FDAnews
www.fdanews.com/articles/89987-plavix-linked-to-lower-risk-of-heart-attack-in-patients-with-drug-eluting-stents

PLAVIX LINKED TO LOWER RISK OF HEART ATTACK IN PATIENTS WITH DRUG-ELUTING STENTS

December 13, 2006

Patients implanted with drug-eluting stents who have not had cardiovascular events or additional procedures within six months of follow-up may benefit from extended use of sanofi-aventis' blood-thinning drug Plavix, according to a study being published in the Jan. 10 issue of The Journal of the American Medical Association (JAMA).

Plavix (clopidogrel bisulfate) is associated with a "significant reduction in risk" for heart attack or death through 24 months after stent implantation, according to the study, which was posted online by JAMA ahead of a meeting of the FDA's Circulatory System Devices Panel on a potential link between the devices and an increased risk of blood clots.

Instructions for the use of drug-eluting stents commercially available in the U.S. specify post-implantation treatment with clopidogrel for at least three months with sirolimus-eluting devices or six months with paclitaxel-eluting devices, the study noted.

The study, conducted by a team from Duke University Medical Center, can be viewed at jama.ama-assn.org/cgi/content/full/297.2.joc60179v1 (http://jama.ama-assn.org/cgi/content/full/297.2.joc60179v1).