Analysis Supports Abbott Vascular's Supera Stent for Endovascular Treatment of Femoropopliteal Disease

July 20, 2016—A study of the initial United States experience in the endovascular management of lower extremity artery atherosclerotic disease with the Supera interwoven wire stent (Abbott Vascular) was published by Miguel Montero-Baker, MD, et al online ahead of print in the Journal of Vascular Surgery.

Noting that the Supera stent was developed to provide increased radial strength, fracture resistance, and flexibility compared with laser-cut nitinol stents, the investigators concluded that stenting of the superficial femoral and popliteal arteries using the Supera stent system appears to be safe and effective. They stated that the device’s interwoven stent design may better serve anatomic areas that are under extreme mechanical stress. These results with the study’s population of highly diseased patients (including very long lesion lengths) are consistent with outcomes of other publications reporting on the use of this device, advised the investigators in JVS.

According to the investigators, the structural limitations of currently available laser-cut nitinol stents in a highly diseased arterial system of the lower extremity are well described. These devices are frequently used in long-segment occlusions at the adductor hiatus and across the knee into the popliteal artery and tibialperoneal trunk, despite concerns related to the high mobility of the knee joint and the potential for external stent compression, fractures, and occlusion. 

As summarized in JVS, patients undergoing stent implantation in the 20-month period after the 2008 US Food and Drug Administration clearance were included. Medical records, radiographic imaging, and procedural data were examined. Procedural angiograms were classified according to TransAtlantic Inter-Society Consensus criteria. Patency and limb loss rates were calculated using Kaplan-Meier analysis.

There were 305 stents implanted in 147 patients. Clinical follow-up was a mean of 12.7 months (range, 0.2–33.7 months), and radiologic follow-up was a mean of 8.4 months (range, 0.2–26.8 months). Most patients had critical limb ischemia, with tissue loss (38.1%) or rest pain (28.6%) as the indication for intervention. Of the 147 patients, 75 (51.02%) underwent a concomitant adjunctive procedure in the treated extremity. 

Primary, assisted primary, and secondary patency rates at 12 months by duplex ultrasound imaging were 89.8%, 91.2%, and 93.2%, respectively, by Kaplan-Meier estimates, with a mean lesion length of 184.5 ± 131.8 mm and mean stented length of 197.5 ± 113.65 mm. Seventeen patients experienced an event requiring successful reintervention in the stented segment (13 for type 1 or 2 restenosis; four for type 3). 

There were eight major amputations, with five of those eight having a patent stent at the time of limb sacrifice. The overall mortality rate was 11.6% during the study period. Knee radiography was performed in 47 patients with devices extending into the popliteal and tibialperoneal segment, and no stent fractures were identified, reported the investigators in JVS.