Abbott's SPIRIT II clinical trial demonstrated from continued positive clinical results for the Xience V Everolimus Eluting Coronary Stent System out to two years, including an observed 40 per cent reduction in major adverse cardiac events (MACE) and an observed 44 per cent reduction in vessel re treatment (ischemia-driven target lesion revascularization, TLR) compared to the Taxus paclitaxel-eluting coronary stent system. The two-year results from the SPIRIT II trial were presented at the SCAI Annual Scientific Sessions in Partnership with ACC i2 Summit.
SPIRIT II is a 300-patient randomised clinical trial, which was conducted in Europe and Asia Pacific to support the launch of Xience V outside the United States. In SPIRIT II, Xience V demonstrated the following key results:
In an analysis of major adverse cardiac events (MACE), Xience V demonstrated an observed 40 per cent reduction in MACE compared to Taxus at two years (6.6 per cent for Xience V vs. 11.0 per cent for Taxus). MACE is an important clinical measure of patient outcomes, defined as cardiac death, heart attack (myocardial infarction or MI), or ischemia-driven target lesion revascularisation.
Xience V demonstrated an observed 44 per cent reduction in ischemia-driven target lesion revascularisation (TLR driven by lack of blood supply) compared to Taxus at two years (3.8 per cent for Xience V vs. 6.8 per cent for Taxus).
"In clinical endpoints such as major adverse cardiac events, retreatment and heart attack, patients treated with Xience V in the SPIRIT II clinical trial continue to fare better than patients treated with Taxus out to two years," said Patrick W. Serruys, M.D., Ph.D., Professor of Interventional Cardiology at Thoraxcentre, Erasmus University Hospital, Rotterdam, and principal investigator of the SPIRIT II clinical trial, who presented the results today. "Xience V is performing as we would expect a next-generation drug eluting stent should over the long term, specifically on the important clinical endpoint of MACE. The low rate of MACE with Xience V compared to Taxus was present at 6 months, one year and now at two years in the SPIRIT II trial."
In a small subset of patients in the SPIRIT II trial, in-stent imaging results were evaluated at two years. In this 117-patient subset, the angiographic in-stent late loss rate was 0.33 mm for Xience V and 0.34 mm for Taxus at two years. In-stent late loss is a measure of vessel renarrowing within the margins of the stent.
Everolimus is licensed to Abbott by Novartis for use on its drug eluting stents.