Reacting to a federal report finding 60 patient deaths occurred after implantation of the new drug-coated stent, the maker of the device says the death rate is about the same for older, less effective bare metal stents.
Marty Schieldhouse, spokesman for the Cordis Corp., a Miami subsidiary of New Brunswick, N.J.-based Johnson & Johnson, says the new device, released in the United States in April, was never expected to improve rates of sub-acute thrombosis occuring with stents.
Schieldhouse says that thrombosis is a relatively rare reaction to stents. Only 1% to 2% of patients with bare-metal stents develop sub-acute thrombosis, and the rate for drug-coated stents appears to be similar, Schieldhouse says.
Schieldhouse says thrombosis caused all of the 60 deaths, though the U.S. Food and Drug Administration, which reported the deaths, said the cause could not yet be determined.
"Until FDA gets to the root of the problems, the agency is encouraging doctors to follow the instructions for use of the stent, and urging them to be vigilant for any patient symptom that may be attributed to hypersensitivity," says the FDA's notification to physicians, released Oct. 29.
The Boston Globe reported on Saturday that cardiologists in the area had been "flooded" with phone calls from patients asking about the notification, which is posted on the FDA Web site.
For example, at Cape Cod Hospital, where 500 people have received the drug-coated stent, 40 patients called about the notification, the Globe says.
The FDA says it received reports describing 290 cases of thrombosis that occurred within 30 days after implantation. Of those patients, 60 died, or at a rate of just over 20%.of the reported thrombosis cases.
In comparison, Schieldhouse reports that the death rate for patients with bare metal stents who develop thrombosis is 25%.
Schieldhouse reports that at last count, Cordis had shipped 450,000 Cypher stents worldwide and that 260,00 of those stents went to the U.S. market.
He adds that the risks of not using stents are much greater. "This is a device that treats very sick people," who would otherwise risk death from heart attacks, he says.