British heart doctors are fighting an effort to end government coverage for drug-coated heart stents, tiny metal-mesh tubes that prop open clogged arteries.
Safety concerns reported last year already have led to more cautious use of the devices around the world. Now, the British agency with the lead role in deciding what the country’s health system pays for wants to stop reimbursements for them.
That would be another blow to makers of the drug-dispensing stents, which have been implanted in nearly 6 million people worldwide.
They are used in angioplasties, one of the world’s most common medical procedures. Doctors inflate a tiny balloon to open a clogged vessel, and a mesh scaffold called a stent is left behind to prop the artery open.
Tuesday is the deadline for public comment on the health agency’s recommendation. Next week, the National Institute for Health and Clinical Excellence will meet to review the proposal and the comment.
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 $2,300, compared to the about $700 for the bare metal versions. That could even lead some people to choose alternatives to angioplasty, like surgery or medication.
“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. Withdrawing drug-eluting stents altogether is probably not a good idea,” Steg said, explaining that the tiny tubes can still be a good choice for certain patients.
Sending the wrong message?
Steg also worried that the British health agency plan would send the wrong message to patients who already have drug-coated stents. “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 proposal. The British Cardiovascular Intervention Society called the advice “fundamentally flawed.” Without drug-coated stents, the society said that some patients would be forced to live with untreatable chest pain.
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 as a revolutionary way of keeping arteries open.
But last year, several studies showed that patients using the stents were more likely to develop potentially fatal blood clots months and even years after their surgeries.
Since the stent worries arose, sales of drug-coated stents have plummeted. The U.S. market is expected to shrink by $1 billion. And Johnson & Johnson, a major stent-maker, recently cut 5,000 jobs in response to declining sales.
Some doctors argue that patients using the 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.”
The U.S. Food and Drug Administration reviewed the safety of drug-coated stents last December. The agency did not restrict their use, but said they should only be used in specific cases. 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 spokeswoman Lucy Betterton. “We respond to reasoned arguments and will be looking to the feedback we’ve had on the draft recommendations.”