5-years patency results of Zilver PTX on the femoro-popliteal arterial segment: A Northern Sydney experience.

Background: The burden of peripheral arterial disease is increasing. Treatment of femoro-popliteal lesions remains challenging despite novel endovascular devices. Drug-eluting stents suppress post-treatment inflammation and reducing neo-intimal hyperplasia to reduce in-stent restenosis.

Methods: A multi-centre retrospective 5-years longitudinal study was undertaken to evaluate freedom from clinically driven target limb revascularisation (FF CD-TLR) and patency of Zilver PTX stents in treating symptomatic femoro-popliteal stenotic lesions. Kaplan-Meier survival curves were used to demonstrate FF CD-TLR, primary, primary assisted and secondary patency.

Results: There were 148 patients and 183 lesions treated with a mean age of 80.3 years and 52% males. The all-cause 5-years mortality was 25%. FF CD-TLR yearly patencies to 5 years were 81%, 67%, 62%, 57% and 52%, respectively, with significantly poorer outcomes for in-stent restenosis, longer stent lengths and lesions at the femoro-popliteal junction. Primary patencies were 63%, 47%, 40%, 34% and 24%, assisted primary patencies were 90%, 75%, 68%, 59% and 48% and secondary patencies were 96%, 94%, 94%, 92% and 92%. Major adverse limb events were 5% at 1-year and cumulative at 5-years was 16%.

Discussion: The clinical outcomes in this study population are comparable to recent publications with smaller cohorts. Our study confirms Zilver PTX has very good primary patency over 5 years with no discernible effect on all-cause mortality in an elderly cohort with particularly long treated lesions. Our results are similar to those seen in younger patients with shorter lesions. Nonetheless, longer lesions required more reinterventions to maintain patency.

Conclusion: Zilver PTX is a safe and durable drug-eluting stent when utilised in the management of femoro-popliteal stenotic lesions with good long-term patency and limited need for re-intervention.