Related Resources • Restenosis • Links to stents and angioplasty

By DrRich

Dateline: October 28, 2002

The FDA's Circulatory System Devices Panel voted unanimously last week to recommend approval of the sirolimus-coated stent (manufactured by Cordis and Johnson & Johnson).  This recommendation came a mere six weeks after the release of data from the SIRIUS trial, which showed a 91% reduction in the incidence of restenosis with the drug-coated stent, as compared to a bare metal stent.  The rapidity of this action is quite unusual for the FDA.

However, the panel did not recommend the broad-based approval sought by the device sponsors.  The panel voted to limit the use of the drug-coated stent to coronary artery lesions like the ones studied in the SIRIUS trial.  In other words, they recommended that the new stent be used only in coronary artery blockages within a certain size range - blockages whose lengths are longer or shorter than those studied in the SIRIUS trial should not receive a drug-coated stent.  New studies will have to be conducted to justify a broader use of these stents.

The panel also expressed concern that they are recommending approval of an entirely new class of product - one that is both a medical device and a drug (a drug, by the way, that is unlike any drugs that most cardiologists have used before.)   Thus, for the first time, when a cardiologist uses multiple stents in a single patient, he/she will be doing more than adding more metal - he/she will also applying larger doses of a drug that is meant to be used only in small doses.  The implications of ratcheting up the dose of sirolimus in this way are not clear.  The panel recommended that the FDA take special care in devising the labeling of this new product (that is, the literature provided both to doctors and to patients) to reflect the unique nature of this stent, and the precautions that may be necessary due to this unique nature.

Despite these cautious sidebars, several panel members acknowledged that drug-coated stents appear to be a major advance in the prevention of restenosis, and are likely to revolutionize the care of coronary artery disease in the United States.  (The FDA itself tacitly agreed with this assessment by expediting the panel review of the sirolimus-coated stent.)

As a result of the panel's action last week, these new stents now appear on track for market release in early-to-mid 2003.