Healthcare Industry News: stent thrombosis
News Release - March 24, 2007
Abbott's XIENCE(TM) V Everolimus Eluting Coronary Stent Superior to TAXUS(R) Stent in SPIRIT III U.S. Pivotal Clinical TrialXIENCE V Demonstrates Superiority in Primary Endpoint of In-Segment Late Loss, Non-Inferiority in Major Secondary Endpoint of Target Vessel Failure and Superiority in Major Adverse Cardiac Events (MACE) in the SPIRIT III U.S. Trial
Data Show Continued Safety and One-Year MACE Superiority for XIENCE V Compared to TAXUS as SPIRIT II International Trial Reaches One Year
ABBOTT PARK, Ill., March 24 (HSMN NewsFeed) -- Data presented today from Abbott's SPIRIT III U.S. pivotal clinical trial at the American College of Cardiology's 56th Annual Scientific Session in New Orleans demonstrated the following key results:
-- The randomized SPIRIT III trial of 1,002 patients comparing Abbott's next-generation XIENCE(TM) V Everolimus Eluting Coronary Stent System with the TAXUS® paclitaxel-eluting coronary stent system met both its primary endpoint and major secondary endpoint.
-- In its primary endpoint of in-segment late loss at eight months, XIENCE V demonstrated superiority to TAXUS with a statistically significant 50 percent reduction in late loss compared to TAXUS (0.14 +/- 0.41 mm XIENCE V, 0.28 +/- 0.48 mm TAXUS, p superior =0.004). In-segment late loss is a measure of vessel renarrowing.
-- In its major secondary endpoint of Target Vessel Failure at nine months, XIENCE V demonstrated non-inferiority to TAXUS with an observed 21 percent reduction in Target Vessel Failure for XIENCE V compared to TAXUS (7.2 percent XIENCE V, 9.0 percent TAXUS, p non- inferior <0.0001). Target Vessel Failure is a measure of re-treatment anywhere within the target vessel and includes cardiac death or heart attack.
-- Subsequent to SPIRIT III meeting its primary and major secondary endpoints, an analysis of nine-month Major Adverse Cardiac Events (MACE), such as cardiac death, heart attack or target lesion revascularization (artery re-treatment due to lack of blood supply), was undertaken in which XIENCE V demonstrated superiority to TAXUS with a statistically significant 44 percent reduction in MACE at nine months compared to TAXUS (4.6 percent XIENCE V, 8.1 percent TAXUS, p superior =0.028).
"Not only did the SPIRIT III trial meet its primary and major secondary endpoints, but it showed a statistically significant reduction in major adverse cardiac events, favoring XIENCE V," said Gregg W. Stone, M.D., of Columbia University Medical Center and the Cardiovascular Research Foundation, New York, principal investigator of the SPIRIT III clinical trial, who presented the results today. "The enhanced freedom from adverse events with XIENCE V, coupled with its low profile, makes the XIENCE V stent an important advance for patients with coronary artery disease."
One-Year SPIRIT II European Clinical Trial Results Demonstrate Continued Safety with XIENCE V; Zero Late stent thrombosis in SPIRIT FIRST and SPIRIT II Under New ARC Definition
In the important clinical endpoint of MACE, one-year follow-up results from 300 patients enrolled in Abbott's randomized SPIRIT II European clinical trial demonstrated superiority for XIENCE V compared to TAXUS in an additional analysis with a statistically significant 71 percent reduction in major adverse cardiac events for XIENCE V-treated patients compared to TAXUS-treated patients (2.7 percent XIENCE V, 9.2 percent TAXUS, p superior =0.04). These data are available in an online poster session to registrants of the American College of Cardiology's 56th Annual Scientific Session.
Under the new Dublin/Academic Research Consortium (ARC) definition of late-stent thrombosis (blood clotting events in stents), which was developed to eliminate variability in the definitions across various drug-eluting stent trials, the late stent thrombosis rate with XIENCE V in the SPIRIT II trial out to one year was zero percent for XIENCE V (0/220 patients treated with XIENCE V) and 1.3 percent for TAXUS (1/76 patients treated with TAXUS). The number of late stent thromboses in the SPIRIT FIRST trial, which compared XIENCE V to the MULTI-LINK VISION® metallic stent, remained zero for patients receiving XIENCE V out to two years of clinical follow-up.
"The statistically significant reduction in major adverse cardiac events that we see in patients treated with XIENCE V in our SPIRIT III U.S. trial is consistent with the reduced MACE rates reported today from our SPIRIT II European trial," said John M. Capek, Ph.D., senior vice president, Abbott Vascular. "Across both of these trials, the risk of cardiac death, heart attack or re-treatment in the diseased artery area in patients was approximately two to three times lower with XIENCE V than with TAXUS."
About XIENCE V
The XIENCE V 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 Asia Pacific in 2006. XIENCE V is currently an investigational device in the United States and Japan. Results from the SPIRIT III trial are intended to support U.S. Food and Drug Administration (FDA) approval of the XIENCE V Stent System and Ministry of Health and Welfare approval in Japan. Abbott expects to submit XIENCE V for U.S. FDA approval in the second quarter of 2007.
Abbott supplies a private-label version of XIENCE V, called the PROMUS(TM) Everolimus-Eluting Coronary Stent System, to Boston Scientific as part of a distribution agreement established between the two companies last year.
About the SPIRIT Family of Trials
SPIRIT FIRST was a first-in-man study comparing the XIENCE V Everolimus Eluting Coronary Stent System with the MULTI-LINK VISION bare metallic stent system. SPIRIT FIRST demonstrated positive results with one MACE event at one year and no additional MACE events out to two years. SPIRIT II is a 300- patient randomized, single-blind, prospective clinical trial evaluating XIENCE V versus TAXUS in Europe and Asia Pacific. SPIRIT III is a large-scale pivotal clinical trial comparing XIENCE V to TAXUS in the United States and Japan. SPIRIT IV is currently enrolling patients and 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. SPIRIT WOMEN is the world's first drug-eluting stent trial to study only women and will evaluate the characteristics of women undergoing stent implantation as well as the performance of XIENCE V in those patients in Europe, Asia-Pacific, Canada and Latin America.
For images of Abbott's XIENCE V stent and other information, please visit the company's online ACC newsroom at http://www.abbottvascular.com/ACCpresskit .
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 65,000 people and markets its products in more than 130 countries.
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