Editorial
Drug-Eluting Coronary Stents — Promise and Uncertainty
N Engl J Med 2007; 356:1059-1060February 12, 2007
- Article
Animation
Stenting for Relief of Arterial Stenosis.
In this issue of the Journal, we publish five Original Articles and two Perspective articles on the subject of drug-eluting coronary stents.1-7 Our motivation is the recent concern that the implantation of drug-eluting stents, as compared with bare-metal stents, may be associated with a small increased risk of late stent thrombosis, a potentially fatal complication (Figure 1Figure 1
Potential Complications of Coronary Stenting: Restenosis in a Traditional Bare-Metal Stent and Late Thrombosis in a Drug-Eluting Stent.). At a meeting of the Circulatory System Devices Advisory Panel of the Food and Drug Administration (FDA) on December 7 and 8, 2006, presentations were made on virtually every aspect of this complex clinical problem.8 In order to inform the medical community, we are publishing these articles, which are representative of the presentations and discussions that took place at the panel meeting. In some cases we provide two views of the same data sets, because different investigators looked at the same data using different analytic approaches. Readers will see that the details of analysis are critical for understanding the conclusions of each of these reports.In addition to the data reported in the Original Articles, the two Perspective articles, by Dr. Andrew Farb and Ashley Boam of the FDA Center for Devices and Radiological Health and by Dr. William Maisel, who served as chair of the Circulatory System Devices Advisory Panel, synthesize a great deal of information on both the benefits and the potential risks of drug-eluting stents. These stents were approved for use in stable patients with relatively noncomplex coronary stenoses, but they have been used in many patients whose clinical features and coronary anatomy fall outside the original specifications. Such off-label use has made assessments of stent safety beyond the setting of clinical trials considerably more challenging. There is also the important matter of adjunctive antiplatelet therapy. Although a science advisory recommending 12 months of dual antiplatelet therapy after placement of a drug-eluting stent was published electronically in January,9 the optimal duration of therapy has not yet been precisely determined.
Millions of patients with coronary artery disease worldwide have received coronary-artery stents, and the enormous health benefits of this technology are not in dispute. Still, when a potentially serious albeit uncommon complication such as stent thrombosis is detected, it is mandatory that everything possible be done to aggressively examine the complication, assess the risk, understand the pathophysiological characteristics, and develop preventive measures. Although not all questions have been answered and areas of uncertainty remain, the FDA acted appropriately by taking expeditious action. We understand that these matters are far from resolved, but our hope is that the articles in this issue of the Journal will inform the medical community and help health professionals make the best decisions for their patients.
This article (10.1056/NEJMe068306) was published at www.nejm.org on February 12, 2007.
- References
References
1
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Full Text | Web of Science | Medline6
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Full Text | Web of Science | Medline7
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Robert J. Applegate, Matthew T. Sacrinty, Michael A. Kutcher, Renato M. Santos, Sanjay K. Gandhi, Talal T. Baki, William C. Little. (2008) “Off-Label” Stent Therapy. Journal of the American College of Cardiology 51:6, 607-614
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Henry H. Ting, Matthew T. Roe, Bernard J. Gersh, John A. Spertus, John S. Rumsfeld, Fang-Shu Ou, John Kao, Kirsten Hall Long, David R. Holmes, Eric D. Peterson. (2008) Factors Associated With Off-Label Use of Drug-Eluting Stents in Patients With ST-Elevation Myocardial Infarction. The American Journal of Cardiology 101:3, 286-292
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David R. Holmes, Dean J. Kereiakes, Warren K. Laskey, Antonio Colombo, Stephen G. Ellis, Timothy D. Henry, Jeffrey J. Popma, Patrick W.J.C. Serruys, Takeshi Kimura, David O. Williams, Stephan Windecker, Mitchell W. Krucoff. (2007) Thrombosis and Drug-Eluting Stents. Journal of the American College of Cardiology 50:2, 109-118
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Praveen Rajasekhar, Neeraj Bhala. (2007) Risks associated with drug-eluting stents. The Lancet 369:9575, 1785
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Boden, William E., O'Rourke, Robert A., Teo, Koon K., Hartigan, Pamela M., Maron, David J., Kostuk, William J., Knudtson, Merril, Dada, Marcin, Casperson, Paul, Harris, Crystal L., Chaitman, Bernard R., Shaw, Leslee, Gosselin, Gilbert, Nawaz, Shah, Title, Lawrence M., Gau, Gerald, Blaustein, Alvin S., Booth, David C., Bates, Eric R., Spertus, John A., Berman, Daniel S., Mancini, G.B. John, Weintraub, William S., . (2007) Optimal Medical Therapy with or without PCI for Stable Coronary Disease. New England Journal of Medicine 356:15, 1503-1516
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Farb, Andrew, Boam, Ashley B., . (2007) Stent Thrombosis Redux — The FDA Perspective. New England Journal of Medicine 356:10, 984-987
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