Jacquelyn A Quin1, Todd H Wagner2,3, Brack Hattler4,5, Brendan M Carr6, Joseph Collins7, G Hossein Almassi8,9, Frederick L Grover10,11, A Laurie Shroyer12,13. 1. Department of Surgery, Veterans Affairs Boston Healthcare System, West Roxbury, Massachusetts. 2. Research Office, Veterans Affairs Health Economics and Research Center, Palo Alto, California. 3. Department of Surgery, Stanford University, Palo Alto, California. 4. Department of Medicine, Rocky Mountain Regional Veterans Affairs Medical Center, Aurora, Colorado. 5. Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora. 6. Department of Emergency Medicine, Mayo Clinic, Rochester, Minnesota. 7. Research Office, Veterans Affairs Cooperative Studies Program, Perry Point, Maryland. 8. Department of Surgery, Clement J. Zablocki Veterans Affairs Medical Center, Milwaukee, Wisconsin. 9. Division of Cardiothoracic Surgery, Department of Surgery, Medical College of Wisconsin, Milwaukee. 10. Division of Cardiothoracic Surgery, Department of Surgery, University of Colorado School of Medicine, Aurora. 11. Department of Surgery, Rocky Mountain Regional Veterans Affairs Medical Center, Aurora, Colorado. 12. Research and Development Office, Northport Veterans Affairs Medical Center, Northport, New York. 13. Department of Surgery, Stony Brook University Renaissance School of Medicine, Stony Brook, New York.
Abstract
IMPORTANCE: The long-term benefits of off-pump ("beating heart") vs on-pump coronary artery bypass grafting (CABG) remain controversial. OBJECTIVE: To evaluate the 10-year outcomes and costs of off-pump vs on-pump CABG in the Department of Veterans Affairs (VA) Randomized On/Off Bypass (ROOBY) trial. DESIGN, SETTING, AND PARTICIPANTS: From February 27, 2002, to May 7, 2007, 2203 veterans in the ROOBY trial were randomly assigned to off-pump or on-pump CABG procedures at 18 participating VA medical centers. Per protocol, the veterans were observed for 10 years; the 10-year, post-CABG clinical outcomes and costs were assessed via centralized abstraction of electronic medical records combined with merges to VA and non-VA databases. With the use of an intention-to-treat approach, analyses were performed from May 7, 2017, to December 9, 2021. INTERVENTIONS: On-pump and off-pump CABG procedures. MAIN OUTCOMES AND MEASURES: The 10-year coprimary end points included all-cause death and a composite end point identifying patients who had died or had undergone subsequent revascularization (ie, percutaneous coronary intervention [PCI] or repeated CABG); these 2 end points were measured dichotomously and as time-to-event variables (ie, time to death and time to composite end points). Secondary 10-year end points included PCIs, repeated CABG procedures, changes in cardiac symptoms, and 2018-adjusted VA estimated costs. Changes from baseline to 10 years in post-CABG, clinically relevant cardiac symptoms were evaluated for New York Heart Association functional class, Canadian Cardiovascular Society angina class, and atrial fibrillation. Outcome differences were adjudicated by an end points committee. Given that pre-CABG risks were balanced, the protocol-driven primary and secondary hypotheses directly compared 10-year treatment-related effects. RESULTS: A total of 1104 patients (1097 men [99.4%]; mean [SD] age, 63.0 [8.5] years) were enrolled in the off-pump group, and 1099 patients (1092 men [99.5%]; mean [SD] age, 62.5 [8.5] years) were enrolled in the on-pump group. The 10-year death rates were 34.2% (n = 378) for the off-pump group and 31.1% (n = 342) for the on-pump group (relative risk, 1.05; 95% CI, 0.99-1.11; P = .12). The median time to composite end point for the off-pump group (4.6 years; IQR, 1.4-7.5 years) was approximately 4.3 months shorter than that for the on-pump group (5.0 years; IQR, 1.8-7.9 years; P = .03). No significant 10-year treatment-related differences were documented for any other primary or secondary end points. After the removal of conversions, sensitivity analyses reconfirmed these findings. CONCLUSIONS AND RELEVANCE: No off-pump CABG advantages were found for 10-year death or revascularization end points; the time to composite end point was lower in the off-pump group than in the on-pump group. For veterans, in the absence of on-pump contraindications, a case cannot be made for supplanting the traditional on-pump CABG technique with an off-pump approach. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01924442.
IMPORTANCE: The long-term benefits of off-pump ("beating heart") vs on-pump coronary artery bypass grafting (CABG) remain controversial. OBJECTIVE: To evaluate the 10-year outcomes and costs of off-pump vs on-pump CABG in the Department of Veterans Affairs (VA) Randomized On/Off Bypass (ROOBY) trial. DESIGN, SETTING, AND PARTICIPANTS: From February 27, 2002, to May 7, 2007, 2203 veterans in the ROOBY trial were randomly assigned to off-pump or on-pump CABG procedures at 18 participating VA medical centers. Per protocol, the veterans were observed for 10 years; the 10-year, post-CABG clinical outcomes and costs were assessed via centralized abstraction of electronic medical records combined with merges to VA and non-VA databases. With the use of an intention-to-treat approach, analyses were performed from May 7, 2017, to December 9, 2021. INTERVENTIONS: On-pump and off-pump CABG procedures. MAIN OUTCOMES AND MEASURES: The 10-year coprimary end points included all-cause death and a composite end point identifying patients who had died or had undergone subsequent revascularization (ie, percutaneous coronary intervention [PCI] or repeated CABG); these 2 end points were measured dichotomously and as time-to-event variables (ie, time to death and time to composite end points). Secondary 10-year end points included PCIs, repeated CABG procedures, changes in cardiac symptoms, and 2018-adjusted VA estimated costs. Changes from baseline to 10 years in post-CABG, clinically relevant cardiac symptoms were evaluated for New York Heart Association functional class, Canadian Cardiovascular Society angina class, and atrial fibrillation. Outcome differences were adjudicated by an end points committee. Given that pre-CABG risks were balanced, the protocol-driven primary and secondary hypotheses directly compared 10-year treatment-related effects. RESULTS: A total of 1104 patients (1097 men [99.4%]; mean [SD] age, 63.0 [8.5] years) were enrolled in the off-pump group, and 1099 patients (1092 men [99.5%]; mean [SD] age, 62.5 [8.5] years) were enrolled in the on-pump group. The 10-year death rates were 34.2% (n = 378) for the off-pump group and 31.1% (n = 342) for the on-pump group (relative risk, 1.05; 95% CI, 0.99-1.11; P = .12). The median time to composite end point for the off-pump group (4.6 years; IQR, 1.4-7.5 years) was approximately 4.3 months shorter than that for the on-pump group (5.0 years; IQR, 1.8-7.9 years; P = .03). No significant 10-year treatment-related differences were documented for any other primary or secondary end points. After the removal of conversions, sensitivity analyses reconfirmed these findings. CONCLUSIONS AND RELEVANCE: No off-pump CABG advantages were found for 10-year death or revascularization end points; the time to composite end point was lower in the off-pump group than in the on-pump group. For veterans, in the absence of on-pump contraindications, a case cannot be made for supplanting the traditional on-pump CABG technique with an off-pump approach. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01924442.
Authors: Todd H Wagner; Brack Hattler; Eileen M Stock; Kousick Biswas; Deepak L Bhatt; Faisal G Bakaeen; Kritee Gujral; Marco A Zenati Journal: JAMA Netw Open Date: 2022-06-01