Press Release
Abbott's Market-Leading XIENCE V® Shows Increasing Clinical Advantages Over TAXUS® Express2™/TAXUS® Liberte™ Between Two and Three Years
In SPIRIT II Trial, XIENCE V Drug Eluting Stent Demonstrates Clinically
Meaningful Reductions Compared to TAXUS in Key Safety Endpoints, Including an
88 Percent Reduction in the Risk of Cardiac Death
at Three Years
March 29, 2009
Orlando, Florida — Long-term data presented today from Abbott's (NYSE: ABT)
SPIRIT II clinical trial demonstrated that the clinical advantages of the XIENCE V® Everolimus Eluting Coronary Stent System
continued to increase between two and three years compared to the TAXUS®
Express2™ Paclitaxel-Eluting Coronary Stent System / TAXUS® Liberte™
Paclitaxel-Eluting Coronary Stent System (TAXUS). Both TAXUS Express2 (73 percent of lesions) and TAXUS Liberte (27 percent of lesions) were used as controls in the
SPIRIT II trial. The data also showed that
patients treated with XIENCE V continue to
experience fewer heart attacks, deaths or repeat procedures at the target
lesion compared to patients treated with TAXUS out to three years. The results
from the SPIRIT II trial were presented during
the i2 Summit at the American College of Cardiology's 58th annual scientific
session in Orlando, Fla.
Between two and three years, Abbott's market-leading XIENCE V maintained a
low cardiac death rate of 0.5 percent, while the
observed cardiac death rate for TAXUS more than tripled during the same time
period (1.3 percent at two years vs. 4.2 percent at three years)*. Similarly, XIENCE V maintained a low, single-digit rate of major
adverse cardiac events (MACE) between two and three years (6.4 percent at two years vs. 6.4 percent at three years), while the observed MACE
rate with TAXUS increased approximately 40
percent between two and three years (10.5
percent at two years vs. 14.9 percent at
three years)*. 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).
| * |
Event rates based on Kaplan-Meier estimates. |
In addition, the SPIRIT II results demonstrated that XIENCE V continues to outperform TAXUS, with XIENCE V showing continued clinical benefits at three
years, including an 88 percent reduction in the
risk of cardiac death and a 57 percent reduction
in the risk of MACE.
"In the clinical outcomes that matter most, such as heart attack, repeat
procedure at the target lesion or death, XIENCE V
demonstrated a consistent reduction compared to TAXUS out to three years,"
said Patrick W. Serruys, M.D., Ph.D., professor of Interventional Cardiology at
Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands, and
principal investigator of the SPIRIT II clinical
trial. "What's even more impressive is that the clinical differences
between XIENCE V and TAXUS continue to widen
between two and three years, confirming the long-term safety and efficacy of
XIENCE V."
In the 300-patient SPIRIT II trial, XIENCE V demonstrated the following key
results at three years:
- An 88 percent reduction in the risk of cardiac death compared to TAXUS
(0.5 percent for XIENCE
V vs. 4.2 percent for TAXUS, p-value=0.024)*.
- A 57 percent reduction in the risk of MACE compared to TAXUS (6.4 percent for XIENCE V
vs. 14.9 percent for TAXUS, p-value=0.029)*.
- An observed 52 percent reduction in the risk of heart attacks (MI) compared
to TAXUS (3.3 percent for XIENCE V vs. 6.8 percent
for TAXUS, p-value=0.20)*.
- An observed 56 percent reduction in the risk of ID-TLR compared to TAXUS
(4.2 percent for XIENCE
V vs. 9.4 percent for TAXUS, p-value=0.092)*.
- No stent thrombosis between two and three years with XIENCE V, and a low
rate of stent thrombosis from zero to three years, per Academic Research
Consortium (ARC) definition of definite/probable stent thrombosis (0.9 percent for XIENCE V
and 2.8 percent for TAXUS, p-value=0.27)*. The ARC definitions of stent thrombosis
were developed to eliminate variability in the definitions across various drug
eluting stent trials.
| * |
Event rates based on Kaplan-Meier estimates; p-values are for
descriptive purposes only |
"The data from the SPIRIT family of trials continue to prove that XIENCE V is an excellent option for patients.
Physicians have embraced this technology, as demonstrated by the market-leading
position of XIENCE V around the world," said
John Capek, Ph.D., executive vice president, Medical Devices, Abbott. "Our
next-generation drug eluting stent in development, XIENCE PRIME, builds upon
the outstanding body of clinical evidence from the SPIRIT family of clinical
trials, while the new stent design and its delivery system build upon the
excellent performance of the VISION cobalt chromium platform, improving
deliverability and helping physicians treat difficult lesions."
XIENCE V is the market-leading drug eluting stent platform, with 50 percent share in the United States, and
market-leading share around the world.
Abbott's next-generation XIENCE PRIME™ Everolimus Eluting Coronary Stent
System utilizes the same drug and polymer as Abbott's market-leading XIENCE V stent and builds upon the proven design of the
MULTI-LINK® family of stents. XIENCE PRIME features a new stent design and
delivery system that are designed to make it more flexible for improved
deliverability. Abbott plans to make XIENCE PRIME available in an expanded size
matrix with lengths up to 38 mm. The company
expects to launch XIENCE PRIME in Europe later this year.
About the SPIRIT II Trial
SPIRIT II is a prospective, multi-center, randomized, single-blind,
controlled clinical trial comparing XIENCE V to
TAXUS in 300 patients (223 XIENCE V patients, 77
TAXUS patients) with either one or two de novo native coronary artery
lesions. Patients from Europe, India and New Zealand were enrolled in the trial
between July 5, 2005, and Nov.15, 2005.
The primary endpoint of the SPIRIT II trial was in-stent late loss at six
months, wherein XIENCE V demonstrated superiority to TAXUS with a statistically
significant 69 percent reduction in late loss
(mean, 0.11 mm for XIENCE
V vs. 0.36 mm for TAXUS). In-stent 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.
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
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
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
72,000 people and markets its products in more than 130 countries.
Media:
Jonathon Hamilton
Jennie Kim |
(408) 624-0314
(408) 332-4176 |
Financial:
Tina Ventura |
(847) 935-9390 |
