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- Fox News

08/27/2007 - British heart doctors are trying to defeat a proposal to end government coverage of drug-coated heart stents, tiny metal-mesh tubes that prop open clogged arteries.

The proposal was made by Britain's National Institute for Health and Clinical Excellence, which has the lead role in deciding what the country's health system pays for.

Tuesday is the deadline for members of the public to submit their comments on the recommendation. Next week, the organization will meet to review the proposal alongside input from the public.

Any new restrictions would further batter the troubled drug-coated heart stents, which have come under increasing attack in the last year. The stents are commonly used in angioplasties, one of the world's most common medical procedures. More than 1 million such procedures are performed in the United States every year.

Through an artery in the leg, doctors snake a tube to blockages that are clogging vessels. A tiny balloon is inflated, and a mesh scaffold called a stent is left behind to prop the artery open.

If the British proposal is adopted, patients would either get a plain, metal stent or be forced to pay for the drug-coated device themselves. Drug-lined stents typically cost about US$2,300 (euro1,685), compared to the approximately US$700 (euro510) for the bare metal versions. That could even lead some people to choose alternatives to angioplasties, like surgeries or medication.

When drug-coated stents were first introduced in 2003, they became the fastest-selling medical device in recent history. The tiny tubes that leak drugs to prevent tissue regrowth, were heralded by doctors as a revolutionary way of keeping patients' arteries open. Nearly 6 million people worldwide now have the drug-lined versions.

But last year, major worries were raised about the safety of drug-eluting stents. Several studies showed that patients receiving the stents were more likely to develop potentially fatal blood clots months and even years after their surgeries.

"This is a pretty drastic step," said Dr. Gabriel Steg, a cardiologist at Bichat Hospital in Paris and spokesman for the European Society of Cardiology.

"We are seeing the pendulum swing too far the other way," Steg said. "Withdrawing drug-eluting stents altogether is probably not a good idea," he said, explaining that the tiny tubes can still be useful for certain patients.

Steg also worried that the British guidance would send the wrong message to patients who already have had drug-coated stents implanted. "We do not want to say that this is a dangerous device," he said. "We still need to see more data on drug-eluting stents before we can have the final word."

The British Cardiovascular Society said that it was "surprised, disappointed and very concerned" by the guidance. The British Cardiovascular Intervention Society was also troubled by the guidance, calling it "fundamentally flawed." Without drug-coated stents, the society said that some patients would be forced to live with untreatable chest pains.

Since the stent worries arose, sales of drug-coated stents have plummeted. The U.S. market is expected to shrink by US$1 billion. And Johnson & Johnson, a major stent-maker, recently cut 5,000 jobs in response to declining sales.

Some doctors argue that the drug-oozing stents have advantages that cannot be matched by bare-metal stents. Patients given bare-metal stents have an increased risk of developing another blockage after the formation of scar tissue, said Dr. Timothy Gardner, medical director of the Center for Heart and Vascular Health at Christiana Care Health Services in Delaware.

"This is not good news for patients," Gardner said. "You would be penalizing patients so they would not benefit from the latest technologies we have to help them."

In the U.S., a special meeting was held by the Food and Drug Administration last December looking into the safety of drug-coated stents. Officials did not restrict the use of drug-coated stents, but stressed they should only be used for specific purposes. Many angioplasties in the U.S. use the devices for circumstances beyond those for which they were approved.

Other countries have been closely monitoring the use of drug-lined stents, but none have made recommendations similar to Britain's.

Britain's health advisory body said that comments from doctors and the public could still influence their ultimate guidance.

"There is always the possibility that the recommendations could change," said Lucy Betterton, a NICE spokeswoman. "We respond to reasoned arguments and will be looking to the feedback we've had on the draft recommendations."

If you or a loved one have been injured during surgical placement of a stent or have been injured as a result of an implanted drug eluting stent (drug coated stent) such as the Boston Scientific Taxus stent or the Johnson & Johnson Cypher stent you may be entitled to compensation. To learn more about the stent recalls, for information regarding your legal rights, or the possiblilty of a class action lawsuit contact our stent lawyers for a free, confidential, case evaluation today. Fill out our online case evaluation form or call us toll free at 1-800-856-6405.