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Abbott's XIENCE V(R) Superior to TAXUS(R) in Key Safety and Efficacy Measures in SPIRIT IV Trial
Date:9/23/2009

SAN FRANCISCO, Sept. 23 /PRNewswire-FirstCall/ -- Late-breaking data from the SPIRIT IV trial demonstrated that Abbott's market-leading XIENCE V(R) Everolimus Eluting Coronary Stent System achieved superiority in the key safety and efficacy measures of target lesion failure (TLF) and target lesion revascularization (TLR) compared to the TAXUS(R) Express2(TM) Paclitaxel-Eluting Coronary Stent System (TAXUS) at one year. With 3,690 patients, the SPIRIT IV trial is one of the largest randomized clinical trials between two drug eluting stents.

In the trial's primary endpoint, XIENCE V demonstrated a statistically significant 38 percent reduction in TLF compared to TAXUS (4.2 percent for XIENCE V vs. 6.8 percent for TAXUS, p-value = 0.001). TLF is defined as 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 TLR (ID-TLR). The standard was established to harmonize the definition of major adverse cardiac events across various drug eluting stent trials. XIENCE V also demonstrated a statistically significant 46 percent reduction in TLR (repeat procedure) compared to TAXUS (2.5 percent for XIENCE V vs. 4.6 percent for TAXUS, p-value=0.001). TLR is one of the major secondary endpoints of the SPIRIT IV trial. The groundbreaking results were presented today by Gregg W. Stone, M.D., professor of medicine at Columbia University Medical Center, during the 2009 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco.

In addition to demonstrating superiority in the primary endpoint of TLF and major secondary endpoint of TLR, XIENCE V demonstrated an impressive low rate of stent thrombosis (blood clots) at one year. Per protocol definition, XIENCE V demonstrated an observed 80 percent reduction in
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