Twelve-Month SUPERB Results Published for Abbott Vascular's Supera Stent

May 13, 2015—Lawrence Garcia, MD, et al published 12-month results of the SUPERB trial evaluating the Supera stent (Abbott Vascular), a self-expanding nitinol stent that incorporates an interwoven-wire design to confer greater strength, flexibility, and fracture resistance. The SUPERB findings are available online ahead of print in Circulation: Cardiovascular Interventions.

SUPERB was a prospective, multicenter, nonrandomized, single-arm, investigational device exemption study that evaluated the safety and effectiveness of the Supera peripheral stent system for the treatment of superficial femoral and proximal popliteal arteries in patients with lifestyle-limiting claudication or rest pain.

Dr. Garcia first presented the SUPERB findings in November during a late-breaking trials session at the VIVA 2014: Vascular InterVentional Advances conference in Las Vegas, Nevada.

As described in Circulation: Cardiovascular Interventions, the SUPERB trial enrolled 264 patients with symptomatic peripheral artery disease undergoing percutaneous treatment of de novo or restenotic lesions in the superficial femoral or proximal popliteal arteries.

The investigators reported that freedom from death, target lesion revascularization, or any amputation of the index limb at 30 days (+7 days) postprocedure was achieved in 99.2% (258/260) of patients (P < .001).

Primary patency at 12 months (360 ± 30 days) was achieved in 78.9% (180/228) of the population (P < .001). Primary patency by Kaplan-Meier analysis at 12 months (360 days) was 86.3%. No stent fracture was observed by independent core laboratory analysis in the 243 stents (228 patients) evaluated at 12 months. Clinical assessment at 12 months demonstrated improvement by at least one Rutherford-Becker category in 88.7% of patients.

The SUPERB study achieved the efficacy and safety performance goals predesignated by the US Food and Drug Administration. On the basis of the high primary patency rate, absence of stent fracture, and significant improvements in functional and quality-of-life measures, the investigators concluded that the Supera stent provides safe and effective treatment of femoropopliteal lesions in symptomatic patients with peripheral artery disease.