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.

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Journal
Circulation
Published
2026-11-10
DOI
https://doi.org/10.1161/circulationaha.125.078842
Primary Topic
Cardiac and Coronary Surgery Techniques
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article
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article

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

Bianca C. Meneghini, John D. Puskas, Luís Roberto Palma Dallan, Torsten Doenst et al.
Circulation
Cardiac and Coronary Surgery Techniques
article

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

Bianca C. Meneghini, John D. Puskas, Luís Roberto Palma Dallan, Torsten Doenst, Fernando Faglioni Ribas, Fabiane Letícia de Freitas, Maurílio Onofre Deininger, David Paul Taggart, Rodrigo Coelho Segalote, Omar Asdrúbal Vilca Mejía, Luiz Augusto Ferreira Lisboa, Carlos Vicente Serrano Junior, Fábio Biscegli Jatene, Renato D. Lópes, Ludhmila Abrahão Hajjar, Alexandre Ciappina Hueb, Pedro Gabriel Melo de Barros e Silva, Bruno Mahler Mioto, Fabiano Gonçalves Jucá, Mauricio Landulfo Jorge Guerrieri, for the FRAGILE Study Group, Felipe Cosentino
article en

Abstract

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.

Circulation
Emory University (US), Duke University (US), Universidade de São Paulo (BR), John Radcliffe Hospital (GB), University of Oxford (GB), Instituto Nacional de Cardiologia (BR), Hospital de Messejana (BR), Beneficência Portuguesa de São Paulo (BR), Hospital Universitário Lauro Wanderley (BR), Jena University Hospital (DE), Hospital das Clínicas Samuel Libânio (BR), Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (BR), Instituto do Coração - HCFMUSP (BR), Duke Clinical Research Institute (US), Friedrich Schiller University Jena (DE)
Cardiac and Coronary Surgery Techniques
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