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Report on Stents Could Spur Increase in Medicare Aid
By Barnaby J. Feder, The New York Times
October 21, 2005
The emerging technique of using stents to open carotid arteries in the neck can be successfully performed by even doctors with limited experience in the procedure, if they receive training, according to preliminary results of a federally mandated study released Thursday.
That finding, as well as results reported on Wednesday from a separate study of carotid stents, could encourage regulators to expand Medicare coverage for the procedure, according to doctors involved in the studies. The federal government has estimated that as many as 200,000 Americans undergo carotid-clearing surgery each year. Regulators approved marketing the stents to a high-risk group that could include as many as 25 percent of those people, but Medicare is covering fewer than 10 percent of them.
Neck stenting is an emerging alternative to more invasive surgery to reduce stroke risks for patients with clogged carotid arteries - the arteries in the neck that carry blood to the brain. Stents are metal cylinders that are used to prop open blood vessels to keep them from reclosing after blockages have been cleared.
The implication of the study, sponsored by Guidant, which makes the Acculink carotid stents, is that doctors' experience and familiarity count for little in neck stenting. That would seem to contradict common medical wisdom and the reported results from many other medical procedures.
Doctors here at the nation's largest annual meeting of physicians who treat patients with stents, where the study results were presented by the independent researchers who compiled them, said that the most likely explanation was that the less experienced doctors had cautiously focused on the easiest cases. And doctors who have participated in such studies warned that the initial data that were presented on Thursday might shift as the study expands. The report on Thursday covered just over 1,600 patients, about two-thirds the long-term goal.
But researchers are also wondering whether the neck stenting procedure is technically less challenging in most cases than had been assumed.
Guidant officials authorized to comment on the training program's success could not be reached. The Food and Drug Administration, which had required Guidant to develop such a training program as a condition of approving the stent last year, would not comment.
The results presented here on Wednesday involved patient trials of a carotid stent, the Precise, which is made by Johnson & Johnson's Cordis subsidiary and is not yet available domestically. Only 3 percent of patients in clinical trials who received the Precise carotid stent needed a second procedure at the same spot within three years. That compared with just over 7 percent of those who had their blockages cleared by surgery and within three years needed a second operation to reopen the artery at the same spot.
The Cordis subsidiary was told last year by regulators that its Precise stent and Angioguard filter system are "approvable," but final clearance has been withheld until Cordis satisfies the Food and Drug Administration that it has dealt with several manufacturing and record-keeping problems related to other products.
A third company, Abbott Laboratories, received approval last month to sell a stent and filter system and several others also expect to enter what analysts say could one day become a billion dollar market.
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