PONE-D-24-51620Association between optical coherence tomography and functionally severe stenosis assessed by quantitative flow ratio in coronary intermediate lesionsPLOS ONE

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Reviewer #1: Yes

Reviewer #2: Yes

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

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Reviewer #1: No

Reviewer #2: Yes

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Reviewer #1: No

Reviewer #2: Yes

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5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Review Comments

Title: Association between optical coherence tomography and functionally severe stenosis assessed by quantitative flow ratio in coronary intermediate lesions.

Background:

Thank you for inviting me to review this important manuscript. The authors have done well in studying a very important subject. They sought to investigate the association between OCT parameters (minimal lumen area and area stenosis) and functionally significant coronary stenosis identified by QFR (QRF 0.80 or less) in patients with intermediate coronary lesions. They found a good correlation between OCT parameters and QRF-determined severe stenosis. I have outlined my comments below.

Comments:

Abstract, introduction

1. Abstract (page 2): The authors should consider adding some baseline characteristics of the participants to the results session.

2. Introduction (page 3): The authors state, “However, the relationship between OCT and coronary stenosis with functional significance under the assessment of QRF has yet to be investigated.” This statement needs a bit more clarity.

3. The authors state, “This study centered on assessing the diagnostic value exhibited by OCT parameters in identifying coronary stenosis with functional significance under the assessment of QRF. This is not clear, and the objective needs to be more specific.

Methods

4. Study design and study population: The authors state, “Date of access to the data for study purposes was 26th August 2020.” – Does this mean they used one day to extract all the data? I think the period for data capturing should be stated.

5. The authors need to be clear on how the patients were selected. Were there any inclusion and exclusion criteria?

6. “This study had been registered in the net of Clinicaltrials.gov” – This needs grammatical correction. They also state the requirement for informed consent was waived. It must be stated which body waived it.

7. There are some grammatical errors in the methodology that need to be corrected.

Results

1. The authors should consider including the participants' sex in the baseline characteristics. What percentage were females?

2. The sample size of 113 patients with 115 lesions is relatively small.

3. The references to the tables and figures did not appear well in the text. The figures should be referred to appropriately in the text, for example, fig (a) on page 9 first line should be fig (4a)

4. Figures and tables: the explanation of the abbreviations should be written alphabetically. In table 3, ‘Ezemab’ should be changed to ezetimibe.

5. The authors state on page 9, paragraph 2, “Upon stenosis being divided according to lesion location in order to assess the diagnostic performance at different vessels, the diagnostic value exhibited by MLA for the identification of significant stenosis for the right coronary artery was heightened.” Rephrasing this will bring some clarity.

6. On page 10, the authors state that OCT was performed for ALL the patients. Meanwhile, 37 patients (40%) were enrolled in the OCT-guided OMT group and 56 patients (60%) in the OCT-guided PCI (OCT-PCI) group. What happened to the rest of the 113 participants?

7. Figure 1 (the flow chart): The authors stated in the methods (page 4) that patients who did not have good angiograms for QRF analysis were excluded from the analysis. However, the figure does not indicate how many patients were excluded based on this reason.

Discussion

1. Some grammatical and typographical errors need to be corrected. Eg ‘ASacquired’ should be ‘AS-acquired’ (page 11, last sentence); OCT-guided PCI instead of OCT-guidance PCI (page 13); FFR-guided PCI instead of FFR-guidance PCI (page 13).

2. The authors need to expand the limitations session, addressing, for example, the small sample size, confounders, and generalizability.

Acknowledgement – Please change ‘my’ to ‘our’.

Reviewer #2: Comments:

Review PLOS ONE, Manuscript: 24 51620

Association between optical coherence tomography and functionally severe stenosis assessed by quantitative flow ratio in coronary intermediate lesions

Article Type: Research Article.

Objective: To investigate the association between optical coherence tomography (OCT) parameters and coronary functionally significant stenosis identified by quantitative flow ratio (QFR) in patients with intermediate coronary lesion (ICL).

General comments: An interesting paper.

Strengths:

A novel topic.

Weaknesses:

Some areas require much more detail.

TITLE:

Comment 1: I think rephrasing the Title along the lines of “Accuracy/relationship of optical coherence tomography to detect/quantify functionally severe stenosis assessed/evaluated by quantitative flow ratio in intermediate coronary lesions” would better reflect the research as I understand it.

I would try to describe this is terms of a PICOS statement

P = Patient, problem or population = patients with intermediate coronary lesion (ICL)

I = Intervention = optical coherence tomography (OCT)

C = Comparison, control or comparator = coronary artery stenosis evaluated by quantitative flow ratio (QFR)

O = Outcome(s) = Accuracy, sensitivity, specificity

S = Study design = a retrospective observational study of diagnostic test accuracy (DTA)

ABSTRACT:

Appropriate.

Keywords: None.

Abbreviations: None.

INTRODUCTION: Appropriate.

The rationale for the study, in the context of what is already known is provided.

The purpose of the study is stated.

MATERIALS and METHODS:

Ethics review. Was the need for informed consent waived?

A retrospective observational study.

A single institution study.

This study had been registered in the net of Clinicaltrials.gov

Comment 2: Did participants form a consecutive, random, or convenience series?

Comment 3: What was the Intended sample size and how it was determined?

Comment 4: Please state explicitly the inclusion and exclusion criteria.

University hospital setting.

Date of study given.

Comment 5: Please describe the study population in terms of background?

QCA assessment

Comment 6: Please provide more technical specifications of the QCA technique, units, cutoffs, etc., and details of the training, and expertise of the persons executing and reading this test.

QFR assessment

Comment 7: Please provide units, cutoffs, etc., and details of the training, and expertise of the persons executing and reading this test.

Comment 8: Please provide details of the training, and expertise of the persons executing and reading this test.

Statistical analyses: Appropriate.

Statistical methods and analytical approach and statistical software that was used for data analysis given and appropriate.

RESULTS:

Association between OCT measurements and QFR measurements: Appropriate

Comparison of AS measured by OCT and QFR: Appropriate

Comparison of clinical characteristics and 1-year follow-up outcomes between OCT guided PCI and optimal medicine therapy (OMT): Appropriate

DISCUSSION

Thorough review of the literature.

The study’s strengths are discussed

The study’s limitations are discussed

Conclusions: Appropriate

Research funded details provided.

Author contributions provided

There are no conflicts of interest

REFERENCES: Appropriate.

Tables: Appropriate.

Table Legends: Appropriate.

Figures: Appropriate.

Figure Legends: Appropriate.

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Reviewer #1: Yes:  Francis Agyekum

Reviewer #2: No

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Attachments

Attachment

Submitted filename: Review Comments.docx

Association between optical coherence tomography and functionally severe stenosis assessed by quantitative flow ratio in coronary intermediate lesions

PONE-D-24-51620R1

Dear Dr. Lu,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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Kind regards,

Giuseppe Filiberto Serraino, M.D., Ph.D.

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #3: All comments have been addressed

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2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #3: Yes

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3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #3: Yes

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4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #3: Yes

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5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #3: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #3: Dear Authors,

I have reviewed the revised version of your manuscript. I would like to commend you for your diligent efforts in addressing the previous comments. With the revisions made, the manuscript has become significantly more valuable and informative. Congratulations on your thorough work.

Best regards

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7. PLOS authors have the option to publish the peer review history of their article (what does this mean? ). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy .

Reviewer #3: Yes:  FERIT BOYUK, MD

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