Will drug-coated stents
revolutionize cardiology?
By DrRich
Dateline: 05/27/02
This week, new data on drug-coated stents were presented at the Paris Course on Revascularization, in France. At this major scientific meeting, new studies revealed yet more evidence that drug-coated stents markedly reduce the major complication seen with non-coated stents - restenosis.
Previous studies showed a remarkably reduced rate of restenosis with sirolimus-eluting stents. Those studies had been performed in "ideal" patients, however, with relatively uncomplicated coronary artery blockages. New data reported this week suggest that restenosis is also greatly reduced even in complex coronary artery lesions when drug-coated stents are used. Further, new information from clinical trials using a different drug-coated stent - this one coated with paclitaxel instead of sirolimus - similarly revealed a very low incidence of restenosis. (The sirolimus-coated stent is made by Johnson & Johnson, while the paclitaxel-coated stents are made by Boston Scientific and Cook.)
Other data were presented suggesting that the increased cost incurred by using drug-coated stents (the cost of the J&J stent, currently approved in Europe, is four times greater than the cost of standard, non-coated stents) is recouped by a marked reduction in the requirement for future invasive procedures.
The nearly steady stream of positive data that have been reported over the last two years with drug-coated stents led some speakers attending the Paris conference to declare an impending revolution in the practice of cardiology. If long-term results with these stents hold up, their efficacy will potentially invalidate virtually all randomized trials conducted to date on the optimal way to treat coronary artery disease. For instance, the indications for performing coronary artery bypass grafting may be significantly reduced, if equivalent or improved results can be obtained with drug-coated stents. And patients with "mild" angina who today are treated with drugs (because the benefits of more aggressive therapy are not considered worth the risk) might receive stents much more readily.
While all this may be true, others at the conference sound a more cautionary note. Nothing in medicine, they remind us, is for free. It may take a year or longer, and it may take following tens of thousands of patients (instead of the thousand or so that have been followed closely so far,) but there is bound to be some "dark side" to the drug-coated stents. Let's adopt the use of these stents, they suggest, in a calibrated way instead of a wholesale way, at least until we have a much better idea of what the full range of potential side effects might be.
This is, no doubt, sound advice. But for the patient who has the need of a stent, and for the doctor who is inserting a stent, current data makes it very difficult to remain satisfied with the traditional non-coated device.
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