JACC. Cardiovascular interventions
Safety and Effectiveness of a Novel Laser-Based Intravascular Lithotripsy System for Coronary Calcium: FRACTURE Study
By McEntegart M, Budrys P, Sharma S and 21 others.
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.