WASHINGTON, Oct. 25 /PRNewswire-FirstCall/ -- A subset analysis of diabetic patients in the SPIRIT II Clinical trial of the XIENCE(TM) V Everolimus Eluting Stent System showed nearly identical rates of in-stent late loss at six months in diabetic patients as those observed in the overall study patient population, according to new results presented today. Abbott also presented new positive nine-month safety data from the SPIRIT II trial, which showed no additional occurrences of MACE (Major Adverse Cardiac Event) or stent thrombosis between six and nine months.
Overall six-month data from SPIRIT II, which demonstrated that the XIENCE V system is statistically superior to Boston Scientific’s TAXUS(R) Paclitaxel- Eluting Coronary Stent System as measured by its primary endpoint of in-stent late loss, was presented last month at the World Congress of Cardiology in Barcelona.
Late loss is a measure of the change in the vessel diameter between the time immediately following stent placement and at six months.
“Diabetic patients present many challenges because of their higher rate of restenosis after treatment,” said Prof. Patrick W. Serruys, M.D., of the Thoraxcenter, Erasmus University Hospital, Rotterdam, and principal investigator of the SPIRIT II clinical trial. “These subgroup results are highly encouraging for difficult-to-treat patients.”
In-stent late loss in the diabetic subgroup analysis was 0.15 mm for XIENCE V vs. 0.39 mm for TAXUS. This is comparable to the overall six-month SPIRIT II study results, which showed late loss of 0.11 mm for XIENCE V and 0.36 mm for TAXUS.
“We believe these results have the potential to differentiate XIENCE V for physicians with patients whose cases present more challenges for treatment,” added John M. Capek, Ph.D., president, Cardiac Therapies, Abbott Vascular. “These data, in addition to the very positive feedback we’ve received from physicians since the recent launch of XIENCE V in Europe, further substantiate our excitement in bringing this product to our physician customers.”
SPIRIT II Clinical Nine-Month Follow-Up Safety Data
Confirming the six-month clinical data recently reported by Abbott, XIENCE V showed low rates of MACE (2.8 percent) and stent thrombosis (0.5 percent) after nine months. There were no additional occurrences of MACE or stent thrombosis between six and nine months.
Results were presented at the Cardiovascular Research Foundation’s 18th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C.
XIENCE V has received a CE mark in Europe and is currently an investigational device in the United States and Japan. The system utilizes everolimus, which has been shown to reduce tissue growth in the coronary vessels following stent implantation, and is based upon the highly deliverable and proven MULTI-LINK VISION(R) coronary stent platform.
About the SPIRIT Family of Trials
The SPIRIT FIRST study of the XIENCE V Stent System showed positive results through two years with no additional MACE events between one and two years. SPIRIT II is a 300-patient study conducted in Europe and Asia Pacific. SPIRIT III is a large-scale pivotal clinical trial comparing XIENCE V to the TAXUS(R) Paclitaxel-Eluting Coronary Stent System in the United States and Japan. SPIRIT IV, which is currently enrolling patients, will evaluate the safety and efficacy of XIENCE V for the treatment of coronary artery disease in a more complex patient population in the United States. SPIRIT V is an international clinical trial that will provide additional clinical experience with XIENCE V in approximately 3,000 patients at 100 clinical sites throughout Europe, Asia, Canada and Latin America. Twelve-month results from SPIRIT II and additional nine-month results from SPIRIT III will be presented in the first half of 2007.
About Abbott’s Drug-Eluting Stent Program
Abbott’s drug-eluting stent is the XIENCE(TM) V Everolimus Eluting Coronary Stent System, which the company launched in Europe earlier this month. In April 2006, Abbott acquired the vascular intervention and endovascular solutions businesses of Guidant Corporation -- the U.S. market leader in metallic stents since the introduction of the company’s first stent system in 1997.
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, effectiveness and ease of use in treating patients with vascular 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 65,000 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 .
Abbott
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