Graduate School of Comprehensive Human Sciences, University of Tsukuba, Tsukuba, Japan.
Department of Health Services Research, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
Pharmacoepidemiol Drug Saf. 2022 Jun;31(6):680-688. doi: 10.1002/pds.5433. Epub 2022 Apr 7.
The coagulation activation leads to thrombotic complications such as venous thromboembolism (VTE) in patients with coronavirus disease-2019 (COVID-19). Prophylactic anticoagulation therapy has been recommended for hospitalized COVID-19 patients in clinical guidelines. This retrospective cohort study aimed to examine the association between pre-admission anticoagulation treatment and three outcomes: in-hospital death, VTE, and major bleeding among hospitalized COVID-19 patients in Japan.
Using a large-scale claims database built by the Medical Data Vision Co. in Japan, we identified patients hospitalized for COVID-19 who had outpatient prescription data at least once within 3 months before being hospitalized. Exposure was set as pre-admission anticoagulation treatment (direct oral anticoagulant or vitamin K antagonist), and outcomes were in-hospital death, VTE, and major bleeding. We conducted multivariable logistic regression analyses, adjusting for a single summarized score (a propensity score of receiving pre-admission anticoagulation) for VTE and major bleeding, due to the small number of outcomes.
Among the 2612 analytic patients, 179 (6.9%) had pre-admission anticoagulation. Crude incidence proportions were 13.4% versus 8.5% for in-hospital death, 0.56% versus 0.58% for VTE, and 2.2% versus 1.1% for major bleeding among patients with and without pre-admission anticoagulation, respectively. Adjusted odds ratios (95% confidence intervals) were 1.25 (0.75-2.08) for in-hospital death, 0.21 (0.02-1.97) for VTE, and 2.63 (0.80-8.65) for major bleeding. Several sensitivity analyses did not change the results.
We found no evidence that pre-admission anticoagulation treatment was associated with in-hospital death. However, a larger sample size may be needed to conclude its effect on VTE and major bleeding.
COVID-19 患者的凝血激活可导致血栓并发症,如静脉血栓栓塞症(VTE)。临床指南建议对住院 COVID-19 患者进行预防性抗凝治疗。本回顾性队列研究旨在研究住院 COVID-19 患者入院前抗凝治疗与三种结局之间的关系:住院期间死亡、VTE 和主要出血。
使用日本医疗数据视觉公司建立的大型索赔数据库,我们确定了至少在住院前 3 个月内有门诊处方数据的住院 COVID-19 患者。暴露设置为入院前抗凝治疗(直接口服抗凝剂或维生素 K 拮抗剂),结局为住院期间死亡、VTE 和主要出血。由于结局数量较少,我们对 VTE 和主要出血进行了多变量逻辑回归分析,调整了单个综合评分(入院前抗凝的倾向评分)。
在 2612 名分析患者中,有 179 名(6.9%)接受了入院前抗凝治疗。未经调整的住院期间死亡发生率分别为 13.4%和 8.5%,VTE 发生率分别为 0.56%和 0.58%,主要出血发生率分别为 2.2%和 1.1%。在校正后的比值比(95%置信区间)分别为住院期间死亡 1.25(0.75-2.08)、VTE 0.21(0.02-1.97)和主要出血 2.63(0.80-8.65)。几项敏感性分析并未改变结果。
我们没有发现入院前抗凝治疗与住院期间死亡相关的证据。然而,可能需要更大的样本量来得出其对 VTE 和主要出血的影响。