January 20, 2011 – European CE mark approval was granted to expand the indication of Abbott’s Xience Prime everolimus-eluting coronary stent for the treatment of critical limb ischemia (CLI) or severe claudication (pain) of the lower leg. CLI is the most advanced form of peripheral artery disease (PAD) that can ultimately lead to limb amputation.
The CE mark was supported by the data generated on the company's Xience V drug-eluting stent from the DESTINY trial. The 140-patient, investigator-sponsored, randomized, controlled, multicenter trial compared the Xience V to Abbott's Multi-Link Vision bare metal stent in patients with CLI of the lower leg. Patients with lesion lengths less than 40 mm were included in this trial.
The 12-month results from DESTINY demonstrated that Xience V had significantly better patency compared to the bare metal stent at 12 months (85.2 percent Xience V vs. 54.4 percent Multi-Link Vision; p=0.0001). This difference was especially pronounced between six and 12 months, where the difference in patency rate significantly diverged, as the rate for the bare metal stent fell to nearly 50 percent while the rate for Xience V remained above 85 percent. These results demonstrated that there is a significant benefit from an everolimus eluting stent versus a bare metal stent. The data from DESTINY were presented this week at the Leipzig Interventional Course (LINC) 2011, a medical congress held in Germany for physicians treating endovascular diseases.
"The DESTINY trial demonstrates that everolimus-eluting stents result in significantly better patency at 12 months compared to bare metal stents for patients with critical limb ischemia of the lower leg, and the use of everolimus eluting stents can potentially provide significantly better outcomes for these patients," said Marc Bosiers, M.D., head of the department of vascular surgery at St. Blasius Hospital in Dendermonde, Belgium, and principal investigator of the DESTINY trial. "A drug-eluting stent such as Xience Prime provides European physicians with another treatment option for patients with short lesions in the lower leg."
The Xience Prime is commercially available in CE mark countries. It has an improved stent design and a delivery system over the Xience V, offering greater flexibility and enhanced deliverability.
For more information: www.abbottvascular.com