IMPERIAL Substudy Supports FDA Approval of Boston Scientific's Eluvia DES for Long Lesions in SFA

November 6, 2018—Boston Scientific Corporation announced clinical outcomes from the IMPERIAL Long Lesion Substudy demonstrating that the company's Eluvia drug-eluting vascular stent system is safe and effective in treating patients with long, complex, calcified lesions within the superficial femoral and proximal popliteal arteries. The new data were presented during a late-breaking clinical trial session at VIVA 2018, the Vascular Interventional Advances annual conference held November 5–8 in Las Vegas, Nevada.

As a result of these findings, the Eluvia stent received FDA approval to treat long lesions within the superficial femoral and proximal popliteal arteries (up to 190 mm in length) in patients with peripheral artery disease (PAD). In September, the FDA approved the Eluvia stent. The company received European CE Mark approval in February 2016.

According to Boston Scientific, the global randomized controlled IMPERIAL trial evaluated the Eluvia stent system in patients with symptomatic PAD. The trial included a single-arm analysis of 50 patients with femoropopliteal artery lesions 140 to 190 mm in length. Baseline characteristics of the patients included an average lesion length of 162.8 ± 34.7 mm, with 70% of lesions classified as moderately to severely calcified and 32% with chronic total occlusions. Because of the severity of their disease, these patients were also experiencing claudication.

At 1 year, the study results demonstrated a primary patency rate of 87.9% and a target lesion revascularization (TLR) rate of 6.5%. Additionally, these patients reported significant improvement in their leg pain and discomfort.

William Gray, MD, Coprincipal Investigator of the IMPERIAL trial, commented in Boston Scientific's announcement, “The lesion lengths, disease complexity, and the baseline characteristics presented in this substudy is more representative of what clinicians see on a daily basis when treating patients with severe cases of peripheral artery disease. The results from this long lesion substudy, combined with those observed in the global randomized controlled IMPERIAL trial, MAJESTIC, and other studies suggest that the Eluvia stent, with its sustained drug-release design, is a highly effective treatment option for femoropopliteal disease even in more complex lesion types.” Dr. Gray is System Chief, Division of Cardiovascular Diseases and President, Lankenau Heart Institute at Main Line Health in Wynnewood, Pennsylvania.

The company advised that the IMPERIAL trial compared the Eluvia stent versus the Zilver PTX stent system (Cook Medical) for the treatment of PAD. Eluvia demonstrated superior results to Zilver PTX, with patients experiencing significantly greater 12-month primary patency of 88.5% compared to 79.5% in patients treated with the Zilver (P = .0119). In addition, patients treated with the Eluvia stent had a 4.5% TLR rate at 12 months versus 9% for the Zilver PTX cohort.

The IMPERIAL results were presented during a late-breaking clinical trial session at TCT 2018, the 30th annual Transcatheter Cardiovascular Therapeutics scientific symposium held September 21–25 in San Diego, California, and at CIRSE 2018, the annual Cardiovascular and Interventional Radiological Society of Europe congress held September 22–25 in Lisbon, Portugal. The findings were published by Dr. Gray et al in The Lancet (2018;392:1541–1551).