Comparative Outcomes of Supera vs Bare Nitinol Stents in FemPop Disease: Insights From the XLPAD Registry

Hollywood, FL (January 24, 2020) – The Supera stent (Abbott Vascular) is a “fundamentally different design”, said Bret Wiechmann, MD, of Vascular & Interventional Physicians in Gainesville, Florida, in his Friday morning presentation on the XLPAD Registry at the International Symposium on Endovascular Therapy (ISET).

In comparison to standard nitinol stents, the Supera offers high flexibility, high compression resistance, and a low chronic outward force, all of which enhance its fracture resistance. Deployment methodology is key, and Dr. Wiechmann noted “unique things to consider” as a result of the Supera’s architecture, describing important steps that include a slightly different approach to sizing, magnification of imaging to visualize the stent cell geometry, and use of a thumb slide for stent release.

Comparative clinical outcomes in U.S. pivotal trial results show the Supera at the top of the list for 1-year patency (91% with nominal deployment, meaning stent length upon deployment was within +/- 10% of the labeled stent length, and 86% with all deployment types) as well as for 3-year freedom from target lesion revascularization [TLR] (94% nominal; 82% all deployment types). It maintained consistent patency even in long lesions, with the SUPERSUB trial showing a 94% 1-year patency rate in lesions averaging 28 cm. A SUPERSUB subgroup analysis of the Supera in severely calcified arteries demonstrated 89% patency at one year and 88% freedom from TLR at 3 years.

The Supera stent demonstrates excellent clinical data despite not having a drug, noted Dr. Wiechmann. Results across clinical trials are not directly comparable, but primary patency from individual U.S. IDE trials at one year was 84% for Zilver PTX (Cook Medical), 89% for Eluvia (Boston Scientific), and 91% for Supera at nominal deployment. Similarly, freedom from TLR at one year was 92% (Zilver), 96% (Eluvia), and 97% (Supera, nominal deployment).

A retrospective study with 871 patients was conducted utilizing data extracted from the Excellence in Peripheral Artery Disease (XLPAD) registry.¹ Patients underwent femoropopliteal balloon angioplasty with either Supera stent implantation in 118 limbs or other contemporary bare nitinol stents in 753 limbs between 2006 and 2016. One-year outcomes included all-cause mortality, target vessel revascularization (TVR), and TLR. Supera showed a lower rate of TVR (7.6% vs 13.4%, P=.08) and a lower 1-year TLR rate (7.6% vs 16.2%, P=.02) compared to the bare nitinol stent group. Time to TLR for Supera was low overall and constant over 12 months, said Dr. Weichmann, while the bare nitinol stent group experienced increased TLR at 6 months, suggesting a higher incidence of clinically significant in-stent restenosis in the bare nitinol stent group. No difference in 12-month TLR was shown with compressed or elongated deployment vs nominal deployment of the Supera stent, which differed from the SUPERB trial, where clinically driven TLR was worse with greater than 40% elongation of the Supera stent.

Reference

1. Armstrong EJ, Jeon-Slaughter H, Kahlon RS, Niazi KA, Shammas NW, Banerjee S. Comparative outcomes of Supera interwoven nitinol vs bare nitinol stents for the treatment of femoropopliteal disease: insights from the XLPAD registry. J Endovasc Ther. 2020 Feb; 27(1): 60-65. doi: 10.1177/1526602819885652.