Compelo Medical Devices is using cookies

We use them to give you the best experience. If you continue using our website, we'll assume that you are happy to receive all cookies on this website.

ContinueLearn More
Close
Dismiss

Pivotal Two Year Results On XIENCE V Drug Eluting Stent Data Published

Data published in Circulation from the SPIRIT III US pivotal trial evaluating the XIENCE V Everolimus Eluting Coronary Stent System demonstrated that patients treated with XIENCE V are less prone to heart attacks or require a repeat intervention than treated with TAXUS Express2 Paclitaxel-Eluting Coronary Stent System (TAXUS). In a study involving 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 when compared to those treated with TAXUS. At two years the study also 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. The 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." The SPIRIT III trial demonstrated the following key results for XIENCE V at two years: • A 45 percent reduction in the risk of MACE compared to TAXUS (7.3 percent for XIENCE V vs. 12.8 percent for TAXUS, p-value=0.004). MACE is an important composite clinical measure of safety and efficacy outcomes for patients, defined as cardiac death, MI or ischemia-driven target lesion revascularization (TLR driven by lack of blood supply). • A 40 percent reduction in the risk of cardiac death or MI (4.0 percent for XIENCE V vs. 6.6 percent for TAXUS, p-value=0.08). • A 32 percent reduction in the risk of TVF compared to TAXUS (10.7 percent for XIENCE V vs. 15.4 percent for TAXUS, p-value=0.04). TVF is a composite clinical measure of safety and efficacy outcomes defined as cardiac death, MI or target vessel revascularization (TVR). • TAXUS (4.3 percent for XIENCE V vs. 6.9 percent for TAXUS, p-value=0.07). • Low rates of stent thrombosis (blood clotting within the treated area) per the Academic Research Consortium (ARC) definition of definite/probable stent thrombosis (1.3 percent for XIENCE V vs. 1.7 percent for TAXUS) and per the SPIRIT III protocol (1.0 percent for XIENCE V vs. 1.7 percent for TAXUS). The ARC definitions of stent thrombosis were developed to eliminate variability in the definitions across various drug eluting stent trials. • Among patients who discontinued anti-platelet therapy with a thienopyridine (clopidogrel or ticlopidine) in the study after six months, trends showed that patients treated with XIENCE V experienced fewer stent thromboses compared to those treated with TAXUS at the end of two years (0.4 percent for XIENCE V vs. 2.6 percent for TAXUS). "XIENCE V continues to demonstrate sustained excellence, and the data demonstrate why it is an important advancement in the treatment of heart disease," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. "The consistent positive clinical trial findings, like those from SPIRIT III, are key contributors to why physicians have quickly adopted XIENCE V, making it the market-leading drug eluting stent in the United States and in key markets around the world."