Abbott's XIENCE V(R) Demonstrates Significantly Lower Rates Of MACE And Stent Thrombosis Compared To TAXUS(R) Liberte

Main Category: Cardiovascular / Cardiology
Also Included In: Clinical Trials / Drug Trials
Article Date: 25 Sep 2009 - 2:00 PDT

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Late-breaking data presented from the COMPARE trial demonstrated that Abbott's (NYSE: ABT) market-leading XIENCE V(R) Everolimus Eluting Coronary Stent System demonstrated significantly better outcomes in key safety and efficacy measures compared to the TAXUS(R) Liberte Paclitaxel-Eluting Coronary Stent System (TAXUS). At one year, XIENCE V demonstrated a significantly lower incidence of major adverse cardiac events (MACE) compared to TAXUS (6.2% XIENCE V vs. 9.1% TAXUS, p-value= 0.023) in the trial's primary endpoint, which is a composite of all death, non-fatal heart attack (myocardial infarction) and target vessel revascularization (TVR). Additionally, XIENCE V demonstrated a significantly lower rate of stent thrombosis compared to TAXUS (0.7% XIENCE V vs. 2.6% TAXUS, p-value=0.002), a significantly lower rate of TVR (2.4% XIENCE V vs. 6.0% TAXUS, p-value=0.0001), and a significantly lower rate of TLR (1.7% XIENCE V vs. 4.8% TAXUS, p-value=0.0002).

The results from the COMPARE trial were presented by Peter Smits, M.D., of Maasstad Ziekenhuis, Rotterdam, the Netherlands, during the 2009 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco.

"The COMPARE trial, which studied a real-world, complex patient population, reaffirms what we saw in SPIRIT IV earlier today and what we've seen throughout our SPIRIT family of trials - with XIENCE V showing consistent, outstanding performance compared to TAXUS, whether it's TAXUS Express in SPIRIT IV or now TAXUS Liberte in the investigator-initiated study COMPARE," said John Capek, Ph.D., executive vice president, Medical Devices, Abbott.

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.

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.

Source: Abbott