Data from an independent meta-analysis of Abbott's SPIRIT-II and SPIRIT-III randomized clinical trials demonstrated that the Xience V Everolimus eluting coronary stent system continues to deliver clinically significant benefits for patients compared to the Taxus paclitaxel-eluting coronary stent system out to two years.

In this meta-analysis, which included patients from the United States, Europe and Asia-Pacific, Xience V demonstrated clinical superiority to Taxus in the endpoints of target vessel failure (TVF) and major adverse cardiac events (MACE) at two years. Xience V also demonstrated significantly lower clinical events rates than Taxus in the key efficacy (target lesion revascularization) and safety (cardiac death or heart attack) components of MACE at two years. The results are being presented by Gregg W Stone, principal investigator of the SPIRIT-III trial, during the Cardiovascular Research Foundation's 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.

"The pooled results from the SPIRIT-II and SPIRIT-III trials demonstrate that Xience V is safer and provides greater efficacy than Taxus at two years," said Dr Stone, professor of medicine at Columbia University Medical Center and chairman, Cardiovascular Research Foundation, New York. "In the meta-analysis at two years, Xience V compared to Taxus demonstrated statistically significant reductions in the combined measure of all-cause death or heart attack, as well as further reducing the need for repeat cardiac procedures - reinforcing that Xience V is a true second-generation stent, which results in improved patient outcomes."

Also presented during TCT, a variety of subgroup analyses from the SPIRIT III trial demonstrated observational evidence of strong performance by Xience V in a variety of patients and lesion types that represent complex patients. The results consistently favoured Xience V compared to Taxus at two years across multiple subgroups examined, including patients with small vessels and multi-vessel patients. In diabetic patients, the analysis showed there were no observed differences between Xience V and Taxus at two years. 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.

"With the subgroup analysis, we saw encouraging trends of lower event rates between one and two years for patients treated with Xience V compared to patients treated with Taxus, regardless of patient or lesion complexity," said John M Capek, executive vice president, Medical Devices, Abbott. "Even though the SPIRIT III trial was not designed for statistical comparisons in subgroups, these positive trends demonstrate that Xience V performs in a consistent manner and gives physicians confidence in Xience V as they consider what is the most effective treatment for their patients."

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.

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