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Boston
Scientific Confirms Long-Term Clotting Risk of Drug-Eluting Stents |
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| September 7, 2006 -- On the heels of several presentations from European hospital centers and amidst heated controversy about late stent thrombosis occurring with drug-eluting stents at this week's World Congress of Cardiology meeting in Barcelona, stent manufacturer Boston Scientific confirmed this morning that it too had found a slightly higher and statistically significant risk of blood clotting in patients who received the Taxus drug-eluting stent, when compared to those with bare metal stents. The results came from the company's own internal data review of 3,500 patients which was completed on June 24 of this year. The analysis looked at late stent thrombosis: blood clotting in and around the stent from the period starting six months after stent implantation. The company's dataset extends to four years in patients who received the Taxus paclitaxel-eluting stent. Boston Scientific spokesperson Paul Donovan stated that the company met with the U.S. Food and Drug Administration on August 1 to discuss its findings. Boston's Chief Medical Officer, Donald Baim, MD, told the Wall Street Journal, "The right thing for us to do as responsible manufacturers is, when we have evidence of an issue, to go forward with regulators." Although thrombosis is a serious event (estimates are that they are fatal almost one-third of the time), Dr. Baim stated to the Journal that the analysis didn't find "that the increased risk in thrombosis translated to a higher rate of death or heart attacks from using the stent." Prior to this morning, both Boston Scientific and Johnson & Johnson / Cordis, manufacturer of the Cypher sirolimus-eluting stent, had stated that there was no difference in stent thrombosis rates of their drug-eluting stents when compared to the bare metal versions. All information supporting these claims came from company-run clinical trials, used to gain F.D.A. approvals.. But concerns over increased thrombosis for drug-eluting stents have been voiced since they were first introduced several years ago. Angioplasty.Org issued an feature report earlier this week detailing this controversy. Cordis Vice President Dennis Donohoe, MD, has confirmed that his company met with the F.D.A. last week, at the government agency's request, to discuss this issue. Cordis has stated that they have seen no such increase in thrombosis in the Cypher stent data. However, it is the opinion of a number of cardiologists that drug-eluting stents, as a class, are more thrombogenic than bare metal stents. And the cause of stent thrombosis is complex. It is not just about the device itself. The issues involved in increased risk of thrombosis are many and they are interconnected: length of prescribed antiplatelet therapy, patient compliance with that therapy, screening of patients by cardiologists for allergic reactions prior to stent implantation, education of non-cardiac physicians about the risks of stopping antiplatelet therapy, even for a few days in the case of elective surgery or dental work. Angioplasty.Org and patients posting on its Cardiology Patients' Forum have been discussing these issues for several years. We are pleased to see increased international attention on the problem and we will be posting a special in-depth report on this topic in the coming days. related
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