Adjudicated thrombotic events in a cotemporary multicenter cohort of patients with COVID-19: findings from the CORONA-VTE Registry

Abstract

Abstract Background Venous thromboembolism (VTE) and arterial thrombosis emerged among the main serious complications of coronavirus disease 2019 (COVID-19) in the early post-infection period and during convalescence. Data are less consistent about how the event rates may have changed over time considering the change in viral variants and COVID-19 therapies, and vaccination status. Purpose To report VTE and arterial thrombotic events in patients with COVID-19, and assess results by vaccination status and over time from a large multicenter patient-level US registry. Methods Adult patients with polymerase chain reaction-confirmed COVID-19 who received inpatient or outpatient care at Mass-General Brigham (MGB) Health system, the largest health system in the Massachusetts that serves 1.5 million patients, were eligible. Data elements were entered into a centralized database by trained research staff. Thrombotic events were adjudicated by two independent physicians. Outcomes were assessed at 30- and 90-day follow-up. Findings were pre-specified to be assessed separately for patients who were hospitalized with COVID-19 vs outpatients. Vaccination status was ascertained for subgroup analysis. Results The study included 4,123 patients from the MGB Health System from 3/13/2020 through 06/03/2022 (age: 53.5 ± 18 years; 55.9% female, Table). Among hospitalized patients, the cumulative incidence of VTE was 7.7% at day 90 (95% CI: 6.2-9.2%). Respective 30-day event rates for arterial thrombosis among hospitalized patients were 4.4% (95% CI: 3.2%-5.5%). Event rates were lower for outpatients (Figure, Panel A). Thirty-day cumulative incidence of VTE and arterial thrombosis/thromboembolism based on history of vaccination (restricted to cohort from 12/14/2020 onward) are presented in Panel B. Conclusions In this multicenter study 30-day adjudicated thrombotic events were frequent in patients with COVID-19, albeit lower among vaccinated patients. Follow-up for 90-day outcomes are being finalized and will be presented at ESC 2023.