DOACs may be safe, effective for VTE prevention in patients with higher weight, BMI
Patients with first-time venous thromboembolism (VTE) who weighed 120 kg or more and had a body mass index (BMI) of 40 kg/m2 or more were not at higher risk for bleeding or recurrent VTE with direct-acting oral anticoagulants (DOACs) versus warfarin.
Higher weight or body mass index (BMI) may not be a contraindication for treatment with direct-acting oral anticoagulants (DOACs) after venous thromboembolism (VTE), according to a recent industry-funded study.
Researchers performed a retrospective cohort study of patients with first-time VTE who were treated with a DOAC or warfarin in the Veterans Health Administration, which uses system-wide guidance for patient selection and shared decision-making regarding DOACs, VTE, and weight. The goal of the study was to assess the associations between weight and BMI and outcomes in those who received a DOAC versus warfarin. The primary outcomes were major bleeding, clinically relevant nonmajor bleeding, and recurrent VTE. Results of the study, which was funded by Bristol Myers Squibb-Pfizer Alliance, were published Nov. 2 by Circulation: Cardiovascular Quality and Outcomes.
The cohort included 51,871 patients who were prescribed a DOAC or warfarin within 30 days of an index VTE diagnosis from 2013 to 2018. Their mean age was 64.5 years, 6.0% were women, and the median weight was 93.4 kg (25th to 75th percentile, 80.5 to 108.6 kg). Overall, 6,934 patients weighed 120 kg or more; 12,660 weighed at least 100 kg but less than 120 kg; 30,645 weighed 60 kg or more but less than 100 kg; and 1,632 weighed less than 60 kg. In the highest- weight group, 38.4% received a DOAC versus 45.4% of the 60- to 100-kg group (P<0.0001). No association was seen between a DOAC prescription and major bleeding, clinically relevant nonmajor bleeding, or recurrent VTE among patients with higher weight and BMI versus those with average weight and BMI. In addition, a DOAC prescription was not associated with increased VTE recurrence versus warfarin for any weight or BMI category.
The researchers noted that their study included only men in the Veterans Affairs (VA) system and could have been affected by residual confounding, among other limitations. “Patients with VTE in higher weight and BMI categories are frequently prescribed DOAC by the VA health care system. The use of DOACs, compared with warfarin, was not associated with increase in bleeding events or recurrent VTE in these patients,” they wrote. “These findings suggest that DOACs can be safe and effective in this population and may argue for broader adoption of pharmacy policies that promote careful patient selection and shared decision making.”