Key result
Laser-based quad-emitter IVL achieves calcium fracture in ~67% of severely calcified coronary lesions.
Why the study?
Intravascular lithotripsy is a promising option for calcium modification, and the safety and effectiveness of a novel laser- and optic-based quad-emitter IVL system in severely calcified de novo coronary lesions needed evaluation.
Is a novel laser- and optic-based quad-emitter intravascular lithotripsy system safe and effective for modifying severely calcified de novo coronary lesions and facilitating stent implantation?
Is a novel laser- and optic-based quad-emitter intravascular lithotripsy system safe and effective for modifying severely calcified de novo coronary lesions and facilitating stent implantation?
Answers are grounded in this paper and cite their sources.
The novel laser-based quad-emitter intravascular lithotripsy system is a safe and effective option to modify severely calcified coronary lesions, achieving calcium fracture in 67% of OCT-evaluated lesions to facilitate stent implantation.
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). 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).
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McEntegart et al. (2026) studied Severely calcified de novo coronary artery lesions (n=420). Laser- and optic-based quad-emitter intravascular lithotripsy (IVL) system vs. Prespecified performance goals (single-arm) was evaluated on Primary safety: 30-day freedom from MACE (cardiac death, myocardial infarction, or target vessel revascularization); Primary effectiveness: procedural success (stent delivery with residual stenosis <50% and freedom from in-hospital MACE). The laser-based quad-emitter IVL system achieved OCT-confirmed calcium fracture in 67% of lesions and a median minimal stent area of 6.51 mm² in severely calcified coronary lesions.
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