Healthcare Industry News: stent thrombosis
News Release - May 14, 2008
XIENCE(TM) V Drug Eluting Stent from Abbott Reduces Major Adverse Cardiac Events in Small Vessel Patients Out to One YearData from SPIRIT II and III Clinical Trials Also Show Improvement in Vessel Renarrowing with XIENCE V Compared to TAXUS in Patients with Small Vessels
BARCELONA, Spain, May 14 (HSMN NewsFeed) -- Data presented today from an independent pooled subset analysis of Abbott's SPIRIT II and SPIRIT III clinical trials demonstrated a clinically significant 51 percent reduction in major adverse cardiac events (MACE) with the XIENCE(TM) V Everolimus Eluting Coronary Stent System compared to the TAXUS® paclitaxel-eluting coronary stent system in patients with small vessels out to one year. The data were presented during an Abbott-sponsored symposium at EuroPCR 2008.
"Clinical evidence from the SPIRIT II and SPIRIT III trials demonstrate that patients with small vessels who are treated with XIENCE V are less likely to experience major adverse cardiac events than patients treated with TAXUS," said Antonio L. Bartorelli, M.D., Centro Cardiologico Monzino, Institute of Cardiology, University of Milan and an investigator in the SPIRIT trials. "Patients with small vessels often present with challenging anatomy that can complicate treatment, so the performance of the XIENCE V drug eluting stent in these patients is encouraging."
The pooled analysis evaluated a subset of 541 patients from the SPIRIT II and SPIRIT III clinical trials who had small vessels (median reference vessel diameter less than 2.765 mm), and lesion lengths that were less than or equal to 28 mm. The results of the meta-analysis demonstrated:
-- A clinically significant 51 percent reduction in the risk of MACE for patients with small vessels who were treated with XIENCE V compared to TAXUS (5.1 percent XIENCE V vs. 10.5 percent TAXUS, p-value=0.021)* at one year. MACE is an important composite clinical measure of safety and efficacy outcomes for patients, defined as cardiac death, heart attack (MI), or ischemia-driven target lesion revascularization (TLR driven by lack of blood supply).
-- An observed 52 percent reduction in the risk of ischemia-driven TLR for XIENCE V compared to TAXUS at one year (3.0 percent XIENCE V vs. 6.2 percent TAXUS, p-value=0.076)*.
-- An observed 50 percent reduction in in-stent late loss (mean, 0.15 mm XIENCE V vs. 0.30 mm TAXUS) and an observed 52 percent reduction in in-segment late loss (mean, 0.10 mm XIENCE V vs. 0.21 mm TAXUS) with XIENCE V compared to TAXUS at six or eight months. Both in-stent and in-segment late loss are measures of vessel renarrowing.
-- No difference in the rates of stent thrombosis between XIENCE V and TAXUS per Academic Research Consortium (ARC) definition or protocol definition. Rates of definite/probable stent thrombosis out to one year under ARC definition were 0.3 percent for XIENCE V and 1.3 percent for TAXUS. Rates of stent thrombosis out to one year per protocol also were 0.3 percent for XIENCE V and 1.3 percent for TAXUS.
"The strong efficacy data for XIENCE V in small vessels adds to the growing body of evidence supporting Abbott's everolimus eluting stent system as an important next-generation treatment for coronary artery disease," said Charles Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs and chief medical officer, Abbott Vascular.
* Event rates are based on Kaplan-Meier estimates; p-values are for descriptive purposes only.
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® 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 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 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 more than 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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