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

ABSTRACT 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.