We would like to thank the J-ELD AF investigators for their support in patient registration and data collection. This study was conducted by the Cardiovascular Institute Academic Organization (CVI ARO), Tokyo, Japan, subsidized and funded by pharmaceutical and medical device companies.
Bristol-Myers Squibb K.K. provided monetary support for this study. This study was partially supported by the Practical Research Project for Life-Style related Diseases including Cardiovascular Diseases and Diabetes Mellitus from Japan Agency for Medical Research and Development, AMED (15656344 and JP17ek0210082). However, there was no conflict of interest between the study center and sponsor concerning the conduct of the study or study outcomes.
Conflict of Interest
Dr. Kadosaka reports no conflict. Dr. Nagai received honoraria from Daiichi Sankyo Co., Ltd., a clinical research grant from JSPS KAKENHI Grant-in-Aid for Scientific Research, and research grants from the Takeda Science Foundation, the Japan Foundation for Aging and Health, and the Uehara Memorial Foundation. Dr. Suzuki received research funding from Daiichi-Sankyo and Mitsubishi-Tanabe. Dr. Sakuma reports no conflict. Dr. Akao received lecture fees from Pfizer, Bristol-Myers Squibb, Boehringer Ingelheim, Bayer Healthcare, and Daiichi-Sankyo. Dr. Yamashita received lecture fees from Bristol Myers Squibb, Daiichi-Sankyo, Bayer, Pfizer, Ono Pharmaceutical, and Toa Eiyo and research funding from Bayer and Daiichi Sankyo. Dr. Okumura received lecture fees from Daiichi-Sankyo, Boehringer Ingelheim, Bristol-Myers Squibb, Medtronic and Johnson & Johnson. Dr. Anzai received honoraria from Daiichi Sankyo Co., Ltd., Ono Pharmaceutical Co., Ltd., Boehringer Ingelheim Japan Co., Ltd., Bayer Pharmaceuticals Co., Ltd., and Bristol-Myers Squibb Co., Ltd., clinical research grants from the Japan Agency for Medical Research and Development and Daiichi Sankyo Co., Ltd., and scholarship funds from Biotronik Japan Co., Ltd., Medtronic Japan Co., Ltd., Win International Co., Ltd., Medical System Network Co., Ltd., and Hokuyaku Takeyama Holdings, Inc.
Availability of Data and Material
The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.
Code Availability: Statistical analysis was performed using SAS Ver. 9.4 (SAS Institute Inc., Cray, NC).
Authors’ Contributions: Contributions by each author according to the Contributor Roles Taxonomy (CRediT; https://www.casrai.org/credit.html):
Takahide Kadosaka: conceptualization, methodology, formal analysis, writing – original draft
Toshiyuki Nagai: conceptualization, methodology, formal analysis, writing – original draft
Shinya Suzuki: data curation, formal analysis, investigation, writing – review & editing
Ichiro Sakuma: investigation, writing – review & editing
Masaharu Akao: investigation, project administration, writing - review & editing
Takeshi Yamashita: funding acquisition, investigation, project administration, supervision, writing - review & editing
Ken Okumura: funding acquisition, investigation, project administration, supervision, writing - review & editing
Toshihisa Anzai: conceptualization, methodology, formal analysis, writing - review & editing
Ethics Approval: This study was performed in conformity to the ethical norms based on the Declaration of Helsinki (revised in 2008) and Ethical Guidelines for Medica and Health Research Involving Human Subjects (Public Notice of the Ministry of Education, Culture, Sports, Science and Technology, and the Ministry of Health, Labor and Welfare in Japan, issued in 2014).
Consent to Participate: Prior to enrollment, the contents of the study were explained to the patients using explanatory documents and consent documents, and written consent was obtained. If a patient withdrew consent during the observation period, all existing data collected from the patient were discarded.