Osamu Iida
Current Position
Kansai Rosai Hospital
Short Topics Session

Topic: One-year outcomes of fluoropolymer-based drug-eluting stent in the femoropopliteal practice: restenosis and aneurysmal degeneration predictors


Objectives: The current study sought to investigate the 1-year risk of restenosis and aneurysmal degeneration, and to explore their associated factors after fluoropolymer-based drug-eluting stent (FP-DES) implantation for symptomatic atherosclerotic peripheral artery disease (PAD) in real-world femoropopliteal (FP) practice.
Background: Although clinical trials demonstrated that FP-PES had favorable 1-year outcomes, its performance and risk of outcomes in real-world practice have not been well elucidated.
Methods: This multicenter, prospective, observational study registered 1204 limbs (chronic limb-threatening ischemia [CLTI]: 34.8%, average lesion length: 19.7 ± 18.4cm, chronic total occlusion: 53.2%, bilateral calcification: 41.9%) of 1097 PAD patients (age: 75 ± 9 years, male: 69.4%, diabetes mellitus: 60.8%) undergoing Eluvia DES implantation for FP lesions. The primary endpoint was 1-year restenosis rate, while secondary endpoints included the rate of target lesion revascularization (TLR), and aneurysmal degeneration. The morphology of in-stent restenosis also was evaluated.
Results: The rate of 1-year restenosis, TLR, and aneurysmal degeneration was 13.4%, 6.2%, 16.3%, respectively. The 1-year incidence of occlusive restenosis was 9.5%, and that of stent thrombosis was 3.3%. Multivariate analysis demonstrated that CLTI, history of revascularization, a smaller reference vessel diameter, chronic total occlusion, and spot stenting were significantly associated with 1-year restenosis, while lower body mass index, intravascular ultrasound use, and subintimal wire passage were significantly associated with 1-year aneurysmal degeneration.
Conclusions: The current study documented clinically acceptable 1-year outcomes after FP-DES implantation in real-world FP practice; however, substantial incidence of stent thrombosis and aneurysmal degeneration was observed.