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Large study doubts the need for many cardiac processes

by Marilynn Marchione.

People with severe but stable heart disease from clogged arteries may have less chest pain if they receive a procedure to improve blood flow rather than just give medication a chance to help, but it will not reduce the risk of having 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 the strongest evidence yet 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" to invasive tests and procedures, Dr. Judith Hochman, New York University.

It can even be damaging: 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 less testing and invasive treatment for such patients in the future, Dr. Glenn Levine, a Bayl or College of Medicine cardiologist with no role in the research. Some doctors still struggle with the study, but it was very well done "and I think the results are extremely credible," he said.

About 1

7 million Americans have clogged arteries that clog the heart's blood supply, which can cause periodic chest pain. Cheap and generic aspirin, cholesterol-lowering drugs and blood pressure medications are known to reduce the risk of a heart attack for these people, but many doctors also recommend a procedure to improve blood flow.

It is either a bypass – open heart surgery to bypass 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 the size, spanning 37 countries and including people with more serious illness – a group likely to benefit from stents or a bypass.

All 5,179 participants had stress tests, usually done on a treadmill, to suggest that blood flow would shrink. Everyone was given lifestyle advice and medicines that improve heart health. Half also received CT scans to rule out dangerous blockages and then proceeded with their medication.

The others were treated as 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 might drugs have been found to be equally effective in reducing risks?

Bypasses and stents fix only a small area. Drugs affect all of the arteries, including other spots that may begin to clog, experts said.

However, pharmaceuticals have greatly improved in recent years.

However, having a procedure turned out to be better at reducing chest pain. Of those who had pain daily or weekly when they entered the study, half in the stent-or-bypass group were free of it within a year, compared to 20% of those who had medication alone. A placebo effect may have sweated these results – people who know they had a procedure tend to credit it with any improvement they experience in symptoms.

Dr. Alice Jacobs, a Boston University cardiologist who led a panel of treatment guidelines a few years ago, said some placebo effects are fading over time, and people with a lot of chest pain who have not received medication may still want a procedure.

"It is intuitive that if you remove the blockage you will do better, you will feel better," but the decision is up to the patient and the doctor, she said.

In short: 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 corrected with a stent, "in my experience, the majority of patients will choose to undergo that procedure" to get improvement immediately, Dr. Jay Giri, a cardiologist at the University of Pennsylvania, did not matter in the study.

Maryann Byrnes-Alvarado is not among them. The 66-year-old New York City woman said she joined the study six years ago after having trouble walking, which "scared me to death", but so did the idea 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 avoided surgery, she said.

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