News | September 24, 2010

SPIRIT IV Continues to Show Excellent Outcomes for Everolimus Stents

September 24, 2010 - Two-year data from the SPIRIT IV trial show that everolimus-eluting stents demonstrated enhanced safety and efficacy in treating de novo native coronary artery lesions when compared to paclitaxel-eluting stents.

SPIRIT IV is the largest clinical trial to date comparing two drug-eluting stents, with nearly 4,000 patients in the United States. The trial compared Abbott's Xience V everolimus-eluting coronary stent system with the Taxus Express2 paclitaxel-eluting coronary stent system. It also examined the differences in performance of the two stents in patients with diabetes. The results were presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2010 meeting in Washington, D.C.

Target lesion failure (TLF) at two years was 30 percent lower in the everolimus-eluting stent (6.9 percent versus 9.9 percent), and ischemia-driven target lesion revascularization (TLR) was also significantly reduced (4.5 percent versus 6.9 percent). In addition to lowering TLF and TLR, the everolimus-eluting stent also reduced the occurrence of heart attacks and stent thrombosis when compared to the paclitaxel-eluting stent.

In patients with diabetes there was a non-significant difference in the rate of TLF.

“The safety and efficacy of the everolimus-eluting stent compared to the paclitaxel-eluting stent, which were established at one year, are sustained at two years,” said Gregg W. Stone, M.D., 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 New York-Presbyterian Hospital/Columbia University Medical Center and co-director of the medical research and education division at the Cardiovascular Research Foundation. Stone is also the principal investigator of the SPIRIT IV trial.

“These are significant findings that support the enhanced clinical outcomes achieved with the everolimus-eluting stent, which is the most commonly used drug-eluting stent,” he added.

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