Two-year data from the SPIRIT III trial, Abbott’s U.S. pivotal trial, demonstrated that its Xience V everolimus-eluting coronary stent system continues to deliver clinically superior benefits compared to Boston Scientific’s Taxus paclitaxel-eluting coronary stent system, according to a presentation at a late-breaking clinical trials session at EuroPCR 2008 in Barcelona, Spain.
In the trial of more than 1,000 patients, Xience V demonstrated a 45 percent reduction in the risk of major adverse cardiac events (MACE) and a 32 percent reduction in the risk of target vessel failure (TVF) at two years as compared to Taxus.
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 U.S. between June 22, 2005 and March 15, 2006.
Gregg W. Stone, MD, from the Columbia University Medical Center and chairman of the Cardiovascular Research Foundation, both located in New York City, and principal investigator of the trial, presented the SPIRIT III two-year results.
“Not only did Xience V clearly differentiate itself from the Taxus stent in the first year after treatment, it has now demonstrated even more positive effects at two years in the SPIRIT III trial," said Stone.
“As measured by clinically significant reductions in TVF and MACE, Xience V demonstrated an even greater improvement in patient outcomes compared to Taxus at two years than at one year, driven by numerically lower rates of heart attacks and lower observed rates of re-intervention of the target lesion. We also saw encouraging trends for lower observed rates of late and very late stent thrombosis in Xience V-treated patients, especially in those who discontinued dual antiplatelet therapy,” he added.
The SPIRIT III trial, which is the basis for the pre-market application of Xience V to the FDA, also demonstrated the following results for Xience V at two years:
- A 40 percent reduction in the risk of ischemia-driven target lesion revascularization as compared to Taxus (4.6 percent for Xience V vs. 7.5 percent for Taxus).
- Low rates of stent thrombosis between one and two years, per Academic Research Consortium (ARC) definition of definite/probable stent thrombosis (0.3 percent for Xience V and 1 percent for Taxus).