MEDINDIA
English
हिन्दी
Español
français
中文
"The pooled results from the SPIRIT II and SPIRIT III trials demonstratethat XIENCE V is safer and provides greater efficacy than TAXUS at two years,"said Dr. Stone, professor of medicine at Columbia University Medical Centerand chairman, Cardiovascular Research Foundation, New York. "In themeta-analysis at two years, XIENCE V compared to TAXUS demonstratedstatistically significant reductions in the combined measure of all-causedeath or heart attack, as well as further reducing the need for repeat cardiacprocedures -- 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 IIItrials demonstrated the following key results for XIENCE V at two years:
-- A clinically significant 31 percent reduction in the risk ofischemia-driven Target Vessel Failure (TVF, cardiac events related to thetreated vessel) compared to TAXUS (10.4 percent for XIENCE V vs. 14.7 percentfor TAXUS, p-value=0.03)*. TVF is a composite clinical measure of safety andefficacy outcomes defined as cardiac death, heart attack (myocardialinfarction or MI) or target vessel revascularization (TVR).
-- A clinically significant 45 percent reduction in the risk ofischemia-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 isan important composite clinical measure of safety and efficacy outcomes forpatients, defined as cardiac death, heart attack (myocardial infarction orMI), or ischemia-driven target lesion revascularization (TLR driven by lack ofblood supply).
-- An observed 28 percent reduction in the risk of all-cause deathcompared 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 comparedto 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 heartattack (MI) compared to TAXUS (3.1 percent for XIENCE V vs. 5.6 percent forTAXUS, p-value=0.03)*.
-- A clinically significant 39 percent reduction in the risk of all-causedeath or heart attack (MI) compared to TAXUS (5.1 percent for XIENCE V vs. 8.3percent for TAXUS, p-value=0.03)*.
-- A clinically significant 41 percent reduction in the risk of cardiacdeath or heart attack (MI) compared to TAXUS (3.8 percent for XIENCE V vs. 6.3percent for TAXUS, p-value=0.04)*.
-- A clinically significant 41 percent reduction in the risk ofischemia-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 asvery late stent thrombosis, per Academic Research Consortium (ARC) definitionof definite/probable stent thrombosis (0.5 percent for XIENCE V and 0.8percent for TAXUS). The ARC definitions of stent thrombosis were developed toeliminate variability in the definitions across various drug eluting stenttrials.
* Event rates are based on Kaplan-Meier estimates; p-values are fordescriptive purposes only.
Strong Results in Complex Patients: SPIRIT III Subgroup Analyses
Also presented during TCT, a variety of subgroup analyses from the SPIRITIII trial demonstrated observational evidence of strong performance by XIENCEV in a variety of patients and lesion types that represent complex patients.The results consistently favored XIENCE V compared to TAXUS at two yearsacross multiple subgroups examined, including patients with small vessels andmulti-vessel patients. In diabetic patients, the analysis showed there were noobserved differences between XIENCE V and TAXUS at two years. The SPIRIT IIItrial was not designed to analyze statistical differences in any of thepatient subgroups, as the sample sizes were too small to draw firmconclusions.
"With the subgroup analysis, we saw encouraging trends of lower eventrates between one and two years for patients treated with XIENCE V compared topatients treated with TAXUS, regardless of patient or lesion complexity," saidJohn M. Capek, Ph.D., executive vice president, Medical Devices, Abbott. "Eventhough the SPIRIT III trial was not designed for statistical comparisons insubgroups, these positive trends demonstrate that XIENCE V performs in aconsistent manner and gives physicians confidence in XIENCE V as they considerwhat is the most effective treatment for their patients."
About XIENCE V
XIENCE V is used to treat coronary artery disease by propping open anarrowed or blocked artery and releasing the drug, everolimus, in a controlledmanner to prevent the artery from becoming blocked again following a stentprocedure. XIENCE V is built upon Abbott's market-leading bare metal stent,the MULTI-LINK VISION(R) Coronary Stent System. The VISION platform isdesigned to facilitate ease of delivery, making it easier for physicians tomaneuver the stent and treat the diseased portion of the artery.
Long-term results with XIENCE V in the SPIRIT III pivotal U.S. clinicaltrial demonstrated a 45 percent reduction in the risk of MACE compared toTAXUS at two years. XIENCE V demonstrated a 32 percent reduction in TVFcompared to TAXUS at two years. XIENCE V also demonstrated a low rate of stentthrombosis between one and two years, defined as very late stent thrombosis,per ARC definition of definite/probable stent thrombosis (0.3 percent forXIENCE V and 1.0 percent for TAXUS). XIENCE V met its primary endpoint in theSPIRIT III clinical trial with a statistically significant 50 percentreduction in in-segment late loss (vessel renarrowing) at eight monthscompared to TAXUS.
The XIENCE V stent is available on both over-the-wire (OTW) and rapidexchange (RX) delivery systems. Rapid exchange is the most widely used type ofdelivery system because it provides physicians additional flexibility to workas single operators during stent procedures.
XIENCE V was approved by the U.S. Food and Drug Administration andlaunched in July 2008, and was launched in Europe and other internationalmarkets in October 2006. XIENCE V is an investigational device in Japan and iscurrently under review by the Ministry of Health, Labour and Welfare and thePharmaceuticals and Medical Devices Agency.
Abbott also supplies a private-label version of XIENCE V to BostonScientific called the PROMUS(TM) Everolimus-Eluting Coronary Stent System.PROMUS is designed and manufactured by Abbott and supplied to BostonScientific as part of a distribution agreement between the two companies.
Everolimus, developed by Novartis Pharma AG, is a proliferation signalinhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on itsdrug eluting stents. Everolimus has been shown to inhibit in-stent neointimalgrowth in the coronary vessels following stent implantation, due to itsanti-proliferative properties.
Additional information about XIENCE V, including important safety andeffectiveness information, is available online at http://www.xiencev.com.
About Abbott Vascular
Abbott Vascular, a division of Abbott, is one of the world's leadingvascular care businesses. Abbott Vascular is uniquely focused on advancing thetreatment of vascular disease and improving patient care by combining thelatest medical device innovations with world-class pharmaceuticals, investingin research and development, and advancing medicine through training andeducation. Headquartered in Northern California, Abbott Vascular offers acomprehensive portfolio of vessel closure, endovascular and coronary products.
About Abbott
Abbott (NYSE: ABT) is a global, broad-based health care company devoted tothe discovery, development, manufacture and marketing of pharmaceuticals andmedical products, including nutritionals, devices and diagnostics. The companyemploys more than 68,000 people and markets its products in more than 130countries.
Abbott's news releases and other information are available on thecompany's Web site at http://www.abbott.com.
SOURCE Abbott
