An Abbott Vascular’s everolimus-eluting Xience V stent resulted in reduced angiographic late loss, noninferior rates of target vessel failure and fewer major adverse cardiac events compared with a Boston Scientific’s paclitaxel-eluting stent Taxus during one year of follow-up, according to a large, prospective randomized trial published in the April 23/30 issues of the Journal of the American Medical Association.
The researchers noted that a thin, cobalt-chromium stent eluting the antiproliferative agent everolimus from a nonadhesive, durable fluoropolymer has shown promise in preliminary studies in improving clinical and angiographic outcomes in patients with coronary artery disease.
Gregg Stone, MD, from the Columbia University Medical Center and The Cardiovascular Research Foundation in New York City, and colleagues undertook the study to “evaluate the safety and efficacy of an everolimus-eluting stent compared with a widely used paclitaxel-eluting stent.”
The SPIRIT III trial, a prospective, randomized, single-blind, controlled trial enrolling patients at 65 academic and community-based U.S. institutions between June 22, 2005, and March 15, 2006, according to researchers. The authors noted that the patients were 1,002 men and women undergoing PCI in lesions 28 mm or less in length and with reference vessel diameter between 2.5 and 3.75 mm.
The investigators said that the angiographic follow-up was pre-specified at eight months in 564 patients and completed in 436 patients. Clinical follow-up was performed at one, six, nine and 12 months.
The patients were randomized 2:1 to receive the Xience V stent (669 patients) or the Taxus stent (333 patients), the authors wrote.
The researchers said that the primary endpoint was non-inferiority or superiority of angiographic in-segment late loss, and the secondary endpoint was non-inferiority assessment of target vessel failure (TVF) events (cardiac death, MI or target vessel revascularization) at nine months. An additional secondary endpoint was evaluation of major adverse cardiac events (cardiac death, MI or target lesion revascularization) at nine and 12 months, according to investigators.
Stone and colleagues found that the angiographic in-segment late loss was significantly less in the Xience V group compared with the Taxus group (mean, 0.14 mm vs. 0.28 mm).
The everolimus stent was non-inferior to the paclitaxel stent for TVF at nine months (7.2 vs. 9 percent, respectively), the researchers reported. The everolimus stent compared with the paclitaxel stent resulted in significant reductions in composite major adverse cardiac events both at nine months (4.6 vs. 8.1 percent) and at one year (6 vs. 10.3 percent), due to fewer MIs and target lesion revascularization procedures, according to Stone and colleagues.
“With a significant reduction in angiographic in-segment late loss, non-inferiority in target vessel failure and a clinical advantage in the composite rate of MACE [major adverse cardiac events] compared to Taxus, Xience V represents an important advance in improving the lives of patients with coronary artery disease,” said Stone
The SPIRIT III two-year results will be presented in mid-May at EuroPCR 2008 in Barcelona, Spain, according to Abbott Park, Ill.-based Abbott.