Quality-of-Life Data From FREEDOM Trial Compare CABG and PCI

October 16, 2013—In the Journal of the American Medical Association (JAMA), Mouin S. Abdallah, MD, et al published findings from an analysis of the FREEDOM trial that evaluated quality of life after percutaneous coronary intervention (PCI) versus coronary artery bypass graft (CABG) surgery among patients with diabetes and multivessel coronary artery disease (CAD) (2013;310:1581–1590).

According to the investigators, the FREEDOM trial demonstrated that, among patients with diabetes mellitus and multivessel coronary artery disease, CABG surgery resulted in lower rates of death and myocardial infarction but a higher risk of stroke when compared with PCI using drug-eluting stents. Whether there are treatment differences in health status, as assessed from the patient's perspective, is unknown.

As summarized in JAMA, the objective of the quality-of-life analysis was to compare the relative effects of CABG and PCI using drug-eluting stents on health status among patients with diabetes mellitus and multivessel CAD.

Between 2005 and 2010, 1,900 patients from 18 countries with diabetes mellitus and multivessel CAD were randomized to undergo revascularization with either CABG (n = 947) or PCI (n = 953) as an initial treatment strategy. Of these, a total of 1,880 patients had baseline health status assessed (935, CABG; 945, PCI) and comprised the primary analytic sample.

Health status was assessed using the angina frequency, physical limitations, and quality-of-life domains of the Seattle Angina Questionnaire at baseline, 1, 6, and 12 months, and annually thereafter. For each scale, scores range from 0 to 100, with higher scores representing better health. The effect of CABG surgery versus PCI was evaluated using longitudinal mixed-effect models.

The FREEDOM investigators reported that at baseline, mean (SD) scores for the angina frequency, physical limitations, and quality-of-life subscales of the Seattle Angina Questionnaire were 70.9 (25.1), 67.3 (24.4), and 47.8 (25.0) for the CABG group and 71.4 (24.7), 69.9 (23.2), and 49.2 (25.7) for the PCI group, respectively. At 2-year follow-up, mean (SD) scores were 96.0 (11.9), 87.8 (18.7), and 82.2 (18.9) after CABG and 94.7 (14.3), 86.0 (19.3), and 80.4 (19.6) after PCI, with significantly greater benefit of CABG on each domain (mean treatment benefit, 1.3 [95% CI, 0.3-2.2], 4.4 [95% CI, 2.7-6.1], and 2.2 [95% CI, 0.7-3.8] points, respectively; P < .01 for each comparison). Beyond 2 years, the two-revascularization strategies provided generally similar patient-reported outcomes.

The investigators concluded that for patients with diabetes and multivessel CAD, CABG surgery provided slightly better intermediate-term health status and quality of life than PCI using drug-eluting stents; however, the magnitude of benefit was small, without consistent differences beyond 2 years, in part due to the higher rate of repeat revascularization with PCI.