Purpose: The purpose of this article is to report the results of a prospective single-center study analyzing the long-term clinical and angiographic outcomes of subintimal angioplasty (SIA) for the treatment of chronic total occlusions (CTOs) of the femoropopliteal artery.
Materials and methods: Patients with severe intermittent claudication or critical limb ischemia (CLI) were enrolled in the study. All lesions were treated with SIA and provisional stenting. Primary end points were technical success, patient survival, limb salvage, lesion primary patency, angiographic binary restenosis (>50%), and target lesion revascularization (TLR). Regular clinical and angiographic follow-up was set at 6 and 12 months and yearly thereafter. Study end points were calculated with life-table survival analysis. Proportional-hazards regression analysis with a Cox-model was applied to adjust for confounding factors of heterogeneity.
Results: Between May 2004 and July 2009, 98 patients (105 limbs, patient age 69.3±9.9 years) were included in the study. Technical success rate was 91.4% with a lesion length of 121±77 mm. Limb-salvage and survival rates were 88.7% and 84.1% at 3 years, respectively. After 12, 24, and 36 months, primary patency was 80.1%, 42.3%, and 29.0%, angiographic binary restenosis was 37.2%, 68.6%, and 80.0%, and TLR was 84.8%, 73.0%, and 64.5%, respectively. CLI was the only adverse predictor for decreased primary patency (hazard ratio [HR] 0.36; 95% confidence interval [CI] 0.16-0.80, p=0.012), whereas significantly less restenosis was detected after spot stenting of the entry and/or re-entry site (HR 0.31; 95% CI 0.10-0.89, p=0.01 and HR 0.20; 95% CI 0.07-0.56, p=0.002, respectively).
Conclusions: Subintimal angioplasty is a safe and effective revascularization technique for the treatment of CTOs of the femoropopliteal artery. Provisional stenting may have a role at the subintimal entry or true lumen re-entry site.