Background: The impact of lipid-rich plaques (LRPs) in the femoropopliteal artery on limb outcomes remains underexplored. We investigated the influence of LRPs on limb outcomes in patients undergoing endovascular therapy (EVT) for femoropopliteal disease. Methods: This single-center, prospective noninterventional observational study included patients undergoing drug-coated balloon angioplasty for femoropopliteal disease between July 2022 and November 2024. Near-infrared spectroscopy-intravascular ultrasound (NIRS-IVUS) assessment was conducted on the entire femoropopliteal arterial segment. LRP was defined as plaque with a maximum lipid-core burden index in any 4-mm region > 400. The primary outcome was major adverse limb events (MALEs) at 12 months. Secondary outcomes included primary patency and target-vessel revascularization (TVR) at 12 months. TVR was defined as any repeat EVT or surgical bypass of any segment of the target vessel. Results: Fifty participants were divided into LRP ( n = 19) and non-LRP ( n = 31) groups. The LRP group had significantly lower freedom from MALE at 12 months compared with the non-LRP group (69.1%, 95% CI: 35.7–87.6 vs 92.3%, 95% CI: 72.1–98.0, log-rank p = 0.01). LRP was associated with poorer freedom from MALE at 12 months (hazard ratio HR: 6.3, 95% CI: 1.3–38.8, p = 0.02). Both groups showed comparable primary patency and freedom from TVR at 12 months (log-rank p = 0.03 for both). LRP was associated with lower primary patency (HR: 5.1, 95% CI: 0.97–26.7, p = 0.054) and lower freedom from TVR (HR: 5.3, 95% CI: 1.01–27.8, p = 0.049) at 12 months. Conclusion: LRPs were associated with poor 12-month limb outcomes in patients undergoing EVT for femoropopliteal disease. University Hospital Medical Information Network (UMIN) Clinical Trials Registry ID: UMIN000049231 .
Sato et al. (2026) studied this question.