VICTORY Trial Confirms Non-Inferiority of High-Pressure Balloon vs Intravascular Lithotripsy (IVL) in Calcified Coronary Lesions: Results from Late-Breaking Presentation at TCT 2025
This news is covered by the Medical Dialogues Bureau present at the TCT Conference 2025, being held in San Francisco, USA.
Ultra high-pressure non-compliant balloons (OPN NCBs) achieve stent expansion equivalent to intravascular lithotripsy (IVL) in complex, heavily calcified coronary lesions, according to findings from the VICTORY Trial. The results, presented as a Late-Breaking Clinical Trial at TCT 2025 in San Francisco, indicate that a simpler and more cost-efficient strategy can deliver comparable efficacy and safety to advanced lithotripsy systems.
The VICTORY Trial was a multicenter, randomized study enrolling 282 patients undergoing percutaneous coronary intervention (PCI) for severely calcified coronary lesions. Participants were assigned in a 1:1 ratio to lesion preparation with either OPN NC super high-pressure balloons (SIS Medical) or intravascular lithotripsy (Shockwave Medical C2 system) prior to stent implantation. The primary endpoint was the final stent expansion index, assessed by optical coherence tomography (OCT). Secondary endpoints included procedural duration, strategy success, major adverse cardiac events (MACE), and device-related complications.
At 30-day analysis, OPN NCBs demonstrated non-inferiority to IVL in achieving stent expansion. Both treatment arms showed high procedural success and a similar safety profile. Rates of perforation, dissection, and slow-flow events were low and statistically comparable. Operators also reported potential procedural advantages with the high-pressure balloon strategy, noting reduced setup time and independence from external generators.
Intravascular lithotripsy has gained popularity for its ability to fracture deep calcium layers using sonic pressure waves, improving stent expansion in resistant lesions. However, its availability and cost remain limiting factors in several regions. In contrast, OPN NC balloons achieve plaque modification through controlled micro-fracture of superficial and mid-layer calcium at burst pressures exceeding 40 atm. The VICTORY findings suggest that in many cases, effective stent expansion can be achieved with this simpler and more accessible technology.
These results may influence global practice, positioning high-pressure balloons as a first-line option for lesion preparation in calcified vessels, with IVL reserved for cases with deeper or refractory calcium.
Long-term follow-up from the VICTORY cohort will assess the durability of these findings at one and two years, focusing on late lumen loss, restenosis, target lesion revascularization, and major adverse cardiac events. Planned subgroup analyses will explore the impact of calcium morphology and vessel size on device performance.
By confirming the non-inferiority of high-pressure balloons to intravascular lithotripsy, the VICTORY Trial supports a practical, cost-conscious approach to calcium modification in PCI—an important step toward broadening access to advanced coronary interventions worldwide.
Reference: Matthias Bossard et al., A Randomized Trial of Intravascular Lithotripsy and Super-High-Pressure Non-Compliant Balloons for Treatment of Calcified and Refractory Coronary Lesions, TCT Conference 2025, San Francisco.
