Magnetic resonance angiography in diagnostic long-term follow-up of primary patency of the MOTIV drug-eluting bioresorbable vascular scaffold in the region below the knee: 5 years of experience

Christian Nasel; Mario Kirschner; Karoline Rizzi; Nicola Schweinhammer; Ewald Moser

doi:10.1371/journal.pone.0313696

Peer Review History

Original SubmissionAugust 9, 2024
13 Sep 2024 Decision Letter - Wenguo Cui, Editor PONE-D-24-33171Magnetic Resonance Angiography in Diagnostic Long-Term Follow-Up of Primary Patency of the MOTIV® Drug-Eluting Bioresorbable Vascular Scaffold in the Region Below the Knee: 5 Years of ExperiencePLOS ONE Dear Dr. Nasel, 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. Please submit your revised manuscript by Oct 28 2024 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols. We look forward to receiving your revised manuscript. Kind regards, Wenguo Cui, Ph.D Academic Editor PLOS ONE Journal Requirements: When submitting your revision, we need you to address these additional requirements. 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf 2. Please note that PLOS ONE has specific guidelines on code sharing for submissions in which author-generated code underpins the findings in the manuscript. In these cases, we expect all author-generated code to be made available without restrictions upon publication of the work. Please review our guidelines at https://journals.plos.org/plosone/s/materials-and-software-sharing#loc-sharing-code and ensure that your code is shared in a way that follows best practice and facilitates reproducibility and reuse. 3. Thank you for stating the following in your Competing Interests section: NO Please complete your Competing Interests on the online submission form to state any Competing Interests. If you have no competing interests, please state "The authors have declared that no competing interests exist.", as detailed online in our guide for authors at http://journals.plos.org/plosone/s/submit-now This information should be included in your cover letter; we will change the online submission form on your behalf. 4. We note that your Data Availability Statement is currently as follows: “All relevant data are within the manuscript and its Supporting Information files.” Please confirm at this time whether or not your submission contains all raw data required to replicate the results of your study. Authors must share the “minimal data set” for their submission. PLOS defines the minimal data set to consist of the data required to replicate all study findings reported in the article, as well as related metadata and methods (https://journals.plos.org/plosone/s/data-availability#loc-minimal-data-set-definition). For example, authors should submit the following data: - The values behind the means, standard deviations and other measures reported; - The values used to build graphs; - The points extracted from images for analysis. Authors do not need to submit their entire data set if only a portion of the data was used in the reported study. If your submission does not contain these data, please either upload them as Supporting Information files or deposit them to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. For a list of recommended repositories, please see https://journals.plos.org/plosone/s/recommended-repositories. If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially sensitive information, data are owned by a third-party organization, etc.) and who has imposed them (e.g., an ethics committee). Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent. If data are owned by a third party, please indicate how others may request data access. 5. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. Additional Editor Comments: Suggest making revisions according to the reviewer's comments and resubmitting for peer review. [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: No ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: N/A Reviewer #2: No ****** 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 ****** 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 ****** 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: Author used contrast enhanced MR-A of the lower limbs in 19 patients with PAD to retrospectively assess patency of a non-metallic drug eluting bioresorbable vascular scaffold (Tyrocore®) in the region below the knee. The probability of primary patency during the observation period of 5 years were computed by clinically driven MR-A censoring which triggered by an assumed target lesion failure. Additional in-vitro experiment was also prepared to prove this particular drug eluting bioresorbable vascular scaffold is compatible with MRI. The manuscript is technically sound, and I have some comments listed below: First, are normalised intra-luminal signal (NIL-SdeBVS) and Normalised deBVS-signal (nSdeBVS) the same or they are different. If they are the same, please make it consistent across the manuscript. Second, is it possible to include raw data to calculate table 2 "nSdeBVS" in the supporting material? And organize the data to show all the visit of each patient so that we can see the trend? Third, since the patients number is very low could author summarize any patient who has three images of before treatment, 1st follow up and image that conclude CD-TLF in the supporting material? Reviewer #2: 1. The sample size of the included patients is small, and the conclusions lack reliability. 2. Lines 96-99 are quite puzzling; please provide a detailed explanation. 3. In lines 102-103, to estimate long-term PP rates, only one patient who underwent CTA was included for comparison, which is not statistically valid, and conclusions cannot be drawn from this. 4. In vitro experiments are conducted; it is recommended to include in vivo animal experiments, as this would make the conclusions more convincing. 5. Lines 225-227 define MAE; however, it is not mentioned later. 6. The results in Table 2 are puzzling and do not align with the defined endpoints; it is suggested to revise Table 2 to indicate "how many individuals experienced the endpoint during each follow-up and the PP probability." ****** 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. 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: No Reviewer #2: No ******** [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0313696.r001
Revision 1
30 Sep 2024 Author Response Journal Requirements: 1st point) The link proposed in Your letter is not valid (URL: https://journals.plos.org/plosone/s/file?id=wjVg/ PLOSOne_formatting_sample_main_body.pdf; accessed last: 2024.09.18). Instead we re-checked the submission guide lines (URL: https://journals.plos.org/plosone/s/submission-guidelines; accessed last: 2024.09.18). For references, as we use EndNote, the most recent style was used. We found some deviations, which were corrected. We hope that this fixes the problems during the review process. 2nd point) According to the standards published by PLoS (URL: https://journals.plos.org/plosone/s/materials-and-software-sharing; accessed last: 2024.09.18) software development was no central part of the manuscript. We employed cran R to evaluate our measurements using only standard functions approved by the publisher. All statistical functions used are publicly available with the cran R kernel or the packages already cited in the original paper. 3rd point) Sorry, we though that this was a direct question. Yes, we would like to state in the new submission: 'The authors have declared that no competing interests exist.' 4th point) Actually, all relevant data are already within the manuscript. However, a Supporting Information-file meeting the “minimal data set”-policy of PLoS was added, not least in any case this was necessary to clearly present all measurements. 5th point) The requested captions were added at the end of the manuscript. Comments to Reviewers Reviewer 1 1st point) We thank reviewer 1 for this comment. These abbreviations have the same meaning. During replacement of older versions, we unintentionally skipped table 2 and figure 4, when we tried to find a most convenient abbreviation for this measure. Now the abbreviation: "NIL-SdeBVS" is used throughout the paper. Figure 4 was also corrected. 2nd point) We provided a supporting information csv-sheet that comprehensively shows all data. Table 2 was rigorously reworked (see also comments to reviewer 2) and should be easier to read now. Our intention was to present the full set without any restrictions, which was obviously too confusing. However, all values of the original submission and the revision can be calculated from the supporting information csv-sheet. 3rd point) We inserted a supporting information figure demonstrating an early occlusion of the deBVS. The corresponding measurements (p19) can be derived from the supporting information csv-sheet. We hope this meets the request. Reviewer 2 1st point) We agree that the sample size is small. Therefore, this was pointed out in the limitations. However, we disagree with reviewer 2 that the conclusions lack reliability, since the compatibility of the Tyrocore®-stent with MRI was also proven in-vitro and could be reliably confirmed with MR-A in-vivo. If this deBVS significantly annihilated the regional MR-signal, we would not have been able to judge a single patient correctly. On the contrary, we did not encounter a diagnostic restriction in any of our cases. Thus, from a statistical point of view we deal with an extremely strong positive statistical effect in favour of unrestricted MRI after implantation of the investigated deBVS. This can be tested already in a small number of cases. Though for statistical purposes a bigger number of cases would have been desirable, one cannot conclude that the direct depiction of patency of vessel segments treated with the deBVS would be not feasible. As diagnostic MRI after placement of this deBVS seems preserved, of course, we reported the number of stents censored and occluded. We do not claim that our retrospectively estimated probability of primary patency is precise enough to hold against future prospective data, but our findings provide a first and reasonable impression that this MR-A assessable deBVS may perform not worse compared to published data of metallic drug eluting stents in the BTK-region. Therefore, the conclusion that the use of a deBVS comparable to the tested one together with MR-A seems recommendable, because diagnostic and treatment options appear to be preserved, may indeed be derived even from our small sample. 2nd point) We agree that presenting the complete data in a clear and well-arranged fashion in the manuscript is difficult. A full step-by-step explanation of the collection and inclusion process of all data is now inserted at the end of the 'Patients'-subsection in the 'Methods'-chapter (revision: lines 96-109). Additionally, the flow chart demonstrating the patient collection (figure 1), was also revised and adapted to the inserted explanation. We hope that this renders the data collection easier to read. 3rd point) There was not at all a comparison between CT-A and MR-A reported in our paper. Just to get a better estimate of the PP-probability of the investigated deBVS, due to the small number of cases, we censored one patient receiving CT-A only for the Kaplan-Meyer estimates. This was clearly stated in the original submission. Nevertheless, this is now explained in more detail in the revision (revision: lines 109-113). On the other hand, according to the strict open data policy of PLoS, we could not simply conceal the patency data of this patient, because we very well knew the state of the deBVS. This is quite different to patients lost to follow-up, where the patency state is not known at all and who, therefore, can be simply excluded. The estimated PP-probability was only used to underline the recommendation that it is worth to consider MR-A instead of diagnostic modalities exposing the patients to radiation, because these scaffolds seem to perform comparable to metallic stents but do not restrict in MR-A like the metallic ones. We do not believe that this skews the data or any of our conclusions, moreover, as this was always clearly communicated to the reader. We hope that this is also acceptable. 4th point) There is absolutely no rationale to sacrifice the life of even a single animal to convince anybody that MR-A can be used with the investigated deBVS, since, as shown in our paper, we have enough evidence in humans already and experimental data from a specimen. We are bewildered that PLoS, given the data of our paper, can agree with this suggestion, which clearly contradicts the 3-R-principle of animal experiments. Of course, taking this into account, an ethics committee in Europe would not accept such experiments and, thus, no animal experiments can or will be conducted. 5th point) We deleted this and a few other abbreviations, which did not conform to PLoS-format standards. 6th point) We recognise that table 2 may be confusing and, therefore, it was rigorously revised. We hope the actual one is easier to read now. Attachments Attachment Submitted filename: Response to Reviewers.doc https://doi.org/10.1371/journal.pone.0313696.r002
30 Oct 2024 Decision Letter - Wenguo Cui, Editor Magnetic Resonance Angiography in Diagnostic Long-Term Follow-Up of Primary Patency of the MOTIV® Drug-Eluting Bioresorbable Vascular Scaffold in the Region Below the Knee: 5 Years of Experience PONE-D-24-33171R1 Dear Dr. Nasel, 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. An invoice will be generated when your article is formally accepted. Please note, if your institution has a publishing partnership with PLOS and your article meets the relevant criteria, all or part of your publication costs will be covered. Please make sure your user information is up-to-date by logging into Editorial Manager at Editorial Manager® and clicking the ‘Update My Information' link at the top of the page. If you have any questions relating to publication charges, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Wenguo Cui, 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 #1: All comments have been addressed ******** 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 ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: N/A ****** 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 ****** 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 ****** 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: Thank you for respond to my comments. Since sample size is very small. It will be great to visualize the progress of the Cumulative normalised deBVS-signal (NIL-SdeBVS) change in MR-A over time on same patient. But it seems this information is still missing. ****** 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: No ******** https://doi.org/10.1371/journal.pone.0313696.r003
Formally Accepted
13 Nov 2024 Acceptance Letter - Wenguo Cui, Editor PONE-D-24-33171R1 PLOS ONE Dear Dr. Nasel, I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now being handed over to our production team. At this stage, our production department will prepare your paper for publication. This includes ensuring the following: * All references, tables, and figures are properly cited * All relevant supporting information is included in the manuscript submission, * There are no issues that prevent the paper from being properly typeset If revisions are needed, the production department will contact you directly to resolve them. If no revisions are needed, you will receive an email when the publication date has been set. At this time, we do not offer pre-publication proofs to authors during production of the accepted work. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few weeks to review your paper and let you know the next and final steps. Lastly, if your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. If we can help with anything else, please email us at customercare@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Professor Wenguo Cui Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0313696.r004

Open letter on the publication of peer review reports

PLOS recognizes the benefits of transparency in the peer review process. Therefore, we enable the publication of all of the content of peer review and author responses alongside final, published articles. Reviewers remain anonymous, unless they choose to reveal their names.

We encourage other journals to join us in this initiative. We hope that our action inspires the community, including researchers, research funders, and research institutions, to recognize the benefits of published peer review reports for all parts of the research system.

Learn more at ASAPbio .