- New Data from SPIRIT II Show Continued Low Rates of MACE with XIENCE V -
CHICAGO, March 31 /PRNewswire-FirstCall/ -- Data presented today from Abbott's SPIRIT II clinical trial demonstrated continued positive clinical results for the XIENCE(TM) V Everolimus Eluting Coronary Stent System out to two years, including an observed 40 percent reduction in major adverse cardiac events (MACE) and an observed 44 percent reduction in vessel retreatment (ischemia-driven target lesion revascularization, TLR) compared to the TAXUS(R) paclitaxel-eluting coronary stent system. The two-year results from the SPIRIT II trial were presented at the SCAI Annual Scientific Sessions in Partnership with ACC i2 Summit.
SPIRIT II is a 300-patient randomized clinical trial, which was
conducted in Europe and Asia Pacific to support the launch of XIENCE V
outside the United States. In SPIRIT II, XIENCE V demonstrated the
following key results:
-- In an analysis of major adverse cardiac events (MACE), XIENCE V
demonstrated an observed 40 percent reduction in MACE compared to
TAXUS at two years (6.6 percent for XIENCE V vs. 11.0 percent for
TAXUS). MACE is an important clinical measure of patient outcomes,
defined as cardiac death, heart attack (myocardial infarction or MI),
or ischemia-driven target lesion revascularization.
-- XIENCE V demonstrated an observed 44 percent reduction in
ischemia-driven target lesion revascularization (TLR driven by lack of
blood supply) compared to TAXUS at two years (3.8 percent for XIENCE V
vs. 6.8 percent for TAXUS).
-- Rates of definite/probable stent thrombosis under the Dublin/Academic
Research Consortium (ARC) definition were 0.9 percent for XIENCE V and
1.4 percent for TAXUS at two years. The ARC definition of late-stent
thrombosis was developed to eliminate variability in the definitions
across various drug eluting stent trials.
"In clinical endpoints such as major adverse cardiac events, retreatment and heart attack, patients treated with XIENCE V in the SPIRIT II clinical trial continue to fare better than patients treated with TAXUS out to two years," said Patrick W. Serruys, M.D., Ph.D., Professor of Interventional Cardiology at Thoraxcentre, Erasmus University Hospital, Rotterdam, and principal investigator of the SPIRIT II clinical trial, who presented the results today. "XIENCE V is performing as we would expect a next-generation drug eluting stent should over the long term, specifically on the important clinical endpoint of MACE. The low rate of MACE with XIENCE V compared to TAXUS was present at 6 months, one year and now at two years in the SPIRIT II trial."
In a small subset of patients in the SPIRIT II trial, in-stent imaging results were evaluated at two years. In this 117-patient subset, the angiographic in-stent late loss rate was 0.33 mm for XIENCE V and 0.34 mm for TAXUS at two years. In-stent late loss is a measure of vessel renarrowing within the margins of the stent.
"At any given point in time, across both the pivotal SPIRIT II and SPIRIT III clinical trials, XIENCE V consistently reduces observed MACE rates by 40 percent or more compared to TAXUS," said Charles Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs and chief medical officer, Abbott Vascular. "The single-digit MACE rate seen with XIENCE V out to two years is encouraging data for interventionalists as they look for ways to improve patient outcomes with next-generation drug eluting stents."
XIENCE V was launched in Europe and other international markets in late 2006. XIENCE V is an investigational device in the United States and Japan, and is currently under review for approval by the U.S. Food and Drug Administration.
Abbott also supplies a private-label version of XIENCE V to Boston Scientific called the PROMUS(TM) Everolimus-Eluting Coronary Stent System. PROMUS is designed, studied and manufactured by Abbott and supplied as part of a distribution agreement between the two companies.
Everolimus is licensed to Abbott by Novartis for use on its drug eluting stents.
For images of Abbott's XIENCE V stent and other information, please visit the company's online newsroom at http://www.abbottvascular.com/presskit.
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 that are recognized internationally for their safety and effectiveness in treating patients with vascular disease.
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 68,000 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 http://www.abbott.com.
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