Abbott's pivotal trial studying the Xience V Everolimus Drug Eluting Coronary Stent System, demonstrated that Xience V continues to deliver clinically superior benefits for patients compared to the Taxus paclitaxel-eluting coronary stent.
In this trial involving 1,000 patients, Xience V demonstrated a 45 per cent reduction in the risk of major adverse cardiac events (MACE) and a 32 percent reduction in the risk of target vessel failure (cardiac events related to the treated vessel) at two years as compared to Taxus.
The spirit III is a prospective, multi-centre, randomized, single-blind, controlled clinical trial which spanned over two-year and results were presented by Dr Gregg W. Stone, principal investigator of the trial at the EuroPCR 2008. He is also represents the Columbia University Medical Centre and chairman, Cardiovascular Research Foundation, New York.
"Not only did Xience V clearly differentiate itself from the Taxus stent in the first year after treatment, it has now demonstrated even more positive effects at two years in the trial " said Dr Stone, "As measured by clinically significant reductions in target vessel failure and MACE, Xience V demonstrated an even greater improvement in patient outcomes compared to Taxus at two years than at one year, driven by numerically lower rates of heart attacks and lower observed rates of re-intervention of the target lesion.
"We also saw encouraging trends for lower observed rates of late and very late stent thrombosis in Xience V-treated patients, especially in those who discontinued dual antiplatelet therapy, he added.
The trial is the basis for the pre-market application of Xience V to the US Food and Drug Administration (FDA), demonstrated 45 per cent reduction in the risk of MACE. There was a 32 per cent reduction in the risk of Target Vessel Failure (TVF), cardiac events related to the treated vessel) compared to Taxus. There was also a 40 per cent reduction in the risk of ischemia-driven target lesion revascularization as compared to Taxus.
Xience V is built upon the proven multi-link vision Coronary Stent System, which facilitates ease of stent delivery to the blocked portion of the artery with a flexible design and precise stent deployment. Unlike other stents, Xience V is easily delivered to the narrowed or blocked artery, as it has the thinnest DES platform available. The proven polymer coating on Xience IENCE V facilitates the release of the drug everolimus, getting it to the right place at the right time. Everolimus has been shown to reduce tissue growth and inflammation.
"From these results, it is clear that Xience IENCE V can deliver a sustained benefit to patients over the long term," said Dr John M Capek, executive vice president, Medical Products, Abbott.