Safety and Efficacy Results Presented for Abbott Vascular's Supera Stent to Treat CFA Lesions

November 8, 2018—Koen Deloose, MD, presented 1-year outcomes from the multicenter, prospective, single-arm trial evaluating the treatment of symptomatic (Rutherford class 2–4) common femoral artery (CFA) stenotic or occlusive lesions with the Supera vascular mimetic implant (VMI) peripheral stent system (Abbott Vascular) at VIVA 2018, the Vascular Interventional Advances annual conference held November 5–8 in Las Vegas, Nevada.

The VMI-CFA trial's primary endpoint is core lab–adjudicated duplex ultrasound primary patency at 12 months. The safety endpoint is the absence of periprocedural adverse events up to 30 days postprocedure. Four Belgian centers and three French centers enrolled 100 patients, all Rutherford class 2, 3, or 4, with de novo lesions (> 50% stenosis) in the CFA. There were 79 patients with claudication and 21 patients with critical limb ischemia. The procedural success rate, defined as < 30% residual stenosis, was 100%, reported Dr. Deloose.

In the VMI-CFA trial, a 12-month cumulative primary patency rate of 95.2% was observed up to 365 days, and the cumulative primary patency rate up to 395 days was 92.8%. The cumulative freedom from target lesion revascularization rate was 97.8%. There were no procedure- or device-related adverse events.

Dr. Deloose concluded that the 1-year data confirm the safety and feasibility of an endovascular approach with the Supera stent in the previously considered "no-stent zone" of the CFA. He noted that a head-to-head randomized controlled trial of Supera versus endarterectomy seems to be a logical sequence to definitively clarify the CFA treatment discussion.

As summarized in the VIVA announcement, the background of the study is that CFA atherosclerotic lesions are one of the last limitations for adoption of endovascular repair as the first-line treatment. The bulky, eccentric, heavily calcified characteristics of CFA plaques, frequent involvement of the femoral bifurcation, easy surgical accessibility, and favorable long-term outcomes continue to make CFA disease treatment part of the surgical domain. In the last 5 years, improvement of the endovascular equipment and technical skills of the operators have led to an increase in percutaneous CFA procedures.