Off-Label Drug-Eluting Stent Use Increases Risk for Adverse Events

Two U.S. registries provide valuable outcomes data on this widespread clinical practice.

Recent concerns about the safety of drug-eluting stents (DES) have highlighted their frequent use in off-label situations (Journal Watch Cardiology Feb 12 2007). In two new studies from large U.S. registries, investigators compared clinical outcomes of DES use for on- and off-label indications.

In the EVENT registry, 1817 of 3323 patients (55%) who received DES between July 2004 and September 2005 had at least one off-label indication, including >1 lesion treated (59%), total stent length ≥36 mm (54%), bifurcation (26%), and vein graft lesion (10%). Compared with patients treated on-label, those treated off-label were more often male and had higher rates of congestive heart failure, prior MI, and prior coronary artery bypass graft. Those tre…

Reviewing Author

Howard C. Herrmann, MD