Shared Decision-Making for Stable Angina: What the COURAGE Trial Can Teach Us

To help make sense of recent studies of the management of stable coronary artery disease (CAD), cardiologists would do well to look to a major study from the recent past — the COURAGE trial, published in the New England Journal of Medicine in 2007. So argues Cleveland Clinic cardiologist Umesh Khot, MD, in a recent editorial in the Cleveland Clinic Journal of Medicine.

“A balanced approach to recommending PCI [percutaneous coronary intervention] first vs. optimal medical treatment first remains the best strategy” for patients with stable angina, writes Dr. Khot.

A COURAGE refresher

COURAGE was notable for showing that PCI did not reduce the risk of death or myocardial infarction (MI) in patients with stable CAD compared with a strategy of optimal medical therapy first. Its findings were heeded, Dr. Khot notes, as the rate of PCI use in this population plummeted in the wake of the trial, declining 60 percent from 2006 to 2011.

Yet Dr. Khot contends that claims that the COURAGE results were “negative” for PCI in stable CAD would be simplistic, in light of the following nuances:

• COURAGE enrolled a narrow group of patients with stable CAD, excluding many common subgroups who stand to benefit from revascularization, such as patients with heart failure, severe angina symptoms or left main artery stenosis.
• Despite perceptions that COURAGE simply compared PCI against optimal medical therapy, it actually compared optimal medical therapy plus PCI first against optimal medical therapy with crossover to PCI if medical therapy failed. Notably, 16.1 percent of patients in the medical therapy group underwent PCI by the end of the first year, and 32.6 percent did so by the end of study follow-up (median of 4.6 years).
• COURAGE required diagnostic angiography to confirm underlying CAD and to exclude left main disease, which is consistent with the notion that diagnostic investigation by cardiac catheterization or CT angiography to confirm or exclude CAD remains mandatory.
• While both treatment groups in COURAGE received optimal medical therapy, the group that received medical therapy alone required more medications to achieve the same outcome as the PCI group.
• Although COURAGE showed no benefit from PCI in terms of death or MI, the PCI-first group had clearly superior outcomes in terms of symptom relief beginning at three months and continuing to 24 months.

Nuanced conclusions from COURAGE

For these reasons, Dr. Khot argues, “[i]t is more accurate to say that in selected patients with moderate symptoms of angina and without heart failure or left main artery disease, a PCI-first strategy has no advantage over an optimal medical treatment-first strategy for the risk of death and myocardial infarction but does lead to earlier angina relief and less long-term need for medication.” Additionally, he notes, an optimal medical treatment-first strategy fails and requires crossover to PCI in up to one-third of cases.

Three other observations are relevant to interpreting the COURAGE trial’s results, he points out:

• Controlling angina symptoms is important and should not be discounted. For many patients, the activity limitations caused by symptoms have serious and important implications for lifestyle and quality of life. “Recognizing the importance of symptom control in stable coronary artery disease is patient-centered care,” Dr. Khot writes.
• Patient decision-making can be complicated. Physicians shouldn’t assume that reducing the risk of death is every patient’s main reason for choosing PCI. A desire for earlier symptom relief, minimization of medical therapy or continuation of highly valued lifestyle activities may be primary motivators for some patients.
• The incremental cost of PCI shrinks over the long run. In a PCI-first strategy, costs are front-loaded. Over time, the higher costs of such a strategy tend to diminish due to crossover to revascularization and increased medical care in patients receiving optimal medical therapy. A cost analysis of the COURAGE trial found that cumulative lifetime costs were only 10 percent higher for patients in the PCI-first group, although that difference was statistically significant.

A patient-centered proposal

All these observations led Dr. Khot to propose in his editorial a three-step approach to counseling patients with stable CAD on their treatment options:

• The first step is to understand the severity of the patient’s symptoms vis-à-vis his or her lifestyle.
• The next step is to determine the patient’s interest in PCI or a similar invasive procedure relative to optimal medical management, as he or she may have strong preferences for one over the other.
• The final step is to engage in a balanced discussion of the advantages and disadvantages of both options — PCI and optimal medical therapy — with the patient, within the context that there is no difference in rates of death and MI.

He concludes that this type of “patient-centered approach to clinical decision-making mandates inclusion of PCI first as an option in the management of stable coronary artery disease.” For most patients with heart failure, class IV angina at rest or left main artery stenosis, he says, referral for revascularization will be indicated. For the remaining patients with confirmed CAD and moderate angina symptoms, decisions should be driven by coronary anatomy, symptom burden and patient desires.

Read the full editorial in Cleveland Clinic Journal of Medicine (2018;85:124-127).