Rigor Reviewed

Rigor-Reviewed Manuscript

Fractional Flow Reserve-Guided Complete vs Culprit-Only Revascularization in Non-ST-Elevation Myocardial Infarction and Multivessel Disease: The SLIM Randomized Clinical Trial.

Name: Αlpha¹ Rigor Record — Fractional Flow Reserve-Guided Complete vs Culprit-Only Revascularization in Non-ST-Elevation Myocardial Infarction and Multivessel Disease: The SLIM Randomized Clinical Trial.
Item: Fractional Flow Reserve-Guided Complete vs Culprit-Only Revascularization in Non-ST-Elevation Myocardial Infarction and Multivessel Disease: The SLIM Randomized Clinical Trial.
Rating: 96
Author: Αlpha¹

Pustjens TFS, Veenstra L, Camaro C, Ruiters AW, Lux Á, Ruzsa Z, Piroth Z, Ilhan M, Vainer J, Gho B, Winkler PJC, Stein M, Theunissen RALJ, Kala P, Polad J, Berta B, Gabrio A, van Royen N, van 't Hof AWJ, Rasoul S

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Αlpha¹ Rigor Review — 3.25★ (Adequate), 0 critical, 1 high issue for “Fractional Flow Reserve-Guided Complete vs Culprit-Only Revascularization in Non-ST-Elevation Myocardial Infarction and Multivessel Disease: The SLIM Randomized Clinical Trial.”

Links back to this Rigor Record.

Αlpha¹ Editorial

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

Αlpha¹ Rigor Review

Rigor Reviewed

3.25 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×3−1.5★
ReportingData & code availability partially met−0.25★

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

Not verified in this report

No data or code availability links were detected to verify.

Problems surfaced3 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

Data authenticity concerns1

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.

Other integrity concernAssessed

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.

This is a well-conducted and well-reported randomized clinical trial with a clear scientific premise, rigorous design, and transparent reporting. The main weakness is the vague data availability statement, which lacks concrete access details. Minor gaps include incomplete specification of some reagents and minor copyedit issues.

Both reviewers independently scored all eight dimensions and agreed on all statuses, so no divergence needed reconciliation. The study type is interventional (randomized controlled trial). Non-applicable sub-criteria (e.g., animal housing, cell line authentication) were excluded from scoring. The statistics verification covered only a subset of tests; the rest remain unverified but no errors were found.

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

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

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

3 integrity concerns flagged (0 high).

Reporting

Eight Dimensions7 pass · 1 warn

The introduction cites prior observational data and randomized trials (e.g., FIRE, SMILE) and notes the limitations of existing evidence, including reliance on visual assessment and mixed STEMI/NSTEMI populations. The rationale for using FFR-guided complete revascularization is clearly linked to the study objective. Limitations of prior research are addressed by the study design (e.g., broader NSTEMI population, FFR-guided approach).

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise with adequate citation of prior work and a logical rationale for the study.

Evidence

paraphrase[Introduction, paragraph 1]

“Evidence supporting complete revascularization in patients with STEMI and multivessel disease is well-established, but evidence in NSTEMI remains limited and is largely based on observational data.”

direct quote[Introduction, paragraph 2]

“Therefore, this study aimed to investigate whether use of FFR-guided complete revascularization of all significant nonculprit lesions improved clinical outcomes compared with culprit-only revascularization during the index procedure in patients with NSTEMI and multivessel disease.”

paraphrase[Discussion, paragraph 3]

“Nevertheless, in the aforementioned studies, physiology guided revascularization was used in less than one-fourth of the participants.”

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise by citing prior observational data and randomized trials, and it identifies the gap in evidence for FFR-guided complete revascularization in NSTEMI.

Evidence

paraphrase[Introduction, paragraph 1]

direct quote[Introduction, last paragraph]

paraphrase[Discussion, paragraph 3]

“Nevertheless, in the aforementioned studies, physiology guided revascularization was used in less than one-fourth of the participants.”

Randomization method (computer-generated, block size 4) and unit (patient) are reported. Blinding is not possible due to the interventional nature, but the open-label design is acknowledged and outcome adjudication was blinded. A sample size calculation with updated event rate is provided. Inclusion/exclusion criteria are pre-specified. Outlier handling is not explicitly described, but the analysis population (as randomized) and per-protocol/as-treated analyses are defined. Controls are inherent in the comparator arm. Independent replication is not applicable for a single pivotal trial.

Sub-criteria

controlsN/A

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 with adequate randomization, blinding of outcome adjudication, power analysis, and pre-specified inclusion/exclusion criteria.

Evidence

direct quote[Methods, Randomization and Study Treatment]

“eligible patients were randomized in a 1:1 ratio using a computer-generated online randomization tool to receive either immediate FFR-guided complete revascularization or culprit-only PCI, with a block size of 4.”

paraphrase[Methods, Primary and Secondary Outcomes]

“An independent event adjudication committee, which consisted of clinicians who were unaware of the treatment assignments, adjudicated all potential outcomes.”

direct quote[Methods, Sample Size]

“Using this updated estimate, a sample size of 226 patients per group was needed to achieve 80% power with a 2-sided α of 5%.”

PASSReviewer 2· 95% conf

The trial design is rigorous with clear randomization, blinding of outcome adjudication, prespecified sample size, and explicit inclusion/exclusion criteria.

Evidence

direct quote[Methods, Randomization and Study Treatment]

paraphrase[Methods, Primary and Secondary Outcomes]

“An independent event adjudication committee, which consisted of clinicians who were unaware of the treatment assignments, adjudicated all potential outcomes.”

direct quote[Methods, Sample Size]

“Using this updated estimate, a sample size of 226 patients per group was needed to achieve 80% power with a 2-sided α of 5%.”

Sex is reported for all participants (72.9% male). Age and health status (comorbidities, GRACE score) are reported. Demographics include age, sex, and comorbidities; race/ethnicity is not reported, which is common in cardiovascular trials. 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 well reported, including sex, age, and comorbidities.

Evidence

direct quote[Results, Baseline Characteristics]

“the majority of patients were male (347 [72.9%])”

direct quote[Results, Baseline Characteristics]

“The mean (SD) age was 65.9 years (10.6)”

direct quote[Table 1]

“Diabetes 65 (27.3) 41 (17.2)”

PASSReviewer 2· 90% conf

Demographic and clinical characteristics are well reported, including age, sex, and comorbidities.

Evidence

direct quote[Results, Baseline Characteristics]

“the majority of patients were male (347 [72.9%])”

direct quote[Results, Baseline Characteristics]

“The mean (SD) age was 65.9 years (10.6)”

direct quote[Table 1]

“Diabetes 65 (27.3) 41 (17.2)”

The protocol was approved by a named ethics committee (medical ethical committee of the Zuyderland Medical Center, protocol number 17-T-142). Informed consent was obtained orally in the presence of an independent third person and subsequently in writing. Regulatory compliance is implied by adherence to CONSORT and the Declaration of Helsinki is not explicitly named, but the approval statement is sufficient.

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 and informed consent are adequately documented.

Evidence

paraphrase[Methods, Study Design]

“The protocol was centrally approved by the medical ethical committee of the Zuyderland Medical Center (17-T-142)”

paraphrase[Methods, Participants]

“Oral informed consent in the presence of an independent third person was obtained from all participants with subsequent written informed consent directly after the index procedure.”

paraphrase[Methods, Study Design]

“followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline.”

PASSReviewer 2· 95% conf

Ethical approval from a named committee and informed consent are clearly documented.

Evidence

paraphrase[Methods, Study Design]

“The protocol was centrally approved by the medical ethical committee of the Zuyderland Medical Center (17-T-142)”

paraphrase[Methods, Participants]

“Oral informed consent in the presence of an independent third person was obtained from all participants with subsequent written informed consent directly after the index procedure.”

paraphrase[Methods, Study Design]

“was registered at ClinicalTrials.gov (NCT03562572), was monitored by an independent clinical trial center, and followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline.”

The trial uses everolimus-eluting stents (Xience) as the preferred stent, which is named with manufacturer. FFR wires and adenosine are mentioned but not fully specified (vendor/catalog not given), which is a minor gap. Statistical software (SPSS version 29.0) is identified. No antibodies, cell lines, or mycoplasma testing are applicable.

Sub-criteria

mycoplasma testingN/A

reagents identifiedINADEQUATE

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 (stents) and software are adequately identified.

Evidence

paraphrase[Methods, Randomization and Study Treatment]

“Everolimus-eluting (Xience) stents were the preferred stents of choice.”

direct quote[Methods, Statistical Analysis]

“All analyses were performed with SPSS version 29.0 (IBM).”

paraphrase[Methods, FFR Management]

“An FFR wire was used, but no vendor or catalog number is given; adenosine is mentioned without specification.”

PASSReviewer 2· 85% conf

The investigational product (stents) and key software are identified, though stent manufacturer is not specified.

Evidence

paraphrase[Methods, Randomization and Study Treatment]

“Everolimus-eluting (Xience) stents were the preferred stents of choice.”

direct quote[Methods, Statistical Analysis]

“All analyses were performed with SPSS version 29.0 (IBM).”

All statistical tests are named (t-test, Mann-Whitney U, chi-square, Fisher exact, Cox proportional hazards, log-rank). Assumptions are handled by design (e.g., non-Gaussian distributions use non-parametric tests). Exact p-values are reported for primary and key secondary outcomes. Effect sizes with 95% CIs are provided. Software is identified. Data presentation includes Kaplan-Meier curves and per-group n. Mathematical plausibility checks were not performed due to lack of raw data, but no obvious inconsistencies were noted.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well-reported, with exact p-values and effect sizes with confidence intervals.

Evidence

direct quote[Methods, Statistical Analysis]

“Baseline variables with non-Gaussian distributions were analyzed using the Mann-Whitney U test and summarized as median (IQR).”

paraphrase[Results, Primary and Secondary Outcomes]

“HR, 0.38 [95% CI, 0.20-0.72]; P = .003”

direct quote[Table 3]

“0.38 (0.20 to 0.72)”

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well-described, with exact p-values and effect sizes with confidence intervals.

Evidence

paraphrase[Methods, Statistical Analysis]

“Baseline continuous variables were summarized in terms of mean (SD) and raw comparisons between groups in these variables were performed via independent sample t tests.”

paraphrase[Results, Primary and Secondary Outcomes]

“HR, 0.38 [95% CI, 0.20-0.72]; P = .003”

direct quote[Table 3]

“0.38 (0.20 to 0.72)”

The paper states 'Data Sharing Statement: See Supplement 3.' The content of Supplement 3 is not available in the provided text, so the concreteness of the access route cannot be verified. No repository deposit or accession numbers are mentioned. Code sharing is not applicable as no custom code is described.

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositNOT REPORTED

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

A data sharing statement is present but vague, and no repository or accession numbers are provided.

Evidence

direct quote[Article Information]

“Data Sharing Statement: See Supplement 3.”

absence[Article Information]

No repository deposit mentioned.

WARNReviewer 2· 80% conf

A data sharing statement is mentioned but not detailed in the main text; no repository or accession numbers are provided.

Evidence

direct quote[Article Information]

“Data Sharing Statement: See Supplement 3.”

The trial is registered (NCT03562572). CONSORT reporting guideline is followed. All pre-specified outcomes are reported, including non-significant ones. Limitations are explicitly discussed. Conclusions are proportional to the evidence. Funding and conflicts of interest are disclosed.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

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 with trial registration, CONSORT adherence, and discussion of limitations.

Evidence

direct quote[Abstract]

“TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03562572”

paraphrase[Methods, Study Design]

“followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline.”

paraphrase[Discussion, Limitations]

“First, the study was not powered for differences in individual components of the composite outcome.”

PASSReviewer 2· 90% conf

The manuscript is transparent with trial registration, CONSORT adherence, and discussion of limitations.

Evidence

direct quote[Abstract]

“TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03562572”

paraphrase[Methods, Study Design]

“followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline.”

paraphrase[Discussion, Limitations]

“First, the study was not powered for differences in individual components of the composite outcome.”

3 copyedit issues flagged: mostly consistency, typo.

Checked 47 references by DOI: 46 verified — 1 no DOI (shown, not verified).

Reproducibility

Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.

Αlpha¹ Rigor Action ItemsFinal pass before journal submission

The published work is robust and well-reported, with only minor reporting gaps. An informed reader should weigh the vague data availability statement and the incomplete specification of FFR wires/adenosine as minor limitations. No erratum or re-analysis is warranted based on the evidence reviewed.

1.
HIGHdata code
In the Article Information section, replace the vague 'Data Sharing Statement: See Supplement 3' with a detailed statement specifying the access mechanism (e.g., data access committee, contact, conditions) and any repository or DOI.
A data sharing statement that merely points to a supplement without specifying access details is inadequate for a data-driven clinical trial and undermines reproducibility.
2.
MEDIUMrigor
In the Methods section (FFR Management), specify the vendor and catalog numbers for the FFR wire and adenosine used in the study.
Full identification of key reagents is necessary for reproducibility and is a standard expectation for interventional trials.
3.
MEDIUMreporting
In the Methods section, explicitly state that the study was conducted in accordance with the Declaration of Helsinki or other relevant ethical standards.
While ethics approval is documented, explicitly naming the ethical standard strengthens the ethics reporting.
4.
MEDIUMreporting
In the Results section (Baseline Characteristics), consider adding a statement about race/ethnicity if data are available, or note their absence.
Reporting race/ethnicity enhances generalizability assessment, though its absence is common in cardiovascular trials.
5.
MEDIUMdata code
If applicable, deposit de-identified aggregate data or statistical analysis code in a public repository with a DOI, and reference it in the data availability statement.
Public data/code deposition would enhance reproducibility and move data_code_availability toward pass.
6.
LOWcopyedit
In Table 2 header, remove the duplicate 'No. (%)' text.
The duplicate text is a minor typo that should be corrected for professionalism.
7.
LOWcopyedit
In the Results section, standardize p-value formatting (e.g., use 'P' consistently and format as 'P = .003' or 'P < .001' consistently).
Consistent formatting of p-values improves readability and avoids minor inconsistencies.

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Fractional Flow Reserve-Guided Complete vs Culprit-Only Revascularization in Non-ST-Elevation Myocardial Infarction and Multivessel Disease: The SLIM Randomized Clinical Trial.

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DOI

10.1001/jama.2025.16189

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Issued Aug 15, 2026Engine 7.39.0

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