In this issue of the Journal, we publish five Original Articlesand two Perspective articles on the subject of drug-elutingcoronary stents.1,2,3,4,5,6,7 Our motivation is the recent concernthat the implantation of drug-eluting stents, as compared withbare-metal stents, may be associated with a small increasedrisk of late stent thrombosis, a potentially fatal complication(Figure 1). At a meeting of the Circulatory System Devices AdvisoryPanel of the Food and Drug Administration (FDA) on December7 and 8, 2006, presentations were made on virtually every aspectof this complex clinical problem.8 In order to inform the medicalcommunity, we are publishing these articles, which are representativeof the presentations and discussions that took place at thepanel meeting. In some cases we provide two views of the samedata sets, because different investigators looked at the samedata using different analytic approaches. Readers will see thatthe details of analysis are critical for understanding the conclusionsof each of these reports.
Figure 1. Potential Complications of Coronary Stenting: Restenosis in a Traditional Bare-Metal Stent and Late Thrombosis in a Drug-Eluting Stent.
Arrows indicate blood flow. An animation showing restenosis and stent thrombosis can be viewed at www.nejm.org.
In addition to the data reported in the Original Articles, thetwo Perspective articles, by Dr. Andrew Farb and Ashley Boamof the FDA Center for Devices and Radiological Health and byDr. William Maisel, who served as chair of the Circulatory SystemDevices Advisory Panel, synthesize a great deal of informationon both the benefits and the potential risks of drug-elutingstents. These stents were approved for use in stable patientswith relatively noncomplex coronary stenoses, but they havebeen used in many patients whose clinical features and coronaryanatomy fall outside the original specifications. Such off-labeluse has made assessments of stent safety beyond the settingof clinical trials considerably more challenging. There is alsothe important matter of adjunctive antiplatelet therapy. Althougha science advisory recommending 12 months of dual antiplatelettherapy after placement of a drug-eluting stent was publishedelectronically in January,9 the optimal duration of therapyhas not yet been precisely determined.
Millions of patients with coronary artery disease worldwidehave received coronary-artery stents, and the enormous healthbenefits of this technology are not in dispute. Still, whena potentially serious albeit uncommon complication such as stentthrombosis is detected, it is mandatory that everything possiblebe done to aggressively examine the complication, assess therisk, understand the pathophysiological characteristics, anddevelop preventive measures. Although not all questions havebeen answered and areas of uncertainty remain, the FDA actedappropriately by taking expeditious action. We understand thatthese matters are far from resolved, but our hope is that thearticles in this issue of the Journal will inform the medicalcommunity and help health professionals make the best decisionsfor their patients.
Source Information
This article (10.1056/NEJMe068306) was published at www.nejm.org on February 12, 2007.
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