November 4, 2019
VMI-CFA Data Support Durability of Endovascular Treatment of Common Femoral Artery at 24 Months
November 5, 2019—VIVA Physicians announced that 24-month safety and efficacy results from the full-cohort of the VMI-CFA trial were presented by Koen Deloose, MD, in a late-breaking clinical trial session at VIVA 2019, the Vascular InterVentional Advances meeting held November 4–7 in Las Vegas, Nevada.
The background of the study is that common femoral artery (CFA) endarterectomy is still considered the gold standard treatment for patients with CFA stenosis, however, 12-month follow-up results of the VMI-CFA study showed that endovascular repair is a safe and effective alternative. The study evaluated the repuncturable Supera vascular mimetic peripheral stent system (Abbott), which can manage bulky, heavily calcified CFA disease due to its extreme crush resistance.
As summarized in the VIVA announcement, the multicenter, prospective, single-arm VMI-CFA trial evaluated the outcomes of the 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 study’s primary efficacy endpoint was 12-month core lab–assessed duplex ultrasound primary patency 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 revascularization (TLR) rate was 97.8%. No procedure- or device-related adverse events were reported.
As presented at VIVA 2019, the 24-month VMI-CFA study results were prospectively analyzed to investigate the longer-term durability of the endovascular approach.
Dr. Deloose stated that 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%. He reported that the “tremendous” shift from Rutherford class 3 to 4 toward Rutherford class 0 to 1 was sustained at 2 years.
These 2-year data confirm that CFA disease can be treated endovascularly with the Supera stent with great outcomes and a very good safety profile, concluded Dr. Deloose, who also advised that the head-to-head SUPERSURG randomized controlled trial of Supera versus endarterectomy will be launched in 2020 to further clarify the CFA treatment discussion.