Abbott Announces Continued Positive Results with Xience VEverolimus Eluting Coronary Stent in Spirit Clinical TrialsSPIRIT FIRST Demonstrates Continued Safety for XIENCE V with No Late Stent Thrombosis or Additional Major Adverse Cardiac Events Out to Three Years
BARCELONA, Spain, May 22, 2007 /PRNewswire-FirstCall/ -- Three-year data from the SPIRIT FIRST trial demonstrated no additional Major Adverse Cardiac Events (MACE), and no late stent thrombosis in patients treated with either Abbott's XIENCE(TM) V Everolimus Eluting Coronary Stent System or its MULTI-LINK VISION(R) metallic coronary stent. Additionally, data presented from a meta- (combined) analysis of SPIRIT II and SPIRIT III trials at nine months reaffirmed the superiority of Abbott's XIENCE V compared to the TAXUS(R) paclitaxel-eluting coronary stent system in a variety of measures.
These data were presented today at the EuroPCR meeting in Barcelona.
"The SPIRIT FIRST results support the long-term safety of the XIENCE V system, with no additional MACE or late stent thrombosis, by both protocol and ARC definitions, out to three years," said Gregg W. Stone, M.D., of Medical Center and the Cardiovascular Research Foundation, New York, and an investigator in the SPIRIT trials. "In addition, a meta-analysis of the SPIRIT II and III data again demonstrated the superiority of the XIENCE V system to the TAXUS system in important measures that matter to patients including renarrowing of a treated vessel and major adverse cardiac events."
A meta-analysis of approximately 1,300 patients from the SPIRIT II and SPIRIT III clinical trials conducted by the Cardiovascular Research Foundation indicated that the XIENCE V system demonstrated superiority over the TAXUS stent in angiographic (imaging) and clinical endpoints, with an excellent safety profile.
Specifically, data from the meta-analysis demonstrated that the XIENCE V Everolimus Eluting Coronary Stent System was superior to the TAXUS stent in:
-- Reducing the occurrence of major adverse cardiac events in patients (4.0 percent XIENCE V treated patients, 8.0 percent TAXUS treated patients, P-superior = 0.004). -- Reducing the number of retreatments in patients due to ischemia, or lack of blood supply (ischemic target lesion revascularization, TLR), (2.4 percent XIENCE V, 5.1 percent TAXUS, P-superior = 0.01). -- Reducing the amount of renarrowing in the vessel within the length of the stent (in-stent binary restenosis), (1.9 percent XIENCE V, 4.9 percent TAXUS, P-superior = 0.02). -- Reducing the amount of renarrowing in the vessel within the length of the stent plus 5 mm beyond the ends of the stent (in-segment restenosis), (4.1 percent XIENCE V, 7.8 percent TAXUS, P-superior = 0.04).
"The combination of long-term safety data from SPIRIT FIRST and superior efficacy data from SPIRIT II and SPIRIT III add to the growing body of evidence supporting the XIENCE V system as an important next-generation technology," said John M. Capek, Ph.D., senior vice president, Abbott Vascular. "We look forward to continuing to expand patient and physician access to the XIENCE V system around the world."
About XIENCE V
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, Labour and Welfare approval in Japan.
Abbott expects to complete Pre-Market Approval (PMA) submission of the XIENCE V system to the U.S. FDA in the second quarter of 2007.
The XIENCE V system utilizes everolimus, which has been shown to reduce tissue proliferation in coronary vessels following stent implantation, and one of the world's most popular metallic platforms -- the MULTI-LINK VISION Coronary Stent System.
XIENCE V is designed, studied and manufactured by Abbott Vascular. Abbott supplies a private-labeled version of XIENCE V to Boston Scientific, called the PROMUS(TM) Everolimus-Eluting Coronary Stent System, as part of a distribution agreement established between the two companies last year.
About the SPIRIT Family of Trials
SPIRIT FIRST is a randomized trial comparing the XIENCE V Everolimus Eluting Coronary Stent System with the MULTI-LINK VISION metallic stent system. SPIRIT II was a randomized clinical trial evaluating XIENCE V versus TAXUS in Europe and Asia Pacific. Professor Patrick Serruys of Rotterdam is the principal investigator in SPIRIT FIRST and SPIRIT II.
SPIRIT III is a large-scale randomized pivotal clinical trial comparing XIENCE V to TAXUS in the United States and Japan. SPIRIT IV is a randomized trial 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. Professor Gregg Stone of Medical Center, N.Y., is the principal investigator in SPIRIT III and SPIRIT IV.
SPIRIT V is an international clinical trial currently enrolling patients that will provide additional data on clinical experience with XIENCE V 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.
Posted: May 2007