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Patency evaluation of the self-expandable Pulsar-18 nitinol stent in patients for the treatment of femoro-popliteal occlusive disease in a national multicenter prospective all comers registry with a follow up period of 12 months.
Between 01/2012 and 08/2012 this all comers multicenter prospective registry enrolled 118 patients (64 male patients) with 151 symptomatic femoro-popliteal lesions Rutherford category II - V for recanalization and implantation of the Pulsar-18 nitinol stent. Primary patency was defined as no binary restenosis on duplex ultrasound (PSVR < 2,5) and respectively no target lesion revascularization performed within 12 months follow up. Drug eluting balloons were not allowed in this registry.
Average lesion length of the femoro-popliteal segment was 111,5 ± 71,4 mm. According to the TASC classification 48 / 151 lesions were TASC D lesions. Mean stent implantation length was 122,7 ± 64,5 mm. A total occlusion was present in 84 of the 150 (56,7 %) treated lesions. Involvement of popliteal segment I-III was present in 28 (18,7 %) lesions. Primary patency after 6 and 12 months was 91,7 % and 79,5%. The clinically driven overall freedom from target lesion revascularization (FTLR) was 93,2 % after 6 months and 81 % after 12 months. ABI, pain free walking distance and Rutherford category improved significantly (p < 0,001) after 6 months and after 12 months. The restenosis rate in patients with diabetes (p = 1,0) and renal insufficiency (p = 0,8) was not significantly higher. Overlapping stents showed a non-significant trend for higher incidence of a significant restenosis. Popliteal stent implantation (P I - III segment) was not associated with a significant higher restenosis rate (p=0,3) after 12 months. For recanalization of chronic total occlusions (CTO) we did not find a significant difference (p = 0,67) in restenosis rate compared to non CTO lesions.
In this all comers registry using the Pulsar-18 self-expandable nitinol stent endovascular intervention of femoro-popliteal disease with a mean lesion length of 111,5 mm for revascularization had a promising primary patency and freedom from target lesion revascularization rate after 6 and 12 months. Diabetes had no negative impact on the patency rate. The primary patency rate in popliteal segments was acceptable with 71,4 % after 12 months.