PHILADELPHIA (AP) – People with severe but stable heart disease from clogged arteries may have less chest pain if given a procedure to improve blood flow rather than just giving medication a chance to help, but it will not reduce the risk of having had a heart attack or dying in the following years, found a large federally funded study.
The results challenge medical dogma and question some of the most common methods in cardiac care. They are still the strongest evidence that tens of thousands of costly stent procedures and bypass operations each year are unnecessary or premature for people with stable disease.
It is a different situation than a heart attack, when a procedure is needed directly to restore blood flow.
For non-emergency cases, the study shows "there is no need to rush" into invasive tests and procedures, Dr. Judith Hochman, New York University.
It can even be harmful: To the doctor's surprise, study participants who had a procedure were more likely to suffer a heart problem or die next year than those treated with medication alone.
Hochman led the study and gave results Saturday at an American Heart Association conference in Philadelphia.
"This study clearly contradicts what has been the common wisdom for the last 30, 40 years" and may lead to minor tests and invasive treatment for such patients in the future, Dr. Glen n Levine, a cardiologist from Baylor College of Medicine without a role in research. Some doctors may still struggle with the study, but it was very well done "and I think the results are extremely credible," he said.
It is either a bypass – open heart surgery for detours around blockages – or angioplasty, where doctors push a tube through an artery to the panty, inflate a small balloon, and place a stent, or mesh posture, to support the artery open.
Twelve years ago, a large study found that angioplasty was no better than a drug to prevent heart attacks and deaths in non-acute heart patients, but many doctors went against the results and quarreled with the methods.
So the federal government spent $ 100 million on the new study, which is twice as large, spanning 37 countries and including people with more serious illness – a group likely to be benefited by stents or a bypass.
All 5,179 participants had stress tests, usually done on a treadmill, at the proposed blood flow, shrinking. Everyone was given lifestyle advice and medicines that improve heart health. Half also received CT scans to rule out dangerous blockages, then proceeded with their medications.
The others were treated like many people with abnormal stress tests are now: They were taken to cardiac catheterization laboratories for angiograms. The procedure involves placing a tube into an important artery and using special dyes to image the heart's blood vessels. Blockages were treated directly, with angioplasty in three quarters of the cases and one bypass in the rest.
Doctors then tracked how many in each group suffered a heart attack, heart-related death, cardiac arrest or hospital stay to aggravate chest pain or heart failure.
After one year, 7% of the invasively treated group had one of these events compared to 5% of those who had medication alone. After four years the trend reversed – 13% of the drug group and 15% of the drug group had suffered a problem. Mean values throughout the study period were equally independent of treatment.
If stents and bypasses had no risks of their own, "I think the results would have shown a total benefit" from them, said another study leader, Dr. David Maron from Stanford University. "But that's not what we found. We found an early injury and a later benefit, and they interrupted each other."
Why can medications prove to be equally effective in reducing risks?
Bypass and stents only fix a small amount Drugs affect all arteries, including other spots that may begin to clog, experts said.
However, drugs have greatly improved in recent years.
However, having a procedure turned out to be better at reducing chest pain. had pain daily or weekly when they entered the study, half in the stent or bypass group were free from it within a year compared to 20% of those who had medication alone. A placebo effect may have sweated these results – people who know that they had a procedure tend to credit it with any improvement they experience in symptoms.
Dr. Alice Jacobs, a cardiologist from Boston University who led a panel for treatment guidelines for n. some years ago, said that some placebo effect fades over time, and people with a lot of chest pain who have not received medication may still want a procedure.
intuitively that if you remove the blockage you will do better, you will feel better, "but the decision is up to the patient and the physician, she said.
Summary: There is no harm in trying drugs first, especially for people with no or little chest pain, doctors said.
When they were told that they have a problem that can be treated with a stent, "in my experience, the majority of patients will choose to undergo that procedure" for improvement directly, said Dr. Jay Giri, a cardiologist at the University of Pennsylvania with no role in the study.
Maryann Byrnes-Alvarado is not among them. The 66-year-old New York City woman said she joined the study for six years then after having trouble walking, which "scared me to death," but so did the thought of a heart procedure.
She was relieved when she was assigned to the medication group. Her doctor changed her blood pressure medication, added a cholesterol drug and aspirin and adjusted her diet. Now her risk factor number is better and she can walk again without difficulty.
"I think I got the best care I could get" and avoids surgery, she said.
Marilynn Marchione can be followed on Twitter at http://twitter.com/MMarchioneAP
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's science education department. AP is solely responsible for all content.
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