JACC Cardiovasc Interv. 2026 Oct 9:S1936-8798(26)02404-0. doi: 10.1016/j.jcin.2026.08.014. Online ahead of print.
ABSTRACT
BACKGROUND: The clinical utility of optical frequency domain imaging (OFDI) for guiding endovascular therapy in femoropopliteal lesions has not been established. Additionally, the prognostic value of OFDI findings during drug-coated balloon (DCB) treatment for femoropopliteal lesions has never been evaluated.
OBJECTIVES: This study aimed to clarify the feasibility of OFDI-guided DCB treatment and investigate the OFDI findings associated with restenosis after DCB treatment in femoropopliteal lesions.
METHODS: This multicenter, prospective, observational study included patients with symptomatic, nonseverely calcified femoropopliteal lesions who underwent DCB treatment under OFDI guidance. Procedural success was defined as residual stenosis of less than 30% without flow compromise and without any procedural complications. The primary outcome was restenosis of the target lesion, defined as a peak systolic velocity ratio of ≥2.5, as measured by duplex ultrasound at rest or target lesion revascularization.
RESULTS: A total of 202 lesions were initially enrolled, of which 35 (17.3%) were excluded primarily because of severe calcification or inadequate OFDI data. Among the 167 analyzable lesions included in the present analysis, the procedural success rate and 1-year freedom from restenosis were 91.6% and 85.5%, respectively. In the procedural OFDI findings, a calcified nodule in the target lesion (subdistribution hazard ratio: 3.25; 95% CI: 1.01-10.42; P = 0.048) was associated with restenosis.
CONCLUSIONS: OFDI-guided DCB treatment is feasible in selected femoropopliteal lesions. An OFDI-detected calcified nodule is associated with an increased risk of restenosis after DCB treatment for femoropopliteal lesions.
PMID:42909422 | DOI:10.1016/j.jcin.2026.08.014