Results from the first randomized controlled trial to directly compare the safety and efficacy of cutting balloon (CB) angioplasty to intravascular lithotripsy (IVL) prior to drug-eluting stent (DES) implantation for the treatment of calcified coronary artery disease found CB to be noninferior to IVL.
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.
Coronary calcium is present in up to 30% of patients undergoing percutaneous coronary intervention (PCI) and is a key contributor to procedural complexity and suboptimal short and long-term clinical outcomes. While several balloon-based devices are available for calcium modification, direct comparisons remain limited. These devices vary significantly in mechanism of action and cost, underscoring the need for head-to-head evaluation.
A total of 413 patients with stable or unstable coronary artery disease with de novo calcified coronary lesions were randomized at 21 sites in the United States. Baseline, lesion and procedural characteristics were similar among both groups. The study was stratified to include two separate cohorts of patients were included: those with planned up-front rotational atherectomy (n=208) and those in whom up-front rotational atherectomy was not planned (n=205). In each cohort, patients were randomized to receive IVL- or CB-facilitated lesion preparation.
The primary endpoint was post-procedural stent area at the site of maximal calcification as measured by core lab-adjudicated, high-definition intravascular ultrasound assessment. The study found that for the post-procedural MSA, the mean (SD) was 8.6 mm2 ± 2.5 for IVL and 8.0 mm2 ± 2.4 for CB (Difference 0.6, 97.5% CI ∞, 1.1mm2, pnoninferiority = 0.007)]. There were no differences in stent expansion or calcium fractures between the two treatment arms in the total study population as well as in both individual cohorts, although interaction testing demonstrated that this effect may have varied based upon whether atherectomy was planned.
Average stent expansion at the site of maximum calcification was similar with 97.7 ± 24.0 for IVL and 97.7 ± 25.9 for CB (p=0.99). The procedural cost difference was $3,632 (95% CI: $2833 to $4418, p < 0.001) with the main cost difference being driven by the cost of the randomized device. Strategy success, defined as stent delivery with a residual stenosis less than 20% in the absence of significant angiographic complication and not having to use alternative calcium modification devices, was also similar with 89.7% for IVL compared with 89.2% for CB (p=0.88). Thirty-day MACCE outcomes were the same between groups at 2.9%.
As part of an imaging-based approach to PCI of significantly calcified coronary lesions, cutting balloon angioplasty is a reasonable strategy when compared with intravascular lithotripsy. Not only is utilizing a cutting balloon safe and effective, it is also significantly less costly."
Suzanne J. Baron, MD, MSc, Director of Interventional Cardiology Research, Massachusetts General Hospital, Boston
The study was an investigator-initiated and investigator-conducted trial supported by a research grant from Boston Scientific Corporation.
Dr. Baron reported research/grant support from Acarix, Abiomed and Boston Scientific Corporation. She also received consultant fees/honoraria from Abbott, Boston Scientific Corporation, Edwards LifeSciences, HeartFlow, Medtronic, Picardia, Shockwave and Zoll Medical.
The results of the study were presented on Sunday, October 26, 2025, at 11:44 a.m. PT in the Main Arena (Hall A, Exhibition Level, Moscone South) at the Moscone Center during TCT 2025.
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