Cardiovascular

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

McEntegart M, Budrys P, et al. • JACC. Cardiovascular interventions • 2026

PubMed 42933913 DOI 10.1016/j.jcin.2026.08.018

TL;DR

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

Key Findings

Results

The primary safety endpoint of 30-day freedom from MACE was met, exceeding the prespecified performance goal.

30-day freedom from MACE was 93.3% (373/400).
The lower bound of the 95% CI was 90.8%, exceeding the 86.2% performance goal (P < 0.0001).
MACE was a composite of cardiac death, myocardial infarction, or target vessel revascularization.
FRACTURE was a prospective, multicenter, single-arm trial.

Results

The primary effectiveness endpoint of procedural success was met, exceeding the prespecified performance goal.

Procedural success was 93.7% (374/399).
The lower bound of the 95% CI was 91.3%, exceeding the 85.8% performance goal (P < 0.0001).
Procedural success was defined as successful stent delivery with final residual stenosis <50% and freedom from in-hospital MACE.

Results

The trial enrolled patients with severely calcified, long coronary lesions.

A total of 420 patients were enrolled (mean age 71.2 ± 9.01 years; 74.0% male).
Median calcified length was 34.4 mm (Q1-Q3: 21.3-52.5 mm).
Lesions were severely calcified de novo coronary lesions.

Results

OCT in a substudy showed extensive calcification at the site of maximum calcification.

OCT was available in 106 patients.
Mean calcium arc was 271.89° ± 77.35°.
Median calcium thickness was 0.88 mm (Q1-Q3: 0.72-1.11 mm).

Results

OCT confirmed calcium fracture in 67% of lesions imaged after treatment.

Calcium fracture was assessed in the OCT substudy (n=106 patients).
Fracture was confirmed in 67% of lesions.

Results

Stent deployment after quad-emitter IVL achieved adequate minimal stent area and expansion by OCT.

Median minimal stent area was 6.51 mm² (Q1-Q3: 4.85-7.78 mm²).
Stent expansion at the site of maximum calcification was 94.2% ± 19.4%.

What This Means

This study tested a new device that uses laser energy delivered through four optical emitters to crack hardened calcium in the walls of heart arteries, so that a stent can be placed properly. It enrolled 420 patients, mostly older men, with severely calcified and fairly long blockages, and followed them for 30 days. It was a single-arm trial, meaning all patients received the device and results were compared against preset benchmarks rather than a control group. About 93% of patients had no major cardiac events (cardiac death, heart attack, or repeat procedure on the treated vessel) at 30 days, and about 94% had a successful procedure, meaning a stent was placed, the remaining narrowing was under 50%, and no major events occurred in hospital. Both results beat the benchmarks set beforehand. In a subgroup of 106 patients imaged with a detailed intravascular scan (OCT), calcium was visibly fractured in about two-thirds of lesions, and stents expanded to about 94% of their intended size at the most calcified spot. This research suggests the device may be a safe and effective way to prepare heavily calcified coronary arteries for stenting. Because there was no comparison group, it cannot show whether it is better than other calcium-modifying methods, and longer-term follow-up would be needed to understand lasting outcomes.

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Citation

McEntegart M, Budrys P, Sharma S, Spratt J, Nef H, Jefferson B, et al.. (2026). Safety and Effectiveness of a Novel Laser-Based Intravascular Lithotripsy System for Coronary Calcium: FRACTURE Study.. JACC. Cardiovascular interventions. https://doi.org/10.1016/j.jcin.2026.08.018

Key Findings

What This Means

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