Excimer Laser Ablation combined with Drug-coated Balloon for De novo Atherosclerotic Lesions in Lower Extremities
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Background
The efficacy of excimer laser ablation (ELA) in de novo atherosclerotic lesions of lower extremity artery disease (LEAD) is unknown.
Objectives
This real-world study aimed to evaluate the safety and efficacy of ELA combined with drug-coated balloon (DCB) versus DCB alone in LEAD patients.
Methods
In 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).
Results
A 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).
Conclusion
In 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 Registration
URL: https://www.chictr.org.cn/ . Unique identifier: ChiCTR2100051263
