Is Angioplasty the Lifesaver It Seems to Be for Heart Patients?

Each year, doctors snake catheters through the circulatory systems of about 600,000 Americans and open obstructed arteries in their hearts.

But a growing number of cardiologists harbor a heretical doubt about angioplasty--a procedure hailed as one of the great advances in the treatment of heart disease in the last quarter-century.

These mavericks suspect many angioplasty patients--if not most of them--would live as long and with no higher risk of heart attack if they never had the procedure. “After 25 years, we have finally begun to address the question: Are we treating too many people who receive no medical benefit?” said Dr. William E. Boden, director of the division of cardiology at Hartford Hospital in Connecticut.

Boden wants to answer that $6-billion question--the estimated annual cost of angioplasties in the United States. He is the study chairman of an ongoing trial that will compare mortality and heart attack rates of more than 3,000 patients with coronary heart disease. The $35-million trial is being conducted at 43 sites in the United States and Canada and is known by the acronym COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation). Half the patients will receive the latest drug treatments and half will receive angioplasty as well as the cutting-edge drug therapy.

If in the next few years the trial reveals that angioplasty adds little to the survival odds of patients with mild or moderate symptoms of heart disease, there could be a dramatic change in the way hundreds of thousands of people with heart disease are treated.

“This disease kills 50% of Americans, and we still don’t know the optimal way of treating it,” said Dr. Steven Nissen, vice chairman of the department of cardiology at the Cleveland Clinic in Ohio, one of the nation’s leading centers of cardiac care and research.

“It’s absolutely the most important cardiac trial under way worldwide right now,” said Dr. William S. Weintraub, professor of medicine at Emory University School of Medicine and one of the trial’s co-investigators.

It is also one of the more controversial. Investigators say they are having trouble enrolling patients, in part because many “interventional” cardiologists and officials at hospitals that perform angioplasties are not referring patients. Those doctors believe that even patients with mild or moderate symptoms should not participate in a trial in which they might not get an angioplasty, Weintraub said.

That’s not surprising, because angioplasty has become an entrenched part of the culture and of the economics of large segments of the cardiology community, Boden said.

“Isn’t it human nature to keep doing what you are being paid to do, until somebody tells you to stop?” he asked.

But some cardiologists argue that while studies such as the COURAGE trial are needed, they don’t measure angioplasty’s greatest benefit: improving the quality of life of heart patients.

“No one can point to a paper that says it prevents heart attacks,” said Dr. Daniel Diver, chief of the section of cardiology and director of the cardiac catheterization lab at St. Francis Hospital and Medical Center in Hartford. “But angioplasty is not meant for that. It’s very good at symptom relief. That’s what it does.”

So why is it that such a common treatment is only now being tested for efficacy 25 years after it was introduced? One reason is that its benefits seemed so self-evident, Boden said.

The procedure opens up arteries that otherwise would remain blocked, potentially killing the patient.

When Andreas Gruentzig, a German physician and pioneer of the procedure, presented pictures of a coronary angioplasty, with tiny balloons opening the arteries of animals, at a meeting of cardiologists in the mid-1970s, “Everybody went, ‘Wow!”’ Boden recalled.

“It spread like wildfire before it was ever subjected to a controlled, randomized trial,” he said.

“The genie was out of the bottle,” agreed Diver, who said the procedure was never reviewed by the U.S. Food and Drug Administration before it was approved.

Angioplasty quickly took a place alongside bypass surgery and drug treatment as chief weapons in the cardiologists’ arsenal of treatments. And over the last two decades, studies have shed light on which procedure works best on certain classes of patients.

For instance, diabetics with severe heart problems are better off undergoing coronary bypass surgery rather than angioplasty, Boden said. A consensus has emerged in the last few years that angioplasty and drugs together might be better treatment than drugs alone for patients diagnosed as suffering from acute coronary syndrome, Weintraub said.

But those with more severe cases account for only about 10% to 25% of the angioplasties performed today, Weintraub and Boden estimated. There have been only a few attempts to gauge whether angioplasty saves lives and prevents heart attacks in the vast majority of heart patients who have less severe symptoms.

The scant evidence available suggests it does not.

One study of more than 1,000 patients in Europe that compared angioplasty with drug treatment showed that 32 patients who received angioplasty died or had a subsequent heart attack, compared with 17 who received drug treatment alone.

The study, however, predated the introduction of coronary stents--devices used to open arteries--which have improved the effectiveness of angioplasty.

Heart patients in other countries where angioplasties are much less common are no more likely to die or have heart attacks than patients in the United States, Boden said.

“We do 600,000 angioplasties a year,” he said. “That’s twice, maybe three times the rate of anywhere else in the world.”

There is also a large regional difference in how often patients are referred for angioplasty. For instance, a study in the New England Journal of Medicine in 1995 showed that doctors in New England were less likely to perform an angioplasty than colleagues in other areas of the country.

“It’s mainly a matter of culture,” said Dr. Harlan Krumholz, a professor of internal medicine at Yale University School of Medicine. “There is often a marked variation in regions. The data are suggestive that what matters is who the doctor and institution is, rather than who the patient is.”

Some cardiologists say that when cardiac catheterization labs are built, they tend to fill up with patients undergoing angioplasty, at a cost of $10,000 to $15,000 per procedure.

“I tell my students, if you go to a baker, you get bread. If you go to a butcher, you get meat,” said Dr. David Silverman, associate professor of medicine at the University of Connecticut School of Medicine. “And if you go to a hospital with a ‘cath’ lab, you get an angioplasty.”

Drug treatments have improved significantly over the last 10 years, with doctors now using aspirin; beta-blockers, which ease the workload of the heart; ACE inhibitors, which can decrease the size of enlarging hearts; and cholesterol-lowering drugs called statins.

But angioplasty has one clear advantage over drugs alone, cardiologists say: By clearing away obstructions in the heart, angioplasty gets rid of angina, as chest pains are called, and that allows heart patients to recover vigor and a sense of well-being much more quickly.

“Angioplasty cures angina, period,” Silverman said. “If I have angina tomorrow, my personal choice would be to go to the catheter lab. But then I’m a weekend warrior who wants to go mountain biking. If I’m a 75-year-old whose major physical activity is reaching for jars off of a shelf, I might feel differently.”

Drug therapy might be able to reduce angina as well as angioplasty, given enough time to work, Nissen at the Cleveland Clinic said.

Angioplasty clears only a tiny bit of the plaque that causes blockages and heart pain, he said. Nissen is investigating whether aggressive use of cholesterol-low-ering drugs can reduce plaque.

Boden and Nissen also point out that angioplasty is no guarantee of long-term relief from symptoms. Even among patients who get a stent during angioplasty, one of every four needed to have a second procedure to reduce blockages, he said.