Abbott has released long-term data for the SPIRIT III pivotal US clinical trial, which demonstrated that the observed clinical advantages of XIENCE V Everolimus Eluting Coronary Stent System continued to increase as compared to the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System (TAXUS).
At three years, XIENCE V demonstrated a 43% reduction in the risk of major adverse cardiac events (MACE) compared to TAXUS (9.1% for XIENCE V vs 15.7% for TAXUS, p-value=0.003).
Dr Stone, an immediate past chairman of the cardiovascular research foundation, New York and principal investigator of the SPIRIT III trial, said: “The SPIRIT III results clearly demonstrate that at three years, patients continue to benefit from having been treated with the XIENCE V stent rather than the TAXUS stent, with fewer repeat cardiac procedures and fewer heart attacks in patients who received XIENCE V.”
XIENCE V demonstrated a low rate of very late stent thrombosis (one to three years) with no additional events between two and three years. Per protocol, XIENCE V demonstrated a 0.2 % very late stent thrombosis rate compared to 1.0% for TAXUS (p-value=0.10) at three years.
SPIRIT III is a prospective, multi-center, randomised, 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 coronary artery lesions. The trial was conducted across 65 academic and community-based centers in the US 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 superior 50% reduction in late loss (mean, 0.14 mm for XIENCE V vs. 0.28 mm for TAXUS, p-value =0.004).