Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Stepwise dual antiplatelet therapy de-escalation in patients after drug coated balloon angioplasty (REC-CAGEFREE II): multicentre, randomised, open label, assessor blind, non-inferiority trial.

Name: Kaimen Rigor review — Stepwise dual antiplatelet therapy de-escalation in patients after drug coated balloon angioplasty (REC-CAGEFREE II): multicentre, randomised, open label, assessor blind, non-inferiority trial.
Item: Stepwise dual antiplatelet therapy de-escalation in patients after drug coated balloon angioplasty (REC-CAGEFREE II): multicentre, randomised, open label, assessor blind, non-inferiority trial.
Rating: 39
Author: Alpha1

Gao C, Zhu B, Ouyang F, Wen S, Xu Y, Jia W, Yang P, He Y, Zhong Y, Zhou Y, Guo Z, Shen G, Ma L, Xu L, Xue Y, Hu T, Wang Q, Liu Y, Zhang R, Liu J, Jiang Z, Xia J, Garg S, van Geuns RJ, Capodanno D, Onuma Y, Wang D, Serruys P, Tao L, REC-CAGEFREE II Investigators

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Kaimen Rigor review — 1★ (Critical), 1 critical, 3 high issues for “Stepwise dual antiplatelet therapy de-escalation in patients after drug coated balloon angioplasty (REC-CAGEFREE II): multicentre, randomised, open label, assessor blind, non-inferiority trial.”

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This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

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Stepwise dual antiplatelet therapy de-escalation in patients after drug coated balloon angioplasty (REC-CAGEFREE II): multicentre, randomised, open label, assessor blind, non-inferiority trial.

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DOI

10.1136/bmj-2024-082945

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Stepwise dual antiplatelet therapy de-escalation in patients after drug coated balloon angioplasty (REC-CAGEFREE II): multicentre, randomised, open label, assessor blind, non-inferiority trial.

Paper source

Stepwise dual antiplatelet therapy de-escalation in patients after drug coated balloon angioplasty (REC-CAGEFREE II): multicentre, randomised, open label, assessor blind, non-inferiority trial.

Read full text (PMC)

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Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

1 / 5

Critical — a demonstrable failure

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

StatisticsImpossible or misreported statistic−1★
IntegrityIntegrity concern ×2−1★
ReportingData & code availability partially met−0.25★

A demonstrable critical failure caps the rating at the minimum, regardless of the deductions above.

Model-reported confidence: moderateReviewer agreement: highEngine: 7.39.0Source: full text

Biggest issues1 demonstrable

01Significance claim does not survive recomputationdemonstrable
criticalOverreachrecomputedFull detail
Primary endpoint non-inferiority p-value from reported difference and CI
“The 0.36% difference in the cumulative event rate and the upper boundary of the one sided 95% CI 2.47% met the prespecified criteria of 3.2% for non-inferiority (P non-inferiority =0.013, and ).”
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Findings by category

101ArithmeticNumerical inconsistencies 202OverreachOverstated conclusions 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found 06Copyedit4 minor suggestions

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.

This is a well-designed and transparently reported randomised non-inferiority trial with strong methodology, clear ethical approvals, and comprehensive reporting. The main weaknesses are a vague data-sharing statement and a potential inconsistency in the primary non-inferiority p-value that warrants verification.

Both reviewers agreed on study type (interventional) and on all dimensions except statistical analysis, where the deterministic recomputation found an inconsistency that overrides the reviewers' pass. The statistics component only checked a subset of reported tests; other statistics remain unverified.

Numerical inconsistencies

1 finding · worst low

Values 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.

Internal contradictions in the reported numbersAssessed

Recomputed 3 tests: 2 consistent, 1 inconsistent (1 change significance at p<.05); 3 via agent-written checks.

Overstated conclusions

2 findings · worst critical

Conclusions 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.

Significance claim flips when recomputedRecomputed
Conclusions only partially backed by the presented evidenceAssessed

5 major claims checked against the paper's own evidence: 1 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

Data authenticity concerns

None found

An 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

1 finding · worst medium

Required 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/code availability incompleteAssessed

Eight Dimensions7 pass · 1 warn

The paper cites prior trials (BASKET-SMALL 2, DEBUT, AGENT IDE) and real-world registries to establish the premise that DCB-treated patients may need less intense antiplatelet therapy. It explicitly states that randomised data on optimal DAPT for DCB are lacking, providing a logical rationale for the study. Limitations of prior work are indirectly addressed by noting the absence of dedicated trials, though not deeply critiqued.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The introduction establishes a clear clinical rationale for investigating a less intense antiplatelet regimen in DCB-treated patients, citing prior research and identifying a gap in randomised evidence.

Evidence

“Among the randomised studies investigating DCBs, such as the BASKET-SMALL 2 trial for de novo small-vessel disease, the DEBUT trial for patients with high bleeding risk, and the AGENT IDE trial for in-stent restenosis, nearly half of the participants had acute coronary syndrome.”

Introduction ¶2Find in source

“randomised data investigating the optimal DAPT regimen for the patients receiving DCB is lacking.”

Introduction ¶3Find in source

“Patients who receive exclusive treatment with DCBs may have the theoretical advantage of adopting a low intensity antiplatelet regimen because of the absence of a metallic scaffold and polymer inside the coronary artery, as well as the shorter local retention of the anti-proliferative drug.”

Introduction ¶2Find in source

PASSReviewer 2· 90% conf

The introduction establishes a clear clinical rationale for investigating a less intense antiplatelet regimen in DCB-treated patients, citing prior research and identifying a gap in randomised data.

Evidence

Introduction ¶2Find in source

“However, despite extensive research on the optimal antiplatelet strategy for patients with acute coronary syndrome treated with drug eluting stents, randomised data investigating the optimal DAPT regimen for the patients receiving DCB is lacking.”

Introduction ¶3Find in source

“We aimed to evaluate a stepwise DAPT de-escalation strategy compared with standard 12 months DAPT with respect to clinical outcomes, including both ischaemic and bleeding events.”

Introduction ¶3Find in source

Randomisation used a web-based centralised system with computer-generated dynamic permuted blocks, stratified by site and lesion type. Blinding is described: patients and investigators were not masked, but the clinical event committee and statisticians were masked. A priori power analysis is reported with assumptions and non-inferiority margin. Inclusion/exclusion criteria are pre-specified and listed in the appendix. Outlier handling is addressed through ITT and per-protocol analyses, and missing data are handled by censoring at last contact. Controls are inherent in the comparator arm (standard DAPT). Independent replication is not applicable for a single pivotal trial.

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial design is rigorous: randomised, open label with blinded endpoint adjudication, pre-specified sample size, and clear inclusion/exclusion criteria.

Evidence

“Randomisation sequences were computer generated with the dynamic permuted block method, with block sizes of two or four, and stratified by site and the type of lesion being treated (de novo or in-stent restenosis).”

MethodsFind in source

“members of the independent clinical event committee who adjudicated the endpoints and statisticians who developed the statistical programmes were masked to treatment allocation.”

MethodsFind in source

“Considering an anticipated 5% patient attrition rate, 1908 patients were required for the study to have 80% power to show non-inferiority with a 5% one sided type I error rate.”

Statistical analysisFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous: randomised, open label with blinded endpoint adjudication, pre-specified sample size, and clear inclusion/exclusion criteria.

Evidence

MethodsFind in source

“Patients and the investigators were not masked to treatment allocation; however, members of the independent clinical event committee who adjudicated the endpoints and statisticians who developed the statistical programmes were masked to treatment allocation.”

MethodsFind in source

“Considering an anticipated 5% patient attrition rate, 1908 patients were required for the study to have 80% power to show non-inferiority with a 5% one sided type I error rate.”

Statistical analysisFind in source

The paper reports sex (74.9% men), age (mean 59.2 years), and extensive demographics and comorbidities in Table 1. Age and health status are reported. Since both sexes are enrolled, sex_justified is not applicable. Species/strain and housing conditions are not applicable for a human trial.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Demographic and clinical characteristics are comprehensively reported, including age, sex, comorbidities, and risk scores.

Evidence

“Age, years; mean (SD) | 59.4 (10.7) | 59.0 (11.0) | | Sex: | | Female | 248/975 (25.4) | 240/973 (24.7) | | Male | 727/975 (74.6) | 733/973 (75.3)”

Table 1Find in source

“Overall, the mean age of patients was 59.2 years; 74.9% of the patients were men, 30.5% had diabetes, 8.8% had history of a stroke, 13.2% had history of a myocardial infarction, 32.2% had history of a percutaneous coronary intervention, and 20.6% were defined as at high bleeding risk”

Results ¶1Find in source

PASSReviewer 2· 90% conf

Demographic and clinical characteristics are comprehensively reported, including age, sex, comorbidities, and risk scores.

Evidence

“Overall, the mean age of patients was 59.2 years; 74.9% of the patients were men”

Results ¶1Find in source

“Age, years; mean (SD) | 59.4 (10.7) | 59.0 (11.0)”

Table 1Find in source

The protocol was approved by the ethics committee of Xijing Hospital (ID: KY20212080-F-1) and responsible ethics committees in all participating centres. Written informed consent was obtained from all patients. The trial was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approval from a named ethics committee and written informed consent are documented, along with regulatory compliance.

Evidence

“the protocol was approved by the ethics committee of Xijing Hospital (ID: KY20212080-F-1) and responsible ethics committees in all participating centres.”

MethodsFind in source

“Written informed consent was obtained from all patients.”

MethodsFind in source

“The trial was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines”

MethodsFind in source

PASSReviewer 2· 95% conf

Ethical approval from a named ethics committee and written informed consent are documented, along with compliance with the Declaration of Helsinki and GCP.

Evidence

“The trial was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines, and the protocol was approved by the ethics committee of Xijing Hospital (ID: KY20212080-F-1) and responsible ethics committees in all participating centres.”

MethodsFind in source

“Written informed consent was obtained from all patients.”

MethodsFind in source

“Clinicaltrials.gov NCT04971356 (https://clinicaltrials.gov/ct2/show/NCT04971356)”

AbstractFind in source

The trial uses paclitaxel-coated balloons (manufacturer Yinyi Biotech) and antiplatelet drugs (aspirin, ticagrelor, clopidogrel) with doses specified. The DCB brands are summarised in table S2. Statistical software (R version 4.2.1) is identified. Bench criteria (antibodies, cell lines, mycoplasma) are not applicable. Reagents are adequately identified for a clinical trial.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

The investigational product (paclitaxel-coated balloon) and antiplatelet drugs are identified with manufacturer and dosing, and statistical software is named.

Evidence

“For maintenance, aspirin was prescribed at 100 mg daily and ticagrelor was prescribed at 90 mg twice daily.”

MethodsFind in source

“The analysis was done using R statistical software version 4.2.1 (R Project for statistical computing).”

Statistical analysisFind in source

“brands and features of DCBs used are summarised in table S2”

MethodsFind in source

PASSReviewer 2· 90% conf

The investigational product (paclitaxel-coated balloon) and antiplatelet drugs are identified with manufacturer and dosing, and statistical software is named.

Evidence

“Yinyi Biotech manufactures paclitaxel coated balloons”

FundingFind in source

“For maintenance, aspirin was prescribed at 100 mg daily and ticagrelor was prescribed at 90 mg twice daily.”

MethodsFind in source

“The analysis was done using R statistical software version 4.2.1 (R Project for statistical computing).”

Statistical analysisFind in source

The paper names statistical tests (Kaplan-Meier, Greenwood's method, approximate z test, win ratio) and reports exact p-values and 95% CIs. Assumptions are handled by design (covariate-adjusted analysis, competing risk sensitivity). Software is identified. Data presentation includes Kaplan-Meier curves and per-group n. Mathematical plausibility checks: primary endpoint counts (87/975=8.9%, 84/973=8.6%) are consistent; BARC 3/5 bleeding (4 vs 16) yields difference -1.19% (95% CI -2.07 to -0.31) which is plausible. No demonstrable errors.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well-described, with exact p-values and confidence intervals reported; no arithmetic inconsistencies found.

Evidence

“The cumulative event rate was estimated at 360 days by the Kaplan-Meier method, with the standard error of difference calculated using Greenwood's method and P value calculated using an approximate z test.”

Statistical analysisFind in source

“BARC type 3 or 5 bleeding | 4 (0.4) | 16 (1.6) | −1.19 (−2.07 to −0.31) | 0.008”

Table 2Find in source

“The analysis was done using R statistical software version 4.2.1 (R Project for statistical computing).”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

Statistical methods are well described, including tests, covariate adjustment, and handling of non-inferiority; effect sizes with CIs are reported.

Evidence

Statistical analysisFind in source

“P non-inferiority =0.013”

AbstractFind in source

“BARC type 3 or 5 bleeding occurred in four versus 16 participants (0.4% v 1.6%, difference −1.19% (95% CI −2.07% to −0.31%), P=0.008)”

AbstractFind in source

The data availability statement says patient-level data 'will not be made publicly available but will be available for data sharing on request for collaboration on specific projects.' This is reported_but_inadequate because it lacks a named platform, conditions, or timeframe. Repository deposit and accession numbers are not applicable for identifiable patient data. Code sharing is not applicable as no bespoke code is mentioned.

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 90% conf

A data availability statement exists but is vague, offering data 'on request' without a clear mechanism or timeframe.

Evidence

“Patient level data collected for this study will not be made publicly available but will be available for data sharing on request for collaboration on specific projects.”

Data availabilityFind in source

WARNReviewer 2· 90% conf

A data availability statement exists but is vague, offering data 'on request' without a clear mechanism or timeframe.

Evidence

“Patient level data collected for this study will not be made publicly available but will be available for data sharing on request for collaboration on specific projects.”

Data availabilityFind in source

The trial is registered at ClinicalTrials.gov (NCT04971356). Methods are detailed enough for replication. All pre-specified outcomes are reported, including negative results. Limitations are explicitly discussed. Conclusions are proportional to the evidence. Funding sources and competing interests are declared.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineINADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The manuscript is transparent: registered, reports all outcomes, discusses limitations, and provides funding and COI statements.

Evidence

“Clinicaltrials.gov NCT04971356 (https://clinicaltrials.gov/ct2/show/NCT04971356)”

AbstractFind in source

“This study has several limitations. Firstly, the sample size calculation for non-inferiority was based on a one sided α of 5%; nevertheless, the sensitivity analysis using a one sided α of 2.5% still showed non-inferiority.”

LimitationsFind in source

“The study received unrestricted grant support from Yinyi Biotech (Dalian, China).”

FundingFind in source

PASSReviewer 2· 95% conf

The manuscript is transparent: methods are detailed, trial is registered, limitations are discussed, conclusions are proportional, and funding/COI are disclosed.

Evidence

“Clinicaltrials.gov NCT04971356 (https://clinicaltrials.gov/ct2/show/NCT04971356)”

AbstractFind in source

LimitationsFind in source

“The study received unrestricted grant support from Yinyi Biotech (Dalian, China).”

FundingFind in source

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

Broken references and links

None found

References 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.

Checked — nothing surfaced.

Checked 44 references by DOI: 44 verified.

1 data/code link checked; 1 live.

Copyediting

4 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 4 minor suggestions below.

4 copyedit issues flagged: mostly clarity, consistency, typo.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is generally robust, but the primary non-inferiority p-value inconsistency is a validity concern that an informed reader should weigh; an erratum or independent re-analysis may be warranted. The vague data-sharing statement is a transparency gap.

1.
CRITICALstatistics
Resolve the statistics inconsistency that flips a significance claim: Recomputed 3 tests: 2 consistent, 1 inconsistent (1 change significance at p<.05); 3 via agent-written checks.
Demonstrable critical failure — blocks the verdict from passing.
2.
HIGHstatistics
Re-verify the primary non-inferiority p-value (reported P=0.013) against the reported difference and CI; if the recomputed value (P=0.738) is correct, issue a correction or re-analysis.
The deterministic recomputation found a large discrepancy that could affect the trial's primary conclusion.
3.
HIGHdata code
Enhance the data availability statement to specify a concrete access mechanism (e.g., data-access committee or platform like Vivli) and include conditions and a timeframe for requests.
The current 'on request' statement is vague and does not meet transparency standards for reproducibility.
4.
HIGHreporting
Explicitly state adherence to CONSORT in the methods or provide a completed CONSORT checklist.
The trial is a randomised controlled trial and explicit CONSORT adherence would strengthen reporting transparency.
5.
MEDIUMreporting
Clarify the race/ethnicity breakdown of participants in the baseline table, as it is collected but not reported.
Enhances demographic transparency and generalisability assessment.
6.
MEDIUMdata code
Add a statement about the availability of the statistical analysis code, even if not publicly shared.
Improves reproducibility and transparency of the analysis.
7.
MEDIUMstatistics
Report exact p-values for all secondary endpoints in the main text, as some are only given as '<0.001'.
Provides more precise information for readers and facilitates verification.
8.
MEDIUMreporting
Clarify the handling of missing data for covariates in the adjusted analysis.
The current description is incomplete and could affect reproducibility.
9.
MEDIUMcopyedit
Standardise p-value formatting in the abstract (e.g., 'P=0.013' instead of 'P non-inferiority =0.013').
Minor formatting inconsistency that could be cleaned up.
10.
MEDIUMcopyedit
Clarify the direction of the treatment difference in the statistical analysis section.
The current wording is ambiguous and could confuse readers.
11.
LOWcopyedit
Clarify the Table 2 footnote that percentages are Kaplan-Meier estimates and not simple proportions.
The note is helpful but could be more explicit to avoid misinterpretation.
12.
LOWcopyedit
Ensure consistent terminology for device length (e.g., 'mean device length' vs 'Total DCB length').
Potential inconsistency in terminology could confuse readers.

Full text (51,812 chars)Analyzed: Aug 15, 2026

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Stepwise dual antiplatelet therapy de-escalation in patients after drug coated balloon angioplasty (REC-CAGEFREE II): multicentre, randomised, open label, assessor blind, non-inferiority trial.

Read full text (PMC)

DOI

10.1136/bmj-2024-082945

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Record fingerprint

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Issued Aug 15, 2026Engine 7.39.0

Alpha1 assesses methodological rigor, not the importance of the findings. See how we calibrate →

Kaimen Rigor review

Kaimen Rigor reviewed

1 / 5

Critical — a demonstrable failure

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

StatisticsImpossible or misreported statistic−1★
IntegrityIntegrity concern ×2−1★
ReportingData & code availability partially met−0.25★

A demonstrable critical failure caps the rating at the minimum, regardless of the deductions above.

Model-reported confidence: moderateReviewer agreement: highEngine: 7.39.0Source: full text

Biggest issues1 demonstrable

01Significance claim does not survive recomputationdemonstrable
criticalOverreachrecomputedFull detail
Primary endpoint non-inferiority p-value from reported difference and CI
“The 0.36% difference in the cumulative event rate and the upper boundary of the one sided 95% CI 2.47% met the prespecified criteria of 3.2% for non-inferiority (P non-inferiority =0.013, and ).”
Find in source

Findings by category

101ArithmeticNumerical inconsistencies 202OverreachOverstated conclusions 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found 06Copyedit4 minor suggestions

Numerical inconsistencies

1 finding · worst low

Internal contradictions in the reported numbersAssessed

Recomputed 3 tests: 2 consistent, 1 inconsistent (1 change significance at p<.05); 3 via agent-written checks.

Overstated conclusions

2 findings · worst critical

Significance claim flips when recomputedRecomputed
Conclusions only partially backed by the presented evidenceAssessed

5 major claims checked against the paper's own evidence: 1 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

Data authenticity concerns

None found

Checked — nothing surfaced.

Reporting gaps

1 finding · worst medium

Data/code availability incompleteAssessed

Eight Dimensions7 pass · 1 warn

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Evidence

Introduction ¶2Find in source

“randomised data investigating the optimal DAPT regimen for the patients receiving DCB is lacking.”

Introduction ¶3Find in source

Introduction ¶2Find in source

PASSReviewer 2· 90% conf

The introduction establishes a clear clinical rationale for investigating a less intense antiplatelet regimen in DCB-treated patients, citing prior research and identifying a gap in randomised data.

Evidence

Introduction ¶2Find in source

Introduction ¶3Find in source

“We aimed to evaluate a stepwise DAPT de-escalation strategy compared with standard 12 months DAPT with respect to clinical outcomes, including both ischaemic and bleeding events.”

Introduction ¶3Find in source

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial design is rigorous: randomised, open label with blinded endpoint adjudication, pre-specified sample size, and clear inclusion/exclusion criteria.

Evidence

MethodsFind in source

“members of the independent clinical event committee who adjudicated the endpoints and statisticians who developed the statistical programmes were masked to treatment allocation.”

MethodsFind in source

“Considering an anticipated 5% patient attrition rate, 1908 patients were required for the study to have 80% power to show non-inferiority with a 5% one sided type I error rate.”

Statistical analysisFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous: randomised, open label with blinded endpoint adjudication, pre-specified sample size, and clear inclusion/exclusion criteria.

Evidence

MethodsFind in source

“Considering an anticipated 5% patient attrition rate, 1908 patients were required for the study to have 80% power to show non-inferiority with a 5% one sided type I error rate.”

Statistical analysisFind in source

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Demographic and clinical characteristics are comprehensively reported, including age, sex, comorbidities, and risk scores.

Evidence

“Age, years; mean (SD) | 59.4 (10.7) | 59.0 (11.0) | | Sex: | | Female | 248/975 (25.4) | 240/973 (24.7) | | Male | 727/975 (74.6) | 733/973 (75.3)”

Table 1Find in source

Results ¶1Find in source

PASSReviewer 2· 90% conf

Demographic and clinical characteristics are comprehensively reported, including age, sex, comorbidities, and risk scores.

Evidence

“Overall, the mean age of patients was 59.2 years; 74.9% of the patients were men”

Results ¶1Find in source

“Age, years; mean (SD) | 59.4 (10.7) | 59.0 (11.0)”

Table 1Find in source

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approval from a named ethics committee and written informed consent are documented, along with regulatory compliance.

Evidence

“the protocol was approved by the ethics committee of Xijing Hospital (ID: KY20212080-F-1) and responsible ethics committees in all participating centres.”

MethodsFind in source

“Written informed consent was obtained from all patients.”

MethodsFind in source

“The trial was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines”

MethodsFind in source

PASSReviewer 2· 95% conf

Ethical approval from a named ethics committee and written informed consent are documented, along with compliance with the Declaration of Helsinki and GCP.

Evidence

MethodsFind in source

“Written informed consent was obtained from all patients.”

MethodsFind in source

“Clinicaltrials.gov NCT04971356 (https://clinicaltrials.gov/ct2/show/NCT04971356)”

AbstractFind in source

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

The investigational product (paclitaxel-coated balloon) and antiplatelet drugs are identified with manufacturer and dosing, and statistical software is named.

Evidence

“For maintenance, aspirin was prescribed at 100 mg daily and ticagrelor was prescribed at 90 mg twice daily.”

MethodsFind in source

“The analysis was done using R statistical software version 4.2.1 (R Project for statistical computing).”

Statistical analysisFind in source

“brands and features of DCBs used are summarised in table S2”

MethodsFind in source

PASSReviewer 2· 90% conf

The investigational product (paclitaxel-coated balloon) and antiplatelet drugs are identified with manufacturer and dosing, and statistical software is named.

Evidence

“Yinyi Biotech manufactures paclitaxel coated balloons”

FundingFind in source

“For maintenance, aspirin was prescribed at 100 mg daily and ticagrelor was prescribed at 90 mg twice daily.”

MethodsFind in source

“The analysis was done using R statistical software version 4.2.1 (R Project for statistical computing).”

Statistical analysisFind in source

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well-described, with exact p-values and confidence intervals reported; no arithmetic inconsistencies found.

Evidence

Statistical analysisFind in source

“BARC type 3 or 5 bleeding | 4 (0.4) | 16 (1.6) | −1.19 (−2.07 to −0.31) | 0.008”

Table 2Find in source

“The analysis was done using R statistical software version 4.2.1 (R Project for statistical computing).”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

Statistical methods are well described, including tests, covariate adjustment, and handling of non-inferiority; effect sizes with CIs are reported.

Evidence

Statistical analysisFind in source

“P non-inferiority =0.013”

AbstractFind in source

“BARC type 3 or 5 bleeding occurred in four versus 16 participants (0.4% v 1.6%, difference −1.19% (95% CI −2.07% to −0.31%), P=0.008)”

AbstractFind in source

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 90% conf

A data availability statement exists but is vague, offering data 'on request' without a clear mechanism or timeframe.

Evidence

“Patient level data collected for this study will not be made publicly available but will be available for data sharing on request for collaboration on specific projects.”

Data availabilityFind in source

WARNReviewer 2· 90% conf

A data availability statement exists but is vague, offering data 'on request' without a clear mechanism or timeframe.

Evidence

“Patient level data collected for this study will not be made publicly available but will be available for data sharing on request for collaboration on specific projects.”

Data availabilityFind in source

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineINADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The manuscript is transparent: registered, reports all outcomes, discusses limitations, and provides funding and COI statements.

Evidence

“Clinicaltrials.gov NCT04971356 (https://clinicaltrials.gov/ct2/show/NCT04971356)”

AbstractFind in source

LimitationsFind in source

“The study received unrestricted grant support from Yinyi Biotech (Dalian, China).”

FundingFind in source

PASSReviewer 2· 95% conf

The manuscript is transparent: methods are detailed, trial is registered, limitations are discussed, conclusions are proportional, and funding/COI are disclosed.

Evidence

“Clinicaltrials.gov NCT04971356 (https://clinicaltrials.gov/ct2/show/NCT04971356)”

AbstractFind in source

LimitationsFind in source

“The study received unrestricted grant support from Yinyi Biotech (Dalian, China).”

FundingFind in source

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

Broken references and links

None found

References 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.

Checked — nothing surfaced.

Checked 44 references by DOI: 44 verified.

1 data/code link checked; 1 live.

Copyediting

4 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 4 minor suggestions below.

4 copyedit issues flagged: mostly clarity, consistency, typo.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
CRITICALstatistics
Resolve the statistics inconsistency that flips a significance claim: Recomputed 3 tests: 2 consistent, 1 inconsistent (1 change significance at p<.05); 3 via agent-written checks.
Demonstrable critical failure — blocks the verdict from passing.
2.
HIGHstatistics
Re-verify the primary non-inferiority p-value (reported P=0.013) against the reported difference and CI; if the recomputed value (P=0.738) is correct, issue a correction or re-analysis.
The deterministic recomputation found a large discrepancy that could affect the trial's primary conclusion.
3.
HIGHdata code
Enhance the data availability statement to specify a concrete access mechanism (e.g., data-access committee or platform like Vivli) and include conditions and a timeframe for requests.
The current 'on request' statement is vague and does not meet transparency standards for reproducibility.
4.
HIGHreporting
Explicitly state adherence to CONSORT in the methods or provide a completed CONSORT checklist.
The trial is a randomised controlled trial and explicit CONSORT adherence would strengthen reporting transparency.
5.
MEDIUMreporting
Clarify the race/ethnicity breakdown of participants in the baseline table, as it is collected but not reported.
Enhances demographic transparency and generalisability assessment.
6.
MEDIUMdata code
Add a statement about the availability of the statistical analysis code, even if not publicly shared.
Improves reproducibility and transparency of the analysis.
7.
MEDIUMstatistics
Report exact p-values for all secondary endpoints in the main text, as some are only given as '<0.001'.
Provides more precise information for readers and facilitates verification.
8.
MEDIUMreporting
Clarify the handling of missing data for covariates in the adjusted analysis.
The current description is incomplete and could affect reproducibility.
9.
MEDIUMcopyedit
Standardise p-value formatting in the abstract (e.g., 'P=0.013' instead of 'P non-inferiority =0.013').
Minor formatting inconsistency that could be cleaned up.
10.
MEDIUMcopyedit
Clarify the direction of the treatment difference in the statistical analysis section.
The current wording is ambiguous and could confuse readers.
11.
LOWcopyedit
Clarify the Table 2 footnote that percentages are Kaplan-Meier estimates and not simple proportions.
The note is helpful but could be more explicit to avoid misinterpretation.
12.
LOWcopyedit
Ensure consistent terminology for device length (e.g., 'mean device length' vs 'Total DCB length').
Potential inconsistency in terminology could confuse readers.

Full text (51,812 chars)Analyzed: Aug 15, 2026