ENDEAVOR IV Trial Results Presented At TCT 2007

Main Category: Medical Devices / Diagnostics
Also Included In: Clinical Trials / Drug Trials;  Cardiovascular / Cardiology;  Diabetes
Article Date: 23 Oct 2007 - 3:00 PDT

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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 trial's 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.

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About CRF and TCT

The Cardiovascular Research Foundation (CRF) in New York City is an independent, non-profit academic institution dedicated to improving the survival and quality of life of patients with cardiovascular disease through research and education. For more than 15 years, CRF has played a major role in realizing dramatic improvements in the lives of patients by establishing the safe use of new technologies and therapies in the subspecialty of interventional cardiology and endovascular medicine.

The Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, conducted by the Cardiovascular Research Foundation, is a global gathering of physicians, researchers, technologists, and industry colleagues working in the field of interventional vascular medicine. It is the world's largest privately run medical conference, attended by more than 10,000 participants each year and featuring the video transmission of more than 100 live patient cases from medical centers around the world. Including lectures, discussion panels, and workshops on the latest clinical findings and cutting-edge technologies, TCT educates medical professionals to ensure that the work of physicians and researchers is translated into improved patient care.

For more information, please visit http://www.ccrf.org/

Source: David Harrison
Cardiovascular Research Foundation

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