Abstract

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.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

URL: https://www.chictr.org.cn/. Unique identifier: ChiCTR2100051263

Funding Statement

This study was supported by Noncommunicable Chronic Diseases-National Science and Technology Major Project (grant no. 2023ZD0504300), the Postdoctoral Fellowship Program and China Postdoctoral Science Foundation (grant no. BX20250267), Youth Fund of Fudan University Affiliated Zhongshan Hospital (grant no. ZSZP202413), Outstanding Resident Clinical Postdoctoral Program of Zhongshan Hospital Affiliated to Fudan University, and the National Natural Science Foundation of China (grant no. 82270507).

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

This study design was approved by the Ethics Committee for the Protection of Human Subjects at Zhongshan Hospital, Fudan University, Shanghai, China. All included patients were informed about the nature of the study and gave their written informed consent.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

The datasets analyzed during this study are available from the corresponding author on reasonable request.

AbbreviationABIAnkle-Brachial IndexASOAtherosclerotic ObliteransBTKBelow-The-KneeCD-TLRClinically Driven Target Lesion ReinterventionChiCTRChinese Clinical Trial RegistryCTOChronic Total OcclusionDADirectional AtherectomyDCBDrug-Coated BalloonELAExcimer Laser AblationFDA U.S.Food and Drug AdministrationISRIn-Stent RestenosisLEADLower Extremity Artery Disease MAE Major Adverse EventMLDMinimal Luminal Diameter PAD Peripheral Arterial DiseasePACSSPeripheral Arterial Calcium Scoring SystemPSVRPeak Systolic Velocity RatioPTAPercutaneous Transluminal AngioplastyRCTRandomized Controlled TrialRVDReference Vessel Diameter