In-stent restenosis (ISR) continues to be a relevant clinical challenge in contemporary PCI practice. In the DES era, its incidence reaches 4–8% during the first year and persists at around 1% annually, accounting for over 10% of current PCI procedures. Although repeat DES implantation remains the guideline-recommended strategy (Class IA), layering multiple metallic components may compromise coronary flow and increase long-term event risk.
The SELUTION4ISR study evaluated the efficacy and safety of a sirolimus-eluting balloon (SELUTION SLR DEB) compared with standard treatment, consisting predominantly of DES re-implantation (~80%) and to a lesser extent plain balloon angioplasty (~20%).
This was a randomized, multicenter, non-inferiority trial including 418 patients with ISR in a single native coronary vessel previously treated with BMS or DES, with lesion length ≤26 mm and reference diameter 2.0–4.5 mm. Lesions with more than two stent layers, complex bifurcations, total occlusions, or visible thrombus were excluded.
The primary endpoint was target lesion failure (TLF), defined as the composite of cardiac death, vessel-related MI, and clinically indicated target lesion revascularization.
At 1-year follow-up, TLF occurred in 15.2% with SELUTION DEB vs. 13.5% with standard treatment, achieving non-inferiority (HR 1.14; 95% CI 0.69–1.90; p=0.608). There were no significant differences in individual components: cardiac mortality (1.9% vs. 1.4%), target-vessel MI (7.1% vs. 4.8%), or target-vessel revascularization (11.9% vs. 11.5%). Safety event rates were also comparable.
Conclusion
SELUTION becomes the first sirolimus-eluting balloon to demonstrate non-inferiority versus current standard practice for ISR treatment, providing an effective alternative that avoids additional metal layers.
Presented by Donald E. Cutlip at TCT 2025 Late-Breaking Clinical Trials, October 26, San Francisco, USA.
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