XIENCE V Stent Reduces Major Adverse Cardiac Events
Long-term data presented for the first time from the SPIRIT III trial, Abbott's U.S. pivotal trial studying the XIENCE V Everolimus Eluting Coronary Stent System, demonstrated that XIENCE V continues to deliver clinically superior benefits for patients compared to the TAXUS 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.
"Not only did XIENCE V clearly differentiate itself from the TAXUS stent in the first year after treatment, it has now demonstrated even more positive effects at two years in the SPIRIT III trial," said Dr. Stone, Columbia University Medical Center and chairman, Cardiovascular Research Foundation, New York. "As measured by clinically significant reductions in target vessel failure and MACE, XIENCE V demonstrated an even greater improvement in patient outcomes compared to TAXUS at two years than at one year, driven by numerically lower rates of heart attacks and lower observed rates of re-intervention of the target lesion. We also saw encouraging trends for lower observed rates of late and very late stent thrombosis in XIENCE V-treated patients, especially in those who discontinued dual antiplatelet therapy."
The SPIRIT III trial of 1,002 patients, which is the basis for the pre- market application of XIENCE V to the U.S. Food and Drug Administration (FDA), demonstrated the following key results for XIENCE V at two years:
-- A 45 percent reduction in the risk of major adverse cardiac events (MACE) compared to TAXUS (7.3 percent for XIENCE V vs. 12.8 percent for TAXUS, p-value=0.004)*. 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).
-- A 32 percent reduction in the risk of Target Vessel Failure (TVF, cardiac events related to the treated vessel) compared to TAXUS (10.7 percent for XIENCE V vs. 15.4 percent for TAXUS, p-value=0.04)*. TVF is a composite clinical measure of safety and efficacy outcomes defined as cardiac death, heart attack (myocardial infarction or MI) or target vessel revascularization (TVR).
-- A 40 percent reduction in the risk of ischemia-driven target lesion revascularization (ID-TLR) as compared to TAXUS (4.6 percent for XIENCE V vs. 7.5 percent for TAXUS, p-value=0.07)*.
-- Low rates of stent thrombosis between one and two years, defined as very late stent thrombosis, per Academic Research Consortium (ARC) definition of definite/probable stent thrombosis (0.3 percent for XIENCE V and 1.0 percent for TAXUS) and per the SPIRIT III protocol (0.2 percent for XIENCE V and 1.0 percent for TAXUS). The ARC definitions of stent thrombosis were developed to eliminate variability in the definitions across various drug eluting stent trials.
"From these results, it is clear that XIENCE V can deliver sustained benefits to patients over the long term," said John M. Capek, Ph.D., executive vice president, Medical Products, Abbott. "We continue to be pleased with the way XIENCE V is performing, with outstanding results that are consistent with what we have seen throughout the SPIRIT III trial."
About the SPIRIT III Trial
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 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 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.