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Abbott's XIENCE(TM) V Everolimus Eluting Coronary Stent Shows Continued Superiority to TAXUS Stent in Reducing Major Adverse Cardiac Events in SPIRIT III Clinical Trial
Date:10/22/2007

In the major secondary endpoint of Target Vessel Failure (TVF), XIENCE

V continued to demonstrate statistical non-inferiority to TAXUS with an

observed 23 percent reduction in Target Vessel Failure for XIENCE V

compared to TAXUS (8.3 percent XIENCE V, 10.8 percent TAXUS) at one

year. Target Vessel Failure is a measure of re-treatment anywhere

within the target vessel and includes cardiac death or heart attack.

-- There was no evidence of a difference in either acute (30 day) or late

thrombosis rates between XIENCE V and TAXUS out to one year.

"To date, XIENCE V is the only drug-eluting stent system that has demonstrated a statistically significant improvement in event-free survival compared to another FDA approved drug-eluting stent in a pivotal randomized clinical trial," said Gregg W. Stone, M.D., of Columbia University Medical Center and the Cardiovascular Research Foundation, New York, principal investigator of the SPIRIT III clinical trial. "In SPIRIT III, the risk for patients on the important clinical endpoint of MACE -- cardiac death, heart attack or retreatment in the diseased artery area -- was approximately 43 percent lower with XIENCE V than TAXUS at 1 year. A reduction in MACE with Xience V compared to TAXUS was also present at 1 year in the smaller SPIRIT II trial, demonstrating that this is a robust, reproducible difference."

There was no evidence of a statistical difference between rates of stent thrombosis for XIENCE V or TAXUS out to one year in the SPIRIT III trial. Rates of late stent thrombosis at one year per protocol were 0.3 percent for XIENCE V and 0.6 percent for TAXUS. Rates of definite/probable late stent thrombosis at one year under ARC definition were 0.5 percent for XIENCE V and 0.6 percent for TAXUS.

A variety of SPIRIT III subgroup analyses showed additional observational evidence of favorable clinical and angiographic results for XIENCE V; however, the
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SOURCE Abbott
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