Off-Label Use of Drug-Eluting Coronary Artery Stents

Off-label use is common and associated with higher rates of short- and long-term complications.

Since drug-eluting stents were approved in 2003 and 2004, their use in percutaneous coronary intervention has increased dramatically. Two studies, one funded by a stent maker and the second by the maker of an antiplatelet medication, compared early and late complications in about 9000 patients receiving drug-eluting stents.

In both studies, about half of stents were used in off-label and untested applications; most instances involved vessel diameters that were either too small or too large, lesions longer than recommended, or re-stenosed lesions. Using various composite markers of complications including stent thrombosis, target vessel revascularization, myocardial infarction, or death, the in-hospital complication rate with off-label use in…

Reviewing Author

Thomas L. Schwenk, MD