Association Between Preoperative Below-The-Knee Runoff and Clinical Outcomes in Patients with Femoropopliteal Occlusive Disease Treated With Drug-Coated Balloons

OBJECTIVE: The objective of this study was to investigate the relationship between preoperative below-the-knee (BTK) runoff and major adverse limb event (MALE)-free survival, as well as clinically-driven target lesion revascularization (CD-TLR) and all-cause mortality, in patients with femoropopliteal occlusive disease (FPOD) treated with drug-coated balloons (DCB). METHODS: A large-scale, multicenter, prospective study was initiated in January 2021. Endpoint outcomes were obtained prior to December 31, 2024. The exposure of interest was BTK runoff, with the primary endpoint being MALE-free survival, and secondary endpoints being CD-TLR and all-cause mortality. Multivariate Cox regression was employed to control for confounding variables, and stratified analyses were conducted. RESULTS: A total of 1757 participants (36.1% male) with a mean (SD) age of 71.2 (9.5) years were enrolled in the study. The median follow-up duration was 1.5 years. In the fully adjusted model, 1 runoff, 2 runoff and 3 runoff were associated with significantly lower incidences of MALE or death compared with 0 runoff (1 runoff: hazard ratio [HR]=0.75, 95% confidence interval [CI]: 0.56, 1.00, p=0.054; 2 runoff: HR = 0.63, 95% CI: 0.46, 0.87, p=0.006; 3 runoff: HR=0.49, 95% CI: 0.34, 0.72, p