Long-term data from the SPIRIT III trial, Abbott's U.S. pivotal trial studying the XIENCE(TM) V Everolimus Eluting Coronary Stent System, demonstrated that XIENCE V continues to deliver clinically superior benefits for patients compared to the TAXUS(R) paclitaxel-eluting coronary stent system.
In this trial of more than 1,000 patients, XIENCE V demonstrated a 45 percent reduction in the risk of major adverse cardiac events (MACE) and a 32 percent reduction in the risk of target vessel failure (cardiac events related to the treated vessel) at two years as compared to TAXUS. The SPIRIT III two-year results were presented by Gregg W. Stone, M.D., principal investigator of the SPIRIT III trial, during the late-breaking clinical trials session at EuroPCR 2008.
About the SPIRIT III Trial
Ad Statistics
Times Displayed: 109208
Times Visited: 6638 MIT labs, experts in Multi-Vendor component level repair of: MRI Coils, RF amplifiers, Gradient Amplifiers Contrast Media Injectors. System repairs, sub-assembly repairs, component level repairs, refurbish/calibrate. info@mitlabsusa.com/+1 (305) 470-8013
SPIRIT III is a prospective, multi-center, randomized, single-blind, controlled clinical trial comparing XIENCE V to TAXUS in 1,002 patients (669 XIENCE V patients, 333 TAXUS patients) with either one or two de novo native coronary artery lesions. The trial was conducted across 65 academic and community-based centers in the United States between June 22, 2005 and March 15, 2006.
The primary endpoint of the SPIRIT III trial was in-segment late loss at eight months, wherein XIENCE V demonstrated superiority to TAXUS with a statistically significant 50 percent reduction in late loss (mean, 0.14 mm for XIENCE V vs. 0.28 mm for TAXUS). In-segment late loss is a measure of vessel renarrowing. In the co-primary endpoint of TVF at nine months, XIENCE V demonstrated statistical non-inferiority compared to TAXUS with an observed 20 percent reduction in TVF (7.2 percent for XIENCE V vs. 9.0 percent for TAXUS).
Additionally, in the pre-specified secondary endpoint of MACE, XIENCE V demonstrated a 43 percent reduction at nine months (4.6 percent for XIENCE V vs. 8.1 percent for TAXUS) and a 42 percent reduction in MACE at one year (6.0 percent for XIENCE V vs. 10.3 percent for TAXUS) compared to TAXUS.
About XIENCE V
The XIENCE V stent system utilizes everolimus, which has been shown to reduce tissue proliferation in the coronary vessels following stent implantation, and is based upon the highly deliverable and proven MULTI-LINK VISION(R) coronary stent platform.
XIENCE V was launched in Europe and other international markets in October 2006. XIENCE V is currently an investigational device in the United States and Japan, and is under review for approval by the FDA. Abbott expects to gain FDA approval for XIENCE V in the second quarter of 2008.
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 http://www.abbottvascular.com/presskit.
