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Press Release
Study Sheds Doubt on Preventive Use of Angioplasty, Stenting
Cardiac Procedure Adds Little Benefit to Optimal Drug Therapy for Those with Stable Coronary Disease
April 26, 2007
A major U.S.-Canadian trial found that percutaneous coronary intervention (PCI)—typically, the use of balloon angioplasty plus stenting—did little to improve outcomes for 2,287 patients with stable coronary artery disease who also received optimal drug therapy and underwent lifestyle changes. Results of the study, led by the Cooperative Studies Program of the U.S. Department of Veterans Affairs (VA) and the Canadian Institutes of Health Research (CIHR), were presented March 27 at the American College of Cardiology meeting in New Orleans and published April 12 in the New England Journal of Medicine.
"We wanted to determine whether there was a clinical benefit to the combination of angioplasty and medical therapy, compared to medical therapy alone. We did not find such a benefit," said lead author William E. Boden, MD, a consultant at the Western New York VA Healthcare Network. Boden is also 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 State University of New York at Buffalo School of Medicine and Biomedical Sciences.
Boden added that while several smaller studies had been done, there was an "absence of information" and the VA-led trial was the largest randomized trial to test the benefits of PCI over optimal medical therapy for stable disease.
The American Heart Association recommends treating stable heart disease with medications and lifestyle changes. Still, the great majority of PCIs performed in the U.S. are in people with stable heart disease. Overall, the procedures account for more than $23 billion in U.S. health care costs each year.
The study, named "Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation" (COURAGE), involved patients at 15 VA medical centers and 35 other U.S. and Canadian hospitals. 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, or 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 medications to lower blood pressure and cholesterol and prevent clots, along with lifestyle programs for smoking cessation, physical activity, and nutrition. Half the study volunteers also underwent percutaneous coronary intervention (PCI), a procedure in which an interventional cardiologist clears plaque from a blocked artery.
For almost all the PCI patients, their procedure consisted of angioplasty, in which a balloon-tipped catheter is used to open up the artery; plus a stent, a wire-mesh tube placed to 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 over, only a few COURAGE patients received this type. But studies have shown little difference between coated and non-coated stents for the prevention of 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 Boden, "but I think the best we can say is that it's palliative."
Boden also pointed to the relatively good outcomes of those who did not undergo the cardiac procedure: "Fully two-thirds of patients in the medical therapy group ultimately became symptom-free and never required an intervention."
Peter Liu, MD, scientific director of the CIHR Institute of Circulatory and Respiratory Health, added, "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."
The VA-CIHR study, conducted between 1999 and 2004, received additional support from pharmaceutical and biotechnology companies that contributed funding, drugs and medical devices or supplies.
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