Debulking With Excimer Laser Coronary Angioplasty Versus Balloon Angioplasty in Patients With in Stent Restenosis (ELDISR Study): A Randomized Controlled Trial

OBJECTIVES: Excimer laser coronary angioplasty (ELCA) is a safe and effective method for lesion preparation. However, its impact on clinical outcomes in patients with in-stent restenosis (ISR) undergoing drug-coated balloon (DCB) angioplasty remains unclear. This study aims to evaluate the effect of ELCA-based lesion preparation on the clinical outcomes of ISR patients treated with standard DCB angioplasty. METHODS: In this prospective, single-center, randomized controlled trial, patients with ISR were randomized 1:1 to either ELCA (+) or ELCA (-). The ELCA (+) group received ELCA for lesion preparation followed by standard DCB angioplasty, while the ELCA (-) group received standard DCB angioplasty alone. The primary endpoint was the rate of target lesion revascularization (TLR) within 1 year. Safety was also evaluated. RESULTS: A total of 110 patients were randomized to either the ELCA (+) group (n = 55) or the ELCA (-) group (n = 55). The mean age of the study participants was 64.5 years, 89 (80.9%) were men and 51 (46.4%) had diabetes mellitus. The procedure was successful in all patients. The primary endpoint event occurred in five patients (cumulative incidence, 9.1%) in the ELCA (+) group and in 13 patients (cumulative incidence, 23.6%) in the ELCA (-) group (HR, 0.38; 95% CI, 0.15-0.95; p = 0.038). CONCLUSIONS: Lesion preparation with ELCA before DCB angioplasty is a safe and effective strategy for patients with ISR, associated with a lower incidence of TLR compared to standard DCB angioplasty alone. However, due to the limited sample size and single-center design, these findings should be considered hypothesis-generating. Future validation requires confirmation through multicenter studies with larger patient populations. TRIAL REGISTRATION: Unique identifier: ChiCTR2300068962.