Treating venous thromboembolism (VTE) with direct oral anticoagulants (DOACs) creates no greater risk of major bleeding or death in the first 90 days of treatment compared with warfarin, a study of community-based data published in The BMJ has found
“We observed consistent results when we assessed patients according to sex, age and chronic kidney disease status. Our results therefore suggest that DOACs may be considered as a treatment option for patients with VTE who are candidates for anticoagulation,” said study author Min Jun from the George Institute for Global Health, Sydney.
The researchers used data from Canada and the USA which included 59,525 adults who had a VTE and were prescribed a DOAC (apixaban, dabigatran or rivaroxaban) or warfarin within 30 days.
Following outcomes for up to 90 days, they found that overall 1967 (3.3%) patients experienced a major bleeding event and 1029 (1.7%) patients died. Statistical analysis showed that patients prescribed a DOAC were no more at risk of these events than those prescribed warfarin.
Data from randomised studies has indicated that the risk of safety events is comparable between warfarin and DOACs. But because clinical trials tend to include only select groups of patients, the researchers say that real-world data is needed to inform clinical practice.
RPS spokesperson and consultant pharmacist in cardiovascular medicine Sotiris Antoniou said: “Real world data is important [because] many of the patients we treat would have been excluded from the clinical trials either due to the presence of co-morbidities, interacting drugs or other factors that meant they met the exclusion criteria.”
“As such this adds to ongoing support that DOACs are at least as safe as warfarin for their licensed indications,” he adds.
But Antoniou noted that the average follow-up in the study, at less than three months, was relatively short and patients were quite young at 64.3 years, which could also explain the results.
Additionally, the majority of DOAC-treated patients in the study received rivaroxaban. The researchers note that future research will need to collect data on the safety of apixaban and dagibatran. They also say that the drug class’s safety should be explored in people with advance chronic kidney disease who have a higher risk of major bleeding compared with other patient groups.
 Jun M, Lix LM, Durand M et al. Comparative safety of direct oral anticoagulants and warfarin in venous thromboembolism: multicentre, population based, observational study. BMJ 2017;359:j4323. doi: 10.1136/bmj.j4323