Study: Drugs, stents equal
It finds angioplasties do not prevent heart attacks or extend life.
By WASHINGTON POST
Published March 27, 2007
WASHINGTON - Propping open clogged arteries with a tiny wire mesh tube called a stent is no better at reducing the risk of heart attack or death in patients with stable heart disease than treatment with medications, according to a large new study that challenges routine use of a procedure that rapidly became standard medical practice.
The study of more than 2,000 patients found that those who had the expensive procedure, known as angioplasty, in nonemergency situations were no less likely to suffer a heart attack or die than those who only took aspirin and other medicines to thin their blood and lower blood pressure and cholesterol, along with adopting lifestyle changes.
The researchers found that the stents were highly successful at improving blood flow and relieving symptoms, including chest pain and shortness of breath, but that the advantage disappeared over time.
Some Tampa cardiologists said the results of the study, despite the publicity, are not new, surprising or groundbreaking.
"I'm not sure why they're making a big deal out of it," said Dr. Fadi Matar, medical director of the Cardiac Care Unit at Tampa General Hospital. "We never thought angioplasty would reduce the rate of heart attacks or reduce the chance of death. In the cardiology world, it's not a big story.
"We keep telling patients that stents don't necessarily make you live longer or have fewer heart attacks."
Tampa cardiologist Xavier Prida said physicians have known that angioplasty primarily improves patients' quality of life by reducing chest pain caused by blockages rather than extending the length of life, which was revealed in an economic analysis of stents about five years ago.
"We have known this for a long time," said Prida, of St. Joseph's Heart Institute. Angioplasty "is a quality of life intervention."
The study is the first large, well-designed comparison of angioplasty to nonsurgical care for patients who are not actually having a heart attack or in imminent danger of one.
"The data are compelling," said William Boden of the University of Buffalo, whose findings were released Monday by the New England Journal of Medicine to coincide with a presentation at a meeting of the American College of Cardiology in New Orleans. "We do too many of these procedures."
Several experts said they expected the findings will prompt a major shift in how doctors treat thousands of patients suffering from heart disease - the nation's leading cause of death.
"These findings are pretty explosive," said Steven Nissen, president of the American College of Cardiology. "I think this is going to shake things up pretty significantly."
But Prida, the Tampa cardiologist, said he doubts the study will reduce the use of stents, since many people simply want to live life without chest pain.
Matar added: "We, as physicians, take care of patients not only to extend their lives but help them lead better lives. That's why we use stents."
The researchers and others stressed that angioplasty clearly benefits patients who are in the throes of a heart attack or are at very high risk for one. But the findings indicate that for a patient whose condition is stable, medical therapy is just as effective at reducing the major risks. Such patients constitute at least one-third of those undergoing the 1.2-million angioplasties performed each year, and perhaps as much as 85 percent.
Some cardiologists who specialize in the procedures, however, argued that the study did not focus on the sickest patients who are most likely to benefit.
But Boden said that the study did include patients with moderate to severe heart disease, and that many such patients have the procedure in the belief it will protect them against heart attacks.
In the procedure, doctors thread a tiny balloon into clogged arteries, inflate the balloon to clear the blockage and insert a stent - a tiny wire lattice strut that props the artery open. The procedures cost at least $40,000.
The findings come on the heels of questions about the safety of a new generation of stents coated with drugs to keep arteries from reclosing. Those concerns had already led doctors to curtail use of the newer devices, and the new findings are expected to have a similar effect on angioplasty overall, some cardiologists said.
"There was an over-exuberance," said William O'Neill, a cardiologist at the University of Miami. "I think we're getting a mid-course correction."
The new study involved 2,287 patients at 50 centers in the United States and Canada who had chest pain or other symptoms because one or more major arteries supplying blood to the heart had clogged. Half the patients received standard medical treatment involving medication and lifestyle changes such as quitting smoking, eating better and exercising. The other half received the same treatment plus angioplasty.
"There was no significant difference," Boden said.
Times staff writer Melanie Ave contributed to this report.
Fast Facts:
Stent popularity
- An angioplasty costs roughly $40,000.
- About 1.2-million angioplasties are done each year in America.
- The industry sells an estimated $3.2-billion worth of stents each year in America.
Stent popularity
- An angioplasty costs roughly $40,000.
- About 1.2-million angioplasties are done each year in America.
- The industry sells an estimated $3.2-billion worth of stents each year in America.