Effectiveness and Safety of Apixaban and Rivaroxaban for Acute Venous Thromboembolism Therapy in Patients with Extremes in Body Weight (ClinicalTrials.gov: NCT03504007).Eur J Haematol. 2020 Jun 17 [Online ahead of print]EJ
To investigate the association of extremes in body weight EBW and outcomes in patients with acute venous thromboembolism (VTE), recurrent VTE, major bleeding, and clinically relevant non-major bleeding were compared between patients with body weight <60 kg, 60-120 kg, and >120 kg.
Consecutive patients enrolled in the Mayo Clinic VTE Registry (03/28/2013-8/31/2019) with acute VTE were followed prospectively. Patient status was assessed in person, by mailing a written questionnaire, or by a scripted phone interview.
Amongst 2577 patients with the weight ranging from 27.0 kg to 263.2 kg, 2123 (82%) had a bodyweight between 60 - 120 kg, 223 (8.7%) bodyweight <60 kg, and 230 (8.9%) bodyweight >120 kg. Patients with bodyweight <60kg treated with DOACs had higher 3- and 6-month incidence of major bleeding compared to the bodyweight 60-120kg group (4.4% vs 1.1%, p=0.03, and 4.4% vs 1.4%, p=0.05, respectively). Patients with bodyweight >120kg and cancer on rivaroxaban had higher VTE recurrence compared to bodyweight 60-120kg group (p=0.01).
Treatment of acute VTE is associated with a higher incidence of bleeding in patients with bodyweight <60kg. A higher VTE recurrence rate occurred only in cancer patients with bodyweight >120kg on rivaroxaban.