Press Release
The New England Journal of Medicine Publication of SPIRIT IV Trial Results Confirm Superior Safety and Efficacy of Abbott's XIENCE V® Drug Eluting Stent Compared to TAXUS
- Separate, Retrospective SPIRIT IV Cost-Effectiveness Analysis Presented
Earlier this Year Concludes XIENCE V Is Economically Dominant Compared to
TAXUS
May 5, 2010
Abbott Park, Illinois (NYSE: ABT)
— Findings from Abbott's SPIRIT IV trial, one of the largest randomized
clinical trials comparing two drug eluting stents, with 3,690 U.S.-based patients, were published today in The New
England Journal of Medicine. The published study results show that one year
after a stenting procedure, patients treated with Abbott's market-leading XIENCE V® Everolimus Eluting Coronary Stent System were
significantly less likely to have a major adverse event such as a heart attack,
repeat procedure or cardiac death, compared to patients treated with a TAXUS®
Express2™ Paclitaxel-Eluting Coronary Stent System (TAXUS). The SPIRIT IV trial also showed that patients treated with
XIENCE V were considerably less likely to
experience a blood clot (stent thrombosis) compared to patients treated with
TAXUS. These results were originally presented during the September 2009
Transcatheter Cardiovascular Therapeutics (TCT) conference.
In the SPIRIT IV trial's primary endpoint of target lesion failure (TLF),
XIENCE V demonstrated a statistically superior 38
percent reduction compared to TAXUS at one year (4.2 percent for XIENCE V
vs. 6.8 percent for TAXUS, p-value=0.001). TLF is defined as a composite measure
of important efficacy and safety outcomes for patients and includes cardiac
death, heart attack attributed to the target vessel (target vessel myocardial
infarction), and ischemia-driven target lesion revascularization (TLR). The
SPIRIT IV trial also found that the one-year rate
of blood clots (stent thrombosis) with XIENCE V
is among the lowest reported to date with any drug eluting stent (0.29 percent per Academic Research Consortium
definition of definite/probable stent thrombosis).
In a subgroup analysis of more than 1,100 patients with diabetes, who
typically are sicker and have more challenging artery disease, XIENCE V
demonstrated a numerically lower TLF rate compared to TAXUS at one year (6.4 percent for XIENCE V
vs. 6.9 percent for TAXUS, p-value=0.80). In the critical safety endpoint of stent
thrombosis as presented during TCT 2009, XIENCE V
demonstrated a 40 percent reduction compared to
TAXUS in patients with diabetes (per ARC definition of definite/probable stent
thrombosis, 0.80 percent for XIENCE V vs. 1.33 percent
for TAXUS, p-value=0.52).
"With more than 3 million stent procedures being performed annually
worldwide, determining the safety and efficacy differences between various drug
eluting stents has important implications for societal health," said Gregg
W. Stone, M.D., professor of medicine at Columbia University Medical Center;
immediate past chairman of the Cardiovascular Research Foundation in New York;
and principal investigator of the SPIRIT IV trial. "With nearly 4,000
patients studied, SPIRIT IV represents the
largest randomized trial of two drug eluting stents completed to date, and
found that the everolimus-eluting stent significantly reduces a patient's risk
of experiencing a heart attack, stent thrombosis, or the need for a repeat
procedure within one year, compared to the paclitaxel-eluting stent. Based on
these results, and results from the 1,800-patient COMPARE study conducted in
the Netherlands, the everolimus-eluting stent has set a new standard for
patient safety and efficacy."
Separately, in a recent retrospective cost-effectiveness analysis of SPIRIT
IV data, researchers found that the clinical benefits offered by XIENCE V translated into lower overall medical costs at
one year after the stenting procedure. The SPIRIT
IV cost-effectiveness analysis, presented by David Cohen, M.D., MSc, of
St. Luke's Mid America Heart Institute in Kansas City, Mo., in March 2010 at
the Optimizing PCI Outcomes symposium sponsored by the Cardiovascular Research
Foundation, found that one-year total medical costs (initial hospitalization
plus follow-up) were approximately $150 lower for patients treated with XIENCE V than those treated with TAXUS. When costs not
related to the original treated vessel (non-target-vessel-revascularization)
were excluded, the one-year medical costs were approximately $450 lower with
XIENCE V than TAXUS. The XIENCE V and TAXUS stents are competitively priced.
"The cost-effectiveness analysis of SPIRIT IV shows that a stent
designed to deliver outstanding clinical benefits can deliver economic benefits
as well," said Dr. Cohen, who is the lead investigator of the SPIRIT IV
cost-effectiveness analysis. "Since the findings were derived from a
multicenter, comparative trial with only clinical follow-up, these results may
be generalizable to most U.S. practice
settings."
"The SPIRIT IV data, published today in The New England Journal of
Medicine, have changed clinical practice as more and more physicians around
the world have embraced the XIENCE V drug eluting
stent. With the additional SPIRIT IV cost-effectiveness analysis, we have
observed favorable economic data based upon the strong clinical results. These
findings should prove valuable as hospitals evaluate different treatment
options for coronary artery disease patients," said Charles A. Simonton,
M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief
medical officer, Abbott Vascular.
More About SPIRIT IV Results
Clinically, in addition to demonstrating superiority in the primary endpoint
of TLF, XIENCE V demonstrated a statistically significant 46 percent reduction
in TLR (repeat procedure) compared to TAXUS at one year (2.5 percent for XIENCE V
vs. 4.6 percent for TAXUS, p-value=0.001). TLR is one of the major secondary
endpoints of the SPIRIT IV trial.
Per protocol definition of stent thrombosis (blood clots) at one year,
XIENCE V demonstrated an observed 80 percent
reduction compared to TAXUS (0.17 percent for
XIENCE V vs. 0.85
percent for TAXUS, p-value=0.004). Per
Academic Research Consortium (ARC) definition of definite/probable stent
thrombosis, XIENCE V demonstrated an observed
74 percent reduction compared to TAXUS at one
year (0.29 percent for XIENCE V and 1.10 percent
for TAXUS, p-value=0.004). The ARC definitions of
stent thrombosis were developed to harmonize the definition of stent thrombosis
across various drug eluting stent trials.
In a retroactive look at the economics of using XIENCE V versus TAXUS from
the SPIRIT IV trial, it was observed that XIENCE V was economically dominant
over TAXUS based upon the clinical results. At one year, total medical costs
(initial hospitalization plus follow-up) were $146 lower per patient with
XIENCE V than with TAXUS. When costs not related to the original treated vessel
(non-target-vessel-revascularization) were excluded, the difference between the
two stents became more pronounced, amounting to a cost savings of $439 per
patient with XIENCE V compared to TAXUS (p=0.02). Excluding the costs not related to the
original treated vessel reflects the cost difference specific to the
performance of the two stents.
The SPIRIT IV cost-effectiveness analysis was based on a retrospective
review of prospectively collected medical resource utilization for all patients
enrolled in the SPIRIT IV trial for initial hospitalization and one year after
enrollment. Cardiovascular hospitalizations, revascularization procedures,
diagnostic catheterization and dual-anti-platelet therapy costs were included.
The analysis assumed equal stent costs for the XIENCE
V and TAXUS stents.
More About XIENCE V
Abbott's market-leading 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.
In some geographies, Abbott 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).
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 is a global leader in cardiac and vascular care with
market-leading products and an industry-leading pipeline. Abbott Vascular
offers a comprehensive cardiac and vascular devices portfolio, including
products for coronary artery disease, vessel closure, endovascular disease, and
structural heart disease.
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 more than 83,000 people and markets its products in more than 130
countries.
Media:
Jonathon Hamilton
Jennie Kim |
(408) 845-3491
(408) 845-1755 |
Financial:
Larry Peepo
Tina Ventura |
(847) 935-6722
(847) 935-9390 |
