Study’s latest phase examines angina treatments
The latest COURAGE Trial focused on the quality of life benefits of two initial treatment strategies for chronic, stable angina: percutaneous coronary intervention (PCI) combined with medical therapy versus medical therapy alone.
Angina is chest pain from narrowed coronary arteries that affects 7 million people in the United States.
To treat it, doctors usually weigh the two options tested in COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation).
“Although both treatment groups improved significantly, the PCI plus medical therapy group had a small but significant incremental benefit for the first two years, but that benefit disappeared by 36 months,” said David Maron, M.D., associate professor of Medicine and Emergency Medicine and one of the co-authors of the report, published this week in the New England Journal of Medicine.
In the first COURAGE publication in NEJM last year, investigators reported that optimal medical therapy without routine PCI can be implemented safely in the majority of patients with stable coronary artery disease — without increasing the risk of death or heart attack.
In the latest report, the researchers turned their attention to how quality of life and relief of angina differs between the two groups of patients. They used the Seattle Angina Questionnaire to assess self-reported, angina-related health status.
They followed 2,287 patients for 4.5 years, during which time patients completed the questionnaire to indicate how often they were having angina, its severity and how much it affected their quality of life.
At baseline 22 percent of the patients were angina free. The questionnaire was repeated at three months, showing that 53 percent were angina free in the PCI group and 42 percent in the medical therapy group.
“That was a statistically significant difference in favor of PCI,” Maron said.
The gap narrowed at 24 months, and by 36 months there was no significant difference in health status between the two groups. Additionally, those patients suffering from more severe angina received greater benefit from PCI than patients suffering with milder angina.
“The bottom line is that if a patient has no angina, PCI is not necessary. If a patient has mild angina, it is safe and reasonable to defer to PCI. Patients with severe angina clearly benefit symptomatically from PCI,” Maron said. “My hope is that this quality of life analysis will provide patients and physicians with useful information as they consider treatment options.”
Maron, who has worked with the COURAGE investigators since the mid-1990s, is a member of the COURAGE executive committee and was chair of the study's optimal medical therapy committee.