Cardiology ·
FRAGILE trial finds similar primary outcomes with off- and on-pump CABG
In a multicenter randomized trial of 508 prefrail or frail adults aged 60 years or older undergoing coronary artery bypass grafting, off-pump and on-pump surgery had similar rates of the 30-day primary composite outcome. Wound infection was more frequent after on-pump surgery; one-year neurocognitive and quality-of-life outcomes did not differ significantly.
- Randomized trial enrolled 508 prefrail or frail CABG patients.
- Primary 30-day composite did not differ significantly.
- Wound infections were more frequent after on-pump CABG.
- One-year neurocognitive outcomes showed no significant difference.
The FRAGILE trial randomized 508 patients aged 60 years or older who were classified as prefrail or frail to off-pump CABG (258 patients) or on-pump CABG (250). The multicenter, open-label trial ran from January 2018 to December 2024. Its primary outcome was a 30-day composite of death, myocardial infarction, stroke, renal failure, acute respiratory distress syndrome, or reoperation for bleeding. Neurocognitive function and quality of life were also assessed through one year.
The primary composite occurred in 28 patients (10.9%) assigned to off-pump surgery and 40 (16.0%) assigned to on-pump surgery. The reported relative risk was 1.47 (95% CI, 0.94–2.31; P=0.09), and the authors concluded that rates were similar. Wound infection was more frequent after on-pump CABG (8.0% vs 3.5%; P=0.04). One-year neurocognitive and quality-of-life outcomes did not differ significantly; estimated survival was 96.1% and 92.8%, respectively (P=0.099).
The findings do not establish superiority of either approach for the primary outcome. The abstract reports no significant differences in neurocognitive outcomes; the full text was not available in the supplied material, limiting assessment of other trial details and outcomes.
In practice
For prefrail or frail adults aged 60 years or older undergoing CABG, this randomized trial found no statistically significant difference between off-pump and on-pump surgery in the 30-day composite outcome, and no significant difference in one-year neurocognitive outcomes. The result does not establish that either approach is superior. Although wound infection was more frequent with on-pump surgery, this was a secondary finding; the supplied abstract alone does not support changing operative practice on that basis.
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Circulation: 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 ↗This is an automated AI-condensed summary that has not yet been reviewed by an editor. Always consult the full item at the original source.