The study aims at understanding the efficiency and safety of using Zilver PTX DES (drug-eluting stent) in treating patients with femoropopliteal ISR (in-stent restenosis). Instead of a large real-world study, it presents an analysis of a small subgroup of patients.
The study subjects were patients at Zilver PTX post-market study, which included 904 symptomatic subjects with femoropopliteal lesions. The study included a five-year outcome, stent radiography, mortality, freedom from TLR, and clinical benefits in 177 patients. The clinical benefits were classified as freedom from deteriorating or persistent ischemic symptoms.
More than 50% of the subjects were diabetics. The mean lesion length among the subjects was 17.8 +/- 10.4 cm. One-third of the subjects had total occlusion lesions. During the study, there was no recorded procedure-related or device-related death or other adverse effects. There were five counts of stent fracture throughout the study (five years). The mortality at five years was 25.1%. The freedom from TLR was 73.4%. The other clinical benefits rate was 63.6%.
The result showed improvement in the ankle-brachial index and Rutherford category through five years. Thus, the study proves the treatment method’s efficiency and safety in treating a difficult-to-treat group of patients.