Why is this study important?

• After drug-eluting stents (DESs), in-stent restenosis (ISR) occurs in 4-8% of patients within one year and continues in over 1% of patients annually (>10% of PCI is ISR)
• Although DES has a Class 1A recommendation, many technologies have been explored to avoid deploying multiple layers of stent
• Paclitaxel drug-coated balloons (DCBs) have emerged as a new option for ISR treatment relative to POBA in clinical studies
• Sirolimus has a wider therapeutic window, but development had previously been delayed due to complexities of drug delivery and tissue uptake 

What question was the study supposed to answer?

• To show that a DEB approach in ISR can achieve non-inferiority to standard of care (SOC) without the addition of another stent layer.
• The SELUTION4ISR trial is a prospective, multicenter, single-blinded, randomized, controlled trial. A total of 418 subjects with bare metal or drug-eluting stent (DES) ISR with up to two previous stent procedures at the target lesion, lesion length <26 mm and reference diameter ≥2.0 mm - ≤4.5 mm were randomized 1:1 to treatment with either the SELUTION SLR DEB (SLR DEB) or SOC, which included either repeat DES or balloon angioplasty without drug coating.
• A subset of subjects underwent planned angiographic and optical coherence tomography follow-up.
• The primary endpoint was target lesion failure, defined as cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularization at 12 months follow-up.
• The study sequentially assessed noninferiority of the SLR DEB to SOC in the overall cohort, followed by noninferiority and then superiority of the SLR DEB to DES in the cohort with only one previous stent at the target lesion.

What did this study show?

• SELUTION DEB is the first and only DEB to demonstrate non-inferiority against a SOC (including 80% DES) for the treatment of ISR. SELUTION DEB is a safe and effective alternative to SOC (~80% DES and 20% BA) ISR treatment, avoiding additional layers of stent
• The role of DEB versus DES for lifetime management of ISR will be studied through long-term follow-up