Navigation Links
Abbott's XIENCE(TM) V Drug Eluting Stent Demonstrates Consistent and Positive Clinical Outcomes Out to Two Years
Date:3/31/2008

- 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.

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 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.


'/>"/>
SOURCE Abbott
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Abbotts XIENCE(TM) V Everolimus Eluting Coronary Stent Shows Continued Superiority to TAXUS Stent in Reducing Major Adverse Cardiac Events in SPIRIT III Clinical Trial
2. Spirit II Results Support Strength of Boston Scientifics Two Drug-Eluting Stent Platforms
3. Large Study Gives Nod to Drug-Eluting Stents in Heart Attack
4. Drug-Eluting Stents Outperform Bare Stents in Heart Attack
5. Abbott Announces Positive One-Year Results from the Worlds First Clinical Trial of a Fully Bioabsorbable Drug Eluting Coronary Stent
6. XTENT Announces Positive Two-Year CUSTOM I and One-Year CUSTOM II Trial Data for Novel Drug-Eluting Stent System
7. Four Analyses of Three-Year Clinical Data Suggest CYPHER(R) Sirolimus-Eluting Coronary Stent May Provide Alternative to Surgery for Patients with Multivessel Disease
8. TAXUS WOMAN Study Reports Positive Clinical Outcomes for the TAXUS(R) Drug-eluting Stent in Women
9. Largest Study to Date Shows Significant Reductions in Risks of Blood Clots and Reintervention With CYPHER(R) Sirolimus-eluting Coronary Stent Compared to Taxus Stent
10. Two-Year Outcomes From Large Head-to-Head Clinical Trial Indicate Similar Safety Profile in Diabetic Patients for Cypher(R) Sirolimus-Eluting Coronary Stent and Taxus Stent
11. Cypher(R) Sirolimus-Eluting Coronary Stent Demonstrates Sustained Clinical Benefits Compared to Bare Metal Stents in Five-Year Randomized Clinical Trial With No Differences in Long-Term Safety
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2016)... , May 24, 2016 ... médica para ayudar a los médicos a compartir sus ... pacientes a escala mundial. Profesionales médicos de Europa, África, ... se han apuntado a la aplicación, que combina la ... un entorno totalmente seguro. Educación   ...
(Date:5/24/2016)...   , Study met ... and superiority in , Excellent plus ... of the ascending colon   , ... B.V. today announced new positive data from the phase III MORA ... standard 2 litre PEG with ascorbate. The study met both primary ...
(Date:5/24/2016)... , May 24, 2016 ARANZ ... for the healthcare sector, has been named the Coretex Hi-Tech ... Awards 2016. Dr Bruce Davey , CEO ... our team.  It,s really good to be recognised for the ... Our products are used in 35 countries around the world ...
Breaking Medicine Technology:
(Date:5/25/2016)... ... May 25, 2016 , ... TransactRx announces the release ... of medical service claims by Pharmacy Benefit Managers that were submitted by Retail ... The TransactRx Cross Benefit Clearinghouse receives standard professional medical claims submitted from the ...
(Date:5/25/2016)... ... , ... America Walks , a national advocacy organization that promotes walking ... of Pittsburgh Graduate School of Public Health , has been awarded a Walking ... from around the country to participate in a four-month training program designed to strengthen ...
(Date:5/25/2016)... (PRWEB) , ... May 25, 2016 , ... ... health insurance, has seen a significant spike in their clients' employee participation for ... annual biometric health screening by implementing a high-deductible health plan with outcome-based deductible ...
(Date:5/25/2016)... ... May 25, 2016 , ... HealthPostures , a national ... leading engineers at the American Society of Safety Engineers Conference in Atlanta, Georgia. ... , Engineers, speakers and exhibitors from more than 40 countries are scheduled to ...
(Date:5/24/2016)... ... 2016 , ... Sterling Global Products is launching a Kickstarter campaign focused on ... dispenser. The campaign kick-off video is located via this link https://youtu.be/WsO4qz2odco . The ... is to raise $1,000 per day for a total of $25,000. The funds will ...
Breaking Medicine News(10 mins):