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Observational Study
. 2022 Mar 28;15(6):630-638.
doi: 10.1016/j.jcin.2022.01.019.

1-Year Outcomes of Fluoropolymer-Based Drug-Eluting Stent in Femoropopliteal Practice: Predictors of Restenosis and Aneurysmal Degeneration

Osamu Iida  1 , Mitsuyoshi Takahara  2 , Yoshimitsu Soga  3 , Terutoshi Yamaoka  4 , Masahiko Fujihara  5 , Daizo Kawasaki  6 , Shigeo Ichihashi  7 , Amane Kozuki  8 , Shinsuke Nanto  9 , Yasushi Sakata  10 , Toshiaki Mano  11 ; CAPSICUM Investigators
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Free article
Observational Study

1-Year Outcomes of Fluoropolymer-Based Drug-Eluting Stent in Femoropopliteal Practice: Predictors of Restenosis and Aneurysmal Degeneration

Osamu Iida et al. JACC Cardiovasc Interv. .
Free article

Abstract

Objectives: This study aimed to investigate the 1-year risk of restenosis and aneurysmal degeneration and explore the associated factors after femoropopliteal implantation of fluoropolymer-based drug-eluting stents (FP-DESs) for symptomatic atherosclerotic peripheral artery disease in real-world practice.

Background: Although clinical trials have demonstrated that FP-DES implantation has favorable 1-year outcomes, its performance in real-world practice has not been well elucidated.

Methods: This multicenter, prospective, observational study evaluated 1,204 limbs (chronic limb-threatening ischemia: 34.8%, mean lesion length: 18.6 ± 9.9 cm, chronic total occlusion: 53.2%, bilateral wall calcification: 41.9%) of 1,097 patients with peripheral artery disease (age: 75 ± 9 years, men: 69.4%, diabetes mellitus: 60.8%, chronic kidney disease: 66.2%) undergoing Eluvia (Boston Scientific) drug-eluting stent implantation for femoropopliteal lesions. The primary outcome measure was 1-year restenosis, whereas the secondary outcome measures were 1-year occlusive restenosis, stent thrombosis, target lesion revascularization, and aneurysmal degeneration.

Results: The 1-year occurrence rates of restenosis (12.9%), occlusive restenosis (9.2%), stent thrombosis (3.3%), target lesion revascularization (6.2%), and aneurysmal degeneration (16.8%) were found. Multivariate analysis demonstrated that dialysis, chronic limb-threatening ischemia, history of revascularization, a smaller reference vessel diameter, chronic total occlusion, and spot stenting were significantly associated with an increased risk of 1-year restenosis, whereas intravascular ultrasound use and subintimal wire passage were significantly associated with an increased risk of 1-year aneurysmal degeneration.

Conclusions: This study documented the 1-year clinical outcomes after femoropopliteal endovascular therapy with FP-DES implantation in real-world practice. The 1-year restenosis rate would be clinically acceptable, whereas the occurrence of occlusive restenosis and aneurysmal degeneration should be noted.

Keywords: aneurysmal degeneration; drug-eluting stent(s); endovascular therapy; femoropopliteal lesions; peripheral artery disease; restenosis.

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Conflict of interest statement

Funding Support and Author Disclosures The CAPSICUM study was supported by the Research Association for Lower Limb Artery Revascularization (LIBERAL) sponsored by the following companies: Boston Scientific Japan K.K., OrbusNeich Foundation, Terumo Corp., and Kaneka Medix Corporation. The funding companies played no role in the design of the study; selection of the enrolled patients; treatment strategy; revascularization procedures or equipment; or collection, analysis, or interpretation of the data. Drs Iida and Soga are consultants who received honoraria from Boston Scientific. Drs Yamaoka, Fujihara, Kawasaki, Ichihashi, and Kozuki have received remuneration from Boston Scientific Japan K.K. Dr Mano received a research grant from Abbott Vascular Japan. Dr Sakata has received honoraria 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. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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