A New Era in PCI: Sirolimus-Eluting Balloon Could Change How We Treat Coronary Disease — Insights from TCT 2025
A New Era in PCI: Sirolimus-Eluting Balloon Could Change How We Treat Coronary Disease — Insights from TCT 2025
Source: TCT 2025 – San Francisco, October 25–28, 2025
(Recent trials presented at TCT 2025 (Oct 25–28, San Francisco) show that sirolimus-eluting balloons may deliver results comparable to stents—while eliminating the need to leave metal behind, signaling a potential shift toward a fully restorative, stent-free PCI strategy).
Highlights from TCT 2025:
1. SELUTION DeNovo Trial (de novo = new lesions)
• Patients: 3,323 with newly diagnosed coronary artery disease.
• Results: Target Vessel Failure (TVF) 5.3 % vs 4.4 % in DES → non-inferior.
• ≈ 80 % avoided stent implantation.
• Meaning: Comparable efficacy with fewer implants → possible paradigm shift in PCI.
2. SELUTION4ISR Trial
• Patients: 418 with in-stent restenosis (ISR).
• Comparator: Standard care (≈ 80 % DES + 20 % balloon angioplasty).
• Target Lesion Failure (TLF): 15.2 % vs 13.5 % → non-inferior.
• Safety: No significant differences in cardiac death, MI, or repeat revascularization.
• Implication: First sirolimus DEB to match DES for ISR without adding metal layers.
3. Expert Perspective
• Dr. Spaulding: “A journey toward stent-free PCI.”
• Dr. Cutlip: Confirmed non-inferiority in ISR management.
• Dr. Sethi: Predicted DEB therapy could become future standard of care.
Key Takeaway:
The sirolimus-eluting balloon shows comparable efficacy, safety, and durability to DES while preserving vessel physiology — a step that may redefine how we treat coronary disease in the years ahead.
