PONE-D-21-35320

Trends and outcomes of percutaneous coronary intervention during the COVID-19 pandemic in Michigan

PLOS ONE

Dear Dr. Gurm,

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“This work was supported by the Blue Cross Blue Shield of Michigan and Blue Care Network as part of the Blue Cross Blue Shield of Michigan Value Partnerships program. The funding source supported data collection at each site and funded the data-coordinating center, but had no role in study concept, interpretation of findings, or in the preparation, final approval or decision to submit the manuscript.”

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“I have read the journal's policy and the authors of this manuscript have the following competing interests: Dr. Azzalini received consulting fees from Teleflex, Abiomed, Asahi Intecc, Abbott Vascular, Philips, and Cardiovascular Systems, Inc. Dr. Sukul receives salary support from the Blue Cross Blue Shield of Michigan for his role in BMC2. Dr. Gurm receives research support from Blue Cross and Blue Shield of Michigan, and Michigan Translational Research and Commercialization for Life Sciences Innovation Hub. He is the co-founder of, owns equity in, and is a consultant to Amplitude Vascular Systems. He also owns equity in Jiaxing Bossh Medical Technology Partnership and is a consultant for Osprey Medical. He is the chair of the Clinical Events Committee for the PERFORMANCE trial sponsored by Contego Medical. The other authors have no disclosures.”

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Additional Editor Comments:

Thank you very much for having submitted this paper for consideration. The reviewers raised some comments and in particular reviewer number 2. The following indications will help you to improve the quality of your paper.

[Note: HTML markup is below. Please do not edit.]

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: 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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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: Yes

Reviewer #2: Yes

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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: Azzalini et al. report an interesting study regarding the evaluation of the influence of the COVID-19 pandemic on temporal trends and outcomes of patients undergoing percutaneous coronary intervention (PCI) during the year 2020 compared to year before (2019). The topic is of high interest due the persistence of the COVID pandemic that is bringing the world health to its knees. Despite numerous previous manuscripts depicting differences in PCI volumes and outcomes between the pandemic and the pre-pandemic era this paper covers a longer period compared to initial reports that exclusively focused on the “first wave” of the pandemic. Furthermore, it gives in-depth insights on the outcomes of all-comers undergoing PCI before and during the COVID-19 pandemic, showing that the worse in-hospital outcomes are not exclusively related to the COVID infection itself but also probably to the “collateral damage” of the COVID-19 pandemic to the entire cardiac care system.

The manuscript is well written, very interesting with a robust statistical methodology. Therefore, I do not have further revisions to propose.

Reviewer #2: The aim of this retrospective, multicenter study was to assess outcomes of patients undergoing percutaneous coronary intervention (PCI) in Michigan during the COVID-19 pandemic in 2020 (between March and December), comparing them to outcomes in the same period of the previous year. The Authors used data from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) PCI registry which included data from all the catheterization laboratories in Michigan. The Authors found a ~15% decrease in overall PCI volume from the pre-pandemic to the pandemic period; monthly mortality rates for primary PCI were in general higher in the pandemic period. Furthermore, patients undergoing PCI in the pre-pandemic period, those undergoing PCI in the pandemic period had a higher risk of death. This last finding was more pronounced in patients presenting with ST-segment elevation myocardial infarction (STEMI).

The topic is interesting, the analyses are elegant and the manuscript clearly written.

I have some considerations:

• Monthly mortality rates for primary PCI were in general higher in the pandemic period, a finding that was however not related to clinically significant system delays in STEMI care. As already mentioned by the Authors, one of the possible interpretations is that patients tried to avoid contacting the emergency services for fear of entering the hospitals. Indeed, it is possible that predominantly patients with very severe symptomatology contacted the emergency services or went to the hospital. In this context, it is also possible that patients waited until they had an advanced clinical situation before asking for assistance. It is known that several patients who were not infected with COVID-19 suffered complications of myocardial infarction associated with late presentation. It would be interesting to add “pain-to-balloon” to the data shown.

• It is important to note also the low absolute number of STEMIs and NSTEMIs in 2020 compared to 2019: perhaps another indication that many patients stayed home and only the most symptomatic called for rescue.

• The authors performed outcome analyses using in-hospital mortality. Although the latter is widely used in the literature, I believe it would be more elegant and objective to use 30-day mortality, if it were available.

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6. 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 #1: Yes: Gianmarco Iannopollo

Reviewer #2: No

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Trends and outcomes of percutaneous coronary intervention during the COVID-19 pandemic in Michigan

PONE-D-21-35320R1

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,

Shukri AlSaif

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 #1: All comments have been addressed

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 #1: Yes

Reviewer #2: (No Response)

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

Reviewer #1: Yes

Reviewer #2: (No Response)

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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 #1: Yes

Reviewer #2: (No Response)

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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 #1: Yes

Reviewer #2: (No Response)

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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 #1: Azzalini et al. report an interesting study regarding the evaluation of the influence of the COVID-19 pandemic on temporal trends and outcomes of patients undergoing percutaneous coronary intervention (PCI) during the year 2020 compared to year before (2019). The topic is of high interest due the persistence of the COVID pandemic that is bringing the world health to its knees. Despite numerous previous manuscripts depicting differences in PCI volumes and outcomes between the pandemic and the pre-pandemic era this paper covers a longer period compared to initial reports that exclusively focused on the “first wave” of the pandemic. Furthermore, it gives in-depth insights on the outcomes of all-comers undergoing PCI before and during the COVID-19 pandemic, showing that the worse in-hospital outcomes are not exclusively related to the COVID infection itself but also probably to the “collateral damage” of the COVID-19 pandemic to the entire cardiac care system.

The manuscript is well written, very interesting with a robust statistical methodology. Therefore, I do not have further revisions to propose.

Reviewer #2: (No Response)

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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 #1: Yes: Gianmarco Iannopollo

Reviewer #2: No

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