Abbott's XIENCE V Shows Outstanding Two-Year Clinical Results Versus TAXUS in Key Safety and Efficacy Measures in SPIRIT IV Trial

September 24, 2010 by Anonymous


Late-breaking data from the SPIRIT IV trial, one of the largest randomized clinical trials between two drug eluting stents, continued to demonstrate outstanding clinical results of Abbott's market-leading XIENCE V Everolimus Eluting Coronary Stent System versus the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System (TAXUS) in key areas of safety and efficacy through two years. The impressive two-year results were presented today by Gregg W. Stone, M.D., professor of medicine at Columbia University Medical Center and NewYork-Presbyterian Hospital, during the Cardiovascular Research Foundation's 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, D.C.

In the trial's composite endpoint, XIENCE V demonstrated a clinically significant 30 percent risk reduction in TLF (target lesion failure) compared to TAXUS (6.9 percent for XIENCE V vs. 9.9 percent for TAXUS, p-value=0.003). TLF is a composite measure of important efficacy and safety outcomes for patients and is defined as cardiac death, heart attack attributed to the target vessel (target vessel myocardial infarction), and ischemia-driven target lesion revascularization (ID-TLR). XIENCE V also demonstrated a clinically significant 34 percent risk reduction in ID-TLR (repeat procedure) compared to TAXUS (4.5 percent for XIENCE V vs. 6.9 percent for TAXUS, p-value=0.004). ID-TLR is one of the major secondary endpoints of the SPIRIT IV trial2.

"The two-year results from SPIRIT IV show that XIENCE V significantly reduces a patient's risk of experiencing a heart attack, stent thrombosis and the need for a repeat procedure," said Dr. Stone, principal investigator of the SPIRIT IV trial. "These are important measures of safety that have a major impact on the lives of the millions of patients who receive a drug eluting stent every year. The positive SPIRIT IV data at two years continue to demonstrate superior safety and efficacy of the XIENCE V stent platform."