Upper extremities deep vein thrombosis treated with oral direct anticoagulants: A prospective cohort study

Limited data are available on the role of direct oral anticoagulants (DOACs) for the treatment of upper extremities deep vein thrombosis (UEDVT). The aim of this study was to assess the effectiveness and safety of DOACs in the treatment of UEDVT. Patients with an objectively confirmed acute UEDVT treated with DOACs were merged from prospective cohorts to a collaborative database. Primary study outcomes were recurrent venous thromboembolism (VTE) and major bleeding occurring during DOAC treatment. Overall, 188 patients were included in the study: mean age 52.4 ± 20.4 years, males 43.6%, patients with active cancer 29.2%. Twenty-nine percent of patients had 2 or more risk factors for VTE, 33.0% had catheter-related or pacemaker-related UEDVT. In 13.8% of patients, DOACs were started one month after UEDVT diagnosis or later. Active cancer was an independent predictor for delayed initiation of DOACs (OR 8.1, 95% CI 3.0–22.2). Mean duration of treatment with DOACs was 5.1 ± 2.8 months. During treatment with DOACs, recurrent VTE occurred in 0.9 per 100 patient-year, major bleeding in 1.7 and all-cause deaths in 6.0 per 100 patient-year. No fatal bleeding or fatal VTE recurrence were observed. During 232.1 patient-years of follow-up after DOAC withdrawal, recurrent VTE occurred in 3.0 per 100 patient-year. The 2019 ESC categories for risk of VTE recurrences were able to discriminate patient groups at different risk of events in the on and off-treatment periods. Our data support the feasibility as well as the effectiveness and safety of DOACs for the treatment of acute UEDVT. •We assessed the effectiveness and safety of DOACs in a prospective cohort of patients with UEDVT.•During DOAC treatment, rate of recurrent VTE and of major bleeding was lower than 1 and 2 per 100 patient-year, respectively.•After DOAC discontinuation, the rate of recurrent VTE was 3.0 per 100 patient-year.•Both recurrent VTE and bleedings mainly occurred in patients with active cancer.