Safety and Effectiveness of a Novel Laser-Based Intravascular Lithotripsy System for Coronary Calcium: FRACTURE Study.
Margaret McEntegart, Povilas Budrys, Samin Sharma et al.
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In 30 seconds
FRACTURE was a prospective, multicenter, single-arm clinical trial evaluating a laser- and optic-based quad-emitter intravascular lithotripsy system in patients with severely calcified de novo coronary lesions. Among 420 enrolled patients, 30-day freedom from major adverse cardiac events was 93.3% (373/400), exceeding the prespecified 86.2% performance goal. Procedural success was 93.7% (374/399), also above its 85.8% performance goal. In the optical coherence tomography substudy, calcium fracture was confirmed in 67% of lesions. The authors concluded that the system can modify severe coronary calcium and facilitate stent implantation.
Key findings
- Thirty-day freedom from major adverse cardiac events was 93.3% (373/400), exceeding the 86.2% performance goal (P < 0.0001).
- Procedural success was 93.7% (374/399), exceeding the 85.8% performance goal (P < 0.0001).
- Optical coherence tomography confirmed calcium fracture in 67% of lesions in the 106-patient substudy.
Why it matters
Severe coronary calcium can complicate stent delivery and implantation. This study provides prospective, multicenter evidence that a novel IVL system achieved high procedural success and met prespecified safety and effectiveness goals in this setting. The OCT findings also offer evidence of calcium modification, although the trial design does not establish comparative benefit over other approaches.
What to keep in mind
The trial was single-arm and assessed outcomes against prespecified performance goals rather than a concurrent comparator. OCT findings came from a substudy of 106 patients.