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Abbott's XIENCE V(R) Demonstrates Impressive Low Rates of Repeat Procedure, Stent Thrombosis and Major Adverse Cardiac Events in Complex, 'Real World' Patients in SPIRIT V Study

Posted on: Thursday, 21 May 2009, 08:00 CDT

Safety and Efficacy Rates in Patients with Challenging Anatomy Consistent with Superior Results from Randomized Clinical Trials

BARCELONA, Spain, May 21 /PRNewswire-FirstCall/ -- New data presented today at EuroPCR from an international, post-approval, single-arm study show that Abbott's market-leading XIENCE V(R) Everolimus Eluting Coronary Stent System demonstrated low rates of repeat procedure (target lesion revascularization), stent thrombosis and major adverse cardiac events (MACE) in a complex patient population. In the SPIRIT V (five) study, XIENCE V (vee) demonstrated a very low 1.8 percent rate of target lesion revascularization (TLR), a 0.7 percent rate of stent thrombosis and a 5.1 percent rate of MACE at one year. MACE is an important composite clinical measure of safety and efficacy outcomes for patients, defined as cardiac death, heart attack (myocardial infarction attributed to the target vessel), and TLR driven by lack of blood supply. The SPIRIT V study evaluated XIENCE V in a diverse, "real world" population of patients and lesion types, including diabetics, patients with multi-vessel disease and patients with highly complex lesions.

"The data from real-world studies are valuable because they reflect a broad patient population that is more representative of the spectrum of disease seen in a typical interventional cardiology practice," said Eberhard Grube, M.D., chief, Department of Cardiology and Angiology, Heart Center Sieburg in Germany and principal investigator of the SPIRIT V study. "The one-year results from SPIRIT V indicate that even in a patient population with a high percentage of complex lesions, XIENCE V exhibits remarkably low event rates, similar to what was seen when XIENCE V was studied in controlled, randomized SPIRIT studies."

SPIRIT V is an international, post-approval study of 2,663 patients. Approximately 100 clinical sites throughout Europe, Asia-Pacific and Canada are participating in the study, ensuring a patient population composed of multiple ethnic groups. The patient and lesion types studied in SPIRIT V include patients with diabetes (30 percent of patients; 794 patients), patients with multi-vessel disease (42 percent of patients; 1,107 patients), patients with highly complex lesions (lesion type B2 or C; 82 percent of lesions; 2,307 patients), patients with moderately or severely calcified lesions (29 percent of lesions; 809 patients), patients with longer lesions (greater than or equal to 20 mm; 28 percent of lesions; 911 patients) that need treatment, and patients with smaller vessels (reference vessel diameter less than or equal to 2.75 mm, 35 percent of lesions, 1,068 patients).* The safety and efficacy of XIENCE V has not been established in the United States for patients with multi-vessel disease, patients with highly complex lesions (lesion type B2 or C), or patients with severely calcified lesions.

The primary endpoint of the study is a composite rate of all death, heart attack (myocardial infarction) and target vessel revascularization at 30 days, in which XIENCE V had a rate of 2.7 percent. At one year, the SPIRIT V study demonstrated the following positive results for XIENCE V:

• A 1.8 percent rate of repeat procedure to the treated lesion (TLR)
• A 0.7 percent cumulative rate of definite/probable stent thrombosis (to one year) and a low 0.2 percent rate of definite/probable late stent thrombosis (between 30 days and one year)
• A 5.1 percent rate of MACE
• A 1.1 percent rate of cardiac death

All events were adjudicated according to the Academic Research Consortium (ARC) definitions by an independent Clinical Events Committee. The ARC definitions were developed to eliminate variability in definitions across various drug eluting stent trials; using ARC definitions to measure events sets a new standard in real-world studies.

"The low occurrence of repeat procedure and stent thrombosis is noteworthy given that the SPIRIT V study includes high-risk patient groups, including diabetics, patients with multi-vessel disease and patients with highly complex or calcified lesions," said Charles Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. "The outstanding data from SPIRIT V and consistently strong performance of XIENCE V across all clinical trials reinforce why physicians throughout the world have embraced this technology."

Abbott also presented five-year results from the SPIRIT FIRST trial, which was a 60-patient, first-in-man study comparing XIENCE V to the MULTI-LINK VISION(R) Coronary Stent System. XIENCE V continued to demonstrate an excellent long-term safety profile with no MACE or stent thrombosis events between one and five years.

As part of the company's commitment to advancing the treatment of coronary artery disease, Abbott's robust post-approval and continued access program is projected to study more than 20,000 XIENCE V patients across several clinical trials. In addition to SPIRIT V, ongoing studies include:

• SPIRIT IV, a continued-access trial looking at a more complex patient population in the United States;
• XIENCE V SPIRIT WOMEN, the world's first drug eluting stent trial to study only female patients will evaluate women in Europe, Asia Pacific, Canada and Latin America;
• XIENCE V USA, a post-approval study being conducted in the United States; and
• XIENCE V INDIA, a post-approval study being conducted in India.

Abbott's next-generation drug eluting stent in development, the XIENCE PRIME(TM) Everolimus Eluting Coronary Stent System, utilizes the same drug and polymer as XIENCE V and is based upon the proven design of the MULTI-LINK(R) family of stents. Abbott plans to make XIENCE PRIME available in an expanded size matrix, including XIENCE PRIME SV for small vessels and XIENCE PRIME LL for long lesions. XIENCE PRIME is pending CE Mark and is not available for sale.

"XIENCE PRIME builds upon the unprecedented body of clinical evidence from the SPIRIT family of clinical trials, and offers advances in the delivery system and an enhanced stent design to make the stent even easier for physicians to deliver to the lesion site," said Robert Hance, president, Abbott Vascular. "We are pleased with the progress we've made to bring this next advancement to physicians and patients, and we look forward to launching XIENCE PRIME in Europe later this year."

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 stent. 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 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. It is also under review with Health Canada.

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 antiproliferative 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.

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.

* Patient/lesion subgroups are not mutually exclusive.

SOURCE Abbott

Source: PR Newswire

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