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Abbott's XIENCE V(R) Superior to TAXUS(R) in Key Safety and Efficacy Measures in SPIRIT IV Trial
Date:9/23/2009

SAN FRANCISCO, Sept. 23 /PRNewswire-FirstCall/ -- Late-breaking data from the SPIRIT IV trial demonstrated that Abbott's market-leading XIENCE V(R) Everolimus Eluting Coronary Stent System achieved superiority in the key safety and efficacy measures of target lesion failure (TLF) and target lesion revascularization (TLR) compared to the TAXUS(R) Express2(TM) Paclitaxel-Eluting Coronary Stent System (TAXUS) at one year. With 3,690 patients, the SPIRIT IV trial is one of the largest randomized clinical trials between two drug eluting stents.

In the trial's primary endpoint, XIENCE V demonstrated a statistically significant 38 percent reduction in TLF compared to TAXUS (4.2 percent for XIENCE V vs. 6.8 percent for TAXUS, p-value = 0.001). TLF is defined as a composite measure of important efficacy and safety outcomes for patients and is defined as cardiac death, heart attack attributed to the target vessel (target vessel myocardial infarction), and ischemia-driven TLR (ID-TLR). The standard was established to harmonize the definition of major adverse cardiac events across various drug eluting stent trials. XIENCE V also demonstrated a statistically significant 46 percent reduction in TLR (repeat procedure) compared to TAXUS (2.5 percent for XIENCE V vs. 4.6 percent for TAXUS, p-value=0.001). TLR is one of the major secondary endpoints of the SPIRIT IV trial. The groundbreaking results were presented today by Gregg W. Stone, M.D., professor of medicine at Columbia University Medical Center, during the 2009 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco.

In addition to demonstrating superiority in the primary endpoint of TLF and major secondary endpoint of TLR, XIENCE V demonstrated an impressive low rate of stent thrombosis (blood clots) at one year. Per protocol definition, XIENCE V demonstrated an observed 80 percent reduction in stent thrombosis compared to TAXUS (0.17 percent for XIENCE V vs. 0.85 percent for TAXUS, p-value=0.004) at one year. Per Academic Research Consortium (ARC) definition of definite/probable stent thrombosis, XIENCE V demonstrated an observed 74 percent reduction in ARC definite/probable stent thrombosis at one year (0.29 percent for XIENCE V and 1.10 percent for TAXUS, p-value=0.004). The ARC definitions of stent thrombosis were developed to harmonize the definition of stent thrombosis across various drug eluting stent trials.

"SPIRIT IV represents one of the largest randomized trials of two drug eluting stents completed to date. Importantly, this study was performed without routine angiographic follow-up, which may result in a tendency to treat lesions which may not be causing symptoms, and potentially impact results," said Dr. Stone, who is also immediate past chairman of the Cardiovascular Research Foundation, New York; and principal investigator of the SPIRIT IV trial. "The SPIRIT IV results show that XIENCE V significantly reduces a patient's risk of experiencing a heart attack, the need for a repeat procedure or stent thrombosis."

Event Rates in Complex Patients

The SPIRIT IV trial included multiple complex patient subgroups, including more than 1,100 patients with diabetes, who typically are sicker and have more challenging artery disease. In patients with diabetes, there was no difference in TLF between XIENCE V and TAXUS at one year (6.4 percent for XIENCE V vs. 6.9 percent for TAXUS, p-value=0.80). In patients without diabetes, XIENCE V demonstrated a 54 percent reduction in TLF compared to TAXUS at one year (3.1 percent for XIENCE V vs. 6.7 percent for TAXUS, p-value<0.0001). In the endpoint of ARC definite/probable stent thrombosis, XIENCE V demonstrated a 40 percent reduction compared to TAXUS in patients with diabetes (0.80 percent for XIENCE V vs. 1.33 percent for TAXUS, p-value=0.52), and a 94 percent reduction compared to TAXUS in patients without diabetes (0.06 percent for XIENCE V vs. 1.00 percent for TAXUS, p-value=0.0009).

In addition, XIENCE V demonstrated low event rates in multiple subgroup analyses, such as patients with smaller vessels (reference vessel diameter less than or equal to 2.75 mm), patients with longer lesions (lesion length greater than 13.3 mm) and patients with multi-vessel disease. In patients with smaller vessels, XIENCE V demonstrated a 43 percent reduction in TLF compared to TAXUS at one year (3.9 percent for XIENCE V vs. 6.8 percent for TAXUS). In patients with longer lesions, XIENCE V demonstrated a 35 percent reduction in TLF compared to TAXUS at one year (4.5 percent for XIENCE V vs. 6.9 percent for TAXUS). In patients with two or more lesions treated, XIENCE V demonstrated a 49 percent reduction in TLF compared to TAXUS at one year (5.1 percent for XIENCE V vs. 10.0 percent for TAXUS).

Key Results from the SPIRIT IV Trial

In the SPIRIT IV trial of 3,690 patients, XIENCE V demonstrated the following key results at one year:

  • A 38 percent reduction in TLF compared to TAXUS (4.2 percent for XIENCE V vs. 6.8 percent for TAXUS, p-value=0.001).
  • A 39 percent reduction in major adverse cardiac events (MACE) compared to TAXUS (4.2 percent for XIENCE V vs. 6.9 percent for TAXUS, p-value=0.0009). MACE is a composite clinical measure of safety and efficacy outcomes for patients, defined as cardiac death, heart attack (myocardial infarction or MI), or ID-TLR driven by lack of blood supply.
  • A 46 percent reduction in TLR compared to TAXUS (2.5 percent for XIENCE V vs. 4.6 percent for TAXUS, p-value=0.001).
  • A 31 percent reduction in cardiac death or target vessel myocardial infarction (MI) compared to TAXUS (2.2 percent for XIENCE V vs. 3.2 percent for TAXUS, p-value=0.09).
  • A 38 percent reduction in heart attacks (MI) attributed to the target vessel compared to TAXUS (1.8 percent for XIENCE V vs. 2.9 percent for TAXUS, p-value=0.04).
  • Comparable rates in cardiac death compared to TAXUS (0.4 percent for XIENCE V vs. 0.4 percent for TAXUS, p-value=1.00).
  • An observed 80 percent reduction in stent thrombosis per protocol definition compared to TAXUS (0.17 percent for XIENCE V vs. 0.85 percent for TAXUS, p-value=0.004).
  • An observed 74 percent reduction in stent thrombosis per ARC definition of definite/probable stent thrombosis compared to TAXUS (0.29 percent for XIENCE V and 1.10 percent for TAXUS, p-value=0.004).

"In SPIRIT IV, XIENCE V demonstrated superiority to TAXUS in the clinically driven endpoint of target lesion failure, which links the results more closely to real-world practice," said Charles A. Simonton, M.D., FACC, FSCAI, vice president, Medical Affairs, and chief medical officer, Abbott Vascular. "The SPIRIT IV results confirm the consistent and outstanding performance of the XIENCE V stent. We believe these results have the potential to be practice-changing based on the strength of the data."

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.

Abbott's market-leading XIENCE V drug eluting stent is commercially available 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.

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.

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.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.

About Abbott

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 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.


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