Enoxaparin for thromboprophylaxis in hospitalized COVID-19 patients: The X-COVID-19 Randomized Trial
Enoxaparin for thromboprophylaxis in hospitalized COVID-19 patients: The X-COVID-19 Randomized Trial
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DOI：
10.1111/eci.13735
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发表时间：
2021-12-26
影响因子：
5.5
通讯作者：
Cattaneo, Marco
中科院分区：
文献类型：
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作者：
Morici, Nuccia;Podda, GianMarco;Cattaneo, Marco
背景尚不确定在普通病房住院的COVID-19患者是否需要比血栓预防推荐剂量更高的抗凝剂。方法这是一项在9个意大利中心进行的多中心、开放标签、随机试验，比较40 mg每日两次对比40 mg o.d. 2020年4月30日至2021年4月25日期间，用于COVID-19患者的依诺肝素。主要疗效结局为静脉血栓栓塞（VTE）的院内发生率：通过连续加压超声（CUS）诊断的无症状或症状性近端深静脉血栓形成（DVT），和/或通过计算机断层扫描血管造影（CTA）诊断的症状性肺栓塞（PE）。次要终点包括主要疗效结局的每个单独组分和死亡、VTE、机械通气、卒中、心肌梗死、入住ICU的复合终点。安全性结局包括大出血。结果由于招募缓慢，研究提前中断。我们在主要分析中纳入了189例入组患者中的183例（96%）（91例为b.i.d.，92 in o.d.）。6例患者（6.5%，0例DVT，6例PE）在o.d.发生主要疗效结局。B. id.组为0，ARR 6.5，95% CI：1.5-11.6。没有伴随的DVT和影像学特征表明，大多数肺动脉闭塞实际上是由局部血栓而不是PE引起的。次要和安全性终点的统计学差异无统计学意义，观察到两个主要出血事件在每个arm. Conclusions没有DVT发生在COVID-19住院患者在普通病房，独立的依诺肝素剂量用于血栓预防。肺动脉闭塞只发生在死亡前。组我们的试验动力不足，事件很少。
Background It is uncertain whether higher doses of anticoagulants than recommended for thromboprophylaxis are necessary in COVID-19 patients hospitalized in general wards Methods This is a multicentre, open-label, randomized trial performed in 9 Italian centres, comparing 40 mg b.i.d. versus 40 mg o.d. enoxaparin in COVID-19 patients, between April 30 2020 and April 25 2021. Primary efficacy outcome was in-hospital incidence of venous thromboembolism (VTE): asymptomatic or symptomatic proximal deep vein thrombosis (DVT) diagnosed by serial compression ultrasonography (CUS), and/or symptomatic pulmonary embolism (PE) diagnosed by computed tomography angiography (CTA). Secondary endpoints included each individual component of the primary efficacy outcome and a composite of death, VTE, mechanical ventilation, stroke, myocardial infarction, admission to ICU. Safety outcomes included major bleeding. Results The study was interrupted prematurely due to slow recruitment. We included 183 (96%) of the 189 enrolled patients in the primary analysis (91 in b.i.d., 92 in o.d.). Primary efficacy outcome occurred in 6 patients (6.5%, 0 DVT, 6 PE) in the o.d. group and 0 in the b.id. group (ARR 6.5, 95% CI: 1.5-11.6). The absence of concomitant DVT and imaging characteristics suggests that most pulmonary artery occlusions were actually caused by local thrombi rather than PE. Statistically nonsignificant differences in secondary and safety endpoints were observed, with two major bleeding events in each arm. Conclusions No DVT developed in COVID-19 patients hospitalized in general wards, independently of enoxaparin dosing used for thromboprophylaxis. Pulmonary artery occlusions developed only in the o.d. group. Our trial is underpowered and with few events.