Primary stenting of femoropopliteal atherosclerotic lesions using new helical interwoven nitinol stents.

Background: The Supera helical interwoven nitinol stent has enhanced flexibility in counteracting fractures when placed in the femoropopliteal arteries and may improve patency. The aim of this study is to assess the early results of the Supera stent in symptomatic patients with femoropopliteal atherosclerotic lesions.

Methods: From October 2011 to April 2013, patients with symptomatic femoropopliteal lesions were treated with angioplasty and primary stenting using the Supera stent. They were followed up at 1, 3, 6, and 12 months with clinical, duplex, and radiographic assessments. Failure was defined as >50% restenosis of the target lesion on duplex ultrasound imaging or stent fracture on X rays.

Results: A total of 78 consecutive patients (46 males, 32 females) with 82 legs, mean age of 78.5 years (range, 57-97 years) were included. Symptoms of claudication, rest pain, and tissue loss were 48 (59%), 8 (10.1%), and 30 (37%), respectively. Ninety-six Supera stents were inserted in total. In 44 (53.7%) of the legs, stents were extended to the popliteal segments. The mean stented length was 12.6 cm (range, 4.0-38.0 cm). The primary patency rates at 6 and 12 months were 83.5% and 78.6%, respectively. The ankle brachial index increased from 0.58 ± 0.16 preoperative to 0.87 ± 0.14 postoperative. There were no stent fractures. Patency rate was not affected by severity of symptoms, stent lengths, femoro/popliteal stents (log-rank test, P = .50, .13, .52). All the patients reported symptomatic improvement. There was no procedural- or device-related morbidity or mortality, no major amputation after revascularization, and 10 patients died of unrelated cardiopulmonary/renal causes on follow-up.

Conclusions: Our early experience shows that the Supera stents are effective in our cohort of elderly patients, with acceptable patency rates. There were no stent fractures so far even with stenting of the popliteal segments.