Press Release
Abbott's XIENCE V® Demonstrates Impressive Low Rates of Repeat Procedure, Stent Thrombosis and Major Adverse Cardiac Events in Complex, "Real World" Patients in SPIRIT V Study
Safety and Efficacy Rates in Patients with Challenging Anatomy Consistent
with Superior Results from Randomized Clinical Trials
May 21, 2009
Barcelona, Spain — New data presented today at EuroPCR from an
international, post-approval, single-arm study show that Abbott's (NYSE: ABT)
market-leading XIENCE V® Everolimus Eluting
Coronary Stent System demonstrated low rates of repeat procedure (target lesion
revascularization), stent thrombosis and major adverse cardiac events (MACE) in
a complex patient population. In the SPIRIT V
(five) study, XIENCE V (vee) demonstrated a very
low 1.8 percent rate of target lesion
revascularization (TLR), a 0.7 percent rate of
stent thrombosis and a 5.1 percent rate of MACE
at one year. MACE is an important composite clinical measure of safety and
efficacy outcomes for patients, defined as cardiac death, heart attack
(myocardial infarction attributed to the target vessel), and TLR driven by lack
of blood supply. The SPIRIT V study evaluated
XIENCE V in a diverse, "real world"
population of patients and lesion types, including diabetics, patients with
multi-vessel disease and patients with highly complex lesions.
"The data from real-world studies are valuable because they reflect a
broad patient population that is more representative of the spectrum of disease
seen in a typical interventional cardiology practice," said Eberhard Grube,
M.D., chief, Department of Cardiology and Angiology, Heart Center Siegburg in
Germany and principal investigator of the SPIRIT
V study. "The one-year results from SPIRIT
V indicate that even in a patient population with a high percentage of
complex lesions, XIENCE V exhibits remarkably low
event rates, similar to what was seen when XIENCE
V was studied in controlled, randomized SPIRIT studies."
SPIRIT V is an international, post-approval study of 2,663 patients.
Approximately 100 clinical sites throughout Europe, Asia-Pacific and Canada are
participating in the study, ensuring a patient population composed of multiple
ethnic groups. The patient and lesion types studied in SPIRIT V include patients with diabetes (30 percent of patients; 794 patients), patients with
multi-vessel disease (42 percent of patients;
1,107 patients), patients with highly complex lesions (lesion type B2 or C; 82 percent of
lesions; 2,307 patients), patients with moderately or severely calcified
lesions (29 percent of lesions; 809 patients),
patients with longer lesions (≥ 20 mm; 28 percent of lesions; 911 patients) that need
treatment, and patients with smaller vessels (reference vessel diameter ≤ 2.75 mm, 35 percent of
lesions, 1,068 patients).* The safety and
efficacy of XIENCE V has not been established in
the United States for patients with multi-vessel disease, patients with highly
complex lesions (lesion type B2 or C), or patients with severely calcified
lesions.
The primary endpoint of the study is a composite rate of all death, heart
attack (myocardial infarction) and target vessel revascularization at 30 days,
in which XIENCE V had a rate of 2.7 percent. At one year, the SPIRIT V study
demonstrated the following positive results for XIENCE V:
- A 1.8 percent rate of repeat procedure to the treated lesion (TLR)
- A 0.7 percent cumulative rate of definite/probable stent thrombosis (to one
year) and a low 0.2 percent rate of
definite/probable late stent thrombosis (between 30 days and one year)
- A 5.1 percent rate of MACE
- A 1.1 percent rate of cardiac death
All events were adjudicated according to the Academic Research Consortium
(ARC) definitions by an independent Clinical Events Committee. The ARC
definitions were developed to eliminate variability in definitions across
various drug eluting stent trials; using ARC definitions to measure events sets
a new standard in real-world studies.
"The low occurrence of repeat procedure and stent thrombosis is
noteworthy given that the SPIRIT V study includes
high-risk patient groups, including diabetics, patients with multi-vessel
disease and patients with highly complex or calcified lesions," said
Charles Simonton, M.D., FACC, FSCAI, divisional vice president, Medical
Affairs, and chief medical officer, Abbott Vascular. "The outstanding data
from SPIRIT V and consistently strong performance
of XIENCE V across all clinical trials reinforce
why physicians throughout the world have embraced this technology."
Abbott also presented five-year results from the SPIRIT FIRST trial, which
was a 60-patient, first-in-man study comparing XIENCE V to the MULTI-LINK
VISION® Coronary Stent System. XIENCE V continued
to demonstrate an excellent long-term safety profile with no MACE or stent
thrombosis events between one and five years.
As part of the company's commitment to advancing the treatment of coronary
artery disease, Abbott's robust post-approval and continued access program is
projected to study more than 20,000 XIENCE V
patients across several clinical trials. In addition to SPIRIT V, ongoing studies include:
- SPIRIT IV, a continued-access trial looking at a more complex patient
population in the United States;
- XIENCE V SPIRIT WOMEN, the world's first drug eluting stent trial to study
only female patients will evaluate women in Europe, Asia Pacific, Canada and
Latin America;
- XIENCE V USA, a post-approval study being conducted in the United States;
and
- XIENCE V INDIA, a post-approval study being conducted in India.
Abbott's next-generation drug eluting stent in development, the XIENCE
PRIME™ Everolimus Eluting Coronary Stent System, utilizes the same drug and
polymer as XIENCE V and is based upon the proven
design of the MULTI-LINK® family of stents. Abbott plans to make XIENCE PRIME
available in an expanded size matrix, including XIENCE PRIME SV for small vessels and XIENCE PRIME LL for long lesions. XIENCE PRIME is pending
CE Mark and is not available for sale.
"XIENCE PRIME builds upon the unprecedented body of clinical evidence
from the SPIRIT family of clinical trials, and offers advances in the delivery
system and an enhanced stent design to make the stent even easier for
physicians to deliver to the lesion site," said Robert Hance, president,
Abbott Vascular. "We are pleased with the progress we've made to bring this
next advancement to physicians and patients, and we look forward to launching
XIENCE PRIME in Europe later this year."
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 stent. 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 marketed 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. It is also under review with
Health Canada.
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.
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.
* Patient/lesion subgroups are not mutually exclusive.
Media:
Jonathon Hamilton
Jennie Kim |
(408) 624-0314
(408) 332-4176 |
Financial:
Tina Ventura |
(847) 935-9390 |
