Cutting balloon angioplasty was found to be non-inferior to intravascular lithotripsy (IVL) in achieving optimal stent expansion for patients with moderate-to-severely calcified coronary lesions undergoing percutaneous coronary intervention (PCI), according to results of the ShortCUT trial presented by Dr. Suzanne J. Baron at TCT 2025. The study also found that cutting balloon angioplasty offered similar procedural and clinical outcomes at a significantly lower procedural cost.
The ShortCUT trial is the first adequately powered, randomized controlled trial to compare intravascular lithotripsy to other balloon-based device for the treatment of calcified coronary artery disease. The trial enrolled 413 patients at 21 U.S. sites, including those presenting with stable angina or non-ST elevation acute coronary syndromes (NSTE-ACS) and moderate-to-severe coronary calcification confirmed by intravascular ultrasound (IVUS). Patients with STEMI, cardiogenic shock, or excessive vessel tortuosity were excluded.
Participants were randomized 1:1 to receive either IVL or cutting balloon angioplasty, with or without planned rotational atherectomy, prior to drug-eluting stent (DES) implantation. The primary endpoint was post-procedural minimal stent area (MSA) at the site of maximal calcium burden, as adjudicated by an independent IVUS core laboratory.
Across the entire study population, the mean post-procedural MSA was 8.6 ± 2.5 mm² with IVL and 8.0 ± 2.4 mm² with the cutting balloon. The between-group difference of 0.6 mm² met the prespecified criterion for non-inferiority (p=0.007). There was no statistical difference in superiority testing (p=0.993). Stent expansion, calcium fracture rates, and strategy success—defined as stent delivery with residual stenosis <20% without requiring an alternative device, were similar between groups (89.7% for IVL vs. 89.2% for cutting balloon).
In subgroup analyses, findings were consistent among patients undergoing planned rotational atherectomy. In those without planned atherectomy, IVL achieved a slightly larger MSA (8.8 ± 2.7 mm² vs. 7.7 ± 2.3 mm²), though both approaches resulted in high rates of stent expansion and similar calcium fracture patterns. Cutting balloon angioplasty did not meet non-inferiority, however this may have been partly due to differences in vessel size between groups, as stent expansion and indices of fracture were similar.
Safety outcomes were excellent, with low complication rates in both groups. The incidence of intraprocedural adverse events and 30-day major adverse cardiac and cerebrovascular events (MACCE) was identical at 2.9%. Device-related complications such as perforation, abrupt closure, or significant dissection were infrequent and comparable.
However, a notable finding was the substantial cost difference between the two modalities. The mean total procedural cost per target vessel was $13,051 for IVL compared with $9,409 for cutting balloon angioplasty, representing a cost difference of $3,632 (p<0.001). This cost gap was consistent across both planned and non-planned atherectomy cohorts.
Investigators concluded that cutting balloon angioplasty is a reasonable, cost-effective, and widely accessible alternative to IVL for the treatment of significantly calcified coronary lesions when guided by intravascular imaging. While both techniques achieved similar safety and efficacy, the lower procedural cost of the cutting balloon approach could have important implications for practice, especially in cost-sensitive healthcare settings.
Reference: Suzanne J. Baron et al., The ShortCUT Trial: Shockwave Lithotripsy Compared to Cutting Balloon Treatment in Calcified Coronary Artery Disease, TCT Conference 2025, San Francisco.https://www.tctconference.com/
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