XIENCE(TM) V Drug Eluting Stent from Abbott Outperforms Market-Leading Stent in Reducing Major Adverse Cardiac Events at...(the U.S. Food and Drug Administration(FD...),Health

-- A 45 percent reduction in the risk of major adverse cardiac events

(MACE) compared to TAXUS (7.3 percent for XIENCE V vs. 12.8 percent for

TAXUS, p-value=0.004)*. MACE is an important composite clinical measure

of safety and efficacy outcomes for patients, defined as cardiac death,

heart attack (MI), or ischemia-driven target lesion revascularization

(TLR driven by lack of blood supply).

-- A 32 percent reduction in the risk of Target Vessel Failure (TVF,

cardiac events related to the treated vessel) compared to TAXUS

(10.7 percent for XIENCE V vs. 15.4 percent for TAXUS, p-value=0.04)*.

TVF is a composite clinical measure of safety and efficacy outcomes

defined as cardiac death, heart attack (myocardial infarction or MI) or

target vessel revascularization (TVR).

-- A 40 percent reduction in the risk of ischemia-driven target lesion

revascularization (ID-TLR) as compared to TAXUS (4.6 percent for

XIENCE V vs. 7.5 percent for TAXUS, p-value=0.07)*.

-- Low rates of stent thrombosis between one and two years, defined as

very late stent thrombosis, per Academic Research Consortium (ARC)

definition of definite/probable stent thrombosis (0.3 percent for

XIENCE V and 1.0 percent for TAXUS) and per the SPIRIT III protocol

(0.2 percent for XIENCE V and 1.0 percent for TAXUS). The ARC

definitions of stent thrombosis were developed to eliminate variability

in the definitions across various drug eluting stent trials.

"From these results, it is clear that XIENCE V can deliver sustained benefits to patients over the long term," said John M. Capek, Ph.D., executive vice president, Medical Products, Abbott. "We continue to be pleased with the way XIENCE V is performing, w
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