Press Release
Circulation Publishes Pivotal Two-Year Results On XIENCE V™ Drug Eluting Stent
Data from SPIRIT III Trial Demonstrate that Patients Treated with XIENCE V Are Less Likely to Have a Heart Attack or
Require a Repeat Intervention Out to Two Years
January 26, 2009
Abbott Park, Illinois (NYSE: ABT)
— Data published online today in Circulation from the SPIRIT III U.S.
pivotal trial evaluating the XIENCE V™ Everolimus
Eluting Coronary Stent System demonstrated that Abbott's market-leading XIENCE V outperforms the TAXUS® Express²™
Paclitaxel-Eluting Coronary Stent System (TAXUS) in reducing major adverse
cardiac events (MACE) at two years. In the SPIRIT
III trial of 1,002 patients, XIENCE V
demonstrated a 45 percent reduction in the risk
of MACE, and a 40 percent reduction in the risk
of cardiac death or heart attack (myocardial infarction, or MI) at two years in
patients treated with XIENCE V compared to those
treated with TAXUS. Additionally, at two years the study demonstrated a 32 percent reduction in the risk of target vessel
failure (TVF, cardiac events related to the treated vessel) for XIENCE V compared to TAXUS. These published results
were first presented in May 2008 at the EuroPCR
Congress in Barcelona.
"As published in Circulation, the SPIRIT III study results
demonstrate that the clinical benefits of XIENCE
V continue to improve between one and two years of follow-up after stent
implantation compared to TAXUS," said Gregg W. Stone, M.D., Columbia
University Medical Center; chairman, Cardiovascular Research Foundation, New
York; and principal investigator of the SPIRIT
III trial. "These data reinforce our earlier findings demonstrating
the excellent angiographic and clinical results with the XIENCE V stent, resulting in fewer heart attacks and
repeat reinterventions."
The SPIRIT III trial demonstrated the following key results for XIENCE V at two years:
- A 45 percent reduction in the risk of MACE compared to TAXUS (7.3 percent for XIENCE V
vs. 12.8 percent for TAXUS, p-value=0.004)*. MACE is an important composite
clinical measure of safety and efficacy outcomes for patients, defined as
cardiac death, MI or ischemia-driven target lesion revascularization (TLR
driven by lack of blood supply).
- A 40 percent reduction in the risk of cardiac death or MI (4.0 percent for XIENCE V
vs. 6.6 percent for TAXUS, p-value=0.08)*.
- A 32 percent reduction in the risk of TVF compared to TAXUS (10.7 percent for XIENCE
V vs. 15.4 percent for TAXUS, p-value=0.04)*. TVF is a composite clinical measure of
safety and efficacy outcomes defined as cardiac death, MI or target vessel
revascularization (TVR).
- TAXUS (4.3 percent for XIENCE V vs. 6.9
percent for TAXUS, p-value=0.07)*.
- Low rates of stent thrombosis (blood clotting within the treated area) per
the Academic Research Consortium (ARC) definition of definite/probable stent
thrombosis (1.3 percent for XIENCE V vs. 1.7 percent
for TAXUS) and per the SPIRIT III protocol (1.0
percent for XIENCE V vs. 1.7 percent for TAXUS). The ARC definitions of stent
thrombosis were developed to eliminate variability in the definitions across
various drug eluting stent trials.
- Among patients who discontinued anti-platelet therapy with a thienopyridine
(clopidogrel or ticlopidine) in the study after six months, trends showed that
patients treated with XIENCE V experienced fewer
stent thromboses compared to those treated with TAXUS at the end of two years
(0.4 percent for XIENCE
V vs. 2.6 percent for TAXUS).
"XIENCE V continues to demonstrate sustained excellence, and the data
demonstrate why it is an important advancement in the treatment of heart
disease," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice
president, Medical Affairs, and chief medical officer, Abbott Vascular.
"The consistent positive clinical trial findings, like those from SPIRIT III, are key contributors to why physicians have
quickly adopted XIENCE V, making it the
market-leading drug eluting stent in the United States and in key markets
around the world."
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 native 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 significant 50
percent reduction in late loss (mean, 0.14
mm for XIENCE V vs. 0.28 mm for TAXUS). In-segment late loss is a measure
of vessel renarrowing. In the co-primary endpoint of TVF at nine months, XIENCE V demonstrated statistical non-inferiority
compared to TAXUS with an observed 20 percent
reduction in TVF (7.2 percent for XIENCE V vs. 9.0 percent
for TAXUS).
Additionally, in the pre-specified secondary endpoint of MACE, XIENCE V
demonstrated a 43 percent reduction at nine months (4.6
percent for XIENCE V vs. 8.1 percent for TAXUS) and a 42
percent reduction in MACE at one year (6.0
percent for XIENCE V vs. 10.3 percent for TAXUS) compared to TAXUS.
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 the Ministry of Health, Labour and Welfare and
the Pharmaceuticals and Medical Devices Agency.
Abbott also supplies a private-labeled XIENCE V to Boston Scientific called
the PROMUS™ Everolimus-Eluting Coronary Stent System. PROMUS is 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.
| * |
Event rates are based on Kaplan-Meier estimates; p-values are
for descriptive purposes only. |
Media:
Jonathon Hamilton
Jennie Kim |
(408) 845-3491
(408) 845-1755 |
Financial:
Tina Ventura |
(847) 935-9390 |