-- A 38 percent reduction in TLF compared to TAXUS (4.2 percent for
XIENCE V vs. 6.8 percent for TAXUS, p-value=0.001).
-- A 39 percent reduction in major adverse cardiac events (MACE) compared
to TAXUS (4.2 percent for XIENCE V vs. 6.9 percent for TAXUS,
p-value=0.0009). MACE is a composite clinical measure of safety and
efficacy outcomes for patients, defined as cardiac death, heart attack
(myocardial infarction or MI), or ID-TLR driven by lack of blood
-- A 46 percent reduction in TLR compared to TAXUS (2.5 percent for
XIENCE V vs. 4.6 percent for TAXUS, p-value=0.001).
-- A 31 percent reduction in cardiac death or target vessel myocardial
infarction (MI) compared to TAXUS (2.2 percent for XIENCE V vs. 3.2
percent for TAXUS, p-value=0.09).
-- A 38 percent reduction in heart attacks (MI) attributed to the target
vessel compared to TAXUS (1.8 percent for XIENCE V vs. 2.9 percent for
-- Comparable rates in cardiac death compared to TAXUS (0.4 percent for
XIENCE V vs. 0.4 percent for TAXUS, p-value=1.00).
-- An observed 80 percent reduction in stent thrombosis per protocol
definition compared to TAXUS (0.17 percent for XIENCE V vs. 0.85
percent for TAXUS, p-value=0.004).
-- An observed 74 percent reduction in stent thrombosis per ARC
definition of definite/probable stent thrombosis compared to TAXUS
(0.29 percent for XIENCE V and 1.10 percent for TAXUS, p-value=0.004).
"In SPIRIT IV, XIENCE V demonstrated superiority to TAXUS in the clinically driven endpoint of target lesion failure, which links the results more closely to real-world practice," said Charles A. Simonton, M.D., FACC, FSCAI, vice president, Medical Affairs, and chief medical officer, Abbott Vascular. "The SPIRIT IV results confirm the consistent and outstanding performance of the XIENCE V stent. We believe these results have the potential to be practice-changing based on the strength of the data."
About XIENCE V