Kim Ju Youn, Kim Juwon, Park Seung-Jung, Park Kyoung-Min, Han Sang-Jin, Kim Dae Kyeong, Park Yae Min, Lee Sung Ho, Park Jong Sung, On Young Keun
Division of Cardiology, Department of Internal Medicine, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Division of Cardiology, Hallym University Sacred Heart Hospital, Anyang, Korea.
Korean Circ J. 2024 Jul;54(7):398-406. doi: 10.4070/kcj.2024.0084. Epub 2024 May 10.
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.
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.
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).
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.
ClinicalTrials.gov Identifier: NCT03554837.
由于抗凝剂所致出血风险高，在高龄患者中进行最佳抗凝治疗具有挑战性。本研究旨在评估标签上规定的低剂量依度沙班（30毫克）在有额外出血风险因素的高龄患者中的治疗效果。
这是一项多中心、前瞻性、非干预性观察性研究，旨在评估标签上规定的低剂量依度沙班在80岁及以上且有不止1个出血风险因素的房颤（AF）患者中的疗效和安全性。
本研究共纳入2448例患者（平均年龄75.0±8.3岁，801例[32.7%]为男性），其中586例（23.9%）为80岁及以上且有额外出血风险因素的患者。与其他患者相比，有额外出血风险因素的高龄房颤患者中主要出血事件频繁发生（未调整风险比[HR]，2.16；95%置信区间[CI]，1.16 - 4.02）；然而，卒中发生率无显著差异（HR，1.86；95% CI，0.98 - 3.55）。在对年龄和性别进行调整后，这两个因素均无显著差异（调整后HR，1.65；95% CI，0.75 - 3.62用于主要出血；调整后HR，1.13；95% CI，0.51 - 2.50用于卒中）。
在合并有更高出血风险的高龄房颤患者中，主要出血事件的发生率显著增加。此外，同一人群中卒中风险有增加趋势。有效的抗凝治疗在这些高危人群中可能很重要，并且可能还需要密切观察出血事件。
ClinicalTrials.gov标识符：NCT03554837。
