Off-label use of drug-eluting stents: assessing the risk
Roxana Mehran* and George D Dangas
Correspondence *Cardiovascular Research Foundation, Columbia University Medical Center, Irving Pavillion, 5th Floor, 161 Fort Washington Avenue, New York, NY 10032, USA
Email rmehran@crf.org
This article has no abstract so we have provided the first paragraph of the full text.
Approval of DESs in the US was granted in 2003 on the basis of data from pivotal clinical trials.1 The first DES to be licensed (sirolimus-eluting Cypher®, Cordis, Miami Lakes, FL) included the labeling indication for its use "in patients with symptomatic ischemic disease due to discrete de novo lesions of length <30 mm in native coronary arteries with a reference vessel diameter of >2.5 to <3.5 mm".4 In the US, the preapproval process for new devices is typically limited to studies undertaken in low-risk patients where the 'controls' have a documented event rate and receive the 'standard of care'. Although this procedure is understandable and appropriate, the labeling indications ultimately granted apply to only the minority of patients.
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