severe calcified coronary lesions and facilitate stent implantation.

REGISTRATION

(Modification of Coronary Calcium With Laser Based Intravascular Lithotripsy for Coronary Artery Disease [FRACTURE]; NCT06181240).

MeSH

Stents, Safety, Coronary Artery Disease, Percutaneous Coronary Intervention, Lasers, Calcium, Tomography, Optical Coherence, Wounds And Injuries, Lithotripsy