Impact of Procedural Techniques on Midterm Patency of Fluoropolymer-Based Drug-Eluting Stent Placed in the Femoropopliteal Artery

Purpose: To investigate the impact of compliance with recommended procedural techniques on the midterm patency of a fluoropolymer-based drug-eluting stent (FP-DES) in the femoropopliteal artery.

Materials and methods: This retrospective study included 200 femoropopliteal lesions (chronic limb-threatening ischemia, 59%; chronic total occlusion, 41%) in 173 patients (male, 66%; diabetes mellitus, 62%; hemodialysis, 40%) with lower extremity arterial disease who underwent intravascular ultrasound (IVUS)-guided endovascular therapy with FP-DES between January 2016 and July 2021. The primary outcome measure was restenosis, defined as a peak systolic velocity ratio of >2.4 based on the duplex US findings. The association between procedural techniques and incidence of restenosis was investigated using Cox proportional hazards regression models.

Results: The 2-year cumulative incidence of restenosis was 19.5% (SD ± 3.3). Multivariate analysis revealed that noncompliance with recommended procedural techniques, such as plaque burden at the stent edge of <50%, a minimum stent area (MSA) of >12 mm², and stent placement within the P1 segment, was independently associated with an increased risk of restenosis (hazard ratios [HRs], 3.22, 4.71, and 4.67 and P = .004, P < .001, and P < .001, respectively). The 2-year restenosis risk for procedures performed in compliance with all 3-technical criteria was 8.4% (SD ± 3.4), whereas the risks for those in compliance with 2-technical criteria or 0- or 1-technical criteria were 25.0% (SD ± 6.2) and 48.6% (SD ± 10.4), respectively. HRs relative to 3-technical criteria compliance were 3.79 (P = .007) and 11.85 (P < .001), respectively.

Conclusions: Noncompliance with recommended procedural techniques, including plaque burden at the stent edge of <50%, MSA of >12 mm², and stent placement within the P1 segment, was significantly associated with an increased risk of 2-year restenosis after FP-DES implantation in the femoropopliteal artery.