Off-Pump versus On-Pump Coronary Artery Bypass Grafting in Prefrail and Frail Patients: 30-Day and 1-Year Outcomes From the FRAGILE Randomized Trial

BACKGROUND: Frailty is associated with worse outcomes after coronary artery bypass grafting (CABG). However, the comparative effectiveness of off-pump CABG (OPCAB) versus on-pump CABG (ONCAB) in prefrail and frail patients remains uncertain. METHODS: This multicenter, randomized, open-label trial enrolled patients ≥60 years of age classified as prefrail or frail, randomized 1:1, between January 2018 and December 2024. The primary outcome was a 30-day composite of death, myocardial infarction, stroke, renal failure, acute respiratory distress syndrome, or reoperation for bleeding. Secondary outcomes included ventilation time, intensive care unit and hospital stay, transfusion requirements, completeness of revascularization, surgical wound infection at 30 days, and neurocognitive function preoperatively and at 1 year. Analyses followed the intention-to-treat principle; relative risks with 95% CIs were estimated. RESULTS: A total of 508 patients were included (OPCAB, n=258; ONCAB, n=250; median age, 68 years [interquartile range, 65.0–73]; 30.5% female). The primary composite outcome occurred in 28 patients receiving OPCAB (10.9%) and 40 patients receiving ONCAB (16.0%; relative risk, 1.47 [95% CI, 0.94–2.31]; P =0.09). Surgical wound infection was more frequent with ONCAB (20 [8.0%] versus 9 [3.5%]; P =0.04). No significant differences were observed in neurocognitive or quality of life outcomes at 1 year. Estimated 1-year survival probabilities were 96.1% and 92.8% in the OPCAB and ONCAB groups, respectively ( P =0.099). CONCLUSION: In prefrail and frail patients undergoing CABG, OPCAB and ONCAB resulted in similar rates of the primary composite outcome. No significant differences between OPCAB and ONCAB were found in neurocognitive outcomes. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02338947.