New Drug-Eluting Balloon Matches Standard Stents in Safety and Effectiveness: SELUTION4ISR Trial
USA: A new drug-eluting balloon (DEB) may offer a safer and equally effective alternative to conventional metallic stents for patients with coronary in-stent restenosis (ISR), according to the results of the SELUTION4ISR Trial, an international study led by researchers at Mount Sinai Hospital, New York. The findings, presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2025 conference in San Francisco, mark a major advancement in interventional cardiology.
ISR is a common complication where a previously treated coronary artery narrows again following stent implantation. The standard approach to managing ISR involves inserting an additional drug-eluting stent (DES) or using balloon angioplasty. However, adding more stent layers can complicate future procedures and increase the risk of recurrent blockages.
The SELUTION4ISR Trial is the first large, U.S.-regulated randomized clinical trial comparing a sirolimus-coated balloon with the current standard of care, which includes repeat stenting or plain balloon angioplasty. The study evaluated the SELUTION Sustained Limus Release (SLR) balloon, which delivers sirolimus—a potent anti-proliferative drug—through a micro-reservoir system that provides sustained release for up to 90 days, mimicking the effects of drug-eluting stents but without leaving a permanent implant.
A total of 418 patients with coronary ISR and one or two prior stents were enrolled in the multicenter, single-blind trial. Of these, 197 received the sirolimus-eluting balloon, while 193 underwent standard treatment (approximately 80% with new DES and 20% with plain balloon angioplasty). The study’s primary endpoint was target lesion failure at one year, measured by the need for repeat intervention or major adverse cardiac events.
Key Findings:
- After one year, the outcomes showed non-inferiority between the sirolimus balloon and standard treatment approaches.
- Target lesion failure was observed in 16.2% of patients treated with the sirolimus balloon and 13.5% in those receiving standard care, with no statistically significant difference.
- The rate of repeat procedures was nearly the same—12.7% for the sirolimus balloon and 12.4% for standard care.
- The sirolimus balloon demonstrated a comparable safety profile, with no increase in complications such as vessel dissection or thrombosis.
According to Dr. Roxana Mehran, Co-Principal Investigator and Director of Interventional Cardiovascular Research at Mount Sinai, “For the first time, we’ve demonstrated that a sirolimus-eluting balloon can perform as effectively as standard therapy for in-stent restenosis while eliminating the need for another metal layer. This represents a simpler and safer treatment option for patients.”
Researchers noted that the balloon performed particularly well among patients who had previously undergone balloon angioplasty, showing improved outcomes compared with non-drug-coated balloons. However, repeat stenting remained slightly superior in patients with only one existing stent layer.
The findings support the sirolimus-eluting balloon as a viable “metal-free” alternative for patients who are at higher risk of complications from additional stent placement or prolonged antiplatelet therapy.
Investigators plan an extended follow-up over five years to assess the long-term safety, durability, and cost-effectiveness of the sirolimus balloon. If confirmed, the results could pave the way for a shift toward “leave nothing behind” strategies in treating coronary restenosis—offering patients a simpler and potentially safer path forward in managing recurrent coronary blockages.
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