DeCamillo Deborah, Ellsworth Stacy, Kaatz Scott, Barnes Geoffrey D
Division of Vascular and Cardiovascular Medicine, University of Michigan, 24 Frank Lloyd Wright, Lobby A, Suite 3201, Ann Arbor, MI, 48105, USA.
Henry Ford Hospital, Detroit, MI, USA.
J Thromb Thrombolysis. 2020 Nov;50(4):844-848. doi: 10.1007/s11239-020-02095-7.
Since 2012 four direct oral anticoagulants (DOAC) have been approved by the US Food and Drug Administration (FDA) for treatment of acute venous thromboembolism (VTE). Clinical trials comparing DOACs to warfarin included more than 13,500 patients. However, included patients were all age 39 years or older. We sought to describe real-world use of DOACs among young adults with acute VTE. Multi-center retrospective case series of young adult patients (age 18-40 years) at two large academic medical centers who initiated any DOAC for VTE therapy in 2015 or 2016. Thrombotic and bleeding events as well as off-label drug use were described using summary statistics. Fifty-seven patients were identified (63.2% female). One of the 57 patients (1.8%) had a thromboembolic event. Seven of the 57 patients (12.3%) experienced a bleeding event, one categorized as a major bleed and six being categorized as clinically relevant non-major bleeding. One of the ten (10%) patients receiving apixaban was not initiated on the FDA-recommended 10 mg twice daily for the first 7 days. Seven of the 47 (14.9%) patients receiving rivaroxaban were not initiated on the FDA-recommended 15 mg twice daily dosing for the first 21 days. Bleeding occurred in approximately 14% of young adult patients treated with DOAC therapy. However, only one patient had their DOAC discontinued due to a major bleeding event. Recurrence of DVT while on DOAC therapy was rare.
自2012年以来,美国食品药品监督管理局(FDA)已批准四种直接口服抗凝剂(DOAC)用于治疗急性静脉血栓栓塞症(VTE)。比较DOAC与华法林的临床试验纳入了超过13500名患者。然而,纳入的患者均为39岁及以上。我们试图描述急性VTE年轻成人中DOAC的实际使用情况。这是一项针对两家大型学术医疗中心2015年或2016年开始使用任何DOAC进行VTE治疗的年轻成人患者(年龄18 - 40岁)的多中心回顾性病例系列研究。使用汇总统计数据描述血栓形成和出血事件以及药物的非标签使用情况。共确定了57名患者(63.2%为女性)。57名患者中有1名(1.8%)发生了血栓栓塞事件。57名患者中有7名(12.3%)经历了出血事件,1例为大出血,6例为临床相关非大出血。接受阿哌沙班治疗的10名患者中有1名(10%)在开始治疗的前7天未按照FDA推荐的每日两次10毫克剂量用药。接受利伐沙班治疗的47名患者中有7名(14.9%)在开始治疗的前21天未按照FDA推荐的每日两次15毫克剂量用药。接受DOAC治疗的年轻成人患者中约14%发生了出血。然而,只有1名患者因大出血事件停用了DOAC。在DOAC治疗期间深静脉血栓形成的复发很少见。