The efficacy and safety of Rivaroxaban for elderly patients with thrombotic diseases

Sha-sha Sun, Jian Cao, Hongbin Liu, Jiakun Luo, Weihao Xu, Lu Liu, Yanqi Di, X. Zou, Jian-hua Li
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Abstract

Objective To investigate the efficacy and safety of Rivaroxaban for elderly patients with thrombotic diseases. Methods This was a retrospective study.A total of 301 elderly patients taking Rivaroxaban from October 2012 to November 2017 at the Second Medical Center of the Chinese PLA General Hospital were consecutively selected.The ages ranged from 60 to 102 years, with an average age of(86.5±8.4)years.Anticoagulation regimens were developed based on comprehensive evaluation of indications, creatinine clearance, ischemia and bleeding risk.Patients were divided into a Rivaroxaban 2.5-5.0 mg/d group(n=72), a 10.0 mg/d group(n=205), and a 15.0-20.0 mg/d group(n=24). Hepatic function, renal function, and coagulation indexes were measured before and after the administration of Rivaroxaban.Fatal bleeding, cardiovascular deaths, all-cause deaths, non-fatal bleeding and thromboembolic events were recorded during the follow-up period. Results The average dose of Rivaroxaban was(9.3±3.0)mg/d, and the minimum dose was 2.5 mg/d.The average follow-up time was(14.9± 13.9)months and the longest follow-up time was 48 months.One patient had intracranial bleeding.Twenty patients(6.6%)died with a cumulative incidence of 25.2%, three(1.0%)died of cardiac events, and 55.0% died of pneumonia and multiple organ failure.Forty patients(13.3%)had non-fatal hemorrhagic events with a cumulative incidence of 42.4%.Seven patients(2.3%)had thromboembolic events with a cumulative incidence of 16.0%, including 2 cases of non-fatal myocardial infarction, 3 cases of cerebral infarction and 2 cases of deep vein thrombosis.After treatment, levels of prothrombin time and fibrinogen significantly increased while levels of D-dimer significantly deceased(P<0.05). Conclusions Compared with previous reports, low-dose Rivaroxaban is safe and effective for elderly patients with thrombotic diseases.However, the risk of bleeding and ischemia should be comprehensively evaluated, and appropriate doses of Rivaroxaban should be selected individually. Key words: Rivaroxaban; Thromboembolism; Hemorrage
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利伐沙班治疗老年血栓性疾病患者的疗效和安全性
目的探讨利伐沙班治疗老年血栓性疾病的疗效和安全性。方法回顾性研究。连续选取2012年10月至2017年11月在中国人民解放军总医院第二医疗中心接受利伐沙班治疗的老年患者301例。年龄60 ~ 102岁,平均(86.5±8.4)岁。抗凝方案的制定是基于适应症、肌酐清除率、缺血和出血风险的综合评估。将患者分为利伐沙班2.5 ~ 5.0 mg/d组(n=72)、10.0 mg/d组(n=205)和15.0 ~ 20.0 mg/d组(n=24)。应用利伐沙班前后测定肝功能、肾功能、凝血指标。在随访期间记录致命性出血、心血管死亡、全因死亡、非致命性出血和血栓栓塞事件。结果利伐沙班平均给药剂量为(9.3±3.0)mg/d,最小给药剂量为2.5 mg/d。平均随访时间(14.9±13.9)个月,最长随访时间48个月。1例患者颅内出血。20例(6.6%)患者死亡,累计发病率25.2%,3例(1.0%)患者死于心脏事件,55.0%患者死于肺炎和多器官衰竭。40例(13.3%)患者发生非致死性出血事件,累计发生率为42.4%。7例(2.3%)患者发生血栓栓塞事件,累计发生率为16.0%,其中非致死性心肌梗死2例,脑梗死3例,深静脉血栓形成2例。治疗后凝血酶原时间、纤维蛋白原水平显著升高,d -二聚体水平显著降低(P<0.05)。结论与以往报道相比,低剂量利伐沙班治疗老年血栓性疾病安全有效。然而,应综合评估出血和缺血的风险,并单独选择合适的利伐沙班剂量。关键词:利伐沙班;血栓栓塞;Hemorrage
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