Coronary restenosis affects one in five patients who receive drug-eluting stents, forcing difficult decisions about repeat interventions that carry cumulative risks and complications. This challenge has driven the search for less invasive alternatives that preserve vessel architecture while preventing tissue regrowth.
The SELUTION4ISR trial demonstrated that sirolimus-eluting balloons achieved comparable safety and efficacy to repeat stenting in 418 patients with in-stent restenosis. Target lesion failure rates at one year were statistically equivalent between the balloon group (16.2%) and control treatments including repeat stents or standard balloon angioplasty (14.5%). The drug-eluting balloon delivers sirolimus directly to vessel walls without leaving permanent hardware, potentially reducing long-term complications associated with multiple stent layers.
This finding addresses a significant gap in interventional cardiology, where repeat stenting creates mechanical challenges and increased thrombotic risk from overlapping metal platforms. Drug-eluting balloons offer theoretical advantages by avoiding additional foreign material while delivering targeted anti-proliferative therapy. However, the technology requires precise deployment and optimal drug transfer, factors that may influence real-world effectiveness compared to controlled trial conditions. The 16% failure rate in both groups underscores that restenosis remains a stubborn clinical problem regardless of treatment approach. While this study establishes non-inferiority for drug-eluting balloons, it represents an incremental advance rather than a breakthrough solution. The choice between approaches will likely depend on lesion characteristics, patient anatomy, and operator expertise rather than clear superiority of either strategy.