TAXUS (mean, 0.14 mm for XIENCE V vs. 0.28 mm for TAXUS).
-- Statistical non-inferiority to TAXUS in the major secondary
(co-primary) endpoint of target vessel failure (TVF) at nine months.
XIENCE V demonstrated an observed 20 percent reduction in TVF compared
to TAXUS (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).
-- An observed 43 percent reduction in the pre-specified secondary
endpoint of major adverse cardiac events (MACE) at nine months
(4.6 percent for XIENCE V vs. 8.1 percent for TAXUS) and an observed
42 percent reduction in MACE at one year (6.0 percent for XIENCE V vs.
10.3 percent for TAXUS) compared to TAXUS. 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
"The low rate of MACE seen with XIENCE V in the SPIRIT III trial can be directly attributed to fewer patients experiencing heart attacks or re-treatment, and is consistent with data from previous trials," said Charles Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs and chief medical officer, Abbott Vascular. "Superior efficacy combined with increased flexibility and deliverability reinforce that XIENCE V is a significant advancement in stent technology that will be a welcome addition to the field of interventional cardiology."
Additional Results from SPIRIT III
There were no significant differences between XIENCE V and TAXUS in the
rates of stent thrombosis either early (less than or
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