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The risk of death, myocardial infarction, or other major cardiovascular events in patients with stable coronary artery disease is no lower with percutaneous coronary intervention (PCI) than with the optimal therapy of drug treatment with lifestyle intervention, says a major prospective study that is predicted to change practice.
The trial, published online on 26 March in the New England Journal of Medicine (http://content.nejm.org, doi: 10.1056/NEJMoa070829), randomised more than 2000 patients with objective evidence of myocardial ischaemia and significant coronary artery disease to PCI or optimal medical treatment. The results showed no difference in mortality from any cause or in the risk of non-fatal myocardial infarction at a median follow up of 4.6 years.
The findings will change practice, said David Taggart, professor of cardiovascular surgery at Oxford University. “This is a very important trial,” he said. “The results reinforce what some of us have believed for some time: that there is an overuse of PCI in some patients with stable coronary artery disease.”
The results illustrate the need for a multidisciplinary approach in which treatment is offered that is in the best interests of patients, rather than individual cardiologists making decisions in isolation, said Professor Taggart. “A significant population of patients can be managed on optimal medical therapy, with no increase in risk of death or MI [myocardial infarction].”
Professor Taggart thought it was surprising how much controversy the results of the trial, known as the COURAGE trial, have generated. “The information was already there from very good trials. COURAGE hasn't really told us anything new but has backed up, in a definitive way, what we already knew.”
PCI has traditionally been used less in Europe than in the United States, because there have not been the same financial incentives to carry out some stenting, said Professor Taggart. “Many European health systems are, to some degree, publicly funded, so there has been a slightly more objective view of what is in patients' best interests.” But use of PCI has been increasing over the past year, he said, and he added that this may now be reviewed.
In an editorial accompanying the study Judith Hochman, professor of cardiology at New York University School of Medicine, and Gabriel Steg, professor of cardiology at Université Paris VII, said, “The COURAGE trial should lead to changes in the treatment of patients with stable coronary artery disease, with expected substantial healthcare savings.”
They pointed out that the optimal medical therapy had proved its effectiveness in the trial. “Secondary prevention has proved its worth, with lipid-modulating therapy, lifestyle modification and the use of aspirin, beta-blockers and ACE inhibitors.”
Revascularisation should be limited to patients whose condition is clinically unstable, who have left main artery disease, or in whom medical treatment has failed to control symptoms, they advised. “PCI should not play a major role as part of a secondary prevention strategy.”
William Boden, professor of medicine and public health at the University of Buffalo School of Medicine and lead author of the COURAGE trial, agreed: “As an initial management approach, optimal medical therapy without routine PCI can be implemented safely in the majority of patients with stable coronary artery disease.” However, he noted that about a third of these patients may subsequently need revascularisation for symptom control or for subsequent development of an acute coronary syndrome.
Professor Taggart thought that guidelines are needed to identify better which patients need surgical intervention and which type of surgery to use. A recent observational study compared cost effectiveness of coronary artery bypass grafting, PCI, and medical management in angina patients. Results in patients who were judged clinically appropriate for coronary revascularisation indicated that coronary artery bypass grafting was cost effective while PCI was not. The authors argued that the clinical benefit of PCI may not be sufficient to justify its cost (BMJ 2007;334:624, doi: 10.1136/bmj.39129.442164.55).
See Short Cuts, p 716, doi: 10.1136/bmj.39170.502581.80.