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Abbott's XIENCE V Continues to Outperform TAXUS With Sustained Clinical Advantages and Impressive Long-Term Safety Results in SPIRIT III Trial

- Market-Leading XIENCE V Demonstrates Single-Digit Rate of Major Adverse Cardiac Events (MACE) at Three Years and a 43 Percent Reduction vs. TAXUS - No Additional Stent Thrombosis between Two and Three Years, and Impressive Low Rate of Very Late Stent Thrombosis for XIENCE V

SAN FRANCISCO, Sept. 21 /PRNewswire-FirstCall/ -- Long-term data presented today from the SPIRIT III pivotal U.S. clinical trial demonstrated that the observed clinical advantages of Abbott's market-leading XIENCE V Everolimus Eluting Coronary Stent System continued to increase as compared to the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System (TAXUS). At three years, XIENCE V demonstrated a 43 percent reduction in the risk of major adverse cardiac events (MACE) compared to TAXUS (9.1 percent for XIENCE V vs. 15.7 percent for TAXUS, p-value=0.003)*. 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). The three-year results from the SPIRIT III trial will be 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.

"The SPIRIT III results clearly demonstrate that at three years, patients continue to benefit from having been treated with the XIENCE V stent rather than the TAXUS stent, with fewer repeat cardiac procedures and fewer heart attacks in patients who received XIENCE V," said Dr. Stone, who is also immediate past chairman of the Cardiovascular Research Foundation, New York; and principal investigator of the SPIRIT III trial.

XIENCE V demonstrated an impressive low rate of very late stent thrombosis (one to three years) with no additional events between two and three years. Per protocol, XIENCE V demonstrated a 0.2 percent** very late stent thrombosis rate compared to 1.0 percent for TAXUS (p-value=0.10) at three years. Per Academic Research Consortium (ARC) definition of definite/probable stent thrombosis, the rate of very late stent thrombosis at three years was 0.3 percent** for XIENCE V and 1.0 percent for TAXUS (p-value=0.34). The ARC definitions of stent thrombosis were developed to eliminate variability in the definitions across various drug eluting stent trials.

Key Results from SPIRIT III

In the 1,002-patient SPIRIT III trial, XIENCE V demonstrated the following key results out to three years:

  --  A 43 percent reduction in the risk of MACE compared to TAXUS (9.1

      percent for XIENCE V vs. 15.7 percent for TAXUS, p-value=0.003).

  --  A 43 percent reduction in the risk of Target Lesion Failure (TLF)

      compared to TAXUS (8.3 percent for XIENCE V vs. 14.4 percent for

      TAXUS, p-value=0.005). TLF is a composite measure of important

      efficacy and safety outcomes for patients, defined as cardiac death,

      target vessel MI and TLR.

  --  A 30 percent reduction in the risk of Target Vessel Failure (TVF)

      compared to TAXUS (13.5 percent for XIENCE V vs. 19.2 percent for

      TAXUS, p-value=0.03). TVF is a composite clinical measure of safety

      and efficacy outcomes defined as cardiac death, MI or ischemia-driven

      target vessel revascularization (TVR).

  --  A 42 percent reduction in the risk of heart attacks (MI) compared to

      TAXUS (3.7 percent for XIENCE V vs. 6.3 percent for TAXUS,

      p-value=0.07).

  --  A 39 percent reduction in the risk of ID-TLR compared to TAXUS (5.4

      percent for XIENCE V vs. 8.9 percent for TAXUS, p-value=0.05).

  --  Per protocol definition, a 0.2 percent** rate of very late stent

      thrombosis compared to 1.0 percent for TAXUS (p-value=0.10). Per ARC

      definition of definite/probable stent thrombosis, the rate of very

      late stent thrombosis was 0.3 percent** for XIENCE V and 1.0 percent

      for TAXUS (p-value=0.34).

  Consistent Results in SPIRIT III Subgroup Analyses

In addition to the positive three-year results for the overall study presentation, subgroup analyses from the SPIRIT III trial demonstrated evidence of the strong performance by XIENCE V in a variety of patients and lesion types that represent complex patients. In patients with diabetes, the analysis showed there was no difference at three years in MACE between XIENCE V and TAXUS (11.0 percent for XIENCE V vs. 10.3 percent in TAXUS)*** . In fact, XIENCE V maintained a consistent rate of clinical events after the first year (8.7 percent MACE at one year and 11.0 percent MACE at three years), whereas TAXUS demonstrated a sustained upward trend in clinical events from one year to three years (4.7 percent MACE at one year and 10.3 percent MACE at three years). In patients without diabetes, the MACE rate for TAXUS at three years was more than double the MACE rate for XIENCE V at three years (9.1 percent for XIENCE V vs. 18.7 percent for TAXUS).

"The SPIRIT III data clearly show that XIENCE V performs in a consistent manner, with clinical benefits continuing to improve over time compared to TAXUS," said Robert Hance, senior vice president, vascular, Abbott. "We are pleased to begin this year's TCT conference with a strong showing of data for Abbott's market-leading XIENCE V, and look forward to presenting the highly anticipated SPIRIT IV one-year results later this week, which should provide physicians with additional valuable insights."

One-year results from the company's SPIRIT IV trial will be presented on Wednesday, Sept. 23, during the first late-breaking clinical trials session of the TCT conference. The SPIRIT IV trial is one of the largest randomized clinical trials between two drug eluting stents, with 3,690 patients enrolled, including more than 1,000 patients with diabetes. The study results will provide valuable information about the efficacy and safety of XIENCE V compared to TAXUS. 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.

About the SPIRIT III Trial

SPIRIT III is a prospective, multi-center, randomized, single-blind, controlled clinical trial comparing XIENCE V to TAXUS in 1,002 patients (669 XIENCE V patients, 333 TAXUS patients) with either one or two de novo coronary artery lesions. The trial was conducted across 65 academic and community-based centers in the United States between June 22, 2005, and March 15, 2006.

The primary endpoint of the SPIRIT III trial was in-segment late loss at eight months, wherein XIENCE V demonstrated superiority to TAXUS with a statistically superior 50 percent reduction in late loss (mean, 0.14 mm for XIENCE V vs. 0.28 mm for TAXUS, p-value =0.004). In-segment 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 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 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 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.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 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.

* Unless otherwise noted, all event rates and p-values are based on Kaplan-Meier estimates; p-values are for descriptive purposes only.

** Stent thrombosis rates are based on binary event rates, and p-values are based on Fisher's Exact Test; p-values are for descriptive purposes only.

*** Subgroup event rates are based on binary event rates.

Source: Abbott

CONTACT: media, Jonathon Hamilton, +1-408-624-0314, or Jennie Kim,
+1-408-332-4176, or Financial, John Thomas, +1-847-938-2655, or Tina Ventura,
+1-847-935-9390, all for Abbott

Web Site: http://www.abbott.com/
 

Posted: September 2009

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