coronary stent system in the primary endpoint of angiographic In-Stent
Late Loss in the SPIRIT II clinical trial at six months, with a
statistically significant 69 percent reduction for XIENCE V. In-stent
late loss is a measure of vessel renarrowing within the margins of the
stent.
-- Superiority for XIENCE V compared to the TAXUS in the primary endpoint
of angiographic In-Segment Late Loss at eight months in the SPIRIT III
clinical trial, with a statistically significant 50 percent reduction
for XIENCE V. In-segment late loss is a measure of vessel renarrowing.
-- An observed 43 percent reduction in major adverse cardiac events (MACE)
compared to TAXUS at one year in SPIRIT III. MACE is an important
clinical measure of safety and efficacy outcomes for patients, and is
defined as cardiac death, heart attack (myocardial infarction or MI),
or ischemia-driven target lesion revascularization (TLR associated with
symptoms or documented lack of blood supply).
-- Non-inferiority to TAXUS with an observed 23 percent reduction in
Target Vessel Failure (TVF) for XIENCE V compared to TAXUS in the
SPIRIT III clinical trial at one year. Target Vessel Failure is a
measure of re-treatment anywhere within the target vessel and includes
cardiac death or heart attack.
Additionally, data from an independent pooled subset analysis of SPIRIT
II and SPIRIT III at one year showed:
-- A statistically significant 59 percent reduction in angiographic
In-Stent Late Loss for XIENCE V compared to TAXUS for lesions in a
reference vessel diameter less than 2.5 mm.
-- An observed 61 percent reduction in angiographic In-Segment Late Loss
for XIENCE V co
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