A two-year study comparing a new generation drug-coated stent, XIENCE™, with a currently used drug eluting stent, TAXUS®, has found that the XIENCE™ stent had superior benefits in more than 1,000 patients and is better at keeping the arteries of chest pain patients clear of blood clots.
Robert J. Applegate, M.D., professor of cardiology and the principal investigator of the study at Wake Forest University Baptist Medical Center, said that Wake Forest Baptist was one of 65 medical centers participating in this latest trial called SPIRIT III, comparing Abbott Vascular’s new generation drug-coated stent called XIENCE™ with the currently available first-generation TAXUS® stent made by Boston Science.
The results comparing the two stents, reported Tuesday at the EuroPCR 2008 meeting in Barcelona, Spain, found that the XIENCE™ compared to TAXUS® had a 43 percent reduction in the risk of major cardiac events, a 32 percent reduction in the risk of vessel failure, a 40 percent reduction in the risk of ischemia-driven target lesion revascularization and lower rates of stent thrombosis.
“These results are extremely encouraging and should provide confidence that the newer generation XIENCE™ drug-coated stent is more effective and at least as safe as the currently used drug-coated stents,” said Applegate. “The new generation XIENCE™ drug-coated stent uses a thinner stent, a gentler coating, and a more powerful drug than the TAXUS® drug-coated stent, which likely contributed to the better results of XIENCE™ compared to TAXUS®.
Based on this information it is anticipated that the FDA will announce its approval for use of the XIENCE™ drug-coated stent in the next several weeks.
The Heart Center at Wake Forest Baptist, which has participated in nine such clinical trials since 2001, did its own evaluation of outcomes in patients receiving stent therapy at Wake Forest Baptist and found similar results last year after concerns were raised about the safety of drug-coated stents.
Stents are used to keep the arteries of chest pain patients open and clear of blood clots.
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