A midterm analysis of patients who received femoropopliteal helical interwoven nitinol stents

Abstract

Background: The aim of this study was to report midterm outcomes (up to 72 months) of patients who received femoropopliteal helical interwoven nitinol stents (Supera Peripheral Stent System, Abbott Laboratories, Inc, Webster, Tex).

Methods: Prospectively collected data on patients treated with femoropopliteal non-drug-eluting angioplasty and helical interwoven nitinol stents were retrospectively analyzed. Patients were followed up with 6, 12, 18, 24, 36, 48, 60, and 72 months clinical, duplex, and radiographic assessments. Restenosis is defined as 50% or greater restenosis of the target lesion on duplex ultrasound imaging.

Results: From October 2011 to September 2018, 315 patients (198 males) with 360 legs and a median age of 78 years (range, 46-100 years) were included. Symptoms of claudication, rest pain, and tissue loss were found in 212 (58.9%), 53 (14.7%), and 150 (41.7%) legs, respectively. In 176 (48.9%) legs, stents were placed in the popliteal segments. The mean stented lesion length was 119.0 mm (range, 40-450 mm). The overall primary patency rates at 6, 12, 24, 36, 48, 60, and 72 months were 90.6%, 80.5%, 73.8%, 68.9%, 65.3%, 63.1%, and 63.1%, respectively. The ankle-brachial pressure index increased from 0.58 6 0.18 preoperatively to 0.87 6 0.16 postoperatively. There were no stent fractures on follow-up. Patency rate was not statistically affected by indication of treatment, lesion calcification, or diabetes, but the length of stents and involvement of popliteal arteries were statistically significantly worse (log-rank test, P ¼ .011 and P ¼ .005). Stents with inner diameters of 4-mm had an initial lower patency compared with 5-mm stents, but the patency rates merged and crossed over at 46 months (log-rank test, P ¼ .131). There was no procedural- or device-related morbidity or mortality, and there were nine major amputations after revascularization.

Conclusions: This study provides long-term clinical data demonstrating that Supera stents are effective and durable. (J Vasc Surg 2020;71:2048-55.)