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Background: In addition to cytokine storm, some patients suffer from thrombotic events including myocardial infarction (MI), cerebrovascular accident (CVA), and venous thromboembolism (VTE) such as deep vein thrombosis (DVT) and pulmonary thromboembolism (PTE) during the course of COVID-19. Objectives: In our study, we aimed to evaluate the effect of high dose intravenous anakinra treatment on development of thrombotic events in severe and critical COVID-19 patients. Methods: This retrospective observational study was conducted at a tertiary referral center in Aksaray, Turkey. The study population consisted of two groups as follows; the patients receiving high dose intravenous anakinra (anakinra group) added to background therapy between 01.09.2021 and 01.02.2022 and the patients treated with standard of care (SoC) as historical control group who were hospitalized between 01.07.2021 and 01.09.2021. COVID-19 disease severity was evaluated according to the National Institute of Health (NIH) severity scale and only severe and critically ill patients who followed-up in the ward were included into the study. All patients received background corticosteroid therapy with 80 mg/day methylprednisolone (or its equivalent) and enoxaparin 0.4 mg/day at the admission and continued consecutive days (SoC). Anakinra was added to the background treatment in patients who did not respond to initial treatment at least two days or concomitantly with steroids in patients with higher risk and/or critical illness at admission and continued until discharge or death. Average starting dose of anakinra was 400 mg/day intravenously and increased gradually to maximum 1600 mg/day if necessary (10 mg/kg/day). Results: We included 114 patients in SoC and 139 patients in Anakinra group into the study.After 1:1 PS matching, 88 patients in SoC and 88 patients in Anakinra group were matched and included into the analysis. After adjustment of potential confounders age, gender, presence of comorbidities (DM, HT, CHD, CRF, chronic lung disease, and malignancy), disease severity, vaccination history, mcHIS scores were not different between two groups. Severe infection (28.4% vs 16%, p=0.05; OR:3.9), development of any thromboembolic event (15.9% vs 3.4%, p=0.005; OR:7.9), PTE (12.5% vs 3.4%, p=0.026; OR:5), MI (6.8% vs 0, p=0.013; OR:6.2) were higher in SoC arm compared to Anakinra. ICU requirement and mortality did not differ between two arms (p=0.2 and p=0.4, respectively). In survival analysis, development of any thromboembolic event, PTE, and MI were higher in SoC compared to Anakinra (Log-Rank; p=0.003, p=0.003 and p=0.007, respectively). Survival rate was also lower in patients with SoC arm than Anakinra in patients who had any thromboembolic event as well as MI (Log-Rank; p=0.03 and pConclusion: Thromboembolic events were seen despite the anticoagulant prophylaxis in our study. Development of thrombosis were associated with hyperinflammation in patients with severe and critical COVID-19. Intravenous high-dose anakinra treatment decreases both venous and arterial events in patients with COVID-19. REFERENCES: NIL. Table 2. Univariate analysis of the patients had any thromboembolic event after Propensity-score (PS) Matching Acknowledgements: NIL. Disclosure of Interests: None declared.
Bektaş et al. (Sat,) studied this question.