Angioplasty, a common medical procedure that unblocks clogged arteries, is no more effective than a regime combining drugs and lifestyle changes in patients with heart disease, suggests a landmark study that challenges the popular practice.
In less threatening cases, the use of angioplasty and stents to open partially locked arteries should be considered only after medication, diet, and exercises regimes, according to the major new study.
The surprising findings, revealed at the American Cardiology Conference in New Orleans on Monday, are expected to fuel a heated debate between cardiologists who encourage long-term approaches and those who favour angioplasties and stent insertions.
Over time, the findings could demote angioplasty to the ranks of a procedure that patients undergo only if lifestyles changes don't achieve their objectives -- not as an automatic first-line, treatment option.
"I think this will influence care. It tells us that a quick fix is not the only answer for our patients and that treating the disease with lifestyle and medications and keeping our patients on these medications is really important," said Dr. Beth Abramson, a Toronto cardiologist and spokesperson for the Heart and Stroke Foundation.
"Now, it's not that angioplasty isn't appropriate for many of our patients. It is in the right context. So if you have chronic heart disease and you haven't recently had a heart attack, then it may be very appropriate that we actually continue to have medications and lifestyle changes instead of a quick fix," Abramson, who was not involved in the study, told CTV's Canada AM.
Patients will be better off not undergoing procedures they don't require, said the lead Canadian researcher in the trial.
"All of us try to do the best we can for our patients, without putting them at risk,'' said Dr. Koon Teo, a cardiologist at Hamilton Health Sciences Centre who also teaches at McMaster University.
"Angioplasty is relatively safe but still, there is a risk from it. And if patients don't have to go for angioplasty, that is good for them," Teo, the lead Canadian researcher of the study, told The Canadian Press.
The study, to be published next month in the New England Journal of Medicine, was led by Dr. William Boden at Buffalo General Hospital in New York state, with funding from the U.S. Department of Veterans Affairs, the Canadian Institutes of Health Research and a variety of pharmaceutical companies.
Boden and colleagues launched the study about 10 years ago, when new heart medications, including cholesterol-lowering statin drugs, came on the scene.
Their hypothesis was that an approach combining lifestyle changes and angioplasties would be better.
`But results of the . . . trial demonstrate that two treatments are not always better than one,'' Boden said in a statement.
A total of 2,287 patients, at 50 Canadian and U.S. hospitals, with so-called stable coronary artery disease were randomly assigned to two groups. The patients, who were studied between 1999 and 2004, suffered from angina and at least 70 per cent blockage in one or more coronary arteries.
The first group underwent angioplasty -- which involves inserting a tiny balloon into an artery to the site of a blockage and then inflating it to reopen the vessel. All the patients in the angioplasty group also received the range of heart medications.
The second group was treated with optimal medical therapy, which involved a range of important drugs to control blood pressure, lower cholesterol and prevent clotting, as well as counselling that urged them to exercise, eat a healthy diet and quit smoking.
After following the patients for a median of 4.6 years, the researchers found that there was no real difference between the two groups in the rate of deaths cause by heart disease, heart attacks or strokes.
The researchers found 211 heart attacks and deaths occurred in the angioplasty group and only 202 among patients who underwent medical therapy alone.
Both groups experienced a significant drop in the amount of chest pain, or angina, which is the main reason why patients undergo angioplasties.
However, the improvement was greater at first among those who underwent angioplasty. But at the end of five years, the amount of chest pain was nearly identical between both groups of patients.
Experts said angioplasty did not help more because it only fixes one blockage while drugs affect all the arteries.
Teo said the findings should help cardiologists feel confident a longer-term approach can be just as useful for stable heart patients as a quick fix. The findings do not, however, apply to patients suffering a heart attack.
"There's always this concern that if we don't do something, something bad may happen,'' he said.
In 2003-04, the most recent year for which there are statistics, there were 167 angioplasties performed for every 100,000 Canadians over the age of 20, according to the Canadian Institute for Health Information.
With files from The Canadian Press
