Press Release
Abbott's XIENCE V™ Drug Eluting Stent Outperforms TAXUS® in Key Efficacy and Safety Endpoints Out to Two Years
New Analysis of SPIRIT II and SPIRIT III Data
Confirms Patients Treated with XIENCE V Are at
Lower Risk of Experiencing Death, a Heart Attack or a Repeat Procedure Compared
to TAXUS® at Two Years
October 13, 2008
Washington — Data from an independent meta-analysis of Abbott's (NYSE: ABT)
SPIRIT II and SPIRIT
III randomized clinical trials demonstrated that the XIENCE V™ Everolimus Eluting Coronary Stent System
continues to deliver clinically significant benefits for patients compared to
the TAXUS® paclitaxel-eluting coronary stent system out to two years. In this
meta-analysis, which included patients from the United States, Europe and
Asia-Pacific, XIENCE V demonstrated clinical
superiority to TAXUS in the endpoints of target vessel failure (TVF) and major
adverse cardiac events (MACE) at two years. XIENCE
V also demonstrated significantly lower clinical events rates than TAXUS
in the key efficacy (target lesion revascularization) and safety (cardiac death
or heart attack) components of MACE at two years. The results are being
presented by Gregg W. Stone, M.D., principal investigator of the SPIRIT III
trial, during the Cardiovascular Research Foundation's 20th annual
Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
"The pooled results from the SPIRIT II and
SPIRIT III trials demonstrate that XIENCE V is safer and provides greater efficacy than
TAXUS at two years," said Dr. Stone, professor of medicine at Columbia
University Medical Center and chairman, Cardiovascular Research Foundation, New
York. "In the meta-analysis at two years, XIENCE
V compared to TAXUS demonstrated statistically significant reductions in
the combined measure of all-cause death or heart attack, as well as further
reducing the need for repeat cardiac procedures – reinforcing that XIENCE V is a true second-generation stent, which
results in improved patient outcomes."
The meta-analysis of 1,302 patients from the SPIRIT
II and SPIRIT III trials demonstrated the
following key results for XIENCE V at two years:
- A clinically significant 31 percent reduction in the risk of
ischemia-driven Target Vessel Failure (TVF, cardiac events related to the
treated vessel) compared to TAXUS (10.4 percent
for XIENCE V vs. 14.7
percent for TAXUS, p-value=0.03)*. 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).
- A clinically significant 45 percent reduction in the risk of
ischemia-driven major adverse cardiac events (MACE) compared to TAXUS (7.1 percent for XIENCE V
vs. 12.3 percent for TAXUS, p-value=0.001)*. MACE is an important composite
clinical measure of safety and efficacy outcomes for patients, defined as
cardiac death, heart attack (myocardial infarction or MI), or ischemia-driven
target lesion revascularization (TLR driven by lack of blood supply).
- An observed 28 percent reduction in the risk of all-cause death compared to
TAXUS (2.4 percent for XIENCE V vs. 3.3 percent for TAXUS, p-value=0.36)*.
- An observed 28 percent reduction in the risk of cardiac death compared to
TAXUS (0.9 percent for XIENCE V vs. 1.3 percent
for TAXUS, p-value=0.56)*.
- A clinically significant 45 percent reduction in the risk of heart attack
(MI) compared to TAXUS (3.1 percent for XIENCE V vs. 5.6 percent
for TAXUS, p-value=0.03)*.
- A clinically significant 39 percent reduction in the risk of all-cause
death or heart attack (MI) compared to TAXUS (5.1
percent for XIENCE V vs. 8.3 percent for TAXUS, p-value=0.03)*.
- A clinically significant 41 percent reduction in the risk of cardiac death
or heart attack (MI) compared to TAXUS (3.8
percent for XIENCE V vs. 6.3 percent for TAXUS, p-value=0.04)*.
- A clinically significant 41 percent reduction in the risk of
ischemia-driven target lesion revascularization (ID-TLR) compared to TAXUS
(4.1 percent for XIENCE
V vs. 6.8 percent for TAXUS, p-value=0.03)*.
- Low rates of stent thrombosis between one and two years, defined as very
late stent thrombosis, per Academic Research Consortium (ARC) definition of
definite/probable stent thrombosis (0.5 percent
for XIENCE V and 0.8
percent for TAXUS). The ARC definitions of stent thrombosis were
developed to eliminate variability in the definitions across various drug
eluting stent trials.
| * |
Event rates are based on Kaplan-Meier estimates; p-values are
for descriptive purposes only. |
Strong Results in Complex Patients: SPIRIT III Subgroup
Analyses
Also presented during TCT, a variety of subgroup analyses from the SPIRIT III trial demonstrated observational evidence of
strong performance by XIENCE V in a variety of
patients and lesion types that represent complex patients. The results
consistently favored XIENCE V compared to TAXUS
at two years across multiple subgroups examined, including patients with small
vessels and multi-vessel patients. In diabetic patients, the analysis showed
there were no observed differences between XIENCE
V and TAXUS at two years. The SPIRIT III
trial was not designed to analyze statistical differences in any of the patient
subgroups, as the sample sizes were too small to draw firm conclusions.
"With the subgroup analysis, we saw encouraging trends of lower event
rates between one and two years for patients treated with XIENCE V compared to patients treated with TAXUS,
regardless of patient or lesion complexity," said John M. Capek, Ph.D.,
executive vice president, Medical Devices, Abbott. "Even though the SPIRIT III trial was not designed for statistical
comparisons in subgroups, these positive trends demonstrate that XIENCE V performs in a consistent manner and gives
physicians confidence in XIENCE V as they
consider what is the most effective treatment for their patients."
About XIENCE V
XIENCE V is used to treat coronary artery disease by propping open a
narrowed or blocked artery and releasing the drug, everolimus, in a controlled
manner to prevent the artery from becoming blocked again following a stent
procedure. XIENCE V is built upon Abbott's
market-leading bare metal stent, the MULTI-LINK VISION® Coronary Stent System.
The VISION platform is designed to facilitate ease of delivery, making it
easier for physicians to maneuver the stent and treat the diseased portion of
the artery.
Long-term results with XIENCE V in the SPIRIT III pivotal U.S. clinical
trial demonstrated a 45 percent reduction in the
risk of MACE compared to TAXUS at two years. XIENCE
V demonstrated a 32 percent reduction in
TVF compared to TAXUS at two years. XIENCE V also
demonstrated a low rate of stent thrombosis between one and two years, defined
as very late stent thrombosis, per ARC definition of definite/probable stent
thrombosis (0.3 percent for XIENCE V and 1.0 percent
for TAXUS). XIENCE V met its primary endpoint in
the SPIRIT III clinical trial with a
statistically significant 50 percent reduction in in-segment late loss (vessel
renarrowing) at eight months compared to TAXUS.
The XIENCE V stent is available on both over-the-wire (OTW) and rapid
exchange (RX) delivery systems. Rapid exchange is the most widely used type of
delivery system because it provides physicians additional flexibility to work
as single operators during stent procedures.
XIENCE V was approved by the U.S. Food and Drug Administration and launched
in July 2008, and was launched in Europe and other international markets in
October 2006. XIENCE V is an investigational
device in Japan and is currently under review by the Ministry of Health, Labour
and Welfare and the Pharmaceuticals and Medical Devices Agency.
Abbott also supplies a private-label version of XIENCE V to Boston Scientific called the PROMUS™
Everolimus-Eluting Coronary Stent System. PROMUS is designed and manufactured
by Abbott and supplied to Boston Scientific as part of a distribution agreement
between the two companies.
Everolimus, developed by Novartis Pharma AG, is a proliferation signal
inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its
drug eluting stents. Everolimus has been shown to inhibit in-stent neointimal
growth in the coronary vessels following stent implantation, due to its
anti-proliferative properties.
Additional information about XIENCE V, including important safety and
effectiveness information, is available online at www.xiencev.com.
About Abbott Vascular
Abbott Vascular, a division of
Abbott, is one of the world's leading vascular care businesses. Abbott Vascular
is uniquely focused on advancing the treatment of vascular disease and
improving patient care by combining the latest medical device innovations with
world-class pharmaceuticals, investing in research and development, and
advancing medicine through training and education. Headquartered in Northern
California, Abbott Vascular offers a comprehensive portfolio of vessel closure,
endovascular and coronary products.
About Abbott
Abbott (NYSE: ABT)
is a global, broad-based health care company devoted to the discovery,
development, manufacture and marketing of pharmaceuticals and medical products,
including nutritionals, devices and diagnostics. The company employs more than
68,000 people and markets its products in more than 130 countries.
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