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No increased risk of major bleeding in DOACs vs warfarin, study finds

The risk of major bleeding and all-cause mortality is similar between direct oral anticoagulants (DOACs) and warfarin, a study has found.

Patients taking DOACs for venous thromboembolism (VTE) were not at increased risk of major bleeding events when compared with warfarin and were also not at increased risk of death from any cause.

The study, carried out by researchers in Canada, looked at records for 59,525 patients who had been prescribed either a DOAC or warfarin for VTE. They found similar levels of risks of major bleeding events and no difference in risk of death after an average follow up of just under 90 days.

The researchers also found that the results remained consistent when they extended the follow up period to 180 days.

They said in the paper: ‘Randomised trials assessing the efficacy and safety of DOAC use compared with vitamin K antagonists for the treatment of venous thromboembolism have shown favourable risk-benefit profiles for DOAC treatment.

‘Although we did not observe a lower risk of major bleeding with DOAC treatment in our study, given the absence of an increased bleeding risk and the advantages associated with its use particularly around frequency of monitoring and dosing, our results suggest that DOACs may be considered as a treatment option for patients with venous thromboembolism who are candidates for anticoagulation.’

The authors also noted that this trial adds important information to the safety profile of DOACs in general clinical practice, as randomised trials typically exclude people with a history of bleeding and are not always designed to compare differences in safety outcomes.

BMJ 2017; available online 17th October

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