For patients with stable angina, those treated with PCI and those treated with optimal medical therapy alone had marked improvements in health status during follow-up; however, the PCI group had small, but significant, incremental benefits that disappeared by three years, according to a COURAGE subset analysis published today in the New England Journal of Medicine.
William S. Weintraub, MD, from the Christiana Care Health System in Newark, Del., and colleagues undertook the study because they said it had not been clearly established whether PCI can provide an incremental benefit in quality of life over that provided by optimal medical therapy among patients with chronic coronary artery disease.
The researchers randomly assigned 2,287 patients with stable coronary disease to PCI plus optimal medical therapy or to optimal medical therapy alone. They assessed angina-specific health status (with the use of the Seattle Angina Questionnaire) and overall physical and mental function (with the use of the RAND 36-item health survey).
At baseline, the investigators found that 22 percent of the patients were free of angina. At three months, 53 percent of the patients in the PCI group and 42 percent in the medical-therapy group were angina-free.
Weintraub and colleagues said that the baseline mean Seattle Angina Questionnaire scores (which range from 0 to 100, with higher scores indicating better health status) were 66 for physical limitations, 54 for angina stability, 69 for angina frequency, 87 for treatment satisfaction and 51 for quality of life.
By three months, the scores had increased in the PCI group, as compared with the medical-therapy group, to 76 vs. 72 for physical limitation, 77 vs. 73 for angina stability, 92 vs. 90 for treatment satisfaction and 73 vs. 68 for quality of life, the authors wrote.
In general, patients had an incremental benefit from PCI for six to 24 months; patients with more severe angina had a greater benefit from PCI. The researchers said that similar incremental benefits from PCI were seen in some but not all RAND-36 domains; and by 36 months, there was no significant difference in health status between the treatment groups.
In an accompanying editorial, Eric D. Peterson, MD, of the Duke Clinical Research Institute in Durham, N.C., and John S. Rumsfeld, MD, PhD, of the University of Colorado in Boulder, wrote that the trial redefined “the contemporary roles of optimal medical therapy and PCI in the management of patients with stable angina.”
“Rather than one victor, COURAGE demonstrates that both treatment strategies can have a profoundly positive effect on patients' health status and suggests complementary roles -- optimal medical therapy as first-line therapy, with PCI reserved for patients who do not have a response or who have severe baseline symptoms," concluded Peterson and Rumsfeld.