Early QOL Advantage of CABG Over PCI for Diabetic Patients Disappears After 2 Years

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Percutaneous coronary intervention (PCI) with stenting and coronary artery bypass graft surgery (CABG) result in similar long-term health status and quality of life (QOL) for patients with diabetes and multivessel disease, according to a substudy from the FREEDOM trial. The findings appear in the October 16, 2013, issue of the Journal of the American Medical Association.

The primary results of FREEDOM demonstrated that CABG led to a benefit over PCI for the composite endpoint of death, MI, or stroke, driven by reductions in all-cause mortality and MI, in diabetic patients with multivessel disease.

For the substudy, investigators led by David J. Cohen, MD, MSc, of Saint Luke’s Mid America Heart Institute (Kansas City, MO), compared the relative effects of CABG vs. PCI on health status and QOL in a cohort of 1,880 patients from the FREEDOM trial randomized to CABG (n = 935) or PCI with DES (n = 945).

Health status was assessed using the angina frequency, physical limitations, and QOL 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.

No Consistent Differences Beyond 2 Years

At 1 month, PCI resulted in greater improvement on both the physical limitations (P < 0.001) and QOL (P = 0.03) subscales compared with CABG. By 6 months, the QOL subscales were similar, but there was a modest advantage for PCI on the physical limitations subscale (P = 0.002). However, by 1 year, scores on both subscales were higher with CABG (P = 0.01 for both) and remained higher through years 2 and 3 of follow-up.

Additionally, both interventions resulted in substantial reductions in dyspnea over time. The rate of improvement initially was more rapid with PCI vs. CABG, but between-group differences were no longer apparent by 6 months (P = 0.99).

In subgroup analysis, there were significant interactions between treatment assignment and both Syntax score and baseline angina. CABG was associated with greater angina relief among patients with daily or weekly angina at baseline (mean adjusted difference, 1.76 points) compared with patients with only monthly (mean adjusted difference, 1.29 points) or no angina (mean adjusted difference, -0.93 points). This pattern remained the same at 2-year follow-up. In addition, patients with an intermediate Syntax score (23-32) had significantly greater angina relief from CABG than PCI (mean adjusted difference, 2.79 points) at 1-year follow-up. Conversely, these benefits were minimal for those with low or high Syntax scores.

Beyond 2 years, however, there were no consistent between-group differences for any of the subscales, although there were significant differences in favor of CABG at 5 years for the physical limitations and QOL subscales.

Reassuring, but with Caveats

According to the study authors, the results are reassuring in that “there are not major differences in long-term health status and quality of life between the 2 treatment strategies. Nonetheless, it is important for patients to recognize that the similar late quality-of-life outcomes with PCI and CABG in the FREEDOM trial were achieved with higher rates of antianginal medication use and the need for more frequent repeat revascularization procedures among the PCI group.” In addition, they say, the finding that angina relief was slightly better with CABG, especially in patients with the most severe angina at baseline, suggests “that CABG should be strongly preferred as the initial revascularization strategy for such patients.”

However, Dr. Cohen and colleagues point out that their results are only applicable to first-generation DES, which were used in the vast majority of PCI procedures in FREEDOM.

In a telephone interview with TCTMD, Ajay J. Kirtane, MD, SM, of Columbia University Medical Center (New York, NY), agreed that the data are very reassuring and also in line with current guidelines that emphasize the heart-team approach.

“Mortality isn’t everything, and data like these are helpful to patients who need to make a decision about surgery vs. PCI,” he said. “Overall QOL incorporates mortality and stroke as well as these other things like angina that we know are important to patients, so it’s great to be able to say to them that overall the 2 interventions look pretty much equivalent.”

Dr. Kirtane added that the apparent upfront advantage for CABG with regard to frequent angina at baseline may simply represent incomplete revascularization with PCI whereby 1 procedure was not enough. Still, he said, for patients seeking less invasive methods, even 2 PCIs are associated with less hospitalization and less impact on QOL than surgery.

Study Details

Mean age of patients was 63 years, and 72% were men. More than 83% had 3-vessel CAD and more than 92% had LAD involvement. At baseline, patients in both the CABG and PCI groups reported significant health status limitations, including daily or weekly angina in 35% and moderate or severe dyspnea in 25%.

Beta blockers were used in approximately 80% of patients and did not differ between groups. Calcium-channel blockers and long-acting nitrates were used less frequently overall, but tended to be higher after PCI than after CABG.

 

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Source:
Abdallah MS, Wang K, Magnuson EA, et al. Quality of life after PCI vs. CABG among patients with diabetes and multivessel coronary artery disease: A randomized clinical trial. JAMA. 2013;310:1581-1590.

 

 

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• CABG Shows Mortality Advantage over PCI in ‘Real-world’ Multivessel Patients
• FREEDOM: CABG Superior to PCI in Diabetic Patients with Multivessel Disease
• PCI, Surgery Show Similar Long-term Mortality in Diabetic, Nondiabetic Patients