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New Drug-Coated Stent Does Well in Early Trial
Date:4/22/2008

But doctors want more data, and device not yet approved for use in U.S.

TUESDAY, April 22 (HealthDay News) -- A new kind of drug-coated stent was better at keeping arteries open than an older stent in the first large-scale U.S. study of the device, researchers report.

"This study suggests that in terms of overall safety and effectiveness, the Xience stent is superior to the Taxus stent, in terms of reduction of major cardiovascular events such as heart attacks at the time of the procedure," said study author Dr. Gregg W. Stone, director of cardiovascular research and education at the Center for Interventional Vascular Therapy, New York-Presbyterian Hospital/Columbia University Medical Center.

But, Stone added, "it is still too early to say whether this translates into a reduction of overall deaths. All we can say is that it is superior to the Taxus stent with a one-year follow-up."

The findings are published in the April 23/30 issue of the Journal of the American Medical Association.

The Xience stent, developed by a division of Abbott Laboratories, is not yet available for use in the United States. An advisory panel of the U.S. Food and Drug Administration has recommended approval, and action is expected later this year.

If approved, the Xience stent would be the fourth drug-coated stent on the American market. It would compete with the Cypher, which is coated with the drug sirolimus and marketed by Johnson and Johnson; Taxus, a Boston Scientific product coated with paclitaxel; and the newest entry, Medtronic's Endeavor, coated with ABT-578, a chemical relative of sirolimus. The Xience stent is coated with a drug called everolimus.

All the drug-coated stents are designed to reduce the risk that the opened coronary artery will close again. It's not yet possible to say which one is superior, Stone said.

"It's very difficult to rank them 1, 2, 3, 4," he said. "That will b
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