Blood clotting is four to five times more likely in patients getting drug-coated heart devices known as stents, compared to the older bare-metal variety, according to a large data analysis released Wednesday.
The analysis came one week before a Food and Drug Administration panel of experts is to meet to discuss the issue.
The Cleveland Clinic analysis of 14 studies with 6,675 patients will likely fuel a growing debate about the safety of drug-coated stents, the tiny wire-mesh devices used to prop open surgically cleared arteries.
Thrombosis, or blood clots, can lead to heart attacks.
The release of the study in the December issue of American Journal of Medicine came one week before the FDA panel is to discuss stent thrombosis, or potentially fatal blood clotting long after the devices are implanted.
“Our analysis found that there is a small, but real hazard of late stent thrombosis with drug-eluting stents more so than with bare-metal stents, likely in the setting of discontinuation of anti-clotting drugs,” said Dr. Deepak Bhatt, a Cleveland Clinic official, in a prepared statement.
“This does not mean that drug-eluting stents should not be used, as other studies have shown that they do significantly reduce the need for repeat procedures compared with bare metal stents,” added Bhatt, associate director of the Cleveland Clinic Cardiovascular Coordinating Center and one of the study’s authors.