Off-label use of drug-eluting stents is associated with increased risks of early and late stent thrombosis, death, and myocardial infarction compared with on-label use.
Does off-label use of drug-eluting stents increase the risk of stent thrombosis and adverse clinical events compared to on-label use?
Off-label use of drug-eluting stents carries a higher risk of stent thrombosis and major adverse cardiovascular events compared to on-label use, necessitating careful patient selection.
Stent Thrombosis Redux — The FDA Perspective Dr. Andrew Farb and Ashley Boam write that as compared with on-label use, off-label use of drug-eluting stents is associated with increased risks of both early and late stent thrombosis, as well as death or myocardial infarction. Given the benefits and risks, physicians should consider certain patient characteristics in deciding whether to use a drug-eluting or a bare-metal stent. Dr. Donald Baim, chief medical and scientific officer of Boston Scientific, and Dr. Steven Nissen, chairman of The Department of Cardiovascular Medicine at The Cleveland Clinic, discuss the risks and benefits of drug-eluting stents.
Farb et al. (2007) conducted an editorial in Coronary artery disease requiring stenting. Off-label use of drug-eluting stents vs. On-label use of drug-eluting stents was evaluated on Early and late stent thrombosis, death, or myocardial infarction. Off-label use of drug-eluting stents is associated with increased risks of early and late stent thrombosis, death, and myocardial infarction compared with on-label use.