Long-term outcomes after treatment of femoro-popliteal disease with Zilver PTX: a multicenter real-world study.

Background: The purpose is to evaluate real-world 5-year outcomes of Cook Zilver PTX drug eluting stent (DES) in femoro-popliteal district from a multicenter experience.

Methods: The retrospective observational multicenter study included patients with peripheral arterial disease treated with Zilver PTX in femoro-popliteal segment. Patients treated outside the instruction for use were excluded. We gathered patient demographics, preoperative comorbidities, clinical, arterial and stent characteristics. Target lesion revascularization (TLR) was defined as reintervention performed for ≥50%-diameter stenosis after recurrent clinical symptoms. Primary outcome was freedom from TLR (ffTLR). Secondary outcomes were stent primary patency (PP), amputation-free survival (AFS).

Results: Patients were 203 (mean age: 73.5years±10.6; male:66.5%), with coronary artery disease in 93 cases (45.8%) and chronic limb-threatening ischemia (CLTI) in 154 (75.9%). Lesion length was ≥200 mm in 39 patients (19.2%), reference vessel mean diameter was 5.5±0.7 mm, lesion was a chronic total occlusion in 153 (75.4%) patients. Mean follow-up was 3.6±2.5 years. At 2, 4 and 5 years: ffTLR was 86.1%, 79.1% and 74.9%, respectively; PP was 73.7%, 64% and 61.2% and AFS was 75.1%, 64.3% and 53.4%, respectively.

Conclusions: In real-world practice, Zilver PTX DES in femoro-popliteal segment reveals favorable 5-year results. Despite the high rate of CLTI patients, ffTLR and PP are comparable with already published randomized trial. However, AFS rate remains low.