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New research findings present that using super-high-pressure non-compliant balloons (NCB) is non-inferior to intravascular lithotripsy (IVL) balloon catheters for lesion preparation and stent enlargement in severely calcified lesions throughout percutaneous coronary intervention (PCI).
Findings had been reported at TCT 2025, the annual scientific symposium of the Cardiovascular Analysis Basis (CRF).
The presence of serious coronary artery calcium impacts roughly one-third of sufferers present process PCI and is a key contributor to procedural and stent failure. To handle these complicated lesions, a variety of specialised gadgets have been developed, together with the IVL balloon catheter which is getting used with rising frequency.
The VICTORY trial was designed to check using a super-high-pressure NCB to IVL for lesion preparation.
A complete of 282 sufferers at three websites in Switzerland and Canada had been randomized one to at least one to IVL (n=142) or the super-high-pressure NCB (n=140) for lesion preparation throughout PCI with drug-eluting stents. Affected person and procedural traits had been related between each teams.
The first endpoint was ultimate stent enlargement assessed by optical coherence tomography (OCT) decided by an impartial imaging core laboratory. The NCB group achieved a median of 85.0% stent enlargement in contrast with 84.0% within the IVL group, assembly non-inferiority (95% CI: 82.5-87.5, p
The usage of NCB resulted in related charges of acute procedural (98.6% versus 97.1%) and technique success (98.6% for each) in contrast with IVL. The outcomes had been constant throughout numerous affected person subgroups. As well as, there have been no important variations in security outcomes, together with coronary artery dissections, perforations, or facet department 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,” stated Matthias Bossard, MD, Head of the CHIP & CTO-PCI Program at Luzerner Kantonsspital Coronary heart Middle, and Assistant Professor in Well being Sciences and Medication on the College of Lucerne.
“With similar safety profiles, the OPN NCB can be a feasible and faster alternative to IVL.”
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Cardiovascular Analysis Basis
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Tremendous-high-pressure non-compliant balloons for calcified coronary lesions noninferior to intravascular lithotripsy (2025, October 28)
retrieved 28 October 2025
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