NEW YORK, NY MAY 6, 2010 Results from the SPIRIT IV clinical trial, which were first presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2009 scientific symposium, were published today in the New England Journal of Medicine.
Data from the trial, a large-scale multi-center study of nearly 4,000 patients in the U.S., showed that everolimus-eluting stents demonstrated enhanced safety and efficacy in the treatment of de novo native coronary artery lesions when compared to paclitaxel-eluting stents. The trial, which was powered for superiority for clinical endpoints without angiographic follow up, also examined the differences in performance of the two stents in patients with diabetes.
"The data published in today's New England Journal of Medicine, and first reported at TCT, demonstrate enhanced safety and efficacy of the everolimus-eluting stent compared to the paclitaxel-eluting stent in this large-scale study without routine angiographic follow-up. The study results also suggest that minimal late loss may be achieved with drug-eluting stents without sacrificing safety," said principal investigator Gregg W. Stone, MD, Professor of Medicine at Columbia University College of Physicians and Surgeons, Director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center and Co-Director of the Medical Research and Education Division at the Cardiovascular Research Foundation.
The primary endpoint of the trial was target-lesion failure (TLF) at one year, a composite measure of cardiac death, target-vessel heart attack or ischemia-driven target-lesion revascularization (TLR). Major secondary endpoints of the trial were ischemia-driven TLR at one year, and the composite rate of cardiac death or target-vessel heart attack at one year.
For everolimus-eluting stents, TLF at one year was 4.2 percent, and for paclit
|Contact: Judy Romero|
Cardiovascular Research Foundation