New study findings show that utilizing super-high-pressure non-compliant balloons (NCB) is non-inferior to intravascular lithotripsy (IVL) balloon catheters for lesion preparation and stent expansion in severely calcified lesions during percutaneous coronary intervention (PCI).
Findings were reported today at TCT® 2025, the annual scientific symposium of the Cardiovascular Research Foundation® (CRF®). TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine.
The presence of significant coronary artery calcium affects approximately one-third of patients undergoing PCI and are a key contributor to procedural and stent failure. To address these complex lesions, a range of specialized devices have been developed, including the IVL balloon catheter which is being used with increasing frequency. The VICTORY trial was designed to compare the use of a super-high-pressure NCB to IVL for lesion preparation.
A total of 282 patients at three sites in Switzerland and Canada were randomized one to one to IVL (n=142) or the super-high-pressure NCB (n=140) for lesion preparation during PCI with drug-eluting stents. Patient and procedural characteristics were similar between both groups.
The primary endpoint was final stent expansion assessed by optical coherence tomography (OCT) determined by an independent imaging core laboratory. The NCB group achieved a median of 85.0% stent expansion compared with 84.0% in the IVL group, meeting non-inferiority (95% CI: 82.5-87.5, p<0.0001). The use of NCB resulted in similar rates of acute procedural (98.6% versus 97.1%) and strategy success (98.6% for both) compared with IVL. The results were consistent across a number of patient subgroups. In addition, there were no significant differences in safety outcomes including coronary artery dissections, perforations, or side branch occlusions.
This study clearly shows that utilizing a super-high-pressure non-compliant balloon is noninferior to intravascular lithotripsy for lesion preparation and stent expansion in severely calcified lesions. With similar safety profiles, the OPN NCB can be a feasible and faster alternative to IVL."
Matthias Bossard, MD, Head of the CHIP & CTO-PCI Program at Luzerner Kantonsspital Heart Center, and Assistant Professor in Health Sciences and Medicine at the University of Lucerne
The study was funded by an unrestricted research grant from SIS Medical (Frauenfeld, Switzerland). SIS Medical was not involved in the study design and trial conduct at any stage.
Dr. Bossard reported receiving grant/research support from Abbott Vascular, Cordis, Boston Scientific, OM Pharma and SIS Medical as well as consultant fees/honoraria from Abbott Vascular, Abiomed/J&J MedTech, Amgen, Astra Zeneca, Bayer, Biosensors, Boston Scientific, Cordis, Daichii, MedAlliance, Mundipharma, Novartis, Novo Nordisk, OM Pharma, Sanofi, SIS Medical and Vifor.
The results of the study were presented on Sunday, October 26, 2025, at 12:06 p.m. PT in the Main Arena (Hall A, Exhibition Level, Moscone South) at the Moscone Center during TCT 2025.
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