LAS VEGAS — A repuncturable vascular mimetic peripheral stent system was safe and effective at 2 years in patients with common femoral artery disease, according to new data from the VMI-CFA study.
Common femoral artery disease is often bulky and heavily calcified and interventions have typically been done by endarterectomy. The repuncturable vascular mimetic peripheral stent system (Supera, Abbott Vascular) is promising in this area because of its extreme crush resistance, Koen R. Deloose, MD, head of the department of vascular surgery at AZ Sint-Blasius Hospital, Dendermonde, Belgium, said during a press conference at VIVA 19.
“Common femoral endarterectomy is not as benign a procedure as previously believed,” he said. “What about endovascular alternatives? Plain old balloon angioplasty does not work in the CFA. But scaffolds do work in the CFA. They can deal with the calcium and prevent early recoil.”
At 2 years, the device was associated with a primary patency rate of 92.8% and a rate of freedom from target lesion revascularization of 97.8%, Deloose said. The cumulative survival rate was 85.5%.
The researchers reported no cases of TLR or loss of primary patency between 1 and 2 years, he said. Healio previously reported on the 1-year results.
In other results, the 2-year rate of freedom from target vessel revascularization was 84.3%, and there were only two cases of clinically driven TLR.
“In 2019, although endarterectomy still remains the golden standard, the historical ‘no endovascular for this baby’ statement is wrong,” Deloose said during a presentation. “There is definitely a place for a safer and as-efficient endovascular therapy in CFA treatment.”
The study included 100 patients (mean age, 72 years; 81% men; 35% with diabetes) with symptomatic CFA disease and Rutherford class 2 to 4 (21% with critical limb ischemia).
Deloose said SUPERSURG, a head-to-head comparison of stenting and endarterectomy, will be launched in 2020. The trial is investigator-initiated and will be partially funded by Abbott, he said. – by Erik Swain
Deloose K, et al. Late-Breaking Clinical Trials. Presented at: VIVA 19; Nov. 4-7, 2019; Las Vegas.
Disclosure: Deloose reports he has financial ties with Abbott Vascular, B. Braun Interventional, BD, Biotronik, Boston Scientific, Contego Medical, Cook Medical, C.R. Bard, GE Healthcare, Medtronic, Philips, Terumo and W.L. Gore and Associates.