NEW ORLEANS, (March 27, 2007) -- Percutaneous coronary intervention plus optimal medical therapy does not improve outcomes in patients with coronary artery disease, compared with optimal medical therapy alone, according to study results presented yesterday at the 56th Annual Scientific Session of the American College of Cardiology in New Orleans, and published online in the New England Journal of Medicine.
The Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) Trial, conducted by the Cooperative Studies Program of the U.S. Department of Veterans Affairs (VA) and the Canadian Institutes of Health Research (CIHR), was a randomized, controlled study involving 2,287 patients with stable coronary artery disease treated at 15 VA medical centers, as well as 35 other U.S. and Canadian medical centers. The study, conducted between 1999 and 2004, was also supported by several pharmaceutical and biotechnology companies that contributed funding, drugs and medical devices or supplies.
COURAGE participants—most of them Caucasian males, with an average age of 62—had at least one coronary artery that was more than 70-percent blocked. They experienced regular chest pain (angina) at least several times per week. About 38 percent had a history of heart attack, 33 percent had diabetes, 71 percent had high cholesterol and 67 percent had high blood pressure.
All participants received optimal medical therapy (OMT), which consisted of multiple medications—including drugs to lower blood pressure and cholesterol and prevent clots—and lifestyle programs for smoking cessation, physical activity, and nutrition. Half the participants also underwent percutaneous coronary intervention (PCI), a procedure in which an interventional cardiologist clears plaque from a blocked artery.
Nearly all of the PCI recipients (93 percent) also had a stent, a wire-mesh tube, placed to help keep open the affected artery. Because drug-eluting stents, which are coated with medications that help prevent scarring, were not approved until the trial was nearly completed, only 31 COURAGE patients received this type of stent. But studies have shown little difference between coated and non-coated stents in their ability to prevent heart attacks and deaths.
At a median follow-up of almost five years, the rates of death, nonfatal heart attack, stroke, and hospitalization for heart disease were the same in the two study groups: those who received only OMT, and those who received PCI plus OMT.
There were also no differences between the groups in cholesterol levels, blood pressure levels, or blood-sugar control. The groups also made lifestyle changes at similar rates: After five years, 75 percent of patients in both groups were following the recommended diet, and about 40 percent were getting regular exercise. The PCI group was more likely to report relief from angina throughout most of the follow-up period, but this difference disappeared over five years of follow-up.
"People assume that once you have PCI, it's curative," said first author and presenter William E. Boden, MD. "I think the best we can say is that it's palliative." Boden is a consultant in cardiology at the Western New York VA Healthcare System in Buffalo. He is also the medical director of Cardiovascular Services for Kaleida Health, chief of cardiology for Buffalo General and Millard Fillmore hospitals, and professor of medicine and public health at the University of New York at Buffalo School of Medicine and Biomedical Sciences.
According to Peter Liu, MD, scientific director of the CIHR Institute of Circulatory and Respiratory Health, "The findings suggest that if a patient with heart disease is doing well, the latest available medications are very effective and there is no need for PCI."
PCI has been shown to help patients with more severe heart disease. However, prior to COURAGE, the efficacy of PCI on improving clinical events had not been rigorously studied in patients with stable heart disease. These patients have regular episodes of angina, usually due to physical exertion or stress.
This study was supported by VA’s Cooperative Studies Program, in collaboration with the Canadian Institutes of Health Research. It was also supported by several pharmaceutical and biotechnology companies that contributed funding, drugs and medical devices or supplies.
The American Heart Association guidelines for treating stable heart disease recommend medications and lifestyle changes. Still, the great majority of the PCIs performed in the United States, and a sizable number in Canada, are in people with stable heart disease. Overall, PCIs account for more than $23 billion in U.S. health care costs each year.
New England Journal of Medicine