Novel Taxus Element Stent Compares Favorably with Earlier Stents

A novel drug-eluting stent incorporating a new alloy and design achieved at least comparable outcomes compared with earlier generation drug-eluting stents and superior outcomes compared with bare metal stents in patients with previously untreated arterial stenosis in the PERSEUS clinical trial program, according to study results presented at the 59th Annual Scientific Session of the American College of Cardiology. Moreover, the new stent appears to be particularly effective for small vessels, experts said.

These studies demonstrate the successful transfer of the TAXUS paclitaxel-eluting stent technology to the new platinum chromium stent (the TAXUS Element Stent], according to lead investigator of the PERSEUS trials, Dean Kereiakes, MD, Medical Director of the Christ Hospital Heart and Vascular Center/the Lindner Center for Research and Education in Cincinnati, OH.

“The new metal alloy is promising, blocking greater radiation with greater radial strength, less recoil, and very low nickel content,” he stated. “The Element’s thinner struts and lower profile make it more conformable and deliverable, as well as more visible [under imaging] than stainless steel or cobalt chromium.”

At a late-breaking clinical trials session during the 59th Annual Scientific Session of the American College of Cardiology, Kereiakes presented outcomes from the PERSEUS Workhorse Study and the PERSEUS Small Vessel Study demonstrating the efficacy and safety of the novel TAXUS Element stent.

The Workhorse Study included 1262 patients with lesions up to 28 mm long and a vessel diameter between 2.75 mm and 4.0 mm. Patients were randomized 3:1 to receive either the TAXUS Element or the TAXUS Express stent. The Element performed as well as the Express for the primary endpoint (target-lesion failure at 12 months; 5.57% and 6.14%, respectively) and the secondary endpoint — in-segment percent diameter stenosis at 9 months (3.09% and 3.12%, respectively).

The PERSEUS Small Vessel study, which included 224 patients with small lesions (ie, less than 20 mm in length and with a vessel diameter from 2.25 mm to <2.75 mm), demonstrated the superiority of the novel stent over the Express stent. In this study, those treated with the Element stent were compared with an historical Express stent control group from the TAXUS V clinical trial. For the primary endpoint of in-stent late loss at 9 months, the TAXUS Element stent was superior (0.38 mm and 0.80 mm, respectively). For the secondary endpoint of target-lesion Failure at 12 months, the Element was statistically and numerically superior to the Express stent: 7.3% versus 19.5%, respectively. The Element remained superior in a propensity adjustment analysis to account for the non-randomized design of the Small Vessel study, Kereiakes told listeners.

Both trials were funded by the Boston Scientific Corporation. Dr. Kereiakes has received research support for Boston Scientific and serves on its Scientific Advisory Board.