SnackableHealth™ | SELUTION4ISR: Sirolimus-Eluting DCB Redefines Treatment Strategy for In-Stent Restenosis

In this SnackableHealth™ episode recorded during TCT 2025, interventional cardiologists Dr. Donald Cutlip and Dr. C. Michael Gibson explored the pivotal SELUTION4ISR trial, which compared a sirolimus-eluting drug-coated balloon (DCB) with drug-eluting stents (DES) and plain balloon angioplasty for patients with in-stent restenosis (ISR).

Dr. Cutlip explained that ISR continues to be a persistent challenge in contemporary PCI practice, particularly when additional stenting may not be ideal. “The concept of a sirolimus-eluting balloon is appealing because it delivers the drug locally without adding another layer of metal,” he noted, emphasizing the potential for improved vessel healing and durability.

The SELUTION4ISR study demonstrated that the sirolimus-eluting DCB achieved comparable or superior late lumen gain and significantly lower restenosis rates compared with repeat DES implantation. The treatment was also associated with fewer procedural complications and excellent safety outcomes, offering a compelling alternative for patients with recurrent ISR or high anatomic complexity.

Dr. Gibson highlighted that consistent and controlled sirolimus release via the micro-reservoir technology of the SELUTION platform could explain these durable outcomes. He concluded that the results “represent a meaningful advance in ISR management and may shift clinical preference toward drug-coated balloons as a first-line approach in selected patients.”