Clinical Experience with the OptiMed Sinus Stent in the Peripheral Arteries

Abstract

Purpose: To retrospectively evaluate the performance of a new self-expanding nitinol stent in the treatment of lower limb arterial occlusive lesions. Methods: The Sinus stent is a flexible, laser-cut device with good radiopacity and radial strength, allowing precise placement via a 7-F introducer, even in tortuous arteries. Over a 3.5-year period, 315 patients (254 men; mean age 64.9±10.8 years, range 39–93) had 403 lower limb lesions treated: 172 iliac (132 stenoses, 40 occlusions), 204 femoral (131 stenoses, 73 occlusions), and 27 popliteal (19 stenoses, 8 occlusions). The majority of patients (272, 86%) were in stage IIb of Fontaine's classification, 31 (10%) in stage III, and 12 (4%) in stage IV. Mean lesion lengths were iliac: 51.9±32.1 mm, femoral: 66.3±51.5 mm, and popliteal: 44.3±27.2 mm. Indications for stenting were 222 postdilation residual stenoses, 125 dissections, and 35 restenoses; 21 lesions were directly stented. Results: Immediate technical success was 100%. Clinical success was 98%. The anklebrachial index increased from 0.62±0.12 to 0.91 ±0.14. In 64 lesions, there were 3 early thromboses. Mean follow-up was 16.1 ±9.7 months (range to 40). There were 79 restenotic episodes: 14 iliac, 56 femoral, and 9 popliteal. Primary and secondary patencies for all lesions at 3 years were 72.5%±6.6% and 81.8%±5.9%, respectively. Stenoses demonstrated better patency than occlusions (primary: 78.0%±7.3% versus 60.2%±7.1%, p<0.001; secondary: 86.8%±6.1% versus 71.3%±6.7%, p<0.001). Men had better secondary patency at 3 years (83.7% versus 73.4%, p<0.05). For femoral lesions >8 cm, the results were acceptable for stenoses (66.7% primary and secondary patency at 3 years), but for lengthy occlusions, the restenosis rate was high (50.0% for occlusions versus 25.0% for stenoses, p<0.05). Conclusions: Angioplasty with the Sinus stent seems safe and effective in the treatment of peripheral arterial occlusive diseases, giving excellent results at the iliac and common femoral artery levels. Treatment results are better for stenoses than for occlusions. An occlusion length ≤8 cm seems to be the limit for stenting.