Press Release
Abbott's XIENCE V® Continues to Outperform TAXUS with Sustained Clinical Advantages and Impressive Long-Term Safety Results in SPIRIT III Trial
— Market-Leading XIENCE V Demonstrates Single-Digit Rate of Major Adverse
Cardiac Events (MACE) at Three Years and a 43
Percent Reduction vs. TAXUS
— No Additional Stent Thrombosis between Two and Three Years, and Impressive
Low Rate of Very Late Stent Thrombosis for XIENCE
V
September 21, 2009
San Francisco — Long-term data presented today from the SPIRIT III pivotal
U.S. clinical trial demonstrated that the observed clinical advantages of
Abbott's (NYSE: ABT)
market-leading XIENCE V® Everolimus Eluting
Coronary Stent System continued to increase as compared to the TAXUS® Express2
Paclitaxel-Eluting Coronary Stent System (TAXUS). At three years, XIENCE V demonstrated a 43
percent reduction in the risk of major adverse cardiac events (MACE)
compared to TAXUS (9.1 percent for XIENCE V vs. 15.7 percent
for TAXUS, p-value=0.003)*. 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 (ID-TLR driven by lack of blood
supply). The three-year results from the SPIRIT
III trial will be presented today by Gregg W. Stone, M.D., professor of
medicine at Columbia University Medical Center, during the 2009 Transcatheter
Cardiovascular Therapeutics (TCT) conference in San Francisco.
"The SPIRIT III results clearly demonstrate that at three years,
patients continue to benefit from having been treated with the XIENCE V stent rather than the TAXUS stent, with fewer
repeat cardiac procedures and fewer heart attacks in patients who received
XIENCE V," said Dr. Stone, who is also
immediate past chairman of the Cardiovascular Research Foundation, New York;
and principal investigator of the SPIRIT III
trial.
XIENCE V demonstrated an impressive low rate of very late stent thrombosis
(one to three years) with no additional events between two and three years. Per
protocol, XIENCE V demonstrated a 0.2 percent** very late stent thrombosis rate compared
to 1.0 percent for TAXUS (p-value=0.10) at three years. Per Academic Research
Consortium (ARC) definition of definite/probable stent thrombosis, the rate of
very late stent thrombosis at three years was 0.3
percent** for XIENCE V and 1.0 percent for TAXUS (p-value=0.34). The ARC definitions of stent thrombosis
were developed to eliminate variability in the definitions across various drug
eluting stent trials.
Key Results from SPIRIT III
In the 1,002-patient SPIRIT III trial, XIENCE V demonstrated the following
key results out to three years:
- A 43 percent reduction in the risk of MACE compared to TAXUS ( 9.1 percent
for XIENCE V vs. 15.7 percent for TAXUS, p-value=0.003).
- A 43 percent reduction in the risk of Target Lesion Failure (TLF) compared
to TAXUS (8.3 percent for XIENCE V vs. 14.4 percent for TAXUS, p-value=0.005). TLF is a composite measure of important
efficacy and safety outcomes for patients, defined as cardiac death, target
vessel MI and TLR.
- A 30 percent reduction in the risk of Target Vessel Failure (TVF) compared
to TAXUS (13.5 percent for XIENCE V vs. 19.2 percent for TAXUS, p-value=0.03). TVF is a composite clinical measure of
safety and efficacy outcomes defined as cardiac death, MI or ischemia-driven
target vessel revascularization (TVR).
- A 42 percent reduction in the risk of heart attacks (MI) compared to TAXUS
(3.7 percent for XIENCE V vs. 6.3 percent for TAXUS, p-value=0.07).
- A 39 percent reduction in the risk of ID-TLR compared to TAXUS (5.4 percent
for XIENCE V vs. 8.9 percent for TAXUS, p-value=0.05).
- Per protocol definition, a 0.2 percent** rate of very late stent thrombosis
compared to 1.0 percent for TAXUS (p-value=0.10). Per ARC definition of definite/probable
stent thrombosis, the rate of very late stent thrombosis was 0.3 percent** for XIENCE
V and 1.0 percent for TAXUS (p-value=0.34).
Consistent Results in SPIRIT III Subgroup Analyses
In addition to the positive three-year results for the overall study
presentation, subgroup analyses from the SPIRIT
III trial demonstrated evidence of the strong performance by XIENCE V in a variety of patients and lesion types that
represent complex patients. In patients with diabetes, the analysis showed
there was no difference at three years in MACE between XIENCE V and TAXUS (11.0
percent for XIENCE V vs. 10.3 percent in TAXUS)***. In fact, XIENCE
V maintained a consistent rate of clinical events after the first year
(8.7 percent MACE at one year and 11.0 percent MACE at three years), whereas TAXUS
demonstrated a sustained upward trend in clinical events from one year to three
years (4.7 percent MACE at one year and 10.3 percent MACE at three years). In patients without
diabetes, the MACE rate for TAXUS at three years was more than double the MACE
rate for XIENCE V at three years (9.1 percent for XIENCE V
vs. 18.7 percent for TAXUS).
"The SPIRIT III data clearly show that XIENCE V performs in a consistent
manner, with clinical benefits continuing to improve over time compared to
TAXUS," said Robert Hance, senior vice president, vascular, Abbott. "We
are pleased to begin this year's TCT conference with a strong showing of data
for Abbott's market-leading XIENCE V, and look
forward to presenting the highly anticipated SPIRIT IV one-year results later
this week, which should provide physicians with additional valuable
insights."
One-year results from the company's SPIRIT IV trial will be presented on
Wednesday, Sept. 23, during the first
late-breaking clinical trials session of the TCT conference. The SPIRIT IV trial is one of the largest randomized
clinical trials between two drug eluting stents, with 3,690 patients enrolled,
including more than 1,000 patients with diabetes. The study results will
provide valuable information about the efficacy and safety of XIENCE V compared to TAXUS. 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.
About the SPIRIT III Trial
SPIRIT III is a prospective, multi-center, randomized, single-blind,
controlled clinical trial comparing XIENCE V to TAXUS in 1,002 patients (669
XIENCE V patients, 333 TAXUS patients) with
either one or two de novo coronary artery lesions. The trial was conducted
across 65 academic and community-based centers in the United States between
June 22, 2005, and March
15, 2006.
The primary endpoint of the SPIRIT III trial was in-segment late loss at
eight months, wherein XIENCE V demonstrated
superiority to TAXUS with a statistically superior 50
percent reduction in late loss (mean, 0.14
mm for XIENCE V vs. 0.28 mm for TAXUS, p-value
=0.004). In-segment late loss is a measure of vessel re-narrowing.
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.
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.
Abbott's market-leading XIENCE V drug eluting stent is commercially
available in the United States, Europe and other international markets. XIENCE V is an investigational device in Japan and is
currently under review by Japan's 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
antiproliferative properties.
XIENCE V is indicated for improving coronary luminal diameter in patients
with symptomatic heart disease due to de novo native coronary artery lesions
(lesions less than or equal to 28 mm) with
reference vessel diameters of 2.5 mm to 4.25 mm. Additional information about XIENCE V, including important safety information, is
available online at www.xiencev.com or www.abbottvascular.com/en_US/content/document/eIFU_XienceV.pdf.
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
72,000 people and markets its products in more than 130 countries.
| * |
Unless otherwise noted, all event rates and p-values are based
on Kaplan-Meier estimates; p-values are for descriptive purposes only. |
| ** |
Stent thrombosis rates are based on binary event rates, and
p-values are based on Fisher's Exact Test; p-values are for descriptive
purposes only. |
| *** |
Subgroup event rates are based on binary event rates. |
Media:
Jonathon Hamilton
Jennie Kim |
(408) 624-0314
(408) 332-4176 |
Financial:
John Thomas
Tina Ventura |
(847) 938-2655
(847) 935-9390 |