New Analysis of SPIRIT II and SPIRIT III Data Confirms Patients Treated with XIENCE V Are at Lower Risk of Experiencing Death, a Heart Attack or a
Repeat Procedure Compared to TAXUS(R) at Two Years
WASHINGTON, Oct. 13 /PRNewswire-FirstCall/ -- Data from an independent meta-analysis of Abbott's SPIRIT II and SPIRIT III randomized clinical trials demonstrated that the XIENCE V(TM) Everolimus Eluting Coronary Stent System continues to deliver clinically significant benefits for patients compared to the TAXUS(R) paclitaxel-eluting coronary stent system out to two years. In this meta-analysis, which included patients from the United States, Europe and Asia-Pacific, XIENCE V demonstrated clinical superiority to TAXUS in the endpoints of target vessel failure (TVF) and major adverse cardiac events (MACE) at two years. XIENCE V also demonstrated significantly lower clinical events rates than TAXUS in the key efficacy (target lesion revascularization) and safety (cardiac death or heart attack) components of MACE at two years. The results are being presented by Gregg W. Stone, M.D., principal investigator of the SPIRIT III trial, during the Cardiovascular Research Foundation's 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
"The pooled results from the SPIRIT II and SPIRIT III trials demonstrate that XIENCE V is safer and provides greater efficacy than TAXUS at two years," said Dr. Stone, professor of medicine at Columbia University Medical Center and chairman, Cardiovascular Research Foundation, New York. "In the meta-analysis at two years, XIENCE V compared to TAXUS demonstrated statistically significant reductions in the combined measure of all-cause death or heart attack, as well as further reducing the need for repeat cardiac procedures -- reinforcing that XIENCE V is a true second-generation stent, which results in improved patient outcomes."
The meta-analysis of 1,302 patients from the SPIRIT II and SPIRIT III trials demonstrated the following key results for XIENCE V at two years:
-- A clinically significant 31 percent reduction in the risk of ischemia-driven Target Vessel Failure (TVF, cardiac events related to the treated vessel) compared to TAXUS (10.4 percent for XIENCE V vs. 14.7 percent for TAXUS, p-value=0.03)*. 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 clinically significant 45 percent reduction in the risk of ischemia-driven major adverse cardiac events (MACE) compared to TAXUS (7.1 percent for XIENCE V vs. 12.3 percent for TAXUS, p-value=0.001). MACE is an important composite clinical measure of safety and efficacy outcomes for patients, defined as cardiac death, heart attack (myocardial infarction or MI), or ischemia-driven target lesion revascularization (TLR driven by lack of blood supply).
-- An observed 28 percent reduction in the risk of all-cause death compared to TAXUS (2.4 percent for XIENCE V vs. 3.3 percent for TAXUS, p-value=0.36)*.
-- An observed 28 percent reduction in the risk of cardiac death compared to TAXUS (0.9 percent for XIENCE V vs. 1.3 percent for TAXUS, p-value=0.56)*.
-- A clinically significant 45 percent reduction in the risk of heart attack (MI) compared to TAXUS (3.1 percent for XIENCE V vs. 5.6 percent for TAXUS, p-value=0.03)*.
-- A clinically significant 39 percent reduction in the risk of all-cause death or heart attack (MI) compared to TAXUS (5.1 percent for XIENCE V vs. 8.3 percent for TAXUS, p-value=0.03)*.
-- A clinically significant 41 percent reduction in the risk of cardiac death or heart attack (MI) compared to TAXUS (3.8 percent for XIENCE V vs. 6.3 percent for TAXUS, p-value=0.04)*.
-- A clinically significant 41 percent reduction in the risk of ischemia-driven target lesion revascularization (ID-TLR) compared to TAXUS (4.1 percent for XIENCE V vs. 6.8 percent for TAXUS, p-value=0.03)*.
-- 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 (0.5 percent for XIENCE V and 0.8 percent for TAXUS). The ARC definitions of stent thrombosis were developed to eliminate variability in the definitions across various drug eluting stent trials.
* Event rates are based on Kaplan-Meier estimates; p-values are for descriptive purposes only.
Strong Results in Complex Patients: SPIRIT III Subgroup Analyses
Also presented during TCT, a variety of subgroup analyses from the SPIRIT III trial demonstrated observational evidence of strong performance by XIENCE V in a variety of patients and lesion types that represent complex patients. The results consistently favored XIENCE V compared to TAXUS at two years across multiple subgroups examined, including patients with small vessels and multi-vessel patients. In diabetic patients, the analysis showed there were no observed differences between XIENCE V and TAXUS at two years. The SPIRIT III trial was not designed to analyze statistical differences in any of the patient subgroups, as the sample sizes were too small to draw firm conclusions.
"With the subgroup analysis, we saw encouraging trends of lower event rates between one and two years for patients treated with XIENCE V compared to patients treated with TAXUS, regardless of patient or lesion complexity," said John M. Capek, Ph.D., executive vice president, Medical Devices, Abbott. "Even though the SPIRIT III trial was not designed for statistical comparisons in subgroups, these positive trends demonstrate that XIENCE V performs in a consistent manner and gives physicians confidence in XIENCE V as they consider what is the most effective treatment for their patients."
About XIENCE V
XIENCE V is used to treat coronary artery disease by propping open a narrowed or blocked artery and releasing the drug, everolimus, in a controlled manner to prevent the artery from becoming blocked again following a stent procedure. XIENCE V is built upon Abbott's market-leading bare metal stent, the MULTI-LINK VISION(R) Coronary Stent System. The VISION platform is designed to facilitate ease of delivery, making it easier for physicians to maneuver the stent and treat the diseased portion of the artery.
Long-term results with XIENCE V in the SPIRIT III pivotal U.S. clinical trial demonstrated a 45 percent reduction in the risk of MACE compared to TAXUS at two years. XIENCE V demonstrated a 32 percent reduction in TVF compared to TAXUS at two years. XIENCE V also demonstrated a low rate of stent thrombosis between one and two years, defined as very late stent thrombosis, per ARC definition of definite/probable stent thrombosis (0.3 percent for XIENCE V and 1.0 percent for TAXUS). XIENCE V met its primary endpoint in the SPIRIT III clinical trial with a statistically significant 50 percent reduction in in-segment late loss (vessel renarrowing) at eight months compared to TAXUS.
The XIENCE V stent is available on both over-the-wire (OTW) and rapid exchange (RX) delivery systems. Rapid exchange is the most widely used type of delivery system because it provides physicians additional flexibility to work as single operators during stent procedures.
XIENCE V was approved by the U.S. Food and Drug Administration and launched in July 2008, and was launched in Europe and other international markets in October 2006. XIENCE V is an investigational device in Japan and is currently under review by the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency.
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 and manufactured by Abbott and supplied to Boston Scientific as part of a distribution agreement between the two companies.
Everolimus, developed by Novartis Pharma AG, is a proliferation signal inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its drug eluting stents. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent implantation, due to its anti-proliferative properties.
Additional information about XIENCE V, including important safety and effectiveness information, is available online at http://www.xiencev.com.
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.
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 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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