Cardiovasc Interv Ther. 2026 May 23. doi: 10.1007/s12928-026-01291-1. Online ahead of print.
ABSTRACT
Drug-coated balloons (DCBs) are increasingly used in femoropopliteal (FP) endovascular therapy (EVT) to limit permanent scaffold implantation. Although this paradigm shift has substantially altered treatment strategies, its effects on real-world clinical outcomes remain unclear. Temporal trends in device selection and clinical outcomes after FP EVT were evaluated in contemporary practice. This multicenter, retrospective study included patients who underwent EVT for de novo FP artery disease at six institutions between July 2017 and December 2023. Patients were stratified into three equal, chronological eras (early, middle, and late). Trends in device use were evaluated, and clinical outcomes, including primary patency and restenosis patterns, were compared. Overall, 2815 patients were included in the analysis. DCB use increased substantially across eras (24.5% vs. 50.6% vs. 70.4%, p < 0.0001). Although the proportion of patients with chronic limb-threatening ischemia increased over time, lesion complexity seemed to decrease, with lower rates of severe calcification and poor distal runoff in the later era. The 1-year primary patency rates were comparable across the three eras (83% vs. 81% vs. 81%, p = 0.2688). Conversely, the incidence of re-occlusion in restenotic lesions declined progressively over time (37% vs. 35% vs. 26%, p = 0.0002). Despite substantial temporal changes in FP EVT strategy, including increased DCB use and more selective scaffold implantation, 1-year outcomes remained stable. Restenosis patterns shifted toward fewer reocclusive failures, indicating qualitative improvement in treatment outcomes. Contemporary FP EVT therefore reflects a more strategy-driven approach that preserves durable outcomes while reducing unfavorable restenosis patterns in real-world practice.
PMID:42177328 | DOI:10.1007/s12928-026-01291-1