Midterm Results of Endovascular Treatment of Superficial Femoral Artery Disease with Biodegradable Stents: Single-Center Experience

Abstract

PurposeTo assess the midterm efficacy of a biodegradable poly-l-lactic acid (PLLA) stent in the treatment of superficial femoral artery (SFA) occlusive disease. Materials and MethodsBetween June 2009 and April 2011, 35 de novo SFA lesions were treated with 43 biodegradable stents. This nonrandomized, retrospective, single-center study included patients with moderate or severe claudication, lower-limb rest pain, or ischemic ulceration restricted to the toes; symptoms were classified as Rutherford category 2 (48.6%), 3 (37.1%), 4 (8.6%), or 5 (5.7%). The population included 28 men and had a mean age of 71 years (range, 51–81 y). Follow-up included clinical examination and color-flow duplex imaging. Mean follow-up was 38.3 months (range, 30–58 mo). ResultsTechnical success was reported in all patients (100%). There were no intraoperative or immediate (< 30 d) complications.. During follow-up, one in-stent occlusion and seven in-stent restenoses occurred, all of which were successfully treated with percutaneous transluminal angioplasty. Primary and secondary patency rates were 77.1% and 97.1% at 24 and 36 months, respectively. No stent recoil or stent fracture was encountered. Late follow-up (> 12 mo) by ultrasound confirmed total reabsorption of the stent structures. Clinical improvement (ie, an upward shift of at least two Rutherford categories) was achieved in all 35 patients. ConclusionsMidterm results for biodegradable PLLA stents for atherosclerotic SFA lesions were associated with high technical success and secondary patency rates, without stent recoil and vessel remodeling.