WASHINGTON, DC OCTOBER 22, 2007 Late-breaking results from the ENDEAVOR IV trial, presented at TCT 2007, the annual scientific symposium of the Cardiovascular Research Foundation, show that the Endeavor zotarolimus-eluting stent met the trials primary endpoint, demonstrating a similar overall safety profile (equivalent rates of death, heart attack, and repeat procedures) to the Taxus paclitaxel-eluting stent at 1 year.
In addition, the Endeavor stent showed a lower rate of less-severe (non-Q-wave) heart attacks at 30 days, but a higher rate of angiographic late loss (artery re-narrowing) at eight months compared to the Taxus stent.
The primary endpoint of the trial, non-inferiority as measured by target vessel failure (TVF) between the two stents, was met, said Martin B. Leon, MD, Founder and Chairman Emeritus, CRF and Professor of Medicine at Columbia University Medical Center. TVF occurred in 6.6 percent of patients receiving the Endeavor stent and 7.2 percent of patients receiving the Taxus stent, a difference that was not statistically significant. The Endeavor stent also demonstrated equivalence to Taxus in several long term measures.
At 12 months, the difference between the rates of target lesion revascularization with the Endeavor (4.5 percent) and Taxus (3.2 percent) stents was not statistically significant. Likewise, target vessel revascularization rates at 12 months were also similar (6.3 percent with Endeavor vs. 6.7 percent with Taxus).
Interestingly, at 30 days, rates of less-severe heart attacks were 0.5 percent with Endeavor compared with 2.2 percent with Taxus, a statistically significant difference. Late loss at eight months, meanwhile, was significantly greater with Endeavor (0.67 mm) compared with Taxus (0.42 mm).
Importantly, in the diabetic subset of 477 patients, Endeavor had similar efficacy compared with Taxus including target lesion revascularization and in-segment restenosis.
The Endeavor IV trial included 1,548 patients at 80 locations and was randomized to treatment with either the Endeavor or Taxus stent.
|Contact: David Harrison|
Cardiovascular Research Foundation