In most patients who receive coronary artery bypass grafting (CABG) and present as a viable candidate for use of either a traditional on-pump strategy or an off-pump (ie, “beating heart”) CABG procedure, no tangible, long-term benefits were identified with use of the off–pump CABG procedure. These findings were published in JAMA Surgery.
Recognizing that the long-term advantages of off-pump vs on-pump CABG remain controversial, investigators sought to assess the 10-year outcomes of and costs associated with the use of off-pump vs on-pump CABG in the Department of Veterans Affairs (VA) Randomized On/Off Bypass (ROOBY; ClinicalTrials.gov identifier: NCT01924442) trial. All analyses were carried out between May 7, 2017, and December 9, 2021, and used an intention-to-treat approach.
The 10-year coprimary endpoints included all-cause death, along with a composite endpoint of patients who had died or had undergone subsequent revascularization (ie, percutaneous coronary intervention [PCI] or repeated CABG). Secondary 10-year clinical endpoints were the subcomponents of the composite endpoint (ie, PCI and repeat CABG), along with post-CABG changes in cardiac symptoms. This was measured via the New York Heart Association (NYHA) and the Canadian Cardiovascular Society (CCS) evaluation tools. When baseline class level was compared with 10-year follow-up class level, the CCS and NYHA class changes were assessed as the following: no change in symptoms; improvement in symptoms; and worsening of symptoms. Further, 10-year atrial fibrillation rates (AF) were compared among patients who had developed new postoperative AF vs those who did not.
A total of 1104 participants, 1097 of whom were men, were enrolled in the off-pump arm, and 1099 individuals, 1092 of whom were men, were enrolled in the on-pump arm. The mean patient age was 63.0±8.5 years in the off-pump group and 62.5±8.5 years in the on-pump group. Overall, 10-year death rates were 34.2% in the off-pump arm vs 31.1% in the on-pump arm (relative risk, 1.05; 95% CI, 0.99-1.11; P =.12).
The median time to the composite endpoint in the off-pump group (4.6 years [IQR, 1.4-7.5 years]) was approximately 4.3 months shorter than that in the on-pump group (5.0 years [IQR, 1.8-7.9 years]). This difference that was statistically significant
(P =.03). No statistically significant 10-year treatment-related differences were documented for any of the other primary or secondary endpoints. These findings were verified with the use of sensitivity analyses.
A major limitation of the study is the fact that the enrolled veteran population was predominantly male and presented with multiple, complex comorbidities. Therefore, these results may not be generalizable to women or to nonveteran patient populations who have different baseline risk characteristics.
“ROOBY-FS documented slightly shorter revascularization-free survival among patients in the off-pump group,” the study authors noted. “For most patients undergoing CABG who present as a viable candidate for either revascularization option, moreover, no tangible long-term advantages of the off-pump CABG procedure were identified compared with the traditional on-pump strategy.”
Disclosure: Some of the study authors have declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Quin JA, Wagner TH, Hattler B, et al. Ten-year outcomes of off-pump vs on-pump coronary artery bypass grafting in the Department of Veterans Affairs: a randomized clinical trial. JAMA Surg. Published online February 16, 2022. doi:10.1001/jamasurg.2021.7578