NEJM ARTICLES COVER DRUG-ELUTING STENT SAFETY CONCERNS

A series of studies comparing drug-eluting stents with bare-metal stents points to an emerging consensus that the longer the drug-eluting devices remain implanted, the greater chances are that patients will develop life-threatening blood clots (thromboses).

Five studies appear together in the March 8 issue of the New England Journal of Medicine (NEJM) along with an editorial by William Maisel, chairman of an FDA panel convened in December 2006 to address the issue of drug-eluting stent safety.

"The turmoil over drug-eluting stents and thrombosis represents both a success and a failure of the U.S. medical-device regulatory system," Maisel said.

Maisel expressed disappointment that "five years have elapsed since the start of the clinical trials and the implantation of millions of drug-eluting stents" and still "much remains uncertain about the long-term safety of the devices."

Drug-eluting stents "were approved for use in stable patients with relatively noncomplex coronary stenoses [narrowed arteries], but they have been used in many patients whose clinical features and coronary anatomy fall outside the original specifications," NEJM editors wrote. Such off-label use "has made assessments of stent safety beyond the setting of clinical trials considerably more challenging."

( http://www.fdanews.com/ddl/34_8/ )