OR32. Efficacy and Safety of Therapeutic Versus Prophylactic Dose of Anticoagulation in Hospitalized Patients with Severe COVID-19 Pneumonia and Coagulopathy: An Open-Label, Randomized Controlled Trial

Abstract

Background and AimsThe use of therapeutic anticoagulation to improve outcomes in COVID-19-associated coagulopathy remains unclear. We aimed to compare the efficacy and safety of therapeutic versus standard prophylactic anticoagulation in this population.Methods and ResultsThis was a single-center, open-label, two-arms, randomized controlled study conducted from 1st April to 15th July 2021. Two-hundred fifty severe COVID-19 patients with coagulopathy were randomly assigned (1:1 ratio) to receive either prophylactic anticoagulation (subcutaneous unfractionated heparin/UFH 5000IU b.i.d or fondaparinux 2.5mg o.d) or therapeutic anticoagulation (weight-adjusted dose UFH or fondaparinux). Anticoagulation was administered until hospital discharge or at the treating physician’s discretion. All patients received international COVID-19 guideline-driven therapy throughout the study. Baseline characteristics were not significantly different (p > 0.05) between both arms, except for the D-dimer and CRP level at admission (p = 0.04; p = 0.001; respectively). During a 30-day follow-up, therapeutic arm revealed significant higher need for NIV/invasive MV (41.3% vs. 29%, p = 0.02), higher progression to ARDS (34.1% vs. 16.1%, p = 0.001), and increased 30-day all-cause mortality (58.7% vs. 15.3%, p < 0.001) as compared with prophylactic arm. There was no significant difference between both arms in the incidence of acute MI (20% vs. 13.6%, p = 0.07), VTE (4.8% vs. 0.8%, p = 0.09), arterial thromboembolism (3.2% vs. 0%, p = 0.29) and overall bleeding (17.6% vs. 6.4%, p = 0.18) at 30-days.ConclusionTherapeutic anticoagulation was considered safe and effective in preventing thromboembolic events, but not in the need for NIV/invasive MV, progression to ARDS and 30-day all-cause mortality in hospitalized patients with severe COVID-19 and coagulopathy.