Cook's Zilver Stent Evaluated at 2 Years for Treating Iliac Artery Disease

September 24, 2010—Michael R. Jaff, DO, and Barry T. Katzen, MD, have published findings from a 2-year clinical evaluation of the Zilver vascular stent (Cook Medical, Bloomington, IN) in the Journal of Vascular and Interventional Radiology (2010;21:1489–1494). The investigators studied the 2-year outcomes of safety and effectiveness for iliac artery stent placement and examined the effects of placement in the common iliac artery and external iliac artery, the degree of initial stenosis, and patient gender on success.

In the study, Zilver vascular stents were placed in 151 consecutive patients whose iliac arteries remained stenotic after percutaneous transluminal angioplasty. Success at 2 years was determined by patency, ankle-brachial index (ABI) scores, and Walking Impairment Questionnaire (WIQ) scores.

The investigators reported that patency, ABI measurements, and WIQ scores showed improvement at 2 years compared with preprocedure measurements. The Kaplan-Meier estimate of overall patency at 2 years was 90% (n = 117). Significant improvements in ABI and WIQ scores were seen at 2 years compared with preprocedural values (P < .01). The 2-year overall success rate was 91%. The degree of initial stenosis, stent location, and patient gender did not affect the success of the Zilver stent (P = .65; P = .58; P = .77). The Kaplan-Meier estimated probability of experiencing a major adverse event related to the device or stent placement procedure by the 2-year follow-up was 2.7%.

The investigators concluded that the Zilver vascular stent remains durable at 2 years in regard to safety and clinical effectiveness and is effective in the common iliac artery and external iliac artery both in male and female patients.