Excimer Laser Ablation combined with Drug-coated Balloon for De novo Atherosclerotic Lesions in Lower Extremities

BackgroundThe efficacy of excimer laser ablation (ELA) in de novo atherosclerotic lesions of lower extremity artery disease (LEAD) is unknown. ObjectivesThis real-world study aimed to evaluate the safety and efficacy of ELA combined with drug-coated balloon (DCB) versus DCB alone in LEAD patients. MethodsIn this prospective, multicenter, real-world trial (ChiCTR2100051263), patients with de novo atherosclerotic lesions of LEAD were enrolled and allocated to either ELA + DCB or DCB-alone group in a 1:1 ratio. The primary endpoint was 12-month primary patency, with secondary endpoints including technical success, clinically driven target lesion reintervention (CD-TLR), and changes in ankle-brachial index (ABI). ResultsA total of 136 patients were enrolled in the study. At baseline, patients in the ELA + DCB group presented significantly higher Rutherford classification (3.7 {+/-} 0.9 vs. 4.2 {+/-} 1.0, p = 0.007) and longer mean lesion lengths (7.4 {+/-} 2.5 cm vs. 8.4 {+/-} 1.9 cm, p = 0.012). The ELA + DCB group demonstrated significantly superior 12-month primary patency (87.5% vs. 71.2%, p = 0.03) and technical success rates (92.7% vs. 79.4%, p = 0.046) compared to the DCB-alone group. Kaplan-Meier analysis further confirmed sustained patency benefit with ELA + DCB (p = 0.015). ConclusionIn this real-world trial, ELA appears to be a promising therapy for LEAD in terms of safety and efficacy. However, these findings need to be corroborated by larger, randomized studies. Clinical Trial RegistrationURL: https://www.chictr.org.cn/. Unique identifier: ChiCTR2100051263