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ITALIAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY
Rivista di Chirurgia Vascolare ed Endovascolare
Italian Journal of Vascular and Endovascular Surgery 2015 Dicembre;22(4):171-80
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
Troisi N., Ercolini L., Chisci E., Frosini P., Pigozzi C., Barbanti E., Romano E., Michelagnoli S.
Department of Surgery, Vascular and Endovascular Surgery Unit, San Giovanni di Dio Hospital, Florence, Italy
AIM: The aim of this paper was to evaluate the early and mid-term 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.