Controlling Angina: Surgical Stents or Medication?

The American Heart Association (AHA) estimates that over 6.8 million Americans experience angina symptoms. Angina is the chest pain or discomfort when there is a decreased blood oxygen supply to an area of the heart muscle. In most cases, the lack of blood supply is due to a narrowing of the coronary arteries, or coronary heart disease. About 1 million angioplasties, a procedure that involves using a tiny balloon to widen the artery and propping the artery open with a stent, are performed in the U.S. each year to relieve these symptoms, but is surgery necessary? Could drug therapy combined with lifestyle changes be just as effective?

For a seven-year investigational study dubbed COURAGE, for Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation, researchers assessed 2,287 people with stable coronary disease in 50 U.S. and Canadian medical centers. Participants had either received angioplasty with stent implants, formally called PCI (percutaneous coronary intervention), with drugs or drug therapy combined with lifestyle changes. While the group receiving PCI had more immediate relief from chest pain and felt fewer physical limitations, within 36 months there was no significant difference in the health status between the two groups. Ultimately, 21 percent of the patients who started on drug therapy alone went on to get PCI treatment. "What one can say is that for people with chronic, stable coronary disease, PCI can be deferred," said study leader Dr. William Weintraub, chief of cardiology at the Christiana Health Care System in Delaware. "They can continue on medication aimed at their specific risk factors-hypertension, lipid disorders, diabetes-and should be encouraged to have a good lifestyle, with exercise, smoking cessation and weight control."

An editorial accompanying the study findings said PCI should not be the treatment of choice for people with stable heart disease. "COURAGE demonstrates that both treatment strategies can have a profoundly positive effect on patients' health status and suggests complementary roles-optimal medical therapy as first-line therapy, with PCI reserved for patients who do not have a response or who have severe baseline symptoms," wrote Dr. Eric Peterson of Duke University Medical Center in Durham, North Carolina, and John Rumsfeld of the Denver Veterans Affairs Medical Center. They calculate that if all patients were to receive the best drug therapy, adding PCI would give better relief to only one out of 17 patients, and only two of every 25 receiving PCI surgery would have a significant improvement in their quality of life.

Researchers say there are other factors that can influence a person's treatment decision. First, the amount of pain an angina sufferer is in. "If people say, ‘My pain is so bad I can't function,' that is one thing," said Dr. Weintraub. "If people say, ‘I have angina, but I'm doing OK,' that's another." Cost could also be a determining factor. Although the current report does not address the issue, an analysis presented by Dr. Weintraub last November found that "PCI adds about $10,000, without any significant gain in years of survival or quality of life." The analysis found that the cost for one year of life added by PCI varies from $150,000 to $300,000.

Dr. Peterson points out that there are hazards as well as benefits associated with PCI. Two of every 1,000 people who undergo PCI will die, 28 will have procedure-related heart attacks, 60 to 90 will have improved relief in symptoms, and 800 will gain no significant benefit above that given by drug treatment. "This study should be enlightening and practice-changing for doctors and patients alike," leading more to try drugs before resorting to the $40,000 heart procedure, he said.

What effects the study will have on the market remains unclear and largely dependent upon whether doctors and insurers embrace the implications of the new data. However, Dr. Peterson said they are already beginning to take notice. A subcommittee of the American College of Cardiology is rewriting its angioplasty guidelines, and the U.S. government insurance systems, Medicare and Medicaid, have commissioned their own study aimed at assessing the value of the procedure.

This latest report on COURAGE findings, published in the August 14 issue of the New England Journal of Medicine, is the second installment. Last year, researchers reported that patients getting drugs alone for angina and for heart disease are no more likely to die or have a heart attack during the follow-up period of 30 to 84 months than those who also received PCI. An economic analysis of COURAGE alternatives is expected to be published in September.