Abstract

Background: Although vessel calcification results in poor clinical outcomes following endovascular therapy (EVT) in patients with peripheral artery disease (PAD), the Impact of calcification severity on clinical outcomes remains unclear. Methods: A total of 394 consecutive patients (mean age 72.4±8.3 years; 74 % male) with PAD who underwent EVT for de novo superficial femoral artery lesions in our hospital from January 2010 to December 2013 were retrospectively analyzed. These patients were stratified into three groups by fluoroscopy and digital subtraction angiography in the AP projection (no calcium group: no visible calcium at the lesion, unilateral group: unilateral calcification at the lesion, bilateral group: bilateral calcification at the lesion). The primary outcome measure was primary patency, while the secondary outcomes were survival and major adverse limb event (MALE). Cox proportional hazard analysis was performed to explore if this classification was an independent predictor of primary patency. Results: 224 (57 %) patients had diabetes, 83 (21 %) were on hemodialysis. Prevalence of TASC C/D was 50% (199 of 394) and prevalence of three groups; no calcium, unilateral and bilateral, was 55% (214 of 394), 28% (110 of 394), 17% (70 of 394), respectively. Mean lesion length and reference vessel diameter at the treated segment was 152.1±95.7 mm and 5.7±0.9 mm. Primary patency at 2 year was 70.0% in no calcium group, 68.9% in unilateral group, and 45.8% in bilateral group, respectively; survival rate at 2 year was 96.4% in no calcium group, 94.6% in unilateral group, and 87.4% in bilateral group, respectively; MALE at 2 year was 1.3% in no calcium group, 4.0% in unilateral group, 8.2% in bilateral group, respectively. Bilateral calcification was an independent predictor of primary patency, as were lesion length, lesion diameter and stent use. Conclusions: Bilateral calcification was independently associated with primary patency, MALE and survival after EVT.

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