Rigor Reviewed

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Efficacy of dual antiplatelet therapy for three months versus 12 months after coronary artery bypass grafting: multicentre, double blinded, randomised controlled trial.

Name: Adcurare Rigor Record — Efficacy of dual antiplatelet therapy for three months versus 12 months after coronary artery bypass grafting: multicentre, double blinded, randomised controlled trial.
Item: Efficacy of dual antiplatelet therapy for three months versus 12 months after coronary artery bypass grafting: multicentre, double blinded, randomised controlled trial.
Rating: 96
Author: Adcurare

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

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Adcurare Rigor Review — 4.75★ (Strong), 0 critical, 3 high issues for “Efficacy of dual antiplatelet therapy for three months versus 12 months after coronary artery bypass grafting: multicentre, double blinded, randomised controlled trial.”

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This rigor review was examined and confirmed by Adcurare Editorial · July 6, 2026

Adcurare Rigor Review

Rigor Reviewed

4.75 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

ReportingEthical approvals partially met−0.25★

Model-reported confidence: highReviewer agreement: moderateEngine: 7.6.0Source: full text

Problems surfaced1 type

Ethics/consent reporting incomplete

This Adcurare Rigor Review uses AI 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 multicentre RCT with clear scientific premise, rigorous design, appropriate statistical methods, and transparent reporting. Minor gaps include missing explicit ethical framework citation, absent race/ethnicity reporting, lack of CONSORT guideline mention, and code sharing not in a version-controlled repository.

Evaluated based on full text by three independent reviewers; verification components checked citations (42 references, none retracted/unfound), statistics (3 tests recomputed consistently), and data link (live). The reviewers diverged on ethical approvals and data code availability; the synthesis resolved these conservatively based on specific evidence. Race/ethnicity was missing but does not affect the overall pass for biological variables.

12 major claims checked against the paper's own evidence: all adequately supported.

Recomputed 3 tests: 3 consistent, 0 inconsistent, 3 via agent-written checks.

Reporting

Eight Dimensions7 pass · 1 warn

Prior work is cited (e.g., PLATO, DACAB, POPular CABG) showing SVG occlusion reduction with ticagrelor DAPT but increased bleeding. The premise that thrombotic risk peaks early post-CABG is used to justify shorter DAPT. The limitation that short-term DAPT had not been tested in CABG is explicitly noted and addressed by the trial design.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The paper clearly establishes its scientific premise by citing prior research on SVG occlusion and DAPT benefits/risks, providing a logical rationale for testing shorter DAPT, and addressing gaps in prior work.

Evidence

paraphrase[Introduction, paragraph 1]

“The introduction cites studies showing up to 20% SVG occlusion within the first year and that ticagrelor-based DAPT reduces SVG failure but increases bleeding risk.”

direct quote[Introduction, paragraph 2]

“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.”

direct quote[Introduction, paragraph 2-3]

“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.”

PASSReviewer 2· 95% conf

The scientific premise is well established with cited prior work, a clear rationale, and limitations of prior research are addressed.

Evidence

direct quote[Introduction, paragraph 1]

“Despite the use of aspirin, up to 20% of patients requiring saphenous vein grafts (SVGs) experience occlusion within the first year after coronary artery bypass grafting (CABG), which is associated with poor outcomes. 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.”

direct quote[Introduction, paragraph 2]

“we tested the hypothesis that three months of DAPT with ticagrelor plus aspirin would be non-inferior to 12 months of treatment in SVG occlusion in patients undergoing CABG, while reducing the bleeding risk associated with prolonged treatment.”

direct quote[Discussion, 'Comparison with other studies' and 'Strengths and limitations of this study']

“A meta-analysis of three randomised trials found that ticagrelor based DAPT, compared with aspirin alone, was associated with a 44% lower risk of SVG failure...but a 154% higher risk of BARC type 2, 3, or 5 bleeding.”

PASSReviewer 3· 95% conf

The introduction clearly establishes the scientific premise, cites relevant prior research, and identifies a gap that the trial addresses.

Evidence

direct quote[Introduction, paragraph 1]

“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.”

direct quote[Introduction, paragraph 3]

“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 via central interactive web response with stratification and block size of 10. Blinding of patients, investigators, outcome assessors, adjudicators, and statisticians. Sample size calculation provided with assumptions and power >80% for joint hypotheses. Inclusion/exclusion criteria defined. Analysis populations (mITT, per protocol, as treated) pre-specified. Missing data handling described (multiple imputation, tipping point analysis).

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 98% conf

The study design is rigorous: a multicentre, double-blind, placebo-controlled RCT with appropriate randomization, blinding, sample size justification, and pre-specified analysis populations.

Evidence

direct quote[Methods, Randomisation and trial intervention, paragraph 2]

“Patients, investigators, outcome assessors, adjudicators, and statisticians were blinded to treatment assignments.”

paraphrase[Methods, Statistical analysis, paragraph 1]

“The sample size calculation assumed a 10% occlusion rate, 10% loss to follow-up, average 2.1 SVG segments per patient, and 90% power at one-sided α=0.025 for non-inferiority margin of 3.5%, yielding 2300 participants.”

direct quote[Methods, Patients, paragraph 1]

“Eligible patients were adults aged 18-80 years who had undergone elective primary CABG surgery with at least one SVG.”

PASSReviewer 2· 95% conf

The trial design is rigorous with clear randomization, blinding, power analysis, inclusion/exclusion criteria, and outlier handling.

Evidence

direct quote[Methods, 'Randomisation and trial intervention']

“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.”

direct quote[Methods, 'Randomisation and trial intervention']

“Patients, investigators, outcome assessors, adjudicators, and statisticians were blinded to treatment assignments. All study drugs, including placebo, were manufactured and supplied under good manufacturing practice standards with strict lot control and quality assurance to ensure consistency and blinding. Active and placebo tablets of identical appearance ensured blinding was maintained throughout the trial.”

direct quote[Methods, 'Statistical analysis']

“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.”

PASSReviewer 3· 98% conf

The trial design is rigorous: multicentre, double-blind, placebo-controlled, with clear randomization, blinding, power analysis, and pre-specified populations.

Evidence

direct quote[Methods, Randomisation and trial intervention]

“Patients, investigators, outcome assessors, adjudicators, and statisticians were blinded to treatment assignments.”

direct quote[Methods, Statistical analysis]

The paper reports sex (20.6% women), age (mean 61.5 years), weight, height, BMI, and a comprehensive list of comorbidities (diabetes, hypertension, etc.) and other health indicators such as creatinine, eGFR, LDL-C, LVEF. Sex is reported for both groups; the study enrolled both sexes, so sex justification is not applicable. Species/strain and housing conditions are not applicable for human trials. All applicable sub-criteria are adequate.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 85% conf

Sex, age, weight, and health status are reported in Table 1; demographics include age, sex, and comorbidities but race/ethnicity is not explicitly reported (likely homogeneous Chinese population).

Evidence

direct quote[Table 1]

“Women: 472 (20.6%); Mean (SD) age (years): 61.5 (8.4)”

absence[Table 1 and Methods]

Race/ethnicity is not explicitly reported.

PASSReviewer 2· 95% conf

Human participant demographics, age, weight, sex, health status are reported in detail; species/strain and housing are not applicable for a human trial.

Evidence

direct quote[Results, paragraph 1]

“The mean age was 61.5 years (SD 8.4), and 472 (20.6%) patients were women.”

direct quote[Table 1]

“Table 1 Baseline characteristics of included patients. Values are number (percentage) unless stated otherwise”

PASSReviewer 3· 85% conf

Key biological variables (age, sex, comorbidities) are reported, but race/ethnicity is not explicitly stated, though it can be inferred as Chinese.

Evidence

direct quote[Results, Table 1]

“Women | 472 (20.6) | 236 (20.5) | 236 (20.7)”

direct quote[Results, Table 1]

“Mean (SD) age (years) | 61.5 (8.4) | 61.3 (8.3) | 61.6 (8.5)”

absence[Results, Table 1 and text]

Race/ethnicity not explicitly reported.

The ethics statement names the central ethics committee at Fuwai Hospital with approval number 2022-1774, and states that all participants gave informed consent. The regulatory compliance statement mentions China's data privacy framework and GDPR alignment, but does not explicitly cite the Declaration of Helsinki or ICH-GCP, which is expected for clinical trials. Therefore, regulatory_compliance is reported_but_inadequate, triggering a warn status.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceINADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 95% conf

Ethics approval and informed consent are adequately reported, but the regulatory compliance statement does not name a recognized ethical framework (e.g., Declaration of Helsinki), making it inadequate.

Evidence

direct quote[Ethics statements]

“This study was approved by the central ethics committee at Fuwai Hospital (approval No 2022-1774) and the collaborating centres”

direct quote[Methods, Trial design and oversight, paragraph 1]

“All patients provided written informed consent.”

direct quote[Methods, Trial design and oversight, paragraph 1]

“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”

PASSReviewer 2· 95% conf

Ethics approval from a named committee with protocol number and informed consent are documented, along with regulatory compliance statements.

Evidence

direct quote[Ethics statements]

“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.”

direct quote[Methods, 'Trial design and oversight']

“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).”

WARNReviewer 3· 90% conf

Ethics approval is reported with a named committee and approval number, and informed consent is stated, but compliance with a recognized international ethical framework (e.g., Declaration of Helsinki) is not explicitly mentioned.

Evidence

direct quote[Ethics statements]

“This study was approved by the central ethics committee at Fuwai Hospital (approval No 2022-1774) and the collaborating centres”

direct quote[Methods, Trial design and oversight]

“All patients provided written informed consent.”

absence[Ethics statements and Methods]

No explicit mention of Declaration of Helsinki or similar framework.

Reagents_identified: The drugs are named with dose (ticagrelor 90 mg twice daily, aspirin 100 mg once daily) and manufacturer (Nanjing Zhengda Tianqing Pharmaceutical in funding statement). Placebo is described as matching. Software_tools_identified: SAS version 9.4 and R version 4.4.2 are specified. Other resources (antibodies, cell lines, etc.) are not applicable.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The investigational products (ticagrelor and aspirin) are adequately identified with dose, regimen, and manufacturer; statistical software is versioned.

Evidence

paraphrase[Methods, Randomisation and trial intervention, paragraph 1; Funding]

“The three-month and 12-month groups received ticagrelor 90 mg twice daily plus aspirin 100 mg once daily, with placebo matching. Drugs were provided by Nanjing Zhengda Tianqing Pharmaceutical.”

direct quote[Methods, Statistical analysis, final paragraph]

“All analyses were done using SAS (version 9.4) and R (version 4.4.2).”

PASSReviewer 2· 90% conf

The investigational product is a drug (ticagrelor and aspirin), which is identified by name, dose, and manufacturer; software tools are identified with versions.

Evidence

direct quote[Methods, 'Randomisation and trial intervention' and Funding]

“The 12 month group received 90 mg ticagrelor twice daily plus 100 mg aspirin once daily for one year after CABG.”

direct quote[Methods, 'Statistical analysis']

“All analyses were done using SAS (version 9.4) and R (version 4.4.2).”

PASSReviewer 3· 90% conf

The investigational drugs and statistical software are adequately identified. No wet-lab resources are used, so other sub-criteria are not applicable.

Evidence

direct quote[Methods, Randomisation and trial intervention; Funding]

“The 12 month group received 90 mg ticagrelor twice daily plus 100 mg aspirin once daily for one year after CABG.”

direct quote[Methods, Statistical analysis]

“All analyses were done using SAS (version 9.4) and R (version 4.4.2).”

direct quote[Funding]

“This trial received drugs from Nanjing Zhengda Tianqing Pharmaceutical.”

All seven sub-criteria are adequate. Tests named (GEE, Cox, Fine-Gray, χ², Fisher's exact). Assumptions verified: proportional hazards test for bleeding and landmark analysis. Exact p-values given (e.g., P=0.008 for non-inferiority, P<0.001 for bleeding superiority). Effect sizes with 95% CIs reported. Software identified with versions. Data presentation includes Kaplan-Meier curves, tables with n and rates, and per-group denominators. No mathematical implausibility detected.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Statistical methods are fully described, tests named, assumptions verified (including proportional hazards test), exact p-values reported, effect sizes with confidence intervals provided, software identified, and data presentation appropriate.

Evidence

paraphrase[Methods, Statistical analysis]

“GEE model for SVG occlusion, Cox regression for bleeding with proportional hazards test and landmark analysis when assumption violated, Fine-Gray regression for competing risk.”

direct quote[Results, Table 2 and text]

“P=0.008 for non-inferiority”

direct quote[Table 2]

“Absolute difference −0.31%, 95% CI −3.13% to 2.52%”

PASSReviewer 2· 90% conf

Statistical tests are named, assumptions verified, exact p-values reported alongside CIs, software identified, data presentation adequate, and mathematical plausibility checks pass.

Evidence

direct quote[Methods, 'Statistical analysis']

“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.”

direct quote[Results, paragraph 5]

“BARC type 2, 3, or 5 bleeding occurred in 95 patients (Kaplan-Meier rate 8.3%) in the three month DAPT group and 149 patients (Kaplan-Meier rate 13.2%) in the 12 month DAPT group (hazard ratio 0.62, 95% CI 0.48 to 0.81; P<0.001).”

direct quote[Table 2]

“Table 2 Primary outcomes and secondary outcomes by modified intention-to-treat analyses”

PASSReviewer 3· 95% conf

Statistical tests are named, assumptions verified for the primary bleeding analysis, exact p-values and effect sizes with CIs are reported, software is identified, and data presentation is appropriate for a large trial.

Evidence

direct quote[Methods, Statistical analysis]

“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...”

direct quote[Results, primary outcomes]

“P=0.008 for non-inferiority”

direct quote[Results, Table 2]

“absolute difference −0.31%, 95% CI −3.13% to 2.52%”

The data availability statement explicitly states that deidentified data and codes are available at Dryad with a persistent identifier. This is reported_and_adequate. The repository deposit is also adequate. Code sharing is included. No accession numbers are needed for this clinical trial. All applicable criteria are met.

Sub-criteria

code sharingADEQUATE

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 90% conf

Data availability statement is adequate with a Dryad DOI; code is also deposited but not in a version-controlled repository, which is a minor gap.

Evidence

direct quote[Data availability statement]

“Deidentified data and codes underlying the results reported in this manuscript are openly and publicly available at Dryad Digital Repository with a persistent identifier: https://doi.org/10.5061/dryad.jsxksn0qs”

PASSReviewer 2· 90% conf

Data and code are openly available with a persistent DOI; the data availability statement is concrete and adequate.

Evidence

direct quote[Data availability statement]

PASSReviewer 3· 95% conf

Data and code are openly available in a public repository (Dryad) with a persistent DOI. The data availability statement is concrete and includes a URL.

Evidence

direct quote[Data availability statement]

“Deidentified data and codes underlying the results reported in this manuscript are openly and publicly available at Dryad Digital Repository”

Methods are detailed and replicable. Trial registration number provided (NCT05380063). All primary and secondary outcomes are reported with effect estimates, including negative results. Limitations are discussed in 11 specific bullet points. Conclusions are cautious and acknowledge generalizability issues. Funding source and COI declarations are present. No reporting checklist (CONSORT) is explicitly referenced, but the paper follows CONSORT structure implicitly.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Reporting is thorough: methods complete, trial registered, all outcomes reported, limitations discussed in depth, conclusions proportional, funding and COI stated. The only gap is the absence of an explicit reporting guideline reference (e.g., CONSORT).

Evidence

direct quote[Abstract, Trial registration]

“ClinicalTrials.gov NCT05380063”

direct quote[Discussion, Strengths and limitations of this study]

“Firstly, a small proportion of patients did not complete the assessment of SVG occlusion... Secondly, 11.4% of patients did not adhere to the study drug...”

direct quote[Competing interests and Funding]

“The TOP-CABG trial was funded by the National Clinical Research Centre for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences (NCRC2022001).”

PASSReviewer 2· 90% conf

Methods are complete, trial is registered (NCT05380063), outcomes are all reported, limitations discussed, conclusions proportional, and funding/COI disclosed.

Evidence

direct quote[Abstract]

“Trial registration ClinicalTrials.gov NCT05380063 (https://clinicaltrials.gov/ct2/show/NCT05380063) .”

direct quote[Discussion, 'Strengths and limitations of this study']

“our large trial evaluated short term DAPT after CABG, providing robust statistical power. However, several limitations should be considered.”

direct quote[Funding and Competing interests]

“The TOP-CABG trial was funded by the National Clinical Research Centre for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences (NCRC2022001). This trial received drugs from Nanjing Zhengda Tianqing Pharmaceutical. The funders had no role in the design and conduct of the study...All authors have completed the ICMJE uniform disclosure form...and declare: support from the National Clinical Research Centre for Cardiovascular Diseases...no financial relationships...”

PASSReviewer 3· 90% conf

Methods are detailed, trial is registered, outcomes are fully reported, limitations are discussed extensively, conclusions are proportional, and funding/COI are disclosed. The only minor gap is no explicit mention of a reporting guideline (e.g., CONSORT).

Evidence

direct quote[Abstract; Methods]

“Trial registration ClinicalTrials.gov NCT05380063”

direct quote[Discussion, Strengths and limitations]

“However, several limitations should be considered. Firstly... Secondly...”

absence[Methods and discussion]

No explicit mention of CONSORT or equivalent.

4 copyedit issues flagged: mostly other, consistency, punctuation.

Checked 42 references: 42 verified.

Reproducibility

1 data/code link checked; 1 live.

Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.

Adcurare Rigor Action ItemsFinal pass before journal submission

The manuscript is of high quality and ready for submission after addressing several minor but important reporting gaps: adding a Declaration of Helsinki compliance statement, including race/ethnicity in Table 1, explicitly citing CONSORT, and clarifying that the code is version-controlled (or moving to GitHub with a DOI).

1.
HIGHethics
Add an explicit statement to the Ethics statements section that the trial was conducted in accordance with the Declaration of Helsinki (and/or ICH-GCP).
Clinical trial standards require explicit mention; reviewers flagged its absence as a reporting gap.
2.
HIGHreporting
Include race/ethnicity (e.g., 'Han Chinese') in Table 1 demographics.
Two reviewers noted the omission; reporting race/ethnicity is standard for human participant studies.
3.
HIGHreporting
Explicitly state adherence to CONSORT reporting guidelines in the Methods section (e.g., 'This trial is reported in accordance with the CONSORT 2010 statement').
The paper follows CONSORT structure but does not cite it; this is expected for journal submission.
4.
MEDIUMdata code
In the data availability statement, specify whether the code is version-controlled and consider citing a commit hash or using a repository like GitHub with a DOI.
Dryad is acceptable but not a version-controlled code repository; clarity improves reproducibility.
5.
MEDIUMcopyedit
Fix the period placement in the data availability statement: move the period before the space after the URL.
Typographical error noted by copyedit pass.
6.
MEDIUMcopyedit
Remove the indexing artifacts at the beginning of the paper ('3 bmj The BMJ...') and after the Abstract ('status released display-pdf...').
These are machine-generated metadata and should not appear in the submitted manuscript.
7.
MEDIUMreporting
Consider whether the secondary outcome 'venous or arterial graft occlusion' in the Abstract is redundant given the primary outcome is SVG occlusion; streamline if appropriate.
Copyedit flagged minor redundancy; concise outcome description improves clarity.
8.
LOWreporting
Add a brief justification for the non-inferiority margin (3.5%) linked to patient-important thresholds, if available.
One reviewer noted the margin was not empirically derived; stating its basis strengthens the design rationale.

Full text (53,371 chars)Analyzed: Jul 6, 2026

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Efficacy of dual antiplatelet therapy for three months versus 12 months after coronary artery bypass grafting: multicentre, double blinded, randomised controlled trial.

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Journal

DOI

10.1136/bmj-2025-088939

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