Boston Scientific's Eluvia wins FDA nod, seen as effective as Cook's Zilver in study
- Boston Scientific’s Eluvia drug-eluting stent proved as effective in treating peripheral artery disease (PAD) as Cook Medical’s Zilver drug-coated vascular stent in a study presented Saturday at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in San Diego. Two days later, Boston Scientific announced the FDA cleared Eluvia.
- The study, designed to determine non-inferiority, is the first head-to-head clinical trial to compare the safety and effectiveness of two different drug-eluting stents to treat PAD, or blockages of the leg arteries. Cook Medical’s device is the only such stent currently available on the U.S. market to treat lesions in the femoral and popliteal arteries.
- The Eluvia stent met the study’s main goal of primary patency, a measure of the blood vessel remaining unobstructed at 12 months. The two stents also had similar safety profiles, according to the research, which was published online in The Lancet.
With years of experience in bringing to market drug-eluting stents for opening clogged coronary arteries, Boston Scientific is now applying its know-how to treat peripheral artery disease. The company has said it expects the Eluvia stent, which is already approved in Europe, to be ready to launch in the U.S. market in 2019.
The aging population and rise in the number of patients with diabetes is increasing the prevalence of PAD. A variety of devices are available to remove blockages in the lower extremities, both surgically and less invasively using a catheter inserted through the blood vessels. These treatments, however, are not always enough to prevent the need for a repeat procedure due to re-narrowing of the artery, according to the Lancet article. This is especially true in patients with long, complex lesions.
An earlier study by Cook Medical showed that the Zilver PTX stent, covered with the drug paclitaxel, significantly reduced the need for a repeat procedure, compared to angioplasty and bare-metal stents.
The Imperial study, funded by Boston Scientific, compared the company’s polymer-coated, paclitaxel-eluting Eluvia stent with the polymer-free, paclitaxel-coated Zilver PTX stent in 465 patients. The role of the polymer is to extend the duration of the drug’s presence in the vessel. The polymers used are the same as those on Abbott Laboratories’ Xience V coronary stents and have well-documented safety profiles, the Lancet article said.
Patients who received the Eluvia stent had a primary patency rate of 86.8%, a more favorable outcome than the 77.5% for patients treated with the Zilver PTX stent. The study also looked at target lesion revascularization (TLR), finding that 4.5% of the Eluvia patients needed an additional procedure, compared with 9.0% of those who received the Zilver stent. Rates for all major adverse events, including TLR and amputation, were 4.9% for the Eluvia patients and 9.0% for the Zilver group.
"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," William Gray, president of the Lankenau Heart Institute in Wynnewood, Pennsylvania, and co-principal investigator of the Imperial study, said in a press release from Boston Scientific.
- Boston Scientific Boston Scientific Eluvia Drug-Eluting Stent Demonstrates Superior Results In IMPERIAL Trial
- The Lancet A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial