This month the European equivalent of the FDA approved the first drug-coated stent for marketing. The Johnson & Johnson sirolimus-coated stent (brand name: Cypher) was quickly approved after results from the RAVEL trial were presented in March, at the American College of Cardiology meeting in Atlanta. The RAVEL trial confirmed the remarkable early finding that there were no instances of restenosis in patients receiving the sirolimus stent, a finding that has now held up for a 12-month follow-up period. Several European cardiologists, impressed by these results, have announced that they will immediately begin using the Cypher stent exclusively in all their patients who need stenting.
Indeed, if drug-coated stents turn out to approach the success rate in clinical practice that they achieved in the RAVEL trial, then virtually all the accepted strategies for treating coronary artery disease will have to be completely revamped.
The Cypher stent is currently priced as much as 400% higher than non-coated stents, so cost is a concern to European hospitals and health care systems. But investigators in the RAVEL trial maintain that their data shows that when one factors in the cost savings produced by eliminating restenosis (not to mention the morbidity to the patients that is avoided,) using the drug-coated stent is actually cost-effective. Further, later this year when a competitive drug-coated stent from another manufacturer is approved in Europe (paclitaxel-coated stents manufactured by Cook, Inc.) costs (at least in Europe) will come down.
In the U.S., manufacturers are waiting for results from trials conducted in America before submitting a request for approval for drug-coated stents to the FDA. The earliest this is expected to happen is sometime in 2003.
Why can't Americans have drug coated stents?
It may seem ironic that American medical research and the American biotech industry once again benefits Europeans much earlier than it benefits Americans. For medical devices, however, this course of events has become the rule rather than the exception. American medical devices are routinely released in Europe 6 to 12 months before they are released in their country of origin. Is this the FDA's fault? Perhaps in a way it is - but the FDA serves the people, and for the past decade the people have wanted the FDA to err on the side of caution. (Congress calls FDA Directors on the carpet far more often when an approved medical product turns out to have flaws than when a good medical product is delayed.) This means the people will continue receiving old-technology stents for quite a while.Perhaps observation of the widespread use of these stents in Europe will uncover problems that are not now apparent. Indeed, based on the premise that nothing in medicine is as good as these stents are said to be, such is likely to be the case. (In a reverse of the old saw, given a roomful of ponies there's got to be some manure in there somewhere.) In this case, waiting a year or so for drug-coated stents might prove to be a boon to some American patients. For now, however, an American wanting the sirolimus-coated stent will need to go to Europe for treatment.
