Indeks
Heart stents, the tiny metal tubes used to prop open diseased arteries, offer only a short-term advantage over drugs in easing pain and fatigue, according to a study that suggests one-third of the 1 million stents used in the U.S. each year may not be needed.
Anti-cholesterol medication used with exercise and dietary changes gave patients equal relief after three years, though stents provided an ``incremental'' advantage early on, researchers said today in the New England Journal of Medicine. An accompanying editorial said doctors treating clogged arteries where a heart attack isn't a serious risk should consider stents only after drugs are tried.
The study poses another challenge for the $4 billion-a-year stent industry, led by Johnson & Johnson and Boston Scientific Corp., which is recovering from questions about safety. The market's future depends on whether doctors and insurers embrace the implications of the new data, said Eric Peterson, a Duke University cardiologist who co-wrote the editorial.
``There are a lot of forces, in terms of payment, the influence of manufacturers and all the shiny, new devices that are coming on to the market, that are encouraging use,'' Peterson said in a telephone interview. ``There is enormous incentive in the medical industry to put things in patients.''
The study, tracking 2,287 patients, was the second installment of a seven-year investigation dubbed Courage. Last year, researchers said a regimen of drugs and lifestyle changes worked as well as stents in avoiding deaths and heart attacks.
Clotting Fears
The 2007 results, released in March, sent Boston Scientific shares down 9 percent over two days; J&J lost 1 percent. They came six months after European researchers reported that newer stents, coated with drugs to reduce scarring in arteries, might raise the risk of deadly clots. Sales of the stents, which cost $2,000 each, plunged, though they've recovered this year as subsequent studies downplayed the clotting concerns.
Today's study likely won't have that effect on manufacturers, said Phil Nalbone, an analyst with RBC Capital Markets in San Francisco. Stents are covered by most insurers and have a relatively good safety record, he said in a telephone interview.
``If it shows some sort of meaningful benefit for just a couple of years' time, that's a very compelling reason to be treated,'' Nalbone said. ``It's a relatively safe procedure, and if you don't do it, you'll probably do it in 12 or 18 months' time from now if your symptoms persist.''
Trading
New Brunswick, New Jersey-based J&J lost 50 cents to $71.20 today in New York Stock Exchange composite trading. For the year, the stock has risen 6.8 percent. Boston Scientific of Natick, Massachusetts climbed 15 cents, or 1.1 percent, to $13.38 and has gained 15 percent this year.
In their latest quarterly earnings reports, stents generated $394 million in sales for J&J and $440 million for Boston Scientific.
Courage measured patients' reports of angina, or chest pain, as well as fatigue and other symptoms that can result from clogged arteries that decrease the flow of oxygen to the heart. It compared patients who took medication, stopped smoking and made other changes to those who followed such a regimen and also underwent an angioplasty, a procedure in which a balloon is inflated to clear an artery and a stent inserted to keep the vessel open.
Comparing Benefits
In both groups, 78 percent reported angina at the start of the study. By three months, 33 percent of angioplasty patients and 42 percent in the drugs-only group said they had chest pains. The difference narrowed at six months and had all but vanished by three years.
With stents or without, health improved, though for the most serious angina, angioplasty provided a quicker benefit that lasted longer, said William Weintraub of Christina Care Health System of Newark, Delaware, the lead author.
``What we can say is that it's safe to defer PCI,'' Weintraub said, referring to the medical procedure in which stents are inserted. ``We can also say that for people with severe angina, it's quite reasonable to do more quick intervention.''
The study was funded by the U.S. Veterans Affairs Department and the Canadian government. A third report, due in September, will weigh the economic costs and benefits of stent use, Weintraub said.
About 1 million angioplasties are performed in the U.S. annually, Peterson said. About one-third are conducted for patients with angina that could be handled as well with drugs, he said.
Advisory Review
Physicians and insurers are starting to take notice, Peterson said. A subcommittee of the American College of Cardiology is rewriting its angioplasty guidelines, and Medicare and Medicaid, the U.S. government insurance systems, have commissioned their own study of the procedure's value.
The findings show angioplasty ``is a safe and effective treatment for patients who have frequent or lifestyle-limiting angina while on medical therapy, said Donald Baim, Boston Scientific's chief medical and scientific officer, in a statement.
``The greater the frequency of angina, the greater the benefit of PCI versus medical therapy alone, although less symptomatic patients can be well managed'' without it, he said.
Anti-cholesterol medication used with exercise and dietary changes gave patients equal relief after three years, though stents provided an ``incremental'' advantage early on, researchers said today in the New England Journal of Medicine. An accompanying editorial said doctors treating clogged arteries where a heart attack isn't a serious risk should consider stents only after drugs are tried.
The study poses another challenge for the $4 billion-a-year stent industry, led by Johnson & Johnson and Boston Scientific Corp., which is recovering from questions about safety. The market's future depends on whether doctors and insurers embrace the implications of the new data, said Eric Peterson, a Duke University cardiologist who co-wrote the editorial.
``There are a lot of forces, in terms of payment, the influence of manufacturers and all the shiny, new devices that are coming on to the market, that are encouraging use,'' Peterson said in a telephone interview. ``There is enormous incentive in the medical industry to put things in patients.''
The study, tracking 2,287 patients, was the second installment of a seven-year investigation dubbed Courage. Last year, researchers said a regimen of drugs and lifestyle changes worked as well as stents in avoiding deaths and heart attacks.
Clotting Fears
The 2007 results, released in March, sent Boston Scientific shares down 9 percent over two days; J&J lost 1 percent. They came six months after European researchers reported that newer stents, coated with drugs to reduce scarring in arteries, might raise the risk of deadly clots. Sales of the stents, which cost $2,000 each, plunged, though they've recovered this year as subsequent studies downplayed the clotting concerns.
Today's study likely won't have that effect on manufacturers, said Phil Nalbone, an analyst with RBC Capital Markets in San Francisco. Stents are covered by most insurers and have a relatively good safety record, he said in a telephone interview.
``If it shows some sort of meaningful benefit for just a couple of years' time, that's a very compelling reason to be treated,'' Nalbone said. ``It's a relatively safe procedure, and if you don't do it, you'll probably do it in 12 or 18 months' time from now if your symptoms persist.''
Trading
New Brunswick, New Jersey-based J&J lost 50 cents to $71.20 today in New York Stock Exchange composite trading. For the year, the stock has risen 6.8 percent. Boston Scientific of Natick, Massachusetts climbed 15 cents, or 1.1 percent, to $13.38 and has gained 15 percent this year.
In their latest quarterly earnings reports, stents generated $394 million in sales for J&J and $440 million for Boston Scientific.
Courage measured patients' reports of angina, or chest pain, as well as fatigue and other symptoms that can result from clogged arteries that decrease the flow of oxygen to the heart. It compared patients who took medication, stopped smoking and made other changes to those who followed such a regimen and also underwent an angioplasty, a procedure in which a balloon is inflated to clear an artery and a stent inserted to keep the vessel open.
Comparing Benefits
In both groups, 78 percent reported angina at the start of the study. By three months, 33 percent of angioplasty patients and 42 percent in the drugs-only group said they had chest pains. The difference narrowed at six months and had all but vanished by three years.
With stents or without, health improved, though for the most serious angina, angioplasty provided a quicker benefit that lasted longer, said William Weintraub of Christina Care Health System of Newark, Delaware, the lead author.
``What we can say is that it's safe to defer PCI,'' Weintraub said, referring to the medical procedure in which stents are inserted. ``We can also say that for people with severe angina, it's quite reasonable to do more quick intervention.''
The study was funded by the U.S. Veterans Affairs Department and the Canadian government. A third report, due in September, will weigh the economic costs and benefits of stent use, Weintraub said.
About 1 million angioplasties are performed in the U.S. annually, Peterson said. About one-third are conducted for patients with angina that could be handled as well with drugs, he said.
Advisory Review
Physicians and insurers are starting to take notice, Peterson said. A subcommittee of the American College of Cardiology is rewriting its angioplasty guidelines, and Medicare and Medicaid, the U.S. government insurance systems, have commissioned their own study of the procedure's value.
The findings show angioplasty ``is a safe and effective treatment for patients who have frequent or lifestyle-limiting angina while on medical therapy, said Donald Baim, Boston Scientific's chief medical and scientific officer, in a statement.
``The greater the frequency of angina, the greater the benefit of PCI versus medical therapy alone, although less symptomatic patients can be well managed'' without it, he said.
