The Heart of the Matter ; Buffalo Researcher Leads Study Comparing Surgery and Drugs

Mar 27, 08:30 PM

Current Headlines: By Henry L. Davis

A major study led by a Buffalo researcher offers the strongest evidence yet that aggressive drug treatment in many patients works just as well to prevent heart attacks and death as do procedures to unclog arteries.

What's more, angioplasty proved only slightly better at relieving chest pain.

The study, reported Monday in the New England Journal of Medicine, challenges longstanding medical practice for the treatment of heart disease.

More than 1 million patients a year have narrowed or blocked arteries of the heart opened by balloon angioplasty and stenting. The study strongly suggests the procedures are unnecessary for many non-emergency patients with chest pain caused by the blockages.

"For two decades, angioplasty has been the standard treatment. It still has an appropriate place. But for the great majority of patients, we now know medical therapy is just as effective," said Dr. William E. Boden, medical director of cardiovascular services at Kaleida Health.

Boden, the lead researcher, announced the results Monday at the American College of Cardiology annual scientific session in New Orleans. He also is professor of medicine and public health at the University at Buffalo.

The findings are forcing a heated debate among doctors over the use of angioplasty -- also known as percutaneous coronary interventions.

This is especially so with the greater availability of more effective medications, in combination with diet and exercise, to reduce cholesterol levels, control blood pressure, prevent blood clots and prevent chest pain.

Balloon angioplasty, wire-mesh stents and other methods to mechanically open a blocked artery remain the gold-standard therapy for people suffering a heart attack and those at very high risk of an attack. But a large portion of Americans who receive the procedures -- there is debate over exactly how many -- have stable heart disease with mild chest pain or no symptoms at all.

"Today, we have breakthrough medications that have changed the playing field. The rational approach will be to start most patients off on medical therapy first before considering a procedure," said Dr. Judith S. Hochman, director of the Cardiovascular Clinical Research Center at New York University and author of an editorial that accompanied Boden's study.

Advocates of medical therapy said studies by Boden and others will give physicians the confidence to offer patients nonsurgical alternatives. The fact that angioplasty is expensive -- around $30,000 -- and carries a small risk of heart attack will play a part in decisions, they said.

"You don't get paid much to tell patients to exercise, not smoke and lower their cholesterol. So, for decades, we've been changing people's plumbing instead of their lifestyles," said Dr. David T. Nash, a Syracuse cardiologist who has written extensively on the benefits of medical therapy for heart disease.

Boden's study, called the COURAGE trial, involved 2,287 patients at 50 hospitals in the United States and Canada over seven years.

Enrolled patients suffered from chronic chest pain, known as angina, and had at least a 70 percent blockage of one or more coronary arteries.

All patients received medications and counseling for diet, exercise and smoking. Half the patients also received angioplasty with stents, which involves doctors snaking a tiny tube through a blood vessel from the groin to the blockage. A tiny balloon then is inflated and a mesh stent inserted to prop open the artery.

There was no difference in rates of survival, heart attacks or stroke. The one benefit found for the angioplasty group was less angina, suggesting that angioplasty does improve symptoms and quality of life.

However, Boden said the difference was modest initially and, after five years, indistinguishable.

"Our hypothesis was that angioplasty and medical therapy together would be superior to medical therapy alone," said Boden. "But contrary to popular belief, medical treatment alone is not inferior and does not pose undue risk."

Dr. Philip R. Sullivan, a cardiologist with the Buffalo Heart Group, said he was impressed with the design of a study that confirmed what many physicians have suspected. However, he cautioned that it may be difficult for doctors to convey the study's message to patients who come in with the expectation of getting angioplasty as a quick fix for chest pain.

"Now, at least, we can offer alternatives with more knowledge. We have an approach that would have been terribly unpopular only a few months ago," he said.

Angioplasty has been around for 30 years. Interventional cardiologists, the specialists who perform angioplasty, strongly defend the procedure.

"It's good these questions are being asked, but I don't see this study leading to a paradigm shift in how patients are treated," said Dr. Gregory J. Dehmer, president of the Society for Cardiovascular Angiography and Interventions.

Critics like Dehmer said the study focused on patients who represent a minority of those with heart disease and excluded patients at higher risk of having heart attacks. He also said medical therapy advocates neglect to account for the strong desire among many patients with mild chest pain to obtain immediate symptom relief.

"Some patients aren't going to tolerate drugs well or find it difficult to stay on a regimen," said Dehmer, a professor of medicine at Texas A&M University. "And what about younger, active patients? Are they going to put up with having angina?"

Boden dismissed the criticism, saying the study purposefully enrolled higher-risk patients, and those studied represent the majority of patients today who receive angioplasty.

The study was funded by the U.S. Department of Veterans Affairs and the Canadian Institutes of Health Research.

e-mail: hdavis@buffnews.com

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