SAN FRANCISCO, September 21 /PRNewswire/ --
-- 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
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(R) Everolimus Eluting Coronary Stent System continued to increase as compared to the TAXUS(R) 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(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.
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