- New Data from SPIRIT II Show Continued Low Rates of MACE with XIENCE V -
CHICAGO, March 31 /PRNewswire-FirstCall/ -- Data presented today from Abbott's SPIRIT II clinical trial demonstrated continued positive clinical results for the XIENCE(TM) V Everolimus Eluting Coronary Stent System out to two years, including an observed 40 percent reduction in major adverse cardiac events (MACE) and an observed 44 percent reduction in vessel retreatment (ischemia-driven target lesion revascularization, TLR) compared to the TAXUS(R) paclitaxel-eluting coronary stent system. The two-year results from the SPIRIT II trial were presented at the SCAI Annual Scientific Sessions in Partnership with ACC i2 Summit.
SPIRIT II is a 300-patient randomized clinical trial, which was
conducted in Europe and Asia Pacific to support the launch of XIENCE V
outside the United States. In SPIRIT II, XIENCE V demonstrated the
following key results:
-- In an analysis of major adverse cardiac events (MACE), XIENCE V
demonstrated an observed 40 percent reduction in MACE compared to
TAXUS at two years (6.6 percent for XIENCE V vs. 11.0 percent for
TAXUS). MACE is an important clinical measure of patient outcomes,
defined as cardiac death, heart attack (myocardial infarction or MI),
or ischemia-driven target lesion revascularization.
-- XIENCE V demonstrated an observed 44 percent reduction in
ischemia-driven target lesion revascularization (TLR driven by lack of
blood supply) compared to TAXUS at two years (3.8 percent for XIENCE V
vs. 6.8 percent for TAXUS).
-- Rates of definite/probable stent thrombosis under the Dublin/Academic
Research Consortium (ARC) definition were 0.9 percent for XIENCE V and
1.4 percent for TAXUS at two years. The ARC definition of late-stent
thrombosis was developed to eliminate variability in the definitions
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