The New England Journal of Medicine recently published several original articles, an editorial and two perspectives pertaining to the risk of stent thrombosis and heart attacks in patients who have drug-eluting and bare-metal stents. Heart patients who have been advised by their cardiologists that they should have a drug-eluting stent implanted should review this research and professional viewpoints at their earliest possible convenience.
Some physician researchers found no significant differences between drug-eluting stents and bare-metal stents in rates of death, myocardial infarction, or stent thrombosis in a pooled analysis of data from four randomized trials. Other physician researchers analyzing four double blind trials found that stent thrombosis after 1 year was more common with drug-eluting stents than with bare-metal stents.
In a large group study, doctors in Sweden determined that drug-eluting stents were associated with an increased rate of death, as compared with bare-metal stents. This trend appeared after 6 months, when the risk of death was 0.5 percentage point higher and a composite of death or myocardial infarction was 0.5 to 1.0 percentage point higher per year.
The FDA convened a panel discussion on the issue of stent thrombosis and the safety of drug-eluting stents in December 2006. Some important questions about drug-eluting stents remain unanswered. What is the magnitude and time course of the increased risk of stent thrombosis when using a drug-eluting stent? What are the long term benefits and safety concerns with respect to drug-eluting stents in patients with complex conditions or coronary lesions? What is the ideal duration of blood thinning drugs after stent implantation?