FDA SAYS MORE STUDIES NEEDED ON DRUG-ELUTING STENT RISKS
There is currently no evidence of increased rates of death or heart attack from drug-eluting stents versus bare-metal stents, but more trials with consistent protocols are needed to adequately assess the risk, an FDA panel concluded Dec. 7.
In September at the World Congress of Cardiology, presentations suggested that patients treated with drug-eluting stents instead of bare-metal stents could be trading restenosis -- a rarely life-threatening condition where the coronary artery re-narrows -- for an increased risk of a much more serious problem: thrombosis, or blood clotting. This issue was also addressed in October at the Transcatheter Cardiovascular Therapeutics conference, where clinical trial results were presented.
In response, the FDA's Circulatory System Devices Panel held a meeting last week to hear from Boston Scientific and Johnson & Johnson subsidiary Cordis, the two companies whose devices -- the Taxus and the Cypher, respectively -- are commercially available and have been linked in some studies with an increase in clotting risk.
The panel found that there is no apparent difference in the risk level for thrombosis between the Taxus and the Cypher.
Furthermore, recent clotting concerns do not outweigh the benefits of drug-eluting stents to treat in-stent restenosis, the panel agreed.