Efficacy of dual antiplatelet therapy for three months versus 12 months after coronary artery bypass grafting: multicentre, double blinded, randomised controlled trial.
Yuan X, Li J, Lei L, Zhang L, Chen K, Chu Q, Feng W, Wang X, Wang X, Xu F, Liu S, Yang Y, Wang X, Wang H, Dong A, Cheng Z, Guo H, Zhou T, Chen X, Ge J, Zhang L, Liu S, Shen Z, Wang J, Wang Y, Li W, Hu S, TOP-CABG Collaborative Group
- DOI
- 10.1136/bmj-2025-088939
- Record issued
- 2026-08-10
- Engine
- 7.29.0
- Exported
- 2026-09-22
Prepared by Alpha1. This document is confidential: it is intended for the recipient it was shared with and must not be redistributed. The live record at alpha1science.com/verify/d930edee-8924-42c2-b431-fb4b246f0bd8 is authoritative.
How this rating was calculated
- ReportingData & code availability not met−0.5★
- ReportingEthical approvals partially met−0.25★
- References were not verified against Crossref/OpenAlex.
- No data or code availability links were detected to verify.
- 01Data and code not shared
The data availability statement is incomplete and no repository, accession numbers, or code repository are provided.
“Deidentified data and codes underlying the results reported in this manuscript are openl”
Data availabilityFind in source
This Kaimen Rigor review uses Kaimen Rigor reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.
The paper describes a well-designed and rigorously analyzed RCT, with strong reporting on most transparency dimensions. The main weaknesses are a garbled and incomplete data availability statement and a missing explicit statement of adherence to a recognized ethical framework (e.g., Declaration of Helsinki). Race/ethnicity is not reported in demographics.
Two independent reviewer runs (same model) agreed on all dimension statuses; only minor checklist-level divergence on demographics (race/ethnicity). Copyedit flagged two issues in the data availability statement. Statistics verification checked 3 tests, all consistent. No retracted or non-existent references were found. Caveat: the statistics verification covers only a subset of reported tests; the paper's statistical conclusions are not fully verified.
Numerical inconsistencies
None foundValues that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.
Checked — nothing surfaced.
Recomputed 3 tests: 3 consistent, 0 inconsistent; 2 recomputed directly from the reported test statistics, 1 via agent-written checks.
- CONSISTENTreported p < .001 · recomputed p = <.001Recomputed hazard ratio 0.62 (95% CI 0.48–0.81), reported p<0.001
“hazard ratio 0.62, 95% CI 0.48 to 0.81; P<0.001”
Taken as given: 0.48–0.81 is a two-sided 95% confidence interval for the hazard ratio of 0.62, not a range, an IQR, or a different interval level; the hazard ratio is a RATIO measure, so the interval is symmetric on the log scale; p<0.001 is the p for THIS estimate, not for another comparison in the same sentenceMethod: back the two-tailed p out of the log-scale CI width and compare it against the printed pHow we recomputed it: pCI(0.62, 0.48, 0.81, 1) - CONSISTENTreported p = .100 · recomputed p = .101Recomputed hazard ratio 0.76 (95% CI 0.55–1.06), reported p=0.10
“hazard ratio 0.76, 95% CI 0.55 to 1.06; P=0.10”
Taken as given: 0.55–1.06 is a two-sided 95% confidence interval for the hazard ratio of 0.76, not a range, an IQR, or a different interval level; the hazard ratio is a RATIO measure, so the interval is symmetric on the log scale; p=0.10 is the p for THIS estimate, not for another comparison in the same sentenceMethod: back the two-tailed p out of the log-scale CI width and compare it against the printed pHow we recomputed it: pCI(0.76, 0.55, 1.06, 1) - CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 1Chi-square test for BARC type 2,3,5 bleeding (3-month vs 12-month DAPT)
“BARC type 2, 3, or 5 bleeding occurred in 95 patients (8.3%) in the three month DAPT group and 149 patients (13.2%) in the 12 month DAPT group”
Taken as given: The two groups are independent (modified intention-to-treat).; The reported counts are from the mITT population (N=1152 and 1138).; The chi-square test is appropriate for a 2x2 table.Method: Two-sided Pearson chi-square test without continuity correction.How we recomputed it: pChi2x2(95, 1057, 149, 989)
Overstated conclusions
None found · partly checkedConclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.
Nothing surfaced — but not everything feeding this category ran (missing: surrogate-endpoint assessment), so read this as a partial clean bill.
6 major claims checked against the paper's own evidence: all adequately supported.
- supportedReviewer 1Three-month DAPT is non-inferior to 12-month DAPT for SVG occlusion at one year.The primary outcome shows an absolute difference of -0.31% (95% CI -3.13% to 2.52%) with P=0.008 for non-inferiority, which is below the prespecified margin of 3.5%.Evidence: Table 2: SVG occlusion 280/2596 (10.8%) vs 283/2529 (11.2%), absolute difference -0.31%, 95% CI -3.13% to 2.52%, P=0.008 for non-inferiority.
“Saphenous vein graft occlusion occurred in 280 of 2596 (10.8%) in the three month DAPT group and 283 of 2529 (11.2%) in the 12 month DAPT group (absolute difference −0.31%, 95% confidence interval (CI) −3.13% to 2.52%; P=0.008 for non-inferiority).”
Results ¶2Find in source - supportedReviewer 1Three-month DAPT is superior to 12-month DAPT for reducing BARC type 2,3,5 bleeding.The primary superiority outcome shows a significant reduction in bleeding: hazard ratio 0.62 (95% CI 0.48 to 0.81), P<0.001.Evidence: Table 2: BARC type 2,3,5 bleeding 95/1152 (8.3%) vs 149/1138 (13.2%), absolute difference -4.67% (95% CI -7.18% to -2.16%), P<0.001.
BARC type 2, 3, or 5 bleeding occurred in 95 patients (8.3%) in the three month DAPT group and 149 patients (13.2%) in the 12 month DAPT group (hazard ratio 0.62, 95% CI 0.48 to 0.81; P<0.001).
Results ¶4reviewer’s wording - supportedReviewer 1The effect of three-month DAPT on SVG occlusion is consistent across prespecified subgroups.The forest plot (Figure 2) shows no significant interactions, and the paper reports Bonferroni-adjusted P values for interactions.Evidence: Figure 2 and text: 'The effect of three month DAPT on SVG occlusion was consistent among prespecified subgroups and post hoc subgroups.'
“The effect of three month DAPT on SVG occlusion was consistent among prespecified subgroups and post hoc subgroups ().”
Results ¶3Find in source - supportedReviewer 2A three month DAPT strategy was non-inferior to the 12 month DAPT strategy in saphenous vein graft occlusion.The primary non-inferiority outcome shows SVG occlusion rates of 10.8% vs 11.2% with a risk difference of -0.31% (95% CI -3.13% to 2.52%) and P=0.008 for non-inferiority, supporting the claim.Evidence: Primary outcome results in Results (Table 2): SVG occlusion 280/2596 (10.8%) vs 283/2529 (11.2%), absolute difference -0.31% (95% CI -3.13% to 2.52%), P=0.008 for non-inferiority.
“Saphenous vein graft occlusion occurred in 280 of 2596 (10.8%) in the three month DAPT group and 283 of 2529 (11.2%) in the 12 month DAPT group (absolute difference −0.31%, 95% confidence interval (CI) −3.13% to 2.52%; P=0.008 for non-inferiority).”
AbstractFind in source - supportedReviewer 2A three month DAPT strategy was superior in reducing bleeding risk.The primary superiority outcome shows BARC type 2,3,5 bleeding in 8.3% vs 13.2% (HR 0.62, 95% CI 0.48-0.81, P<0.001), supporting the claim.Evidence: Primary superiority outcome in Results: BARC type 2,3,5 bleeding 95/1152 (8.3%) vs 149/1138 (13.2%), HR 0.62 (95% CI 0.48-0.81), P<0.001.
“BARC type 2, 3, or 5 bleeding occurred in 95 patients (8.3%) in the three month DAPT group and 149 patients (13.2%) in the 12 month DAPT group (absolute difference −4.67%, 95% CI −7.18% to −2.16%; P<0.001).”
AbstractFind in source - supportedReviewer 2The findings for other secondary outcomes were also similar between the two groups.Secondary outcomes such as SVG failure, MACCE, graft stenosis, and occlusion rates are reported with similar rates and overlapping CIs, supporting the claim.Evidence: Results for secondary outcomes in Table 2 and text: SVG failure 17.4% vs 18.2%, MACCE 2.3% vs 2.7%, etc.
The secondary outcomes of SVG failure occurred in 201/1152 patients (17.4%) in the three month DAPT group and 207/1138 patients (18.2%) in the 12 month DAPT group (absolute difference −0.46%, 95% CI −4.59% to 3.67%).
Results ¶4reviewer’s wording
Data authenticity concerns
None foundAn adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.
Checked — nothing surfaced.
Reporting gaps
2 findings · worst highRequired detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.
- Data and code not sharedAssessed
- Ethics/consent reporting incompleteAssessed
The introduction cites major trials (PLATO, DACAB, POPular CABG) and a meta-analysis, establishing the background. The rationale for short-term DAPT is based on the pathophysiology of SVG occlusion. The paper acknowledges limitations of prior work, such as lack of evidence on optimal DAPT duration.
“Studies have shown a statistically significant reduction in SVG failure with ticagrelor based dual antiplatelet therapy (DAPT) for 12 months, but at the expense of increased bleeding risk.”
“The pathophysiology of SVG occlusion provides a biological rationale for short term DAPT after CABG, and data show that the thrombotic risk is highest in the early phase after surgery and decreases thereafter.”
“Recent trials support the efficacy and safety of short term DAPT after percutaneous coronary intervention, but such an approach has not been tested in patients with CABG.”
“Studies have shown a statistically significant reduction in SVG failure with ticagrelor based dual antiplatelet therapy (DAPT) for 12 months, but at the expense of increased bleeding risk.”
“The pathophysiology of SVG occlusion provides a biological rationale for short term DAPT after CABG, and data show that the thrombotic risk is highest in the early phase after surgery and decreases thereafter.”
“Recent trials support the efficacy and safety of short term DAPT after percutaneous coronary intervention, but such an approach has not been tested in patients with CABG.”
Randomization was centrally via interactive web response system with site-stratified block randomization (block size 10). Patients, investigators, outcome assessors, adjudicators, and statisticians were blinded. A priori sample size calculation provided power ≥90% for both primary outcomes. Inclusion and exclusion criteria were pre-specified and detailed. Missing data handling was described via multiple imputation and sensitivity analyses.
“Eligible patients were randomly assigned through a centrally interactive web response system to DAPT for either three months or 12 months in a 1:1 ratio using a site stratified block randomisation with a block size of 10 on postoperative day 5.”
“Patients, investigators, outcome assessors, adjudicators, and statisticians were blinded to treatment assignments.”
“With an annual occlusion rate of 10% in the DAPT group, a loss to follow-up of 10%, and an average of 2.1 SVG segments in each patient, we estimated that 2300 participants could provide at least 90% power at a one sided α of 0.025 to show a 3.5% non-inferiority margin in the SVG occlusion rate between the two groups.”
“Eligible patients were randomly assigned through a centrally interactive web response system to DAPT for either three months or 12 months in a 1:1 ratio using a site stratified block randomisation with a block size of 10 on postoperative day 5.”
“Patients, investigators, outcome assessors, adjudicators, and statisticians were blinded to treatment assignments.”
Table 1 reports sex (20.6% women), mean age (61.5 years), BMI, comorbidities, and other baseline characteristics. Both sexes are included, so no single-sex justification is needed. Species/strain and housing conditions are not applicable for a human study.
“The mean age was 61.5 years (SD 8.4), and 472 (20.6%) patients were women.”
The paper states approval by the central ethics committee at Fuwai Hospital (approval No 2022-1774) and written informed consent. However, the regulatory compliance statement only refers to the data privacy framework of China, which is functionally aligned with GDPR, but does not name a standard ethical framework like Declaration of Helsinki or ICH-GCP. Thus regulatory_compliance is not_reported, leading to a warn.
“This study was approved by the central ethics committee at Fuwai Hospital (approval No 2022-1774) and the collaborating centres; all participants gave informed consent before taking part in the study.”
“This study was approved by the central ethics committee at Fuwai Hospital (approval No 2022-1774) and the collaborating centres; all participants gave informed consent before taking part in the study.”
“All patients provided written informed consent.”
“Our trial was conducted in strict accordance with the data privacy and security framework of China, which is functionally aligned with the EU’s General Data Protection Regulation (see supplementary file, section S2).”
The drugs are named with dose and regimen, and the manufacturer (Nanjing Zhengda Tianqing Pharmaceutical) is stated in the funding section. The software used (SAS 9.4, R 4.4.2) is reported. Other resource categories (antibodies, cell lines, etc.) are not applicable.
“This trial received drugs from Nanjing Zhengda Tianqing Pharmaceutical.”
“All analyses were done using SAS (version 9.4) and R (version 4.4.2).”
“The 12 month group received 90 mg ticagrelor twice daily plus 100 mg aspirin once daily for one year after CABG.”
“This trial received drugs from Nanjing Zhengda Tianqing Pharmaceutical.”
“All analyses were done using SAS (version 9.4) and R (version 4.4.2).”
The paper names GEE, Cox regression, Fine-Gray, and landmark analysis. The proportional hazards assumption was tested and addressed. Exact p-values are reported (e.g., P=0.008 for non-inferiority, P<0.001 for bleeding). Effect sizes are given with 95% CIs. Software is identified. Data presentation includes tables and Kaplan-Meier curves. No arithmetic inconsistencies were detected.
“As the proportional hazards assumption for the bleeding outcome was not met (P=0.0073) (supplementary figure S2), we conducted a prespecified 90 day landmark analysis to estimate the absolute differences and hazard ratios.”
“P=0.008 for non-inferiority”
“Saphenous vein graft occlusion occurred in 280 of 2596 (10.8%) in the three month DAPT group and 283 of 2529 (11.2%) in the 12 month DAPT group (absolute difference −0.31%, 95% confidence interval (CI) −3.13% to 2.52%; P=0.008 for non-inferiority).”
The data availability statement is present but truncated: 'Deidentified data and codes underlying the results reported in this manuscript are openl...' No repository, DOI, or accession numbers are given. Code sharing is not specified. The statement is reported_but_inadequate at best, and no applicable sub-criterion is adequate. Thus the dimension fails.
“Deidentified data and codes underlying the results reported in this manuscript are openl sis . BMJ 2019 ; 367 : l5476 . 10.1136/bmj.l5476 31601578 PMC6785742”
“Deidentified data and codes underlying the results reported in this manuscript are openl”
The trial is registered (NCT05380063). The methods are comprehensive. All primary and secondary outcomes are reported, including null results. A dedicated strengths and limitations section lists 11 limitations. Conclusions are proportional to the evidence. Funding and competing interests are stated. The only missing element is a reference to a reporting guideline (CONSORT), which is a minor omission.
“Trial registration ClinicalTrials.gov NCT05380063 .”
“Trial registration ClinicalTrials.gov NCT05380063 .”
“Firstly, a small proportion of patients did not complete the assessment of SVG occlusion and were excluded from the main analysis, which may potentially bias the results towards non-inferiority.”
“The TOP-CABG trial was funded by the National Clinical Research Centre for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences (NCRC2022001).”
Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.
Broken references and links
None found · partly checkedReferences checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.
Nothing surfaced — but not everything feeding this category ran (missing: data/code link verification), so read this as a partial clean bill.
Copyediting
2 minorWording, consistency and formatting errors that need correcting before submission.
No major wording or formatting errors. 2 minor suggestions below.
2 copyedit issues flagged: mostly typo, other.
- MINORtypoData availability statement“openl sis . BMJ 2019 ; 367 : l5476 . 10.1136/bmj.l5476 31601578 PMC6785742”→ Replace with a proper statement, e.g., 'Deidentified data and code are available at [repository URL].'The current text is garbled and likely a copy-paste error.
- MINORotherData availability statement“Deidentified data and codes underlying the results reported in this manuscript are openl”→ Complete the sentence with the repository details and a URL, e.g., 'are openly available at [repository URL]'.The statement is cut off, likely a formatting error.
Post-publication audit: The paper is robust on study design and analysis, but the garbled data availability statement and missing Declaration of Helsinki statement are reporting deficiencies that warrant correction via an erratum. An informed reader should weigh these gaps when assessing reproducibility and ethical oversight. The overall conclusions appear reliable, but the data sharing issue is a concern.
- 1.HIGHdata codeIssue a correction to replace the garbled data availability statement with a complete statement specifying a repository (e.g., Dryad, Zenodo, or a managed-access platform) with a DOI or accession number, and provide code in a public repository (e.g., GitHub) with a permanent identifier.The current statement is unintelligible and fails to meet journal requirements for data and code sharing, undermining reproducibility.
- 2.HIGHethicsAdd an explicit statement of adherence to the Declaration of Helsinki or ICH-GCP in the ethics section (e.g., in the 'Ethical approval' paragraph).Most journals require a statement of compliance with an internationally recognized ethical framework; the current statement only references Chinese data privacy law.
- 3.MEDIUMreportingReport race/ethnicity of participants in Table 1 or on the demographics section.Race/ethnicity is a standard demographic variable; its absence is a minor reporting gap, especially for a trial in a single country.
- 4.LOWreportingReference the CONSORT reporting guideline in the methods section or discuss adherence.Although not mandatory, citing a reporting guideline is a best practice and improves transparency.
- 5.LOWcopyeditCorrect the typo in the data availability statement by replacing the garbled text with a proper sentence.The current text appears to be a copy-paste error and should be cleaned up.
The star rating is the report’s one-glance summary. Every paper starts at 5★ and loses stars for the concrete problems the review finds — so a rating is never a vague average, it’s a running total you can read line by line under “How this rating was calculated.”
- Reporting — 8 dimensionseach dimension that fully fails−½★
- each dimension partially met−¼★
- Statistics · Integrity · Claimseach serious problem−1★
- each medium problem−½★
- Citationseach retracted or unverifiable reference−¼★
- Copyeditonly when the manuscript needs a full edit−½★
The rating never drops below 1★, and a demonstrable critical failure (an impossible statistic, a proven ethics violation) caps it at 1★ on its own — so the stars can never look healthy when the verdict is CRITICAL.
The rating draws on a panel of agents. Three independent Kaimen Rigor reviewers grade the eight dimensions below across several independent passes (the shown verdict is their majority vote — steadier than any single run), isolate the paper’s major claims and check its own evidence backs them, and flag integrity concerns. Alongside them, a citation agent resolves every reference against Crossref, OpenAlex, and Retraction Watch; a statistics agent recomputes reported tests; and rule-based checks verify that declared data/code links actually resolve. Full text is required — an abstract-only submission is not analyzed.
Graded against NIH, MDAR, ARRIVE 2.0, CONSORT, EQUATOR, and RRID guidelines. A dimension that doesn’t apply to the study type is skipped, never penalized.
This Kaimen Rigor review is model-assisted and is not a substitute for formal expert review. It complements human evaluation by surfacing potential methodological concerns — verify each finding against the source.