Abbott to Present Comprehensive
Safety and Efficacy Data on XIENCE™ V Drug Eluting Stent to
FDA Advisory Committee on November 29
Data in Pre-Market Approval
Application Are First Ever to Demonstrate Superiority of
One Drug Eluting Stent Over Another in a Randomized Controlled
Clinical Trial
New Data Released Confirms Consistency of Results for Late
Loss, TVF, MACE, TLR, Cardiac Death, MI, Thrombosis
Across all XIENCE V Studies
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November 27, 2007 -- Abbott Park, Illinois --
Abbott today released a summary
of clinical highlights on the XIENCE™ V
Everolimus Eluting Coronary Stent System, which will be presented November 29
to the Circulatory System Devices Advisory Panel, an advisory committee to the
U.S. Food and Drug Administration (FDA). The clinical summary was released in
conjunction with the posting of the Panel briefing documents on the FDA Web
site (www.fda.gov ). The advisory panel will
review the data and recommend if the FDA should approve XIENCE V, a next-generation
drug eluting stent for the
treatment of coronary artery disease.
"The data we have submitted to the FDA to support the
approval of XIENCE V is robust, consistent across several independent randomized
trials and shows sustained positive results over
time," said John M. Capek, Ph.D., executive vice president, Medical
Products, Abbott. "XIENCE V is the only drug eluting stent that has
demonstrated clinical superiority over another drug eluting stent in a
randomized clinical trial, and we look forward to sharing our data with the FDA
Advisory Panel as they review this important new technology for physicians and
patients."
New data made available today as part of the Panel
documents include two-year safety results from a pooled subset of 603 patients
from the SPIRIT
II and SPIRIT III
trials (422 treated with XIENCE V). Results from
this subset are consistent with the positive SPIRIT
III one-year data and the pooled analysis of the SPIRIT II and SPIRIT III
trials at one year presented last month at TCT 2007. The new two-year subset
data analysis shows similar low rates of major adverse cardiac events (MACE),
target vessel failure (TVF), cardiac death, heart attack, and stent thrombosis
as previously reported in the SPIRIT trials. The pooled two-year subset data
also show similar rates of death, myocardial infarction (MI), and late stent
thrombosis (31-758 days) between XIENCE V and the
TAXUS® Paclitaxel-Eluting Coronary Stent System at two years.
XIENCE V Clinical Program Highlights
During the FDA Advisory Panel meeting, Abbott will
present data from across its SPIRIT clinical program. In the SPIRIT family
of trials, XIENCE V demonstrated:
- Proven superiority in the primary endpoint of
in-segment late loss (a measure of vessel renarrowing) in the SPIRIT
III
clinical trial, with XIENCE V demonstrating a
50 percent reduction in in-segment late loss
compared to TAXUS at eight months.
- An observed 23 percent reduction in the major
secondary endpoint of Target Vessel Failure (retreatment anywhere within
the target vessel) compared to
TAXUS at one year in SPIRIT III. TVF rates in the
pooled SPIRIT II and SPIRIT III analyses were consistent with the SPIRIT III
one-year results, with XIENCE V demonstrating an
observed 29 percent reduction in TVF at one year
in the pooled SPIRIT II and SPIRIT III analysis and an observed 28 percent reduction
in TVF at two years in the pooled
two-year subset of SPIRIT II and SPIRIT III.
- 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
(cardiac death, heart attack, TLR or reintervention). MACE rates in the pooled
SPIRIT II and SPIRIT
III analyses are consistent with the SPIRIT
III one-year results, demonstrating an observed 47 percent reduction in MACE
in XIENCE V-treated patients at one year in the pooled
SPIRIT II and SPIRIT
III analysis and an observed 48 percent
reduction in MACE in XIENCE V-treated patients at
two years in the pooled two-year subset of SPIRIT
II and SPIRIT III.
- Similar to SPIRIT III one-year and pooled SPIRIT
II and SPIRIT III one-year results, there
were low rates of cardiac death, MI and stent thrombosis out to two years in
the pooled two-year subset of SPIRIT II and SPIRIT III, with 98.2
percent cardiac death free survival and 97
percent heart attack free survival at two years in patients treated with
XIENCE V.
- No statistical difference in the rates of late
(>30 days) stent thrombosis
between XIENCE V and TAXUS at one year in SPIRIT III (0.5 percent
XIENCE V vs. 0.6
percent TAXUS, ARC definite/probable definition), at two years in the
pooled subset analysis of SPIRIT II and III (0.8 percent XIENCE V vs.
1.3 percent TAXUS, ARC definite/probable
definition) or between years one and two in the pooled subset analysis of SPIRIT
II and III (0.3
percent XIENCE V vs. 0.0 percent TAXUS, ARC definite/probable
definition).
"Across all of the SPIRIT trials, XIENCE V
has met its primary and major secondary endpoints, demonstrating either
noninferiority or clinical superiority compared to TAXUS, the most widely used
drug eluting stent," said Gregg W. Stone, M.D., of Columbia University
Medical Center and the Cardiovascular Research Foundation, New York, principal
investigator of the SPIRIT III clinical trial.
"The data out to two years also demonstrate XIENCE
V is safe, with low rates of death, heart attack and stent thrombosis,
which were comparable to TAXUS, with improved efficacy in terms of freedom from
clinical restenosis."
Robust Post-Approval Program
Abbott's robust continued access and post-approval
program is projected to enroll more than 14,000 XIENCE V patients across
a variety of planned clinical trials. As part of the Panel briefing documents
released today, Abbott also outlined plans for its XIENCE V USA trial, a 5,000
patient post-approval trial designed to study safety outcomes such as late
stent thrombosis, death, MI and
revascularization with follow-up out to five years. The study also will
evaluate patient compliance with antiplatelet therapy.
In addition to XIENCE V USA, SPIRIT IV is a
3,690-patient continued access trial that is currently enrolling patients and
will evaluate the safety and efficacy of XIENCE V
for the treatment of coronary artery disease in a more complex patient
population in the United States. SPIRIT V is an international clinical trial
that will provide additional clinical experience with XIENCE V in approximately
3,000 patients at approximately 100 clinical sites throughout Europe, Asia, Canada
and Latin
America. XIENCE V SPIRIT WOMEN is the world's
first drug eluting stent trial to study only women and will evaluate the
characteristics of 2,000 women undergoing stent implantation as well as the
performance of XIENCE V in those patients in
Europe, Asia-Pacific, Canada and Latin America. Both SPIRIT V and XIENCE V
SPIRIT WOMEN are currently enrolling patients.
Abbott filed its Premarket Approval (PMA) submission
for XIENCE V with the FDA on June 1, 2007. XIENCE V was launched in Europe
and other international
markets in 2006. XIENCE V is currently an
investigational device in the United States and Japan.
About Abbott
Abbott 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 65,000 people and markets its products in more than 130
countries.
Source: Abbott
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