Two-year data of the VMI-CFA trial, presented today at the 2019 Vascular and InterVentional Advances (VIVA) meeting (4–7 November, Las Vegas, USA) confirm that common femoral artery (CFA) disease can be treated endovascularly with the Supera stent (Abbott Vascular).
Although CFA endarterectomy is still considered the gold standard treatment for patients with CFA stenosis, 12-month follow-up results of the VMI-CFA study showed that endovascular repair is a safe and effective alternative. The repuncturable Supera vascular mimetic peripheral stent system can manage bulky, heavily calcified CFA disease due to its extreme crush resistance.
To investigate the longer-term durability of the endovascular approach, the 24-month VMI-CFA study results were prospectively analysed. No new loss of primary patency or TLR was reported, resulting in a cumulative primary patency rate of 92.8% and a freedom from TLR rate of 97.8% at 730 days. The cumulative survival rate was 85.5%. The tremendous shift from Rutherford class 3–4 toward Rutherford class 0–1 was sustained at 2 years.
The multicentre, prospective, single-arm VMI-CFA trial evaluated the outcomes of treatment of symptomatic (Rutherford class 2–4) CFA stenotic or occlusive lesions with the Supera stent in 100 patients. All patients had de novo lesions (>50% stenosis). The primary efficacy endpoint was core lab–assessed duplex ultrasound primary patency at 12 months, and the primary safety endpoint was the absence of periprocedural adverse events up to 30 days postprocedure.
The cumulative primary patency rates up to 365 and 395 days were 95.2% and 92.8%, respectively. The cumulative freedom from target lesion revascularisation (TLR) rate was 97.8%. No procedure- or device-related adverse events were reported.
Koen R Deloose (Dendermonde, Belgium), who presented the two-year results at VIVA, announced that a head-to-head randomised controlled trial of Supera versus endarterectomy (SUPERSURG RCT) will be launched in 2020 to further clarify the CFA treatment discussion.