Use of a low-profile stent in atherosclerotic iliac artery disease: The results of 4-FIRST (4-French Iliac Revascularization with low-profile Stent Technology) Registry

Aim. The aim of this paper was to evaluate the early and midterm outcomes of a low-profile stent (Astron® Pulsar; Biotronik AG, Bülach, Switzerland) in the revascularization of atherosclerotic iliac artery disease. Methods. Between April 2009 and March 2014 36 low-profile 4-F Astron® Pulsar stents were implanted in 31 patients in our Center. All data concerning these stents was prospectively collected in a dedicated registry. Early and mid-term (2 years) outcomes have been evaluated in terms of primary patency, primary assisted patency, secondary patency, absence of target lesion restenosis (TLR), healing of the lesions/relief of symptoms, and limb salvage. Results. The patients were predominantly males (18/31, 58.1%) with a mean age of 71.9 years (range 45-88). Mean duration of follow-up was 18.7 months (range 1-46). The estimated 2-year primary patency, primary assisted patency, secondary patency, absence of TLR, and limb salvage were 89.3%, 89.3%, 95.2%, 81.8%, and 100% respectively. Uni-and multivariate analysis showed that Rutherford class 6, a stent with a ≤5 mm diameter, and no post-stent balloon dilatation are independent predictors of poor results in terms of patency and absence of TLR. Conclusion. Use of low-profile 4-F Astron® Pulsar stent in atherosclerotic iliac lesions is safe and effective. At 2 years, the patency and the absence of TLR could be considered acceptable. The use of stents with a diameter ≥6 mm and poststent balloon dilatation should always be recommended.