, Yoshimitsu Soga1
, Osamu Iida21Kokura Memorial Hospital, Kitakyushu, Japan; 2Kansai Rosai Hospital, Amagasaki, Japan.
OBJECTIVES: The objective was to investigate the long-term efficacy of FP stenting with nitinol stents for CLI.
METHODS: This study was a multicenter retrospective study. From January 2004 to December 2011, 598 consecutive patients (865 limbs; mean age 74.4±10.3 years; 61.5 % male) who underwent successful FP stenting with self-expandable nitinol stents for de novo lesions, CLI were retrospectively analyzed. Outcome measures were primary patency (PP), secondary patency (SP), overall survival (OS), amputation free survival (AFS), limb salvage (LS), major adverse cardiovascular events (MACE; all-cause death, myocardial infarction and stroke), MALE (repeat revascularization for the limb or major amputation [defined as above-the-ankle amputation]). Restenosis was defined as >2.4 of peak systolic velocity ratio by duplex or >50% stenosis by angiogram. Primary patency was defined as treated vessels without restenosis and repeat revascularization. Secondary patency was defined as target vessels that become totally occluded and are reopened by repeat revascularization.
RESULTS: Sixty-six percent of the patients had diabetes, and 39% were on hemodialysis. The mean follow-up period was 19.1±17.2 months. PP was 77.0%, 59% and 46.7%, and SP was 93.9%, 87.9% and 80.3% at 1, 3 and 5 years, respectively. OS was 83.4%, 63.1% and 49.6%, and AFS was 78.5%, 59.9%, 46.7%, and LS was 93.3%, 90.8%, 90.8%, and freedom from MACE was 82.1%, 61.5%, 45.7%, and freedom from MALE was 77.9%, 71.9%, 48.8%, respectively. On multivariate analysis by Cox proportional hazard ratio, female gender (hazard ratio [HR], 1.4; p=0.048), body mass index (HR, 1.05; p=0.04), cilostazol administration (HR, 0.63; p=0.005), and TASC ΙΙ class C/D (HR, 1.67; p=0.007) were the independent predictors of primary patency after successful FP stenting.
CONCLUSIONS: The outcomes of CLI patients due to FP disease who underwent nitinol stent implantation were feasible, but their prognosis was poor.
AUTHOR DISCLOSURES: O. Iida: Nothing to disclose; Y. Soga: Nothing to disclose; Y. Tomoi: Nothing to disclose.
Posted April 2013