Real-world outcomes of Cook Zilver PTX in femoro-popliteal district from multicenter experience

Abstract

Background: The purpose is to evaluate the follow-up outcomes after femoro-popliteal stenting with Cook Zilver PTX in a multicenter experience.

Methods: Collected data from four Units were retrospectively joined and analyzed considering Zilver PTX deployed from August 2009 according to the instruction for use. Patient demographics, preoperative comorbidities, Rutherford classification, arterial characteristics and stent data were considered. Target lesion revascularization (TLR) was defined as reintervention performed for ≥50% diameter stenosis after recurrent clinical symptoms. Primary outcome was the freedom from TLR (ffTLR) and its risk factors. Secondary outcomes were primary patency (PP) of the stent, amputation-free survival (AFS) and their risk factors.

Results: Considering 203 patients (mean age: 73.5 years ±10.6; male: 66.5%) and 263 stents (median 2 stents/patient, range 1-5stent/patient), chronic limb-threatening ischemia (CLTI) affected 154 patients (75.9%). The length of the treated lesion was <120 mm in 99 (48.8%), ≥120 mm and <200 mm in 65 (32%) and ≥200 mm in 39 (19.2%) cases, respectively; the reference vessel mean diameter was 5.5±0.7 mm; chronic total occlusion was treated in 153 (75.4%) patients, the popliteal artery was involved in 56 (27.6%) cases and prior endovascular intervention was performed in 27 (13.3%) cases. Two or more crural run-off vessels were patent in 124 (61.1%). Mean follow-up was 23.2 months ±21.3. At 1, 2 and 3 years, the ffTLR was 90.6±4.2%, 86.4±6.1% and 80.4±8.3%, respectively, and the PP was 85.6±5.0%, 74.2±7.6% and 72.7±8.2%, respectively. Negative prognostic factor for ffTLR and PP was the reference vessel diameter (P=0.001 and P<0.001, respectively). At 1, 2 and 3 years, the AFS was 81.8±6.0%, 75.5±7.1% and 74.2±7.5% respectively; coronary artery disease (P=0.041) and CLTI (P=0.011) resulted negative prognostic factors.

Conclusions: In the real-world practice, around 3/4 of patients were treated for CLTI. The rate of ffTLR is high, and PP is substantially lower. A small vessel diameter (<5 mm) is a negative factor for both ffTLR and PP. The rate of AFS is about 75% at 2 years and CLTI and coronary artery disease are negative prognostic factors.