Korean Circulation Journal

The Korean Society of Cardiology (대한심장학회)
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Optimal Dose of Edoxaban for Very Elderly Atrial Fibrillation Patients at High Risk of Bleeding: The LEDIOS Registry

  • Ju Youn Kim (Division of Cardiology, Department of Internal Medicine, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Juwon Kim (Division of Cardiology, Department of Internal Medicine, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Seung-Jung Park (Division of Cardiology, Department of Internal Medicine, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Kyoung-Min Park (Division of Cardiology, Department of Internal Medicine, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Sang-Jin Han (Division of Cardiology, Hallym University Sacred Heart Hospital) ;
  • Dae Kyeong Kim (Department of Cardiology, Busan Paik Hospital, Inje University College of Medicine) ;
  • Yae Min Park (Division of Cardiology, Department of Internal Medicine, Gachon University Gil Medical Center) ;
  • Sung Ho Lee (Division of Cardiology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University College of Medicine) ;
  • Jong Sung Park (Department of Cardiology, Dong-A University Hospital) ;
  • Young Keun On (Division of Cardiology, Department of Internal Medicine, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine)
  • Received : 2024.02.27
  • Accepted : 2024.04.24
  • Published : 2024.07.01
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Abstract

Background and Objectives: Optimal anticoagulation in very elderly patients is challenging due to the high risk of anticoagulant-induced bleeding. The aim of this study was to assess outcomes of on-label reduced-dose edoxaban (30 mg) in very elderly patients who had additional risk factors for bleeding. Methods: This was a multi-center, prospective, non-interventional observational study to evaluate the efficacy and safety of on-label reduced-dose edoxaban in atrial fibrillation (AF) patients 80 years of age or older and who had more than 1 risk factor for bleeding. Results: A total of 2448 patients (mean age 75.0±8.3 years, 801 [32.7%] males) was included in the present study, and 586 (23.9%) were 80 years of age or older with additional risk factors for bleeding. Major bleeding events occurred frequently among very elderly AF patients who had additional bleeding risk factors compared to other patients (unadjusted hazard ratio [HR], 2.16; 95% confidence interval [CI], 1.16-4.02); however, there were no significant differences in stroke incidence (HR, 1.86; 95% CI, 0.98-3.55). There were no significant differences for either factor after adjusting for age and sex (adjusted HR, 1.65; 95% CI, 0.75-3.62 for major bleeding; adjusted HR, 1.13; 95% CI, 0.51-2.50 for stroke). Conclusions: In very elderly AF patients with comorbidities associated with greater risk of bleeding, the incidence of major bleeding events was significantly increased. In addition, risk of stroke showed tendency to increase in same population. Effective anticoagulation therapy might be important in these high-risk population, and close observation of bleeding events might also be required.

Keywords

Acknowledgement

The authors sincerely thank the LEDIOS Registry sites and staff for their commitment and contributions to the study. The authors also thank Ji-Su Goag from Daiichi Sankyo Korea for their support of the trial.

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