January 28, 2009 - Data published this week in the online journal Circulation from the SPIRIT III U.S. pivotal trial demonstrates that the XIENCE V everolimus-eluting coronary stent system outperforms the TAXUS Express2 paclitaxel-eluting coronary stent system in reducing a patient’s likelihood of suffering a heart attack or requiring a repeat intervention out to two years.
In the SPIRIT III trial of 1,002 patients, XIENCE V demonstrated a 45 percent reduction in the risk of MACE, and a 40 percent reduction in the risk of cardiac death or heart attack (myocardial infarction, or MI) at two years in patients treated with XIENCE V compared to those treated with TAXUS. Additionally, at two years the study demonstrated a 32 percent reduction in the risk of target vessel failure (TVF, cardiac events related to the treated vessel) for XIENCE V compared to TAXUS. These published results were first presented in May 2008 at the EuroPCR Congress in Barcelona.
"As published in Circulation, the SPIRIT III study results demonstrate that the clinical benefits of XIENCE V continue to improve between one and two years of follow-up after stent implantation compared to TAXUS," said Gregg W. Stone, M.D., Columbia University Medical Center; chairman, Cardiovascular Research Foundation, New York; and principal investigator of the SPIRIT III trial. "These data reinforce our earlier findings demonstrating the excellent angiographic and clinical results with the XIENCE V stent, resulting in fewer heart attacks and repeat reinterventions."
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 native 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 significant 50 percent reduction in late loss (mean, 0.14 mm for XIENCE V vs. 0.28 mm for TAXUS). In-segment late loss is a measure of vessel renarrowing. In the co-primary endpoint of TVF at nine months, XIENCE V demonstrated statistical non-inferiority compared to TAXUS with an observed 20 percent reduction in TVF (7.2 percent for XIENCE V vs. 9.0 percent for TAXUS).
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. The XIENCE V stent is available on both over-the-wire (OTW) and rapid exchange (RX) delivery systems.
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