PONE-D-20-15844

Trends and Outcomes of Elective PCI at Sites Without Cardiac Surgery On-Site: The Early Michigan Experience

PLOS ONE

Dear Dr. Gurm,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

Reviewers have raised concerns about issues of clinical practice and about the actual definition of elective PCI. Moreover, it is unusual to include CIN in the composite endpoint of MACE, although one has to acknowledge that the Authors have extensively worked on such topic and have a huge amount of data. This point, along with center volume of PCI, should be properly discussed as suggested.

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PLOS ONE

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'Competing interests: Hitinder S. Gurm receives research funding from BCBSM and the National Institutes of Health and is a consultant for Osprey Medical. The authors have declared that no competing interests exist.'

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. 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 #1: Partly

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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3. 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 #1: No

Reviewer #2: No

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4. 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 #1: Yes

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: 1. Thanks for your research about the safety of elective PCI. The term "elective" is unusual as you have many NSTEMI and UA in your registry that require urgent or semi urgent PCI. For the other cases, i haven't found if the ischemia was previously documented and, when documented, the severity of ischemia.

Despite your propensity matched score, we observe more prior MI, more CVD, more previous HF, more left main disease in the group of patients who benefit from a PCI in a site with a surgical department.

2. Femoral access remains high 52% and maybe discussed

3. the same for the high use of Ticagrelor, high probably for NSTEMI. Therefore the term "elective" may be changed.

3. These data confirm several previous data. They are reassuring for your state, but what are the new informations for the readers ?

4. Multivessel disease and poylarterial disease are not reported and may be on interest in the discussion.

5. What's your definition of "high risk" patients and low risk patients ?

Thanks for your contribution

Reviewer #2: The authors have undertaken an analysis of the BMC-2 registry studying in hospital and post discharge outcomes in patients undergoing PCI startified by whether the PCI was undertaken in a surgical vs non-surgical centre. The authors report no differences in in-hospital outcomes, 90 day readmissions or cost of procedure following PSM analysis in the whole population aswell as a high risk subgroup. The analysis adds to the large body of literature published in this arena already, but presents additional data including the readmission data, and a subgroup analysis around a higher risk cohort. The manuscript is well written. i have number of recommendations:

1) Throughout the mnanuscript the authors refer to the cohort as an elective PCI cohort. This is misleading, UA and NSTEMI cases for the majority of PCI procedures in this analysis. They should probably rename their cohort as a nonPPCI or ACS / elective cohort.

2) Their choice of MACE is unusual. they have included CIN (which contributes the majority of outcome events). This is inappropriate. MACCE should probably be in hospital mortality, CVA, AMI/ Stent thrombosis and perhaps re-intervention. NACE could include major bleeding.

3) the 90 days data is limited to only 10% of population that they could match to medicare claims database. I think that this should be more overt in the abstract, as it is slightly misleading otherwise. the limitations should be re-emphasised in the limitations section of discussion

4) It would be good to have a figure showing centre volume in the individual centres, as i think that is useful for the reader. where there is a lot of data around centre-volume outcomes, do the authors think it is a good idea that activity is redistributed from higher to lower volume centres? (authors report redictribution of activity and discuss it in the context of patients having PCI more locally)

5) urgent / emergent surgery-was this due to complications? perhaps if data available re indiciation of this surgery would be very interesting as very little of this type of data.

Overall an interesting analysis that could be imporved with some additional work.

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Reviewer #1: Yes: Pierre SABOURET

Reviewer #2: Yes: Mamas A. Mamas

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Trends and outcomes of non-primary PCI at sites without cardiac surgery on-site: The early Michigan experience

PONE-D-20-15844R1

Dear Dr. Gurm,

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 Andò, 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 #2: 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 #2: Yes

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

Reviewer #2: 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 #2: No

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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 #2: Yes

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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 #2: the authors have satisfactorily answered all my comments and addressed the issues that i raised. manuscript requires no further changes

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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.

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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 #2: No