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: Αlpha¹ Rigor Record — 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: Αlpha¹

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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Αlpha¹ 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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Αlpha¹ Editorial

This rigor review was examined and confirmed by Αlpha¹ Editorial · August 15, 2026

Αlpha¹ Rigor Review

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

Problems surfaced4 types

Numerical inconsistencies1

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

Overstated conclusions2

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

Reporting gaps1

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

This Αlpha¹ 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.

Critical findings

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

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.

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.

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

2 integrity concerns flagged (0 high).

Reporting

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

direct quote[Introduction, paragraph 2]

“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.”