More threads by David Baxter PhD

David Baxter PhD

Late Founder
Studies Say Newer Stents for Arteries Show Promise
By BARNABY J. FEDER, New York Times
September 5, 2007

Makers of stents and many cardiologists who implant them said yesterday that reports at this year?s major meeting of European cardiologists bolstered their confidence in the safety of the newer drug-coated versions of the devices, which are used to prop open coronary arteries.

?It?s clear that the benefits outweigh the risks,? said Dr. Bonnie H. Weiner, a cardiologist in Worcester, Mass., who is the president of the Society for Cardiovascular Angiography and Interventions, the leading professional society in the United States for such specialists. ?The data this year is much more consistent with people?s clinical experience.?

Two major studies reported at last year?s meeting of the European group, in Barcelona, raised questions about the safety of the drug-coated stents and helped cause a decline in their use.

The findings this year were far from decisive enough to end all debate about when to use the newer drug-coated stents rather than older and cheaper bare metal versions ? or whether all stents are used in too many cases when drugs or bypass surgery would serve patients better.

But they may help halt the decline in stent sales, which hit nearly $6 billion globally last year but have since fallen sharply. They are forecast to be as much as $1 billion lower this year in the United States alone.

Shares in Boston Scientific, the leader in the domestic market, rose 37 cents, or nearly 3 percent, to $13.20 in trading yesterday on the New York Stock Exchange. The company, based in Natick, Mass., recently reported second-quarter drug-coated stent sales of $437 million, down from $637 million in the 2006 quarter.

The sales decline represented both fewer procedures and more use of the bare metal stents, which were associated with lower risks of clots forming in them long after implantation. The main advantage of the drug-coated stents has been that they do a better job of keeping the arteries open, which reduces the potential risks and costs of repeat procedures.

The device makers? best news from the five-day meeting in Vienna, which ends today, came Sunday from Dr. Stefan K. James, who reported that Swedes who received newer drug-coated stents did not run a higher risk of death and heart attacks when four years of data was considered. That finding is contrary to shorter-term data reported by Dr. James and his colleagues in March in The New England Journal of Medicine and at a safety meeting last December run by the United States Food and Drug Administration.

The Swedish data comes from a registry of the several thousand Swedes who annually get stents. Registry data reflects real-world medicine but is considered harder to interpret and less reliable than data from carefully planned and controlled clinical trials.

Cardiologists said that the extra year of Swedish data added a much larger number of patients with drug-coated stents and represented an extra year of experience implanting them. That may have led to better results.

At the Vienna meeting yesterday, Dr. Sigmund Silber of Germany reported that no additional cases of late clotting had been reported in a final group of patients completing the five-year follow-up period required in one major clinical trial of the Taxus stent from Boston Scientific.

It was the latest study to suggest that the problem of potentially deadly clots forming in drug-coated stents long after they were implanted might not be as serious as many doctors and patients had feared.

?I don?t think this changes the fundamentals for the stent market," said Timothy B. Nelson, who follows the major stent makers for Piper Jaffray. Mr. Nelson said that none of the studies suggested the drug-coated stents were safer than the older stents and that doctors using them would still have to be very confident that patients would keep taking aspirin and Plavix, a anticlotting medicine.

Guidelines call for taking the two drugs for at least a year after receiving a drug-coated stents but many doctors suggest that patients stay on them indefinitely if possible.

Another registry report presented yesterday underscored the potential for continued controversy. Dr. Phillip Gabriel Steg, a cardiologist in Paris, summarized data from nearly 2,300 patients who received single stents during major heart attacks at 94 hospitals in North and South America, Europe, New Zealand and Australia. He said that 8.6 percent of those who got drug-coated stents died during the two-year study period, versus 1.6 percent of those who got bare metal stents.

Cardiologists said that, as in Sweden, longer-term results might change the outcomes. Also, the patients studied were not typical of most of those who get stents. Most patients who undergo angioplasty ? a balloon inflation in the artery to clear a blockage ? followed by stenting do so to gain relief from chest pains and other symptoms of narrowed arteries, not as part of the emergency removal of blockages during a heart attack.

That study reflected how angioplasty has become the preferred treatment for patients suffering heart attacks. Another major report presented Monday at the meeting suggested that there was no advantage to giving patients ReoPro, an anticlotting antibody treatment, before or during angioplasty, at least if the procedure is performed within four hours of the onset of symptoms.

The study, presented by Dr. Stephen Ellis of the Cleveland Clinic Foundation, is one of many to raise doubts about the value of clot-busting or clot-inhibiting drugs as part of heart attack therapy despite the widespread belief among doctors that they should be beneficial.
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