LAS VEGAS — A peripheral stent was safe and effective for treatment of common femoral artery lesions at 12 months, according to data presented at VIVA 18.
“Among vascular surgeons, the common femoral artery remains one of the last areas of open reconstruction,” Koen R. Deloose, MD, head of the department of vascular surgery at AZ Sint-Blasius Hospital in Dendermonde, Belgium, said during a presentation. “And there are good arguments in support of such near-religion. The area has a high flexion zone, is safe and accessible for surgery and is associated with superb long-term surgical patencies. Plaques are often bulky, eccentric and heavily calcified. And frequently, there is femoral bifurcation involvement.”
However, he said, in most cases, the common femoral artery (CFA) area is “ripe for tailored endovascular penetration.” He noted that the TECCO trial showed a lower 1-month mortality and morbidity rate for stenting vs. surgery in CFA interventions.
Prompted by those results, Deloose and colleagues conducted the prospective, multicenter, single-arm VMI-CFA trial to assess the performance of a peripheral stent (Supera Peripheral Vascular Mimetic Implant Device, Abbott Vascular) in 100 patients (mean age, 72 years; 81% men) with symptomatic CFA disease and Rutherford class 2 to 4 (21% with critical limb ischemia).
The primary efficacy endpoint was primary patency with no reintervention at 12 months. The primary safety endpoint was periprocedural adverse events, defined as death, amputation and target lesion revascularization, at 30 days.
The technical success rate was 100% and no patient had residual stenosis greater than 30% after the procedure, Deloose said.
The 12-month rate of primary patency was 95.2% and the 12-month rate of freedom from clinically driven TLR was 97.8%, according to the researchers.
The 12-month survival rate was 91.8% and the 12-month rate of freedom from target vessel revascularization was 92.6%.
Most patients improved to Rutherford class 0 or 1 at 12 months, Deloose said.
The primary safety endpoint occurred in two patients, both of whom required TLR, he said.
“In 2018, although common femoral endarterectomy remains the gold standard, the historical ‘no endovascular for this baby’ statement is wrong,” Deloose said. “A newer generation of devices, such as the high crush resistant, repuncturable Supera stent, are facilitating an endovascular approach. A head-to-head randomized controlled trial of Supera vs. endarterectomy seems to be a logical sequence to clarify definitively the CFA treatment discussion.” – by Erik Swain
DeLoose KR, et al. Late-Breaking Clinical Trials. Presented at: VIVA 18; Nov. 5-8, 2018; Las Vegas.
Disclosure: Deloose reports he received honoraria from Abbott Vascular, Bard Peripheral Vascular/Lutonix, B. Braun, Biotronik, Boston Scientific, Cardionovum, GE Healthcare, Medtronic, Spectranetics, Straub Medical and Terumo; consulted for Abbott Vascular, Biotronik, Boston Scientific, GE Healthcare, Philips and Terumo; and received research grants from Abbott Vascular, Bard Peripheral Vascular and Biotronik.