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

Abstract

Intravascular lithotripsy (IVL) has emerged as a promising option to modify calcium. 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. 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. 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 mm² (Q1-Q3: 4.85-7.78 mm²), 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]). The quad-emitter IVL system is a safe and effective option to modify severe calcified coronary lesions and facilitate stent implantation. (Modification of Coronary Calcium With Laser Based Intravascular Lithotripsy for Coronary Artery Disease [FRACTURE]; NCT06181240).