ORLANDO, Florida, March 29 /PRNewswire/ --
- In SPIRIT II Trial, XIENCE V Drug Eluting Stent Demonstrates Clinically Meaningful Reductions Compared to TAXUS in Key Safety Endpoints, Including an 88 Percent Reduction in the Risk of Cardiac Death at Three Years
Long-term data presented today from Abbott's (NYSE: ABT) SPIRIT II clinical trial demonstrated that the clinical advantages of the XIENCE V(R) Everolimus Eluting Coronary Stent System continued to increase between two and three years compared to the TAXUS(R) Express2(TM) Paclitaxel-Eluting Coronary Stent System / TAXUS(R) Liberte(TM) Paclitaxel-Eluting Coronary Stent System (TAXUS). Both TAXUS Express2 (73 percent of lesions) and TAXUS Liberte (27 percent of lesions) were used as controls in the SPIRIT II trial. The data also showed that patients treated with XIENCE V continue to experience fewer heart attacks, deaths or repeat procedures at the target lesion compared to patients treated with TAXUS out to three years. The results from the SPIRIT II trial were presented during the i2 Summit at the American College of Cardiology's 58th annual scientific session in Orlando, Fla.
Between two and three years, Abbott's market-leading XIENCE V maintained a low cardiac death rate of 0.5 percent, while the observed cardiac death rate for TAXUS more than tripled during the same time period (1.3 percent at two years vs. 4.2 percent at three years)*. Similarly, XIENCE V maintained a low, single-digit rate of major adverse cardiac events (MACE) between two and three years (6.4 percent at two years vs. 6.4 percent at three years), while the observed MACE rate with TAXUS increased approximately 40 percent between two and three years (10.5 percent at two years vs. 14.9 percent at three years)*. 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 (ID-TLR driven by lack of blood supply).
In addition, the SPIRIT II results demonstrated that XIENCE V continues to outperform TAXUS, with XIENCE V showing continued clinical benefits at three years, including an 88 percent reduction in the risk of cardiac death and a 57 percent reduction in the risk of MACE.
In the clinical outcomes that matter most, such as heart attack, repeat procedure at the target lesion or death, XIENCE V demonstrated a consistent reduction compared to TAXUS out to three years, said Patrick W. Serruys, M.D., Ph.D., professor of Interventional Cardiology at Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands, and principal investigator of the SPIRIT II clinical trial. What's even more impressive is that the clinical differences between XIENCE V and TAXUS continue to widen between two and three years, confirming the long-term safety and efficacy of XIENCE V.
In the 300-patient SPIRIT II trial, XIENCE V demonstrated the following key results at three years:
-- An 88 percent reduction in the risk of cardiac death compared to TAXUS (0.5 percent for XIENCE V vs. 4.2 percent for TAXUS, p-value=0.024)*. -- A 57 percent reduction in the risk of MACE compared to TAXUS (6.4 percent for XIENCE V vs. 14.9 percent for TAXUS, p-value=0.029)*. -- An observed 52 percent reduction in the risk of heart attacks (MI) compared to TAXUS (3.3 percent for XIENCE V vs. 6.8 percent for TAXUS, p-value=0.20)*. -- An observed 56 percent reduction in the risk of ID-TLR compared to TAXUS (4.2 percent for XIENCE V vs. 9.4 percent for TAXUS, p-value=0.092)*. -- No stent thrombosis between two and three years with XIENCE V, and a low rate of stent thrombosis from zero to three years, per Academic Research Consortium (ARC) definition of definite/probable stent thrombosis (0.9 percent for XIENCE V and 2.8 percent for TAXUS, p-value=0.27)*. The ARC definitions of stent thrombosis were developed to eliminate variability in the definitions across various drug eluting stent trials.
* Event rates based on Kaplan-Meier estimates; p-values are for descriptive purposes only.
The data from the SPIRIT family of trials continue to prove that XIENCE V is an excellent option for patients. Physicians have embraced this technology, as demonstrated by the market-leading position of XIENCE V around the world, said John Capek, Ph.D., executive vice president, Medical Devices, Abbott. Our next-generation drug eluting stent in development, XIENCE PRIME, builds upon the outstanding body of clinical evidence from the SPIRIT family of clinical trials, while the new stent design and its delivery system build upon the excellent performance of the VISION cobalt chromium platform, improving deliverability and helping physicians treat difficult lesions.
XIENCE V is the market-leading drug eluting stent platform, with 50 percent share in the United States, and market-leading share around the world.
Abbott's next-generation XIENCE PRIME(TM) Everolimus Eluting Coronary Stent System utilizes the same drug and polymer as Abbott's market-leading XIENCE V stent and builds upon the proven design of the MULTI-LINK(R) family of stents. XIENCE PRIME features a new stent design and delivery system that are designed to make it more flexible for improved deliverability. Abbott plans to make XIENCE PRIME available in an expanded size matrix with lengths up to 38 mm. The company expects to launch XIENCE PRIME in Europe later this year.
About the SPIRIT II Trial
SPIRIT II is a prospective, multi-center, randomized, single-blind, controlled clinical trial comparing XIENCE V to TAXUS in 300 patients (223 XIENCE V patients, 77 TAXUS patients) with either one or two de novo native coronary artery lesions. Patients from Europe, India and New Zealand were enrolled in the trial between July 5, 2005, and Nov.15, 2005.
The primary endpoint of the SPIRIT II trial was in-stent late loss at six months, wherein XIENCE V demonstrated superiority to TAXUS with a statistically significant 69 percent reduction in late loss (mean, 0.11 mm for XIENCE V vs. 0.36 mm for TAXUS). In-stent late loss is a measure of vessel re-narrowing.
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.
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 Japan's 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(R) 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 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 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 72,000 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 www.abbott.com.
Media, Jonathon Hamilton, +1-408-624-0314, or Jennie Kim, +1-408-332-4176, or Financial, Tina Ventura, +1-847-935-9390, all of Abbott