Midterm Outcome of Balloon-Expandable Polytetrafluoroethylene-Covered Stents in the Treatment of Iliac Artery Chronic Occlusive Disease

Purpose: To evaluate the 4-year results of polytetrafluoroethylene (PTFE)-covered stents in the treatment of iliac artery occlusive disease. Methods: Between January 2003 and September 2010, PTFE-covered stents were implanted in 115 iliac arteries of 87 patients (73 men; mean age 60 11 years) in a single center. The lesions were classified as TASC II A (n=40), B (n=41), C (n=7), and D (n=27). There were 69 primary endograft placements, while 46 procedures were performed after previous bare metal stent placement (reintervention group). Follow-up consisted of clinical investigation, ankle-brachial index (ABI) measurement, and duplex ultrasound scanning. In this retrospective analysis, outcomes were reported on a per-limb basis. Results: The median Rutherford classification decreased from category 3 at baseline to 0 after the procedure (p<0.001) and the ABI increased from 0.66 +/- 0.24 to 0.89 +/- 0.21 (p<0.001). The primary limb patency was significantly higher in the primary treatment group (p=0.03): 88.7% at 1 year, 86.4% at 2 years, and 71.5% at 4 years compared to the reintervention group (77.9%, 72.1%, and 53.0%, respectively). Univariate analysis revealed prior stent placement as the only factor associated with loss of primary patency. The freedom from target lesion revascularization (TLR) in the primary treatment group was 95.2% at 1 year, 89.6% at 2 years, and 74.4% at 4 years, which did not differ significantly from rates in the reintervention group (88.0%, 82.3%, and 63.8%, respectively). Conclusion: The use of PTFE-covered stents for occlusive disease in the iliac arteries is related to satisfactory limb patency rates and high freedom from TLR. Previous stent placement was related to a lower primary patency rate. Additional studies are indicated to establish subgroups that may specifically benefit from covered stents. J Endovasc Ther. 2012;19:797-804