Three Years Since the FDA Advisory Panel on Drug-Eluting Stents: What Have We Learned about Off-Label Use and Stent Thrombosis?

The arrival of drug-eluting stents in interventional cardiovascular practice heralded a new era in the management of patients with symptomatic coronary artery disease. Indeed, while bare metal stents were a clear technological breakthrough, improving acute procedural success while inhibiting elastic recoil and negative remodeling, the vessel response known as intimal hyperplasia and consequent restenosis limited their applicability to relatively non-complex lesion subsets.1,2 Drug-eluting stents were devised to target this last hindrance, and did so in impressive fashion. Multiple randomized controlled trials proved the efficacy of both the sirolimus-eluting and paclitaxel-eluting coronary stent systems, with marked reductions in restenosis (target vessel revascularization) of roughly 50–70% compared to bare metal stents, while safety was demonstrated by similar rates of death and myocardial infarction.3–14 It is not surprising therefore, that drug-eluting stent usage rapidly rose to approximately 90% of all percutaneous coronary interventions by early 2006. Since so-called “on-label” indications (2.5–3.75 mm diameter vessels up to 28–30 mm in length) typically comprise only 30–40% of interventional practice, “off-label” use (i.e., bifurcation, ostial, left main or vein graft disease, chronic total occlusion, in-stent restenosis, ejection fraction From the Department of Medicine, Division of Cardiovascular Disease, Winthrop University Hospital, Mineola, New York. Disclosures: Dr. Naidu is a consultant to Medtronic Cardiovascular, Cordis Corporation and Abbott Vascular. He is also a member of the speakers bureau of Daichi Sankyo-Lilly, Abbott Vascular, Medtronic Cardiovascular, and Cordis Corportion. Address for Correspondence: Srihari S. Naidu, MD, FACC, FAHA, FSCAI. Assistant Professor of Medicine, SUNY – Stony Brook School of Medicine, Director, Cardiac Catheterization Laboratory, Winthrop University Hospital, 120 Mineola Blvd, Suite 500, Mineola, NY 11501. E-mail: ssnaidu@winthrop.org

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