Clinical Data Supporting XIENCE V
The robust clinical program for XIENCE V includes long-term data from a total of 1,362 patients enrolled in the SPIRIT FIRST, SPIRIT II and SPIRIT III trials, as well as continued access and post-approval programs that will enroll more than 14,000 XIENCE V patients.
The FDA approved XIENCE V based, in large part, on superior results from the 1,002 patient SPIRIT III U.S. pivotal clinical trial, in which XIENCE V demonstrated statistical superiority to TAXUS on the study's primary endpoint of in-segment late loss (vessel renarrowing) at eight months, with a statistically significant 50 percent reduction (mean, 0.14 mm for XIENCE V vs. 0.28 mm for TAXUS). XIENCE V also demonstrated statistical non-inferiority to TAXUS in the co-primary endpoint of target vessel failure (TVF, cardiac events related to the stented vessel) at nine months, with an observed 20 percent reduction (7.2 percent for XIENCE V vs. 9.0 percent for TAXUS). 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).
In May 2008, Abbott presented two-year data from the SPIRIT III trial demonstrating that XIENCE V continues to deliver positive clinical benefits for patients. At two years, the XIENCE V demonstrated the following key results:
-- 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-driv
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