Abbott's XIENCE V(R) Superior to TAXUS(R) in Key Safety and Efficacy Measures in SPIRIT IV Trial (1)

SAN FRANCISCO, September 23 /PRNewswire/ --

At One Year, XIENCE V Demonstrates:

-- Statistical Superiority on Primary Endpoint of Target Lesion Failure, with a 38 Percent Reduction Compared to TAXUS

-- 74 Percent Reduction in Stent Thrombosis (Blood Clots) Compared to TAXUS

-- Low Event Rates across Multiple Subgroups of Complex Patients

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

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