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October 12, 2006 -- Reinforcing the controversy over the potential dangers of drug-eluting stents and late stent thrombosis, Drs. Sanjay Kaul and George Diamond of Cedars-Sinai Medical Center in Los Angeles published an editorial in yesterday's Cardiosource, an online publication of the American College of Cardiology. The two cardiologists start with a comparison between the recent public health uproar over e-coli infected spinach and the potential increase in deaths due to late stent thrombosis with drug-eluting stents. Dr. Kaul, Director of the Vascular Physiology and Thrombosis Research Laboratory at Cedars-Sinai and Dr. Diamond who serves as Regional Medical Director, cite the reported increase in late stent thrombosis of 0.6% annually (see Angioplasty.Org's coverage of the World Congress of Cardiology presentations for more detail). When combined with their observation that 45% of stent thrombosis events are fatal, the authors conclude that in the U.S. alone, where a million patients are implanted with stents annually and 80% of those are of the drug-eluting variety, over 2,000 deaths a year may be caused by drug-eluting stent thrombosis, as they write, "a risk far worse than that of tainted spinach." The cause of the increased incidence of late stent thrombosis has been the subject of many presentations and articles, and it is an issue, as Angioplasty.Org previously has reported, that is by no means a new one. What is new is the level of public concern and the admission that there in fact may be a problem. The editorial put some of its criticism in perspective, citing the fact that there haven't been large-scale definitive trials to verify the increased thrombosis rate, and probably never will be. And that there may be multiple causes for the problem: early cessation of antiplatelet therapy by patients has been shown to cause an increase in stent thrombosis. The FDA has announced a meeting to discuss the issues surrounding drug-eluting stents, to be held in December. In a couple of weeks, a roundtable discussion will also be held at one of the major interventional cardiology meetings of the year, the TCT in Washington. However, in a pointed comparison of the government's actions in the two public health issues they are referencing, the authors quote two FDA pronouncements at the head of their editorial: the first warns people not to eat bagged spinach; the second is about drug-eluting stents:
The authors of the editorial challenge these claims of a significant reduction in restenosis, citing, among other details, the use of thicker-strutted bare metal stents in the comparison studies (thinner struts = less restenosis). In fact a significant portion of the Cardiosource editorial is devoted to the notion that the reduction in restenosis between drug-eluting stents and the earlier bare metal type is not as large as is reported in company-sponsored clinical trials, that the trade-off is perhaps not worth it, thus the Shakespearean title of yesterday's Cardiosource editorial: "Drug-Eluting Stents: An Ounce of Prevention for a Pound of Flesh?" The editorial concludes with some specific recommendations, similar to some suggestions made last month in Angioplasty.Org's Patient Alert on Late Stent Thrombosis. Drs. Kaul and Diamond write:
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