Press Release
New Data Reinforces Safety Profile of Abbott's Market-Leading XIENCE V® Drug Eluting Stent
- In XIENCE V USA Study, XIENCE V Demonstrates Low Blood Clot Rate at One
Year in Real-World Patient Population
- In SPIRIT V Diabetes Trial, XIENCE V Demonstrates Zero Cases of Stent
Thrombosis at One Year in Patients with Diabetes
May 25, 2010
PARIS, May 25, 2010 – Two late-breaking clinical trials presented today at
the EuroPCR 2010 conference reinforced the outstanding clinical data supporting
Abbott's market-leading XIENCE V® Everolimus
Eluting Coronary Stent System. In the XIENCE V
USA study of more than 5,000 real-world, complex patients, XIENCE V demonstrated a low rate of blood clots (stent
thrombosis) at one year (0.84 percent per
Academic Research Consortium [ARC] definition of definite/probable stent
thrombosis). In a subset of approximately 1,800 less complex patients (referred
to as "standard risk"), XIENCE V
demonstrated a one-year stent thrombosis rate of 0.34
percent per ARC definition of definite/probable stent thrombosis.
"The low stent thrombosis rate demonstrated by XIENCE V is impressive
given the complexity of the patient population included in the XIENCE V USA trial, and confirms that the stent
thrombosis results seen with XIENCE V in earlier
randomized clinical trials are consistent in real-world clinical practice,"
said James Hermiller, M.D., director of Cardiovascular Interventions, St.
Vincent Hospital in Indianapolis, Ind., and principal investigator of the
XIENCE V USA trial.
The XIENCE V USA study also showed that stent thrombosis rates remained low
even when dual anti-platelet therapy (DAPT) was temporarily or permanently
discontinued. In the overall XIENCE V USA
population, patients who interrupted DAPT usage after six months showed a
subsequent late stent thrombosis rate of zero
percent. In the subset of standard risk patients, those who interrupted
DAPT usage after 30 days also showed a subsequent late stent thrombosis rate of
zero percent. DAPT compliance in the XIENCE V USA study was 79.4 percent at one year.
XIENCE V USA is a post-market, single-arm registry evaluating outcomes in
5,054 XIENCE V patients based in the United States with follow-up out to five
years. The study is designed to examine the safety of the XIENCE V stent in an all-comers patient population from
real-world clinical settings. The standard risk subset included 1,827 patients.
The primary endpoint of XIENCE V USA is a measure
of stent thrombosis every year out to five years, as defined by ARC. The ARC
definitions of stent thrombosis were developed to eliminate variability in the
definitions across various drug eluting stent trials. Mitch Krucoff, M.D.,
FACC, FCCP, director, Cardiovascular Devices Unit, Duke Clinical Research
Institute in Durham, N.C., is co-principal investigator of the XIENCE V USA trial.
XIENCE V Superior to TAXUS in Primary Endpoint of SPIRIT
V Diabetes Trial
Abbott also presented data today from the SPIRIT V Diabetes study, an
international randomized clinical trial comparing XIENCE
V to the TAXUS® Liberte™ Paclitaxel-Eluting Coronary Stent System
(TAXUS) in 324 patients with diabetes. In the trial's primary endpoint of
in-stent late loss1, XIENCE V
demonstrated superiority to TAXUS (0.19 mm for
XIENCE V vs. 0.39
mm for TAXUS; p=0.0001). In-stent late
loss is a measure of vessel re-narrowing after a stent procedure.
The SPIRIT V Diabetes trial also showed encouraging observational evidence
of low event rates for diabetic patients treated with XIENCE V including:
- In the composite endpoint of cardiac death, heart attack attributed to the
treated vessel (target vessel myocardial infarction) and ischemia-driven target
lesion revascularization (TLR), XIENCE V
demonstrated an observed 10 percent reduction
compared to TAXUS (11.2 percent for XIENCE V vs. 12.5 percent
for TAXUS, p-value=0.71*).
- In the composite endpoint of cardiac death and target vessel myocardial
infarction (MI), XIENCE V demonstrated an observed 61
percent reduction compared to TAXUS (3.7
percent for XIENCE V vs. 9.6 percent for TAXUS, p-value=0.04*).
- In the endpoint of cardiac death, XIENCE V demonstrated an observed rate of
0.5 percent compared to 2.9 percent for TAXUS (p-value=0.10*).
- In the endpoint of ischemia-driven TLR, XIENCE V demonstrated an observed
rate of 8.4 percent compared to 3.8 percent for TAXUS (p-value=0.16*).
- In the endpoint of target vessel MI, XIENCE V demonstrated an observed rate
of 2.8 percent compared to 8.7 percent for TAXUS (p-value=0.04*)
- In the endpoint of stent thrombosis, XIENCE V demonstrated zero cases of
blood clots (ARC definite/probable stent thrombosis) at one year compared to
1.9 percent for TAXUS (p-value=0.11*).
The clinical outcomes from the SPIRIT V Diabetes trial are observational as
the trial was not powered to analyze statistical differences in any of the
clinical endpoints.
XIENCE V and Abbott's next-generation XIENCE PRIME™ Everolimus Eluting
Coronary Stent System are approved for the treatment of patients with diabetes
in CE Mark (Conformité Européenne) countries. XIENCE
PRIME is an investigational device in the United States and is not
available for sale.
About XIENCE V
Abbott's market-leading XIENCE V drug eluting stent is marketed in the
United States, Europe, Japan and other international markets.
Everolimus, developed by Novartis Pharma AG, is an anti-proliferative drug
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.
In the United States, 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 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 approximately 83,000 people and markets its products in more than 130
countries.
| 1 |
In the SPIRIT V Diabetes trial, the primary endpoint of
in-stent late loss was pre-specified for superiority testing. |
| * |
P-values are for descriptive purposes only. |
Media:
Jonathon Hamilton
Jennie Kim |
(408) 624-0314
(408) 332-4176 |
Financial Community:
Larry Peepo
Tina Ventura |
(847) 935-6722
(847) 935-9390 |
