SUPERB Supports Abbott Vascular's Supera Stent for SFA/PPA Treatment

November 4, 2014—VIVA Physicians, Inc. announced that Lawrence Garcia, MD, presented findings from the SUPERB trial during a late-breaking trials session at the VIVA 2014: Vascular InterVentional Advances meeting in Las Vegas, Nevada. SUPERB was a prospective, multicenter, nonrandomized, single-arm, investigational device exemption study that evaluated the safety and effectiveness of Abbott Vascular’s Supera peripheral stent system for the treatment of superficial femoral (SFA) and proximal popliteal arteries (PPA) in patients with lifestyle-limiting claudication or rest pain.

As summarized in the VIVA announcement, SUPERB key inclusion criteria included Rutherford Becker (RB) 2 through 4, SFA or PPA lesions between 40 and 140 mm, ≥ 3 cm above knee joint, and ≥ one vessel runoff.

The primary safety endpoint was freedom from a composite of all death, clinically driven target lesion revascularization (TLR), or any amputation of the index limb at 30 days (+7 days) and was compared to a performance goal (PG) of 88%. The primary effectiveness endpoint was SFA patency at 12 months (390 days), defined as freedom from restenosis (diameter stenosis > 50% with a peak systolic velocity [PSV] ratio ≥ 2 by ultrasound) and TLR, and was compared to a PG of 66%. Mean age was 68.7 years, and 36.4% were female. There were 43.5% diabetic patients, 79.9% were current or former smokers, and 9.1% had renal insufficiency. Mean lesion length was 78.1 mm, and 72.7% had moderate to severe calcification.

Primary patency (12 month) was 78.9% (VIVA method), which was superior to the PG 66% (P < .001). In the intention-to-treat population, freedom from TLR rates at 1, 2, and 3 years were 89%, 84%, and 82%, respectively. In severely calcified lesions, 12-month patency was 89% and freedom from TLR at 3 years was 87%. In nominally deployed stents (± 10% stent length), a higher 12-month primary patency was observed (90%) compared with those not deployed to nominal (eg, elongated). Nominal deployment also resulted in high freedom from TLR at 1, 2, and 3 years (97%, 96%, and 94%).

The data showed that severely elongated stents (> 40%) had the least durability through 3 years. There was only one stent fracture through 3 years. Proper artery preparation and Supera deployment result in patency and TLR rates that were among the best reported for SFA and PPA interventions. Nominal deployment or slight compression had the best outcomes and durability.

In stents deployed to a nominal length, there was minimal decrease in freedom from TLR between 1 and 3 years, 97% to 94%. Results were good in complex lesions regardless of lesion length. There was a remarkably low fracture rate after 3 years, concluded the SUPERB investigators.