{ "abstract": "Background: For over three decades, the comparative effectiveness of off-pump versus on-pump coronary artery bypass grafting (CABG) has been debated. Although randomized controlled trials (RCTs) generally report modest long-term advantages for on-pump CABG, potential off-pump benefits remain uncertain particularly among high-risk patients. To address this knowledge gap, this CABG individual participant data meta-analysis (CABG-IPD-MA) will analyze de-identified patient records from the only three multicenter RCTs reporting 5-year follow-up (ROOBY, GOPCABE, and CORONARY) and test five protocol-driven hypotheses.\n\nMethods: Across short-term, intermediate, and longer-term periods, this PRISMA-IPD-compliant study will use a one-stage IPD meta-analysis framework to compare off-pump versus on-pump CABG for two co-primary endpoints [i.e., all-cause mortality and a composite metric comprised all-cause death, nonfatal acute myocardial infarction, and repeat revascularization (i.e., repeat CABG or percutaneous coronary intervention)] at 1 and 5 years; at 30 days/in-hospital, perioperative stroke will also be included in the composite. Secondary endpoints include individual sub-components of the composite endpoint and resource-utilization; resource-utilization analyses will be exploratory-only. Eligible studies included all post-2001 multicenter RCTs reporting off-pump versus on-pump post-CABG 5-year outcomes. Re-verified June 2025, the original 2019 PRISMA-IPD-guided systematic review identified only three eligible RCTs; prior publications reported these RCTs as having low Cochrane risk-of-bias. All three RCTs’ participants ( n = 9494) will be included. This CABG-IPD-MA study’s hierarchical hypotheses will evaluate: (1) overall unadjusted treatment effects; (2) overall risk-adjusted treatment effects; (3) prespecified high-risk subgroups’ risk-adjusted treatment effects; (4) the impact of complete revascularization; and (5) the concordance between this CABG-IPD-MA study’s findings with an aggregate-data meta-analysis findings. All primary CABG-IPD-MA analyses will utilize an intention-to-treat framework. Prespecified sensitivity analyses will evaluate findings under alternative treatment-conversion and high-risk restrictions.\n\nDiscussion: By pooling and harmonizing individual patient-level records from the only three contemporary multicenter RCTs reporting long-term follow-up, this study was designed to provide precise, clinically relevant assessments of off-pump versus on-pump benefits. These CABG-IPD-MA analyses will evaluate short-, intermediate-, and long-term outcomes exploring whether specific patient subgroups may derive any differential treatment benefits. Findings are expected to generate high-quality, clinically actionable evidence to support future patient-centered decision-making, clinical guideline refinements, and health policy decision-making.", "abstract_shown": true, "affiliations": [], "article_type": null, "arxiv": null, "author_total": 29, "authors": [ { "name": "Samuel R. Greenberg", "orcid": "0000-0002-4176-3958" }, { "name": "Mario Gaudino", "orcid": "0000-0002-1297-1758" }, { "name": "Weiwei Tao", "orcid": "0009-0003-2579-0037" }, { "name": "Daniel H. Wolbrom", "orcid": "0000-0001-5803-691X" }, { "name": "Jie Yang", "orcid": "0000-0003-3469-5931" }, { "name": "Frederick L. Grover" }, { "name": "Kara A. Mollura", "orcid": "0009-0006-1913-0325" }, { "name": "Lichun He", "orcid": "0009-0001-5088-9296" }, { "name": "Wilko Reents", "orcid": "0000-0002-7312-2581" }, { "name": "Andre Lamy", "orcid": "0000-0003-2777-7621" }, { "name": "A. Laurie Shroyer", "orcid": "0000-0001-6461-0623" }, { "name": "on behalf of the CABG-IPD-MA study team (see Supplementary Material 1)" }, { "name": "Hossein Almassi" }, { "name": "Ramin Ebrahimi" }, { "name": "Brack Hattler" }, { "name": "Jacquelyn Quin" }, { "name": "Jessica Rove" }, { "name": "Elaine Tseng" }, { "name": "Faisal Bakaeen" }, { "name": "Andreas Boening" }, { "name": "Brendan Carr" }, { "name": "P.J. Deveraux" }, { "name": "Anno Diegeler" }, { "name": "Stephen Fremes" }, { "name": "Leonard Girardi" }, { "name": "Salim Yusuf" }, { "name": "Hyun Jy Chung" }, { "name": "Joseph Collins" }, { "name": "Annette Wiseman" } ], "bibtex": "https://research.draconitic.com/paper/d9jzcx3dychzr.bib", "cited_by": 0, "doi": "10.1186/s13063-026-10001-4", "fulltext_url": null, "id": "d9jzcx3dychzr", "issns": [ "1745-6215" ], "landing_url": "https://link.springer.com/10.1186/s13063-026-10001-4", "language": null, "licence": "CC-BY-4.0", "licence_label": "CC BY 4.0", "licence_source": "article", "licence_url": "https://creativecommons.org/licenses/by/4.0", "metadata_licence": null, "native_subjects": [ [ "openalex", "2746|Cardiac and Coronary Surgery Techniques" ] ], "openalex": "W7220451763", "pdf_url": null, "pmcid": null, "pmid": null, "published": "2026-10-05", "publisher": "Springer Science and Business Media LLC", "ris": "https://research.draconitic.com/paper/d9jzcx3dychzr.ris", "sources": [ { "first_seen": "2026-10-30T12:20:30Z", "native_id": "10.1186/s13063-026-10001-4", "source": "crossref", "url": "https://link.springer.com/10.1186/s13063-026-10001-4" } ], "subjects": [ { "field": "medicine", "origin": "openalex:2746|Cardiac and Coronary Surgery Techniques", "subfield": "surgery" } ], "title": "Pooling individual off-pump and on-pump coronary artery bypass patient records from three contemporary multicenter, randomized, controlled trials: an individual participant data meta-analysis protocol", "title_text": "Pooling individual off-pump and on-pump coronary artery bypass patient records from three contemporary multicenter, randomized, controlled trials: an individual participant data meta-analysis protocol", "type": "peer-reviewed", "updated_at": "2026-10-30T12:20:30Z", "url": "https://research.draconitic.com/paper/d9jzcx3dychzr", "venue": "Trials", "versions": [] }