Ten-Year Outcomes of Off-Pump vs On-Pump Coronary Artery Bypass Grafting in the Department of Veterans Affairs: A Randomized Clinical Trial.
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....
| Publicado en: | JAMA Surgery Vol. 157; no. 4; pp. 303 - 311 |
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| Autores principales: | , , , , , , , |
| Formato: | research randomized controlled trial Journal Article |
| Publicado: |
American Medical Association
Apr2022
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=156341316&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 156341316 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 21686254 FTFX jtl: JAMA Surgery issn: 21686254 maglogo: N pubinfo: dt: Apr2022 vid: 157 iid: 4 pid: 30 pub: American Medical Association place: Chicago, Illinois artinfo: ui: 156341316 156341316 NLM35171210 156341316 10.1001/jamasurg.2021.7578 NLM35171210 156341316 ppf: 303 ppct: 8 formats: tig: atl: Ten-Year Outcomes of Off-Pump vs On-Pump Coronary Artery Bypass Grafting in the Department of Veterans Affairs: A Randomized Clinical Trial. aug: au: Quin, Jacquelyn A. Wagner, Todd H. Hattler, Brack Carr, Brendan M. Collins, Joseph Almassi, G. Hossein Grover, Frederick L. Shroyer, A. Laurie affil: Department of Surgery, Veterans Affairs Boston Healthcare System, West Roxbury, Massachusetts sug: subj: Veterans Cardiovascular Care Coronary Arteriosclerosis Surgery Coronary Artery Bypass Adverse Effects Middle Age Coronary Artery Bypass Female Treatment Outcomes Male Human Canada Comparative Studies Multicenter Studies Randomized Controlled Trials Evaluation Research Validation Studies Clinical Assessment Tools Scales Middle Aged: 45-64 years Female Male ab: 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. pubtype: Academic Journal doctype: research randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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