Drug-eluting versus bare-metal stents for first myocardial infarction in patients with atrial fibrillation: A nationwide population-based cohort study

Nen-Chung Chang; Patrick Hu; Tien-Hsing Chen; Chun-Tai Mao; Ming-Jui Hung; Chi-Tai Yeh; Ming-Yow Hung

doi:10.1371/journal.pone.0227571

Peer Review History

Original SubmissionSeptember 24, 2019
24 Oct 2019 Decision Letter - Giuseppe Coppola, Editor PONE-D-19-23376 Drug-eluting versus bare-metal stents for first myocardial infarction in patients with atrial fibrillation: a nationwide population-based cohort study PLOS ONE Dear Ming-Yow Hung 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. We would appreciate receiving your revised manuscript by Dec 08 2019 11:59PM. When you are 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. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. 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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 ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: Yes ****** 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. 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(Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: Introduction: the quoted guidelines are outdated; the Authors should review the entire section according to the last iteration of the ACC/AHA and ESC guidelines, both about type of stent and about antithrombotic regimen; for completeness, they should put their study (enrolling started more than 10 years ago) in context to the evidences of that era. Discussion: the Authors should discuss their study in the light of three major RCTs comparing DES and BMS for patients considered at high risk of bleeding, such as ZEUS (Valgimigli et al.), LEADES-FREE (Urban et al.) and SENIOR (Varenne et al.) , and also of observational studies reporting management of patients with AF and coronary stents (see Potter at al, Clin Cardiol. 2018 Apr;41(4):470-475. doi: 10.1002/clc.22898). Reviewer #2: The authors deals with a very important issue, that is to say use of antiplatelet therapy in patients already on anticoagulants for AF. The paper is well written and the statistical analysis solid, thus the conclusions are reliable. I only have some minor questions: 1. In Table 1 patients are divided in categories according to their CHA2DS-VASc score, and score 1 and 2 are included in the some category. In my opinion pts with a CHA2DS2-VASc score = 1 should be separated from pts with a score of 2, because they could even not receive an anticoagulant 2. How can pts have a score of 0, if they have at least cardiovascular disease? 3. What about pts not on warfarin? Only about 9% of pts are on warfarin: and the other ones? Are they on DOAC? Which type at which dose: full or reduced? ****** 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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Revision 1
15 Dec 2019 Author Response �Response to reviewers We would like to extend our thanks to the reviewers for the constructive comments regarding our manuscript, entitled, “Drug-eluting versus bare-metal stents for first myocardial infarction in patients with atrial fibrillation: A nationwide population-based cohort study” (Manuscript number PONE-D-19-23376). We have revised the manuscript point by point in accordance with the reviewer’s suggestions, as indicated by the itemized responses below. Reviewer #1: 1. Introduction: the quoted guidelines are outdated; the Authors should review the entire section according to the last iteration of the ACC/AHA and ESC guidelines, both about type of stent and about antithrombotic regimen; for completeness, they should put their study (enrolling started more than 10 years ago) in context to the evidences of that era. Response to reviewer: We appreciate the reviewer’s comments. We have reviewed the entire section according to the last iteration of the ACC/AHA and ESC guidelines, both about type of stent and about antithrombotic regimen. We also have described the development of evidence over time through our study period. Guidelines and reviews of the literature have been added to the “Introduction” sections in this revised manuscript (Page 3, lines 65-68, Page 4, lines 69-84 and 89-91 and Page 5, lines 92, 94 and 97-101). Thank you for your comment. 2. Discussion: the Authors should discuss their study in the light of three major RCTs comparing DES and BMS for patients considered at high risk of bleeding, such as ZEUS (Valgimigli et al.), LEADES-FREE (Urban et al.) and SENIOR (Varenne et al.), and also of observational studies reporting management of patients with AF and coronary stents (see Potter at al, Clin Cardiol. 2018 Apr;41(4):470-475. doi: 10.1002/clc.22898). Response to reviewer: We appreciate the reviewer’s comments. As the reviewer suggested, we have added the detailed reviews of the 3 major RCTs and 1 observational study regarding the management of patients with AF and coronary stents to the “Discussion” section in this revised manuscript (Page 20, lines 334-338, Page 21, lines 359-370 and Page 22, lines 371-380). Thank you for your comment. Reviewer #2: 1. In Table 1 patients are divided in categories according to their CHA2DS-VASc score, and score 1 and 2 are included in the same category. In my opinion pts with a CHA2DS2-VASc score = 1 should be separated from pts with a score of 2, because they could even not receive an anticoagulant. Response to reviewer: We appreciate the reviewer’s comments. We have modified and improved the data presentation of the subgroup analysis in Table 1 and Figure 3. Thank you for your comment. 2. How can pts have a score of 0, if they have at least cardiovascular disease? Response to reviewer: We appreciate the reviewer’s comments. While all patients included in this study should have at least a CHA2DS2-VASc score of 1, the reason why some patients had a score of 0 is that we defined the coronary artery disease by using ICD-9-CM diagnosis prior to the index admission. We apologize for this coding error, and have redefined the coronary artery disease using ICD-9-CM diagnosis “during” or prior to the index admission. We have modified and improved the data presentation of the subgroup analysis in Table 1 and Figure 3. Thanks for your reminder and comment. 3. What about pts not on warfarin? Only about 9% of pts are on warfarin: and the other ones? Are they on DOAC? Which type at which dose: full or reduced? Response to reviewer: We appreciate the reviewer’s comments. The available Taiwan NHIRD in our study included only inpatient claims data with no information of medications from the outpatient claims data and pharmacy claims data. Furthermore, although the DOAC has been covered by Taiwan’s NHI system since 2012, our study period was from 1997 to 2011. Therefore, the use of oral anticoagulants was infrequent in our study. We have added the above statement to the limitation section in this revised manuscript (Page 25, lines 442-446). Thank you for your comment. �List of changes The page and reference numbers in this list are those in the revised and re-submitted manuscript. All of the above revisions are highlighted with underlines and red color in the revised manuscript. Thank you very much for your recommendations. 1. Page 3, lines 65-68, Page 4, lines 69-84 and 89-91 and Page 5, lines 92, 94 and 97-101: As the reviewer suggested, guidelines and reviews of the literature were added. 2. Page 20, lines 334-338, Page 21, lines 359-370 and Page 22, lines 371-380: As the reviewer suggested, the detailed reviews of the 3 major RCTs and 1 observational study regarding the management of patients with AF and coronary stents were added. 3. Page 25, lines 442-446: As the reviewer suggested, the reasons why the use of oral anticoagulants was infrequent in our study were added. 4. Page 26, line 479: The author contribution for revising this manuscript was added. 5. Page 28, 29, 30, 31, 33 and 35: The reference number was sequentially changed as follows: 11 to 9, 8 to 10, 9 to 17, 10 to 18, 12 to 21, 13 to 22, 14 to 23, 15 to 24, 16 to 25, 17 to 26, 18 to 27, 19 to 28, 20 to 29, 21 to 30, 22 to 31, 23 to 32, 24 to 34, 25 to 35, 26 to 36, 27 to 37, 28 to 38, 29 to 39, 30 to 40, 31 to 46, 32 to 47, 33 to 48, 34 to 49, 35 to 50, 36 to 51, 37 to 52, 38 to 53, 39 to 54. 6. Page 28: One reference (J Am Coll Cardiol. 2006; 48:854-906.) was added as reference 8. 7. Pages 29-30: 6 references (Lancet. 2013; 381:1107-15.; Thromb Res. 2015; 135:26-30.; Circulation. 2019; 140:e125-e151.; N Engl J Med. 2016; 375:2423-34.; N Engl J Med. 2017; 377:1513-24.; Circulation. 2018; 138:527-36.) were added as reference 11-16. 8. Pages 30-31: 2 references (J Am Coll Cardiol. 2011; 58:e44-122.; Circ Cardiovasc Interv. 2016; 9. pii: e004395.) were added as reference 19, 20. 9. Page 33: One reference (Circulation. 2008; 117:261-95.) was added as reference 33. 10. Pages 35: 5 references (J Am Coll Cardiol. 2015; 65:805-15.; N Engl J Med. 2015; 373:2038-47.; Lancet. 2018; 391:41-50.; Ann Intern Med. 2007; 146:857-67.; Clin Cardiol. 2018; 41:470-75.) were added as reference 41-45. Attachments Attachment Submitted filename: 20191215 Response to Reviewers_R2.doc https://doi.org/10.1371/journal.pone.0227571.r002
23 Dec 2019 Decision Letter - Giuseppe Coppola, Editor Drug-eluting versus bare-metal stents for first myocardial infarction in patients with atrial fibrillation: a nationwide population-based cohort study PONE-D-19-23376R1 Dear Dr. Ming-Yow Hung, We are pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it complies with all outstanding technical requirements. Within one week, you will receive an e-mail containing information on the amendments required prior to publication. When all required modifications have been addressed, you will receive a formal acceptance letter and your manuscript will proceed to our production department and be scheduled for publication. Shortly after the formal acceptance letter is sent, an invoice for payment will follow. To ensure an efficient production and billing process, please log into Editorial Manager at https://www.editorialmanager.com/pone/, click the "Update My Information" link at the top of the page, and update your user information. If you have any billing related questions, 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 enable them to help maximize its impact. If they will be preparing press materials for this manuscript, you must inform our press team as soon as possible and 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. With kind regards, Giuseppe Coppola Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0227571.r003
Formally Accepted
31 Dec 2019 Acceptance Letter - Giuseppe Coppola, Editor PONE-D-19-23376R1 Drug-eluting versus bare-metal stents for first myocardial infarction in patients with atrial fibrillation: a nationwide population-based cohort study Dear Dr. Hung: I am pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please notify them about your upcoming paper at this point, to enable them to help maximize its impact. If they will be preparing press materials for this manuscript, 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. For any other questions or concerns, please email plosone@plos.org. Thank you for submitting your work to PLOS ONE. With kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Giuseppe Coppola Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0227571.r004

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