Overview
- In the 3,341‑patient SELUTION DeNovo trial, a sirolimus‑eluting balloon first strategy was noninferior to routine drug‑eluting stents for de novo disease, with target vessel failure of 5.3% versus 4.4% at one year and 80% of patients avoiding stent implantation.
- The U.S. SELUTION ISR trial found the sirolimus‑eluting balloon noninferior to a blended standard of care for in‑stent restenosis, with target lesion failure of 15.2% versus 13.5% at one year and a 99.18% posterior probability for noninferiority.
- A randomized comparison showed cutting balloon angioplasty noninferior to intravascular lithotripsy for calcified lesions on core‑lab IVUS, with similar stent expansion and a mean procedural cost that was $3,632 lower for the cutting balloon strategy.
- The VICTORY trial reported super‑high‑pressure non‑compliant balloons noninferior to intravascular lithotripsy for final stent expansion by OCT in severely calcified lesions, with comparable procedural success and safety.
- All results were presented at TCT 2025 in San Francisco with disclosed industry funding, and investigators reported no significant safety differences at one year while emphasizing the need for extended follow‑up.