Boston Scientific's Eluvia DES Evaluated for Femoropopliteal Lesions in IMPERIAL Trial
September 22, 2018—Boston Scientific announced 12-month data from the IMPERIAL trial evaluating the company's Eluvia paclitaxel-eluting vascular stent system versus the Zilver PTX paclitaxel-eluting peripheral stent (Cook Medical) in patients with symptomatic peripheral artery disease (PAD).
The results were presented during a late-breaking clinical trial session at TCT 2018, the 30th annual Transcatheter Cardiovascular Therapeutics scientific symposium and at CIRSE 2018, the annual Cardiovascular and Interventional Radiological Society of Europe congress. TCT 2018 is being held September 21–25 in San Diego, California. CIRSE 2018 is being held September 22–25 in Lisbon, Portugal. The clinical findings were published online by William A. Gray, MD, et al in The Lancet.
According to Boston Scientific, IMPERIAL is the first head-to-head trial comparing two different drug-eluting stent systems for the treatment of PAD. The global, multicenter, randomized controlled trial is composed of 465 patients with superficial femoral artery and proximal popliteal artery lesions up to 140 mm in length. The Eluvia stent exhibited superior rates of primary patency and higher rates of freedom from target lesion revascularization (TLR) at 1 year when compared to those treated with Zilver PTX.
Key 1-year findings from the IMPERIAL trial for Eluvia versus Zilver include:
- Primary patency rate (88.5% vs 79.5%; P = .0119)
- TLR rate (4.5% vs 9%)
- Freedom from major adverse events (95% vs 91%)
Dr. Gray, who serves as Coprincipal Investigator of the IMPERIAL trial, commented in the company's press release, "These impressive clinical outcomes suggest that sustained elution of paclitaxel, delivered by the Eluvia stent, better matched the timing of restenosis in the SFA that can occur months later, thereby reducing the need for repeat interventions. Based on these findings, we believe that the Eluvia stent can be a preferred therapy option when treating patients with arterial blockages in the superficial femoral or proximal popliteal arteries." Dr. Gray is System Chief, Division of Cardiovascular Disease at Main Line Health and President, Lankenau Heart Institute in Wynnewood, Pennsylvania.
The Eluvia stent system received European CE Mark approval in February 2016. In the United States, it is an investigational device and not available for sale, advised Boston Scientific.