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SPIRIT IV trial shows everolimus stent sets new standard for event-free survival
Date:9/23/2009

SAN FRANCISCO, CA SEPTEMBER 23, 2009 Late-breaking data from SPIRIT IV, a large-scale multi-center study of nearly 4,000 patients in the U.S., shows that an everolimus-eluting stent demonstrated enhanced safety and efficacy in the treatment of de novo native coronary artery lesions when compared to a paclitaxel-eluting stent, and showed that "low late loss" may be achieved with drug-eluting stents without sacrificing safety.

Unlike similar prior studies (SPIRIT FIRST, SPIRIT II and SPIRIT III), the SPIRIT-IV trial was powered for superiority for clinical endpoints without angiographic follow up.

The trial also examined the differences in performance of the two stents in patients with diabetes.

"The results with the everolimus stent demonstrate enhanced safety and efficacy compared to the paclitaxel stent in this large-scale study without routine angiographic follow-up and sets a new standard for event-free survival after [implantation of a drug-eluting stent]," said principal investigator Gregg W. Stone, MD, immediate past chairman of CRF, professor of medicine at Columbia University Hospital and Director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center.

Results of the study were presented at the 21st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation (CRF).

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 TLR at one year, and a composite of cardiac death or target vessel heart attack at one year.

For the everolimus stent, TLF at one year was 4.2 percent, and for the paclitaxel-eluting stent, TLF was 6.8 percent, a signific
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Contact: Judy Romero
jromero@crf.org
347-407-2774
Cardiovascular Research Foundation
Source:Eurekalert

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