A large and long-awaited study finds that angioplasty works no better than medication at preventing heart attacks or death, a finding that could slow the growth of one of medicine's most common cardiac interventions.
The research comes on the heels of a growing debate over whether some patients are getting unnecessary angioplasty, a procedure that involves using a tiny balloon and metal scaffolds called stents to prop open clogged arteries.
Angioplasty is recommended for those with fully blocked arteries or who have had a heart attack. But the new study, presented at the American College of Cardiology's annual meeting in New Orleans yesterday, should give doctors and their patients with partially obstructed arteries the confidence to put off angioplasty or to skip surgery altogether, according to the researchers.
"The results are very striking," said Dr. Steven Nissen , president of the American College of Cardiology, who was not involved in the study. "This is important for patients because it does now mean patients have choices. If your symptoms aren't so severe and aren't interfering with your lifestyle, you can afford to wait."
Half of the 2,300 patients studied underwent angioplasty and took heart drugs, and were told to make lifestyle changes, such as exercising, losing weight, and giving up smoking. The other half received only lifestyle counseling and medication, including drugs to lower cholesterol, relax blood vessels, slow heart rate, and prevent blood clots. Both groups fared equally well after an average of 4 1/2 years, according to the study, also published online yesterday in The New England Journal of Medicine.
Stent manufacturer Boston Scientific Corp. of Natick criticized the study yesterday as not breaking any new ground, and said stents improve quality of life for patients with clogged arteries. The authors said their research suggested that improvements in quality of life were not statistically significant over the course of the study.
The use of angioplasty to open clogged arteries has taken off since the mid-1990s, increasing from about 430,000 procedures in 1995 to nearly 1.3 million in 2004 , with many of the more recent surgeries being done proactively, rather than after a life-threatening event.
The popularity of angioplasty has spurred debate among cardiologists, some of whom think the procedure is overused.
Dr. William Boden of Buffalo General Hospital said he designed the new study to determine how much added benefit angioplasty provided for people with few symptoms -- and was surprised to discover that, statistically, there was none.
The good news for patients, he said in a news conference: "You are no more or less at risk of developing a heart attack or dying if you defer angioplasty until some time down the road."
Angioplasty did provide a better quality of life than drugs alone for patients experiencing angina, the discomfort or chest pain that occurs when the heart muscle is deprived of oxygen.
Nissen said that angioplasty remains the treatment of choice for patients with a fully blocked artery, and that campaigns are underway to make sure patients having heart attacks are taken to hospitals that can swiftly perform an angioplasty.
Nissen and others said they think the procedure is probably done more often than needed, though the study's authors said they did not want to speculate about the amount of overuse.
Dr. William Maisel, a cardiologist at Beth Israel Deaconess Medical Center, said the bottom line is that patients and doctors need to make sure they're using angioplasty for the right reasons.
"To place a stent to reduce the chances of a heart attack or to prevent someone from dying, those are not reasons to put in a stent," said Maisel, chairman of a federal panel that examined stent safety.
Boston doctors tend toward the conservative, so they probably use the procedure less often than doctors elsewhere, according to Dr. Frederic S. Resnic, director of the cardiac catheterization laboratory at Brigham and Women's Hospital. Roughly 30 percent of the Brigham patients who get angioplasty have heart disease but are not in immediate danger of having a heart attack, he said.
"We have always been very careful to have detailed discussions with our patients with stable coronary artery disease, to make sure that they are comfortable and understand that we are considering the procedure to relieve the symptoms of angina, and reduce the number and amount of medications needed," he said.
The team of researchers, which included several from Hartford Hospital and the VA Connecticut Healthcare System, said their study may offer fresh evidence that heart disease is more of a systemwide than a localized problem in the body.
Using a stent addresses just one problem spot, but fails to correct other potentially more dangerous fat deposits in the diseased arteries.
The study, known as COURAGE, was paid for by the US Department of Veterans Affairs and the Canadian Institutes of Health Research , as well as 11 pharmaceutical companies, including Pfizer Inc., the maker of the world's top-selling drug, the cholesterol-lowering pill Lipitor .
The researchers acknowledge that one significant limitation of their study was that 85 percent of the patients were men and only 14 percent were non white.
Boston Scientific, which makes drug-coated stents, was sharply critical of the study.
"The results of the COURAGE trial don't really tell us much we didn't already know about the relative benefits of stents over drug therapy in the treatment of cardiovascular disease," the company said in a statement. "Stents have improved the lives of millions of patients, as amply demonstrated by a broad range of clinical trials and real-world experiences, but their benefits are found in safe, durable, and minimally-invasive relief of angina, rather than in further improving the already good survival of stable angina patients on medical therapy."
The company also criticized the study for failing to include drug-coated stents, which were not on the market when the study began.
Boden said that because drug-coated stents have not been shown to improve lifespan, using them instead of bare-metal stents would not have changed the study's results.
Boston Scientific's stock price lost $1 or 6.6 percent yesterday.