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Abbott's XIENCE(TM) V Drug Eluting Stent Demonstrates Consistent and Positive Clinical Outcomes Out to Two Years
Date:3/31/2008

drug eluting stent trials.

"In clinical endpoints such as major adverse cardiac events, retreatment and heart attack, patients treated with XIENCE V in the SPIRIT II clinical trial continue to fare better than patients treated with TAXUS out to two years," said Patrick W. Serruys, M.D., Ph.D., Professor of Interventional Cardiology at Thoraxcentre, Erasmus University Hospital, Rotterdam, and principal investigator of the SPIRIT II clinical trial, who presented the results today. "XIENCE V is performing as we would expect a next-generation drug eluting stent should over the long term, specifically on the important clinical endpoint of MACE. The low rate of MACE with XIENCE V compared to TAXUS was present at 6 months, one year and now at two years in the SPIRIT II trial."

In a small subset of patients in the SPIRIT II trial, in-stent imaging results were evaluated at two years. In this 117-patient subset, the angiographic in-stent late loss rate was 0.33 mm for XIENCE V and 0.34 mm for TAXUS at two years. In-stent late loss is a measure of vessel renarrowing within the margins of the stent.

"At any given point in time, across both the pivotal SPIRIT II and SPIRIT III clinical trials, XIENCE V consistently reduces observed MACE rates by 40 percent or more compared to TAXUS," said Charles Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs and chief medical officer, Abbott Vascular. "The single-digit MACE rate seen with XIENCE V out to two years is encouraging data for interventionalists as they look for ways to improve patient outcomes with next-generation drug eluting stents."

XIENCE V was launched in Europe and other international markets in late 2006. XIENCE V is an investigational device in the United States and Japan, and is currently under review for approval by the U.S. Food and Drug Administration.

Abbott also supplies a private-label version of XIENCE V to Boston Scientific called the PROMUS(TM) Everolimu
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