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Original research
Residual risks of ischaemic stroke and systemic embolism among atrial fibrillation patients with anticoagulation: large-scale real-world data (F-CREATE project)
  1. Toshiki Maeda1,
  2. Takumi Nishi1,2,
  3. Shunsuke Funakoshi1,
  4. Kazuhiro Tada1,3,
  5. Masayoshi Tsuji4,
  6. Atsushi Satoh1,
  7. Miki Kawazoe1,
  8. Chikara Yoshimura1,
  9. Hisatomi Arima1
  1. 1 Department of Preventive Medicine and Public Health, Faculty of Medicine, Fukuoka University, Fukuoka, Japan
  2. 2 Department of Research Planning and Information Management, Fukuoka Institute of Health and Environmental Sciences, Fukuoka, Japan
  3. 3 Division of Nephrology and Rheumatology, Department of Internal Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan
  4. 4 Department of Lifestyle and Welfare Information, Kindai University Kyushu Junior College, Fukuoka, Japan
  1. Correspondence to Dr Toshiki Maeda, Department of Preventive Medicine and Public Health, Faculty of Medicine, Fukuoka University, Fukuoka 814-0180, Japan; tmaeda{at}


Objective Among patients with atrial fibrillation, the risks of ischaemic stroke and systemic embolism (IS/SE) are high even with effective anticoagulation. Using large-scale, real-world data from Japan, this study aims to clarify residual risks of IS/SE attributable to modifiable risk factors among patients with atrial fibrillation who are taking oral anticoagulants.

Methods The study design we employed was a retrospective cohort. Health check-ups and insurance claims data of Japanese health insurance companies were accumulated from January 2005 to June 2017. We identified 11 848 participants with atrial fibrillation who were on oral anticoagulants during the study period. We set the modifiable risk factors as hypertension, diabetes and dyslipidaemia. A Cox proportional hazards model was used to obtain the effects of the risk factors for IS/SE.

Results During an average of 3 years’ follow-up, 200 cases of IS/SE occurred (incidence rate 0.57 per 100 person-years). In multivariable analyses, older age (65–74 vs <65 years; adjusted HR 2.02 (95% CI 1.49 to 2.73)), hypertension (adjusted HR 1.41 (1.04 to 1.92)) and dyslipidaemia (adjusted HR 1.46 (1.07 to 1.98)) were significantly associated with increased risk of IS/SE. Percentage of IS/SE risk attributable to modifiable risk factors (hypertension, diabetes and dyslipidaemia) was 30.0% (16.1% to 41.6%).

Conclusion Among patients with atrial fibrillation on anticoagulant therapy, approximately one-third of the residual risks were estimated to be attributable to modifiable risk factors such as hypertension, diabetes and dyslipidaemia.

  • atrial fibrillation
  • stroke
  • cardiac risk factors and prevention

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  • Contributors TM and HA conceived the present study. HA and MT acquired the data of present study. TN and TM made database. TM performed statistical analyses. TM, HA and TN handled funding and supervision. TM and HA drafted the manuscript. SF, KT, AS, MK and CY made critical revision of the manuscript for key intellectual content.

  • Funding This work was supported by JSPS KAKENHI Grant Numbers 18K17404 and 19H03879.

  • Competing interests HA received research grants from Daiichi Sankyo and Takeda, lecture fees from Bayer, Daiichi Sankyo, Fukuda Denshi, MSD, Takeda, Teijin and fees for consultancy from Kyowa Kirin. CY received research grants from Fukuda Denshi and Fukuda Lifetec Kyushu, and lecture fees from Fukuda Denshi, Fukuda Lifetec Kyushu, Pacific Medico, Philips Respironics, Daiichi Sankyo, Takeda, Otsuka. There are no other conflicts of interest to be declared.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Patient consent for publication Obtained.

  • Ethics approval Our study was approved by Fukuoka University Clinical Research and Ethics Centre (2017M008) and conforms to the principles outlined in the Declaration of Helsinki.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data may be obtained from a third party and are not publicly available. The data underlying this article were provided by JMDC thus the data are not publicly available.