Incidence, predictors, and prognosis of in-stent occlusion after endovascular treatment with nitinol stents for femoropopliteal lesions.

OBJECTIVE: Widespread use of self-expanding nitinol stent-based endovascular treatment (EVT) for femoropopliteal (FP) lesions has been fueled by its less-invasive nature and modest durability; however, prevalence, predictors and prognosis of in-stent occlusion are undefined and were investigated here.

METHODS: This study entailed a multicenter, retrospective analysis of a prospectively maintained database. Between January 2004 and December 2011, 2447 de novo FP lesions (mean length, 143 ± 87 mm; 52% chronic total occlusions) from 2008 patients (mean age, 73.0 ± 9.2 years; 71% male; 61% diabetics; 32% critical limb ischemia; and 24% on hemodialysis) were treated with nitinol stent-based EVT. Study outcome was in-stent occlusion: rates (1, 3, and 5 years), predictors and association with limb prognosis.

RESULTS: In-stent occlusion rate was 5.2%, 11.2%, and 16.4% at 1, 3, and 5 years, respectively (mean follow-up, 2.3 ± 1.7 years). Female sex, critical limb ischemia, and Transatlantic Inter-Society Consensus II class C/D (multivariate Cox proportional hazard ratio [HR], 1.75, 1.49, and 3.34, respectively) were independent predictors of in-stent occlusion after FP stenting, which was associated with poor limb prognosis (major amputation, HR 6.35; major adverse limb event, major adverse limb event, HR, 21.1).

CONCLUSIONS: Moderate in-stent occlusion rates were observed after nitinol stent-based EVT. Closer attention is warranted with high-risk cases because of poorer limb prognosis.