New drug-covered stents widely used to prop open clogged arteries are associated with an increased risk of blood clots, heart attacks and death for the majority of patients receiving the devices, an expert panel concluded. Based on the finding, the special 21-member Food and Drug Administration panel recommended that the agency issue new warnings to doctors and patients that the devices' safety has not been established except for relatively low-risk patients, for whom the stents were originally tested and approved.
The panel stressed that the tiny metal-lattice struts, known as drug-eluting stents, offer advantages over older bare-metal versions for some patients, with the benefits outweighing the risks for the relatively healthy patients for whom the devices have been tested. It remains unclear whether the devices are causing the complications in other patients; the side effects could be occurring because these patients tend to be sicker. But panel members concluded that until that question can be answered, doctors and patients should be alerted about the potential risks. Several members said they hoped that would make doctors more cautious about using the devices.
The panel also recommended that patients who have the stents take anti-clotting drugs for at least a year. More than 6 million people worldwide have had the drug-coated devices implanted, including perhaps 3 million in the United States. At least 800,000 new patients get them each year, making the stents the most common device used to treat heart disease and one of the most common medical procedures of any kind. The panel's recommendations apply to at least 60 percent of those patients.
The FDA is not bound to follow the recommendations, but an official said the agency would respond rapidly. Patients who get the stents had been advised to take aspirin and the drug Plavix? for three to six months to reduce the risk of blood clots. Recent studies have indicated that patients may need to take the drugs longer, perhaps indefinitely, but Plavix is expensive and increases the risk of serious bleeding.
