ABBOTT PARK, Ill., Sept. 14 Abbott (NYSE: ABT) announced today that the Chinese State Food and Drug Administration (SFDA) has approved its XIENCE V(R) Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease (CAD) - the leading cause of death in China. XIENCE V is the only drug eluting stent to have demonstrated superiority over the TAXUS(R) Paclitaxel-Eluting Coronary Stent System (TAXUS) in the primary endpoints of two randomized, pivotal (phase III) clinical trials. The company plans a fourth-quarter launch for XIENCE V in China, which is the second-largest drug eluting stent market in the Asia-Pacific region after Japan. With approval in China, XIENCE V is now available in every Asia-Pacific market except Japan, where approval is anticipated at the end of this year.
"Since it first became commercially available in 2006, XIENCE V has become the market-leading drug eluting stent around the world due to its excellent outcomes and outstanding deliverability," said Robert Hance, senior vice president, vascular, Abbott. "As the incidence of heart disease and the number of annual stent procedures continue to increase in China, it is critical for physicians and patients to have access to one of the most advanced drug eluting stent technologies. We look forward to making XIENCE V available in China."
According to the China Chronic Heart Disease 2006 Annual Report, nearly 50 percent of all deaths annually in China are due to CAD, and the prevalence of coronary artery disease has steadily increased each year. Approximately 150,000 patients annually undergo a stent procedure for the treatment of CAD, and the number of procedures is growing by more than 20 percent each year in China.
"Heart disease is a serious health issue in China, with more patients being diagnosed each day, so it is critical to have access to advanced technology, such as XIENCE V, that can help improve patient outcomes," said Run Lin Gao, M.D., vice president, Chinese Medical Doctor Association.
"Clinical trial results show that XIENCE V has a strong safety and efficacy profile, with impressively low rates of major adverse cardiac events and target vessel failure. Based on the strength of the data supporting it, XIENCE V is a welcome addition to the heart disease treatment options available to physicians in China," said Yong Huo, M.D., president-elect, Chinese Society of Cardiology.
SPIRIT Body of Data for XIENCE V
The clinical program for XIENCE V includes outstanding long-term results from the SPIRIT family of trials, including data from more than 60 patients based in China. In October 2008 at the Transcatheter Cardiovascular Therapeutics annual meeting, Abbott presented two-year results from a meta-analysis of the SPIRIT II and SPIRIT III* randomized clinical trials, which included 1,302 patients from the United States, Europe and the Asia-Pacific region. In this meta-analysis, XIENCE V demonstrated a 45 percent reduction in the risk of major adverse cardiac events (MACE) compared to TAXUS at two years (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 (ID-TLR driven by lack of blood supply).
XIENCE V also demonstrated significantly lower clinical events rates than TAXUS in the key efficacy (ID-TLR) and safety (cardiac death or heart attack) components of MACE at two years in the SPIRIT II and SPIRIT III meta-analysis. XIENCE V demonstrated a 41 percent reduction in the risk of ID-TLR compared to TAXUS (4.1 percent for XIENCE V vs. 6.8 percent for TAXUS, p-value=0.03)**, and a 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)**.
In March 2009 at the American College of Cardiology annual meeting, Abbott presented long-term data from the SPIRIT II clinical trial of 300 patients, which 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. XIENCE V demonstrated a 57 percent reduction in the risk of MACE compared to TAXUS at three years (6.4 percent for XIENCE V vs. 14.9 percent for TAXUS, p-value=0.029)**.
In addition, there was no occurrence of 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)** in the SPIRIT II trial. The ARC definitions of stent thrombosis were developed to eliminate variability in the definitions across various drug eluting stent trials.
In May 2009 at EuroPCR, Abbott presented one-year data from the SPIRIT V (five) international, single-arm study, which evaluated XIENCE V in 2,663 patients - including more than 60 patients enrolled at two sites in China. XIENCE V demonstrated low rates of repeat procedure (target lesion revascularization or TLR), stent thrombosis and MACE in a diverse, "real world" population of patients and lesion types, including patients with diabetes, patients with multi-vessel disease and patients with highly complex lesions. In the SPIRIT V study, XIENCE V demonstrated a very low 1.8 percent rate of TLR, a 0.7 percent rate of definite/probable stent thrombosis and a 5.1 percent rate of MACE at one year. For the SPIRIT V trial, MACE is defined as a composite of cardiac death, heart attack (myocardial infarction not clearly attributed to a non-target vessel), or TLR.
In September 2009, data from the company's SPIRIT IV trial comparing XIENCE V to TAXUS will be presented at the Transcatheter Cardiovascular Therapeutics annual meeting. With 3,690 patients, the SPIRIT IV trial is one of the largest head-to-head randomized clinical trials between two drug eluting stents and includes more than 1,000 patients with diabetes.
More 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 drug coated stent will be available in China on the rapid exchange (RX) delivery system. 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.
Abbott's market-leading XIENCE V drug eluting stent is marketed in the United States, Europe and other international markets. 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.
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 antiproliferative properties.
XIENCE V is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (lesions less than or equal to 28 mm) with reference vessel diameters of 2.5 mm to 4.25 mm. Additional information about XIENCE V, including important safety information, is available online at www.xience.cn, www.xiencev.com or www.abbottvascular.com/en_US/content/document/eIFU_XienceV.pdf.
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.
* Both TAXUS Express2 (73 percent of lesions) and TAXUS Liberte (27 percent of lesions) were used as controls in the SPIRIT II trial. TAXUS Express2 was the control in the SPIRIT III trial.
** Event rates based on Kaplan-Meier estimates. P-values are for descriptive purposes only.