Key result
In patients treated with DOACs for acute VTE, bodyweight <60 kg was associated with a higher 3-month incidence of major bleeding compared to bodyweight 60-120 kg (4.4% vs 1.1%, P=0.03).
Why the study?
The study was conducted to investigate the association of extremes in bodyweight with clinical outcomes in patients receiving therapy for acute venous thromboembolism.
Do apixaban and rivaroxaban alter the risk of recurrent VTE or bleeding in acute VTE patients with extremes in bodyweight compared to those with normal bodyweight?
Cohort (n=2,577)
Do apixaban and rivaroxaban alter the risk of recurrent VTE or bleeding in acute VTE patients with extremes in bodyweight compared to those with normal bodyweight?
Absolute Event Rate: 4.4% vs 1.1%
p-value: p=0.03
DOAC therapy for acute VTE is associated with higher bleeding risk in patients <60 kg and higher recurrence risk in cancer patients >120 kg on rivaroxaban.
May warrant bleeding caution with DOACs in low-bodyweight acute VTE; leaves open optimal dosing pending randomized confirmation.
OBJECTIVES: To investigate the association of extremes in bodyweight (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 bodyweight <60 kg, 60-120 kg, and >120 kg. METHODS: 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. RESULTS: Among 2577 patients with weight ranging from 27.0 kg to 263.2 kg, 2123 (82%) had a bodyweight between 60 and 120 kg, 223 (8.7%) had bodyweight < 60 kg, and 230 (8.9%) had bodyweight >120 kg. Patients with bodyweight <60 kg 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 = .03, and 4.4% vs 1.4%, P = .05, respectively). Patients with bodyweight >120 kg and cancer on rivaroxaban had higher VTE recurrence compared to bodyweight 60-120kg group (P = .01). CONCLUSIONS: Treatment of acute VTE is associated with a higher incidence of bleeding in patients with bodyweight <60 kg. A higher VTE recurrence rate occurred only in cancer patients with bodyweight >120 kg on rivaroxaban.
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Wysokiński et al. (2020) conducted a cohort in acute venous thromboembolism (VTE) (n=2,577). Bodyweight <60 kg vs. Bodyweight 60-120 kg was evaluated on 3-month incidence of major bleeding (p=0.03). In patients treated with DOACs for acute VTE, bodyweight <60 kg was associated with a higher 3-month incidence of major bleeding compared to bodyweight 60-120 kg (4.4% vs 1.1%, P=0.03).
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