Background: Although the 1-year clinical outcomes of fluoropolymer-based drug-eluting stents (FP-DES) were favorable for the treatment of real-world femoropopliteal lesions in symptomatic peripheral artery disease (PAD), their performance beyond 1 year remained unknown. The current study determined the 3-year clinical course of FP-DES implantation for real-world femoropopliteal lesions.
Methods: This multicenter, prospective, observational study evaluated 1204 limbs (chronic limb-threatening ischemia, 34.8%; mean lesion length, 18.6 ± 9.9 cm, chronic total occlusion: 53.2%) of 1097 patients with PAD (age, 75 ± 9 years; diabetes mellitus, 60.8%) undergoing FP-DES implantation for femoropopliteal lesions. The primary outcome measure was 3-year restenosis. The secondary outcome measures included 3-year occlusive restenosis, stent thrombosis, target lesion revascularization (TLR), and aneurysmal degeneration.
Results: The 3-year cumulative occurrence of restenosis was 27.3%, whereas that of occlusive restenosis, stent thrombosis, and TLR was 16.1%, 7.3%, and 19.6%, respectively. The annual occurrence of restenosis decreased by 12.0%, 9.5%, and 5.8% in the first, second, and third year, respectively ( p < 0.001). Similarly, the rates of occlusive restenosis and stent thrombosis decreased ( p < 0.001 and p = 0.007, respectively), whereas the rate of TLR remained unchanged for 3 years ( p = 0.15). The incidence of aneurysmal degeneration at 3 years (15.7%) did not significantly differ from that at 1 and 2 years ( p = 0.69 and 0.20, respectively).
Conclusions: This study highlights the favorable long-term clinical course of FP-DES in real-world practice, emphasizing the importance of monitoring for occlusive restenosis and stent thrombosis while considering the potential onset of aneurysmal degeneration.
Competing Interests: Declaration of conflicting interestsDrs Iida and Soga are consultants who received honoraria from Boston Scientific. Drs Yamaoka, Fujihara, Kawasaki, and Ichihashi received remuneration from Boston Scientific Japan KK. Dr Mano received a research grant from Abbott Vascular Japan. Dr Sakata received an honorarium from Otsuka Pharmaceutical, Daiichi Sankyo, Takeda Pharmaceutical, Mitsubishi Tanabe Pharma, Medtronic Japan, and Boehringer Ingelheim Japan; a research grant from Edwards Lifesciences, FUJIFILM RI Pharma, REGiMMUNE, and Roche Diagnostics; and a scholarship (educational) grant/endowed chair from Otsuka Pharmaceutical, Johnson & Johnson, St Jude Medical Japan, Daiichi Sankyo, Takeda Pharmaceutical, Mitsubishi Tanabe Pharma, Teijin Pharma Limited, Boehringer Ingelheim Japan, Bayer Yakuhin, BIOTRONIK Japan, Boston Scientific, and Medtronic Japan. The remaining authors have no conflicts of interest to declare.