Stents lift risks for some heart patients
Conflict with earlier study attributed to recording method
MUNICH - Drug-coated stents were linked to a higher death rate when given to people with a certain type of heart attack, a finding that may limit doctors' use of the mesh tubes to prop open arteries.
The heart attack patients died at more than four times the rate when they received a drug-coated device compared with patients who had received an older, bare-metal stent, researchers led by Philippe Gabriel Steg said yesterday at the European Society of Cardiology meeting in Vienna. These patients should no longer be given drug-eluting stents, Steg said.
"This data is serious," said Eckhart Fleck, the doctor who runs Germany's largest catheterization laboratory in Berlin.
Despite the latest findings, the devices were shown to be safer than previously thought in a study released Sunday by researchers who examined all stent patients in Sweden.
Boston Scientific Corp. and Johnson & Johnson have seen demand for their drug-coated stents fall since researchers in 2006 found an association between the devices and potentially fatal blood clots.
Steg's study followed almost 2,400 heart attack patients for the two years after they had received either a bare-metal or a drug-coated stent.
The death rate among drug-coated stent patients was 4.7 times higher when compared to those that had received bare-metal stents, Steg said. After some statistical adjustments, the risk was about six times higher for heart attack patients.
Heart attack patients may be especially vulnerable because the narrowing of blood vessels in response to the attack can lead to the wrong size and placement of the stent, producing a gap in which clots can form.
"Patients are now very wary about these stents," Steg said. "Personally, I don't use these stents in heart attack patients any longer."
The research is a type of observational study known as a registry, which limits the conclusions it can offer, cardiologists said. The Swedish study released in Vienna this week was also a registry. The results are substantially different from other real world registry data, including the Swedish registry, that showed no increased risk of death among patient getting drug-coated stents, Christopher Allman, a spokesman for New Brunswick, New Jersey-based Johnson & Johnson, said in an e-mailed statement. The discrepancy in the studies can be explained by differences in recording patient death rates and variations in patient population, Steg said.
