SAN FRANCISCO — Two different balloon devices developed for the treatment of calcified coronary lesions were found noninferior to intravascular lithotripsy (IVL) at a lower cost in separate major multicenter randomized trials.

One trial was conducted with a cutting balloon and the other with a noncompliant balloon deployed at high pressure, but the conclusions were similar, leading each of the principal investigators to characterize the balloons as “less costly” and “reasonable” alternatives to IVL. Researchers presented the results of the two trials — ShortCUT and VICTORY — at Transcatheter Cardiovascular Therapeutics (TCT) 2025.

First Major Randomized Trial to Challenge Lithotripsy

Until now, no major randomized trial has compared a balloon device to IVL for treatment of calcified coronary lesions, according to Suzanne J. Baron, MD, MSc, director of interventional cardiology research at Massachusetts General Hospital in Boston.

Baron, who led the ShortCUT trial, said IVL is the most common method of treating calcified lesions in the coronary vasculature despite efforts to bring forward other technologies — which is why researchers chose the procedure as the comparator for the two noninferiority studies.

In ShortCUT, 413 patients were enrolled at 21 sites in the US. Randomization to the cutting balloon or IVL was performed after patients had been selected for a planned rotational atherectomy or no planned atherectomy, allowing the effect of this variable, if any, to be evaluated as a secondary endpoint.

The protocol for use of either the balloon or IVL were strictly defined. Participating investigators were told to size the IVL device in a 1:1 ratio to vessel diameter. The cutting balloon was sized 0.5 mm smaller than the reference vessel diameter and deployed at high pressure (16-20 atmospheres). Patients with stable angina or non-ST–segment elevation myocardial infarction acute coronary syndrome with flat or down-trending biomarkers were eligible for inclusion.

For the primary minimal stent area (MSA) endpoint evaluated at 30 days, the mean MSA was smaller for the cutting balloon than for the IVL (8 vs 8.6 mm²), but this difference was well within the predefined noninferiority margin of 1.2 mm² (P = .007 for noninferiority), Baron reported.

In the atherectomy cohort, the difference was even smaller — 8.3 vs 8.4 mm² — and again highly significant for noninferiority (P < .001), she said, but for the nonatherectomy cohort, the lower MSA in the cutting balloon group (7.4 vs 8.3 mm²) did not reach significance for noninferiority (P = .399), Baron reported.

However, the negative result in the nonatherectomy group could be misleading, according to Baron. MSA is calculated by reference vessel size. Given that numerically smaller vessel sizes in the cutting balloon cohort and the fact that stent expansion normalizes the reference vessel, in the change in MSA might have been the wrong comparison for the nonatherectomy group, she said.

Cost Appears to Be the Only Difference for Balloon Strategy

The researchers found no significant differences between strategies for procedural complications, strategy success, or 30-day major adverse cardiac events, but the cost per target vessels was more than $3000 lower ($7776 vs $10,885; P < .001) for the balloon strategy vs IVL, they reported.

The results of the VICTORY trial using a different balloon platform were similar. In VICTORY, 282 patients in Switzerland and Canada with an acute or chronic coronary syndrome with severely calcified lesions were randomly assigned to receive IVL or the OPN device from SIS Medical, a twin-layer highly noncompliant balloon.

For the primary outcome of percent stent expansion at 30 days, the balloon was associated with a slight numerical advantage (85% vs 84%), which was well within the predefined 10% acceptable margin of difference (P < .0001 for noninferiority), according to Matthias Bossard, MD, a cardiologist and researcher at the Luzerner Kantonsspital, in Lucerne, Switzerland, who led the research.

The trial found no signal for superiority of the balloon compared with IVL (P = .0570), and no significant differences emerged for any secondary outcome, including acute procedural success (P = .903), strategy success, MSA, or target vessel failure.

Adverse events, such as side branch occlusion, perforations, and major bleeding were infrequent in both groups and did not differ significantly. Similarly, adverse outcomes at 30 days, including all-cause mortality, stent thrombosis, and target vessel revascularization, were observed in only a few patients in both groups, and their incidence did not differ significantly, Bossard reported.

Cost was not a focus of the VICTORY trial, but the lower average procedure time for balloon preparation of calcification approached statistical significance (70 vs 79 minutes), according to Bossard. Given the comparable efficacy and safety, he concluded that the balloon device in this study “is a lower cost alternative” to IVL that “may be faster to use.”

The two discussants for these trials agreed that MSA and stent expansion are strongly predictive of long-term outcomes and are reasonable surrogate endpoints for these relatively small trials. However, they both suggested the conclusions would have been stronger with outcomes past 30 days.

Antonio Colombo, MD, director of the cardiac catheterization laboratory at Columbus Hospital in Milan, Italy, said although the ShortCUT data support balloon treatment of calcifications, he is not convinced it will replace IVL, which is effective and generally easy to use, as a first-line approach.

Jeffrey Moses, MD, chairman of cardiology at Good Samaritan University Hospital in West Islip, New York, said more experience and data should better define where balloons fit in relationship to IVL or other methods of preparing calcified lesions for percutaneous coronary interventions.

However, Moses said a balloon-first strategy might be considered in at least some patients because it does not eliminate other alternatives, including IVL, if adequate results are not achieved.

The ShortCUT trial was investigator-initiated. Baron reported financial relationships with Abbott, Boston Scientific, Edwards Lifesciences, Heartflow, Medtronic, Pi-Cardia, Shockwave, and Zoll Medical. The VICTORY trial received funding from SIS Medical, with which Bossard reported a financial relationship. He also reported financial relationships with Abbott Vascular, Abiomed, Amgen, AstraZeneca, Bayer, Biosensors, Boston Scientific, Cordis, Daiichi Sankyo, MedAlliance, Mundipharma, Novartis, Novo Nordisk, OM Pharma, Sanofi, and Vifor. Moses reported financial relationships with Covanos, Orchestra Biomed, OSTIAL, and Xenter. Columbo reported no relevant financial conflicts of interest.

Ted Bosworth is a freelance writer in New York City.