The analysis included groups that differed widely, Garratt noted. "For example, there were 10 percent women in one trial, 80 percent in another," he said. "It seems troubling to make sweeping statements about safety on such widely varying patient populations."
Recent changes in cardiology practice may have also undermined the report's importance, Garratt added. Worries about restenosis surfaced about a year ago, he said, and have led to changes in medical practice. But the new analysis largely includes studies done before then.
"Our effort to reduce stent clotting is paying off," Garratt said, mostly through a concentration on dual therapy involving clot-preventing medications. Cardiologists are now very careful to have stent recipients take both Plavix and aspirin, which act on blood platelets to prevent clotting, he said.
"This report could mistakenly be taken in such a way to make someone choose product A over product B," Garratt said. "The power of observation in the study is not enough to make that sweeping of a change."
The use of drug-coated stents is also being limited, at least in his practice, said Dr. Joseph B. Muhlestein, professor of medicine at the University of Utah, Salt Lake City. "If the patient has a low risk of restenosis, we get by with a bare-metal stent," he said.
Muhlestein found some comfort in the relatively low rate of deaths and complications described in the report. "The situation perhaps is not as bad as we worried," he said.
Muhlestein's group has been working on its own safety analysis of drug-coated stents, he added. "The data do not go against the belief that the siromilus stent might be safer than the paclitaxel stent," the expert said.
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