Department of Pharmacy, The First Affiliated Hospital of Henan University of Science and Technology, No. 24 Jinghua Road, Jianxi District, Luoyang, China.
Department of Pharmacy, People's Hospital of Guilin, No.12 Civilization Road, Xiangshan District, Guilin, China.
Adv Ther. 2024 Jan;41(1):391-412. doi: 10.1007/s12325-023-02717-5. Epub 2023 Nov 21.
Venous thromboembolism (VTE) consists of deep vein thrombosis (DVT) and pulmonary embolism (PE). Rivaroxaban is a direct oral anticoagulant (DOAC) inhibiting activated coagulation factor X (FXa), and exerts several advantages in the treatment of VTE compared to conventional therapy. However, the efficacy and safety of rivaroxaban in elderly patients with VTE was still poorly understood.
The study was carried out using an observational and non-interventional approach. A total of 576 patients aged ≥ 60 years with newly diagnosed VTE were included in the study. All patients received rivaroxaban with recommended treatment duration of ≥ 3 months for secondary prevention. In addition, 535 elderly patients with various diseases except VTE were included in the study in a retrospective and randomized way.
The total bleeding rate was 12.2% (70/576). Major bleeding and non-major clinically relevant (NMCR) bleeding occurred in 4 (0.69%) patients and 5 (0.87%) patients, respectively. The rate of recurrent VTE was 5.4%. The mean level of D-dimers was increased by 467.2% in the elderly patients with VTE compared with the elderly patients without VTE. The elderly patients with VTE receiving rivaroxaban at a dose of 10 mg once daily (n = 134) had lower risk for bleeding (3.7% vs 14.7%; P = 0.001) and a similar rate of recurrent VTE (4.5% vs 5.7%; P = 0.596) as compared to the elderly patients with VTE receiving rivaroxaban at higher doses including 15 mg once daily and 20 mg once daily (n = 442). In addition, age, concomitant aspirin, hemoglobin, activated partial thromboplastin time (APTT), and rivaroxaban doses were independent predictive factors for bleeding events.
The study suggested that a dose of 10 mg once daily should be the priority in elderly patients with VTE receiving long-term rivaroxaban anticoagulation therapy in view of reduced bleeding risk.
静脉血栓栓塞症（VTE）包括深静脉血栓形成（DVT）和肺栓塞（PE）。利伐沙班是一种直接口服抗凝剂（DOAC），可抑制活化凝血因子 X（FXa），与传统治疗相比，在 VTE 的治疗中有许多优势。然而，利伐沙班在老年 VTE 患者中的疗效和安全性仍知之甚少。
本研究采用观察性和非介入性方法进行。共纳入 576 例年龄≥60 岁的新发 VTE 患者。所有患者均接受利伐沙班治疗，推荐治疗时间≥3 个月以进行二级预防。此外，以回顾性和随机的方式纳入了 535 例患有除 VTE 以外的各种疾病的老年患者。
总出血率为 12.2%（70/576）。4 例（0.69%）患者发生主要出血，5 例（0.87%）患者发生非大出血且有临床意义（NMCR）的出血。VTE 复发率为 5.4%。与无 VTE 的老年患者相比，VTE 老年患者的 D-二聚体水平平均升高 467.2%。每日接受 10mg 利伐沙班治疗的 134 例 VTE 老年患者出血风险较低（3.7%比 14.7%；P=0.001），VTE 复发率相似（4.5%比 5.7%；P=0.596），而每日接受 15mg 和 20mg 利伐沙班治疗的 442 例 VTE 老年患者出血风险较高。此外，年龄、同时使用阿司匹林、血红蛋白、活化部分凝血活酶时间（APTT）和利伐沙班剂量是出血事件的独立预测因素。
鉴于出血风险降低，该研究表明，在接受长期利伐沙班抗凝治疗的老年 VTE 患者中，每日 10mg 剂量应优先考虑。
