key: cord-1035522-rg40noys authors: Nachtigall, Irit; Hohenstein, Sven; Bollmann, Andreas; Bonsignore, Marzia; Husser, Daniela; Kuhlen, Ralf; Hellmann, Andreas Meier title: Thrombembolic Events in Hospitalized COVID-19 Patients: What is the Role of the Sex? date: 2021-08-12 journal: TH Open DOI: 10.1055/a-1585-9536 sha: 2e0ad1106f25e25cbf78aa2ddf598c6cf4c50b0d doc_id: 1035522 cord_uid: rg40noys nan We analyzed claims data from 83 hospitals in the Helios Group. All patient 19,501 cases admitted between February 1 st , 2020 and February 8 th , 2021 with the International Statistical Classification of Diseases and Related Health Problems (ICD-10) code U07.1 (¼ PCR-confirmed infection with SARS-CoV-2), were included. The following ICD-10 codes were used as definitions: Thrombocytopenia: D69.5, D69.6, pulmonary embolism: I26, thrombosis: I80, I81, I82, sinus vein thrombosis: G08, I67.6, I63.6. Only cases which were completed in the hospital, were included for hospital mortality n8,533. The following ICD-10 codes were used as definitions: Thrombocytopenia: D69.5, D69.6, pulmonary embolism: I26, thrombosis: I80, I81, I82, sinus vein thrombosis: G08, I67.6, I63.6. Only cases which were completed in the hospital, were included for hospital mortality (n ¼ 8,533). We used the R software for statistical programming (version 4.0.2) for all analyses. The multivariable analyses of TE and in-hospital mortality were analyzed via logistic regression with log link function. In these models, we used sex, age (as numerical variable), comorbidities, and the frailty risk score 1 as predictors; in the models for in-hospital mortality, TE was an additional predictor. 19,501 patients aged 0 -103y (median 74y, Q25 ¼ 59y, Q75 ¼ 83y), 9,537 women (48.91%) and 9,964 men (51.09%) were included for the whole analysis, for calculation of the mortality 8,533 cases (85.64%) were included. Patient characteristis of the total cohort and the subcohort with thromboembolic events are shown in ►Table 1. At least one TE was coded in 963 patients (4.94%) (433 pulmonary embolisms, 371 thrombocytopenias, 249 thromboses and 2 sinus vein thromboses, several events per patient being possible), incidence rate was 4,938 (per 100,000 cases; 95% CI: 4640-5254). TE occurred in 4.94% of all inpatients; men were affected by 5.73% (571 / 9.964) and women by 4.11% (392 / 9,537). The distribution of age and sex in thrmoboembolic events is shown in ►Figure 1. In the multivariate regression analysis, independent risk factors for developing TE were among others male In our cohort of Covid-19 inpatients, TE occurred in approx. 5%; involved mostly pulmonary embolisms and affected mainly men in their 60ies. In addition to various pre-existing conditions, we found the male sex to be a major independent risk factor for the development of TE. TE are a common complication of COVID-19 and have been reported to occur in ca. 7% of inpatients treated with thromboembolism prophy-laxis. 2 Several possible pathomechanisms have been discussed, including a direct endothelial damage 3 as well as an antibody-mediated activation of platelets via the Fcγ-IIa receptor. 4 Men are at an increased risk of a severe course of Covid-19 5 ; TE are presumably part of this multifactorial, gender-specific risk. The antibody-mediated activation of platelets via the Fcγ-IIa receptor has also been suggested as pathomechanism for TE after Vaxzevria. 6 It is unclear, why younger women seem to be affected more often by this complication. In general, sinus vein thromboses occur mostly in younger women. 7 The EMA reviewed 62 cases of cerebral venous sinus and 24 of splanchnic vein thromboses reported until March 22th, 2021. Although most of the cases reported have occurred in women <60y, no specific risk factors like sex or age were confirmed; the risk for TE after the vaccinations was estimated at 1: 100 000. In summary, we found that a large number of Covid-19 inpatients have thromboembolic complications, at a frequency that is 5000 times higher than the one of TE after Vaxzevria. Although similar pathomechanisms have been discussed for both, the development of TE in Covid-19 and after vaccination, these two phenomena differ clearly in the type of thromboses that occur and in the sex distribution. The observational design of our study based on claims data are a strong limitation; at best, the results can provide a signal, especially information on medications and their different impact on both sexes need to be addressed. To our opinion, the sex aspect of thromboembolic events in Covid-19 and after Vaxzevria has not been adequately addressed so far and needs further investigation. Development and validation of a Hospital Frailty Risk Score focusing on older people in acute care settings using electronic hospital records: an observational study Incidence and mortality due to thromboembolic events during the COVID-19 pandemic: Multisourced population-based health records cohort study Waves of SARS-CoV-2 Infection and Blood Coagulation-A Link and Beyond Antibody-induced procoagulant platelets in severe COVID-19 infection Clinical course and factors associated with outcomes among 1904 patients hospitalized with COVID-19 in Germany: an observational study Thrombotic Thrombocytopenia after ChAdOx1 nCov-19 Vaccination Prognosis of cerebral vein and dural sinus thrombosis: results of the International Study on Cerebral Vein and Dural Sinus Thrombosis (ISCVT) Conflict of Interest RK declares to hold shares of Fresenius, all other authors declare not to have any conflicts of interest.