Intracoronary Stenting and Restenosis - Randomized Trial of Drug-Eluting Stent Implantation or Drug-Coated Balloon Angioplasty According to Neointima Morphology in Drug-Eluting Stent REstenosis 5: Rationale and Design of the ISAR-DESIRE 5 Trial.

Abstract

In-stent restenosis (ISR) is the leading cause of revascularization failure, occurring in up to 10% of patients within 10 years after drug-eluting stent (DES) implantation, and is associated with increased mortality and rehospitalization. Guideline-writing authorities recommend DES over drug-coated balloons (DCB) for ISR treatment. However, this indication is mainly based on trials that did not incorporate intravascular imaging. Recent findings suggest that optical coherence tomography (OCT) patterns in ISR may influence treatment outcomes. The ISAR-DESIRE 5 trial is a randomized study to evaluate whether OCT-defined ISR tissue morphology affects treatment with DES versus DCB. 376 patients with ISR will be stratified by OCT pattern (homogeneous vs. non-homogeneous) and randomized 1:1 to DES or DCB. The trial is powered to detect an interaction between OCT pattern and treatment modality on the 24-month incidence of major adverse cardiac events and represents a step toward establishing a more individualized approach to ISR management.Trial registration (ClinicalTrials.gov): NCT05544864.