Analysis of Data Across Multiple Drug Eluting Stent Trials Reinforces Positive Clinical Performance of XIENCE V(R)
By Abbott, PRNESaturday, April 2, 2011
Pooled Analysis of Nearly 7,000 Patients Confirms Outstanding Performance of XIENCE V, Includes Thousands of Patients with Complex Disease
NEW ORLEANS, April 3, 2011 - A pooled analysis of the SPIRIT II, III, IV and COMPARE trials presented
today further reinforces the positive clinical performance of Abbott's (NYSE:
ABT) market-leading XIENCE V(R) Everolimus Eluting Coronary Stent System. As
part of the analysis of all four trials, two-year results on the safety and
efficacy of XIENCE V compared to TAXUS(R) Liberte(R) and TAXUS(R)
Express2(TM) Paclitaxel-Eluting Coronary Stent Systems (TAXUS) were presented
at the American College of Cardiology's (ACC) 60th Annual Scientific Session
and i2 Summit 2011 in New Orleans.
In a presentation given by Dean J. Kereiakes, M.D., medical director of
The Christ Hospital Heart and Vascular Center in Cincinnati, Ohio, predictors
of artery re-blockage, cardiac death or heart attack were evaluated out to
two years in nearly 7,000 patients from the SPIRIT II, III, IV and COMPARE
clinical trials. The data demonstrated that use of XIENCE V resulted in
significantly lower clinical event rates following a stent procedure. In the
pooled analysis, XIENCE V demonstrated a 36 percent reduction in the risk of
major adverse cardiac events (MACE) compared to TAXUS (7.3 percent for XIENCE
V versus 11.1 percent for TAXUS, p-value<0.001). 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
retreatment of a lesion (ischemia-driven target lesion revascularization, or
ID-TLR).
"XIENCE V consistently demonstrated low adverse cardiac event rates in
trial after trial," said Dr. Kereiakes. "The SPIRIT II, III, IV, and COMPARE
pooled analysis suggests that XIENCE V reduced the occurrence of adverse
events compared to patients treated with the TAXUS stent. The low event rates
demonstrated by XIENCE V in these trials are especially impressive given the
complexity of patients in the SPIRIT IV and COMPARE trials and confirm that
the results seen with XIENCE V in earlier randomized clinical trials are
consistent with clinical practice."
XIENCE V Shows Positive Results in Data Presented at ACC
In addition to the 36 percent reduction in the risk of overall MACE
compared to TAXUS, data also were presented at ACC from the pooled analysis
that demonstrated the following for XIENCE V:
- A 47 percent reduction in the risk of heart attack (2.9 percent for XIENCE V versus 5.5 percent for TAXUS, p-value<0.001) - A 40 percent reduction in the risk of cardiac death or heart attack (4.0 percent for XIENCE V versus 6.6 percent for TAXUS, p-value<0.001) - A 36 percent reduction in the risk of ID-TLR (4.1 percent for XIENCE versus 6.6 percent for TAXUS, p-value<0.001) - A 70 percent reduction in the risk of stent thrombosis, defined as definite or probable according to ARC (Academic Research Consortium) (0.7 percent for XIENCE V vs. 2.3 percent for TAXUS, p-value<0.0001)
"The pooled analysis of the SPIRIT II, III, IV and COMPARE trials further
supports the strong body of clinical evidence that has made XIENCE V a
leading drug eluting stent technology for patients and physicians," said
Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical
Affairs, and chief medical officer, Abbott Vascular. "XIENCE V's long-term
clinical performance is backed by clinical data from more than 30,000
patients worldwide."
The SPIRIT trials were sponsored and conducted by Abbott. SPIRIT IV
included 3,690 patients, many of whom presented with multiple medical
complexities, including more than 1,100 patients with diabetes, and patients
with small vessels, long lesions, and multiple lesions. The COMPARE study was
a physician-initiated trial involving 1,800 patients with complex vascular
disease. This pooled analysis was performed independently of Abbott. TAXUS
Liberte was the control in COMPARE and TAXUS Express2 was the control in
SPIRIT II, SPIRIT III and SPIRIT IV.
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 a proliferation signal
inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its
drug eluting vascular devices. Everolimus has been shown to inhibit in-stent
neointimal growth in the coronary vessels following stent implantation, due
to its anti-proliferative 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) 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/static/cms_workspace/pdf/ifu/coronary_intervention/XIENCE_V_Everolimus_Eluting_Coronary_Stent_System.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 nearly 90,000 people and markets its products in more than
130 countries.
Abbott's news releases and other information are available on the
company's Web site at www.abbott.com.
Media, Jonathon Hamilton, +1-408-624-0314, or Kathleen Rinehart, +1-408-307-9266, or Financial, Larry Peepo, +1-847-935-6722, or Tina Ventura, +1-847-935-9390, all of Abbott
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