Safety and Effectiveness of a Novel Laser-Based Intravascular Lithotripsy System for Coronary Calcium: FRACTURE Study
Authors' conclusion
The quad-emitter IVL system is a safe and effective option to modify severe calcified coronary lesions and facilitate stent implantation.
Study context
- Population
- Patients with severely calcified de novo coronary lesionsenrolled, 106 patients with optical coherence tomography (OCT) · OCT substudy 106
- Participants
- 420 patients
- Exposure
- Quad-emitter intravascular lithotripsy (IVL) against prespecified performance goals
- Quad-emitter IVLn = 420
- Outcome
- Freedom from MACE (composite of cardiac death, myocardial infarction, or target vessel revascularization), primary safety endpoint
- Follow-up
- 30 days
Methodological detailsoptical coherence tomography (OCT) substudy, endpoints evaluated against prespecified performance goals
- Optical coherence tomography (OCT) substudy
- Endpoints evaluated against prespecified performance goals
Main finding
As reported in the abstract
Quad-emitter IVL
93.3%
373/400 of 420
- Lower bound of 95% CI
- 90.8%
Observational data: associations, not effects.
Further findings
| Outcome | Values |
|---|---|
| Procedural success (successful stent delivery with a final residual stenosis <50% and freedom from in-hospital MACE), primary effectiveness endpoint | quad-emitter IVL 93.7% |
- Procedural success (successful stent delivery with a final residual stenosis <50% and freedom from in-hospital major adverse cardiac events (MACE)), primary effectiveness endpoint — Lower bound of 95% CI
- 91.3%
- Procedural success (successful stent delivery with a final residual stenosis <50% and freedom from in-hospital MACE), primary effectiveness endpoint: exceeding the 85.8% performance goal [P < 0.0001]
Calcified length
- Median calcified length
- 34.4 mm (Q1-Q3: 21.3-52.5 mm)
- Descriptive
OCT findings among 106 patients with OCT
- Calcium arc at site of maximum calcification
- 271.89° ± 77.35°
- Median calcium thickness at site of maximum calcification
- 0.88 mm (Q1-Q3: 0.72-1.11 mm)
- Calcium fracture confirmed by OCT, of lesions
- 67%
- Median minimal stent area
- 6.51 mm² (Q1-Q3: 4.85-7.78 mm²)
- Stent expansion at site of maximum calcification
- 94.2% ± 19.4%
- OCT substudy
Original publication
Safety and Effectiveness of a Novel Laser-Based Intravascular Lithotripsy System for Coronary Calcium: FRACTURE Study. JACC Cardiovasc Interv. Published 26 October 2026. doi:10.
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