Recent studies such as ECLIPSE have demonstrated the safety of non-compliant (NC) balloons compared with orbital atherectomy, while IVL has shown efficacy in registries and non-comparative studies. Still, a direct head-to-head evaluation was needed.
The VICTORY Trial (Intravascular Lithotripsy vs. Super-High-Pressure Non-Compliant Balloon for Treatment of Calcified and Refractory Coronary Lesions) was a prospective, multicenter, randomized non-inferiority study.
Patients with acute or chronic coronary syndromes and severely calcified lesions (OCT-guided) requiring DES implantation were included. STEMI and cardiogenic shock were excluded.
Participants were randomized 1:1 to lesion preparation with OPN non-compliant balloon (OPN NCB) or IVL. The primary endpoint was percentage stent expansion (SE) by OCT. Secondary endpoints included adequate (>80%) or optimal (>90%) expansion, procedural success, strategy success, and 30-day safety outcomes.
A total of 282 patients were randomized across Switzerland, Canada, and Poland. Mean age 71 years; 25% women; 30% diabetes; 40% prior MI; ~60% multivessel disease. Most lesions showed severe angiographic calcium and ≥270° calcium burden on OCT.
Regarding the primary outcome, final stent expansion was similar between groups (mean difference: 1.0%, 95% CI −2.45 to 4.45; superiority p=0.57; non-inferiority p<0.0001), confirming the non-inferiority of OPN NCB compared with IVL. The results were consistent across subgroup analyses.
Final SE was similar between groups (mean difference 1.0%; 95% CI −2.45 to 4.45; superiority p=0.57; non-inferiority p<0.0001). Secondary outcomes were also comparable, including procedural success (92% vs. 86%) and strategy success (98.6% both). Safety outcomes showed low perforation rates (≤1%) and infrequent MACE (2.9% vs. 8.0%; p=0.081) without significant differences.
Conclusions
OPN NCB achieved stent expansion and safety outcomes similar to IVL, emerging as a more accessible and cost-effective option for OCT-guided treatment of severely calcified coronary lesions.
Presented by Matthias Bossard at TCT 2025 Late-Breaking Clinical Trials, October 26, San Francisco, USA.
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