Cutting balloon angioplasty and use of super-high-pressure non-compliant balloons (NCBs), respectively, were noninferior to intravascular lithotripsy (IVL), based on findings from the Short-CUT and VICTORY trials presented at TCT 2025 in San Francisco.

In the Short-CUT trial, a total of 413 patients with moderate-to-severely calcified coronary lesions undergoing PCI were randomized to either IVL- or cutting balloon-facilitated lesion preparation. Participants were stratified into two cohorts: 1) planned up-front rotational atherectomy (n=208); and 2) unplanned up-front rotational atherectomy (n=205). The primary endpoint was post-procedural stent area at the site of maximal calcification.

Results showed the mean post-procedural minimum stent area was 8.6 mm for IVL and 8.0 mm for the cutting balloon group. "There were no differences in stent expansion, calcium fractures, strategy success, intraprocedural adverse events or MACE out to 30 days between the two treatment groups," said Suzanne J. Baron, MD, MSc, in presenting the findings.

Additionally, cost analyses demonstrated that procedural cost was significantly higher with IVL use (a difference of $3,632), primarily driven by the cost of the randomized device. Baron also noted that when the primary endpoint was stratified by atherectomy plan, results were similar between the overall study cohort and patients who underwent planned atherectomy. However, cutting balloon angioplasty did not meet noninferiority among patients who underwent unplanned atherectomy, potentially due to differences in vessel size between groups.

"As part of an imaging-based approach to PCI of significantly calcified coronary lesions, cutting balloon angioplasty is a reasonable strategy when compared with IVL," said Baron. "Not only is utilizing a cutting balloon safe and effective, it's also significantly less costly."

In the VICTORY trial, researchers compared the use of a super-high-pressure NCB to IVL for lesion preparation, randomizing 882 patients at three sites in Switzerland and Canada to either of the procedures on a one-to-one basis. The primary endpoint was final stent expansion assessed by optical coherence tomography.

Overall findings showed a median of 85% stent expansion in the NCB group compared with 84% in the IVL group, meeting noninferiority. Similar rates of acute procedural and strategy success were observed across both groups, as well as several patient subgroups, and there were no significant differences in safety outcomes including coronary artery dissections, perforations or side branch occlusions, researchers said.

"This study clearly shows that utilizing a super-high-pressure NCB is noninferior to IVL for lesion preparation and stent expansion in severely calcified lesions," said Matthias Bossard, MD, who presented the findings. "With similar safety profiles, the [super-high-pressure] NCB can be a feasible and faster alternative to IVL."

Clinical Topics: Acute Coronary Syndromes, Invasive Cardiovascular Angiography and Intervention, Interventions and ACS, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: Transcatheter Cardiovascular Therapeutics, TCT25, Angiography, Acute Coronary Syndrome