Apixaban is safe and effective in real-world setting for treatment of venous thromboembolism

Many patients suffering from venous thromboembolism may benefit from real-world data on the direct oral anticoagulant (DOAC) apixaban, which shows a significant lower risk of major bleeding as well as recurrent venous thromboembolism (VTE) when compared with warfarin.

A retrospective study of VTE patients receiving outpatient pharmacotherapy with apixaban or warfarin in clinical practice showed that the risks of major bleeding and recurrent VTE were significantly lower among patients who received apixaban. These findings offer the first evidence on safety and effetiveness of apixaban in treating and preventing VTE in a real-world setting [1]. Results from the AMPLIFY trial show that the DOAC apixaban was non-inferior to low-molecular-weight heparin followed by warfarin in treatment of acute VTE. There was also significantly less major bleeding with apixaban [2]. According to clinical practice guidelines, DOACs are recommended over vitamin K antagonists (VKAs) for VTE without associated cancer diagnosis [3]. However, the safety and effectiveness of apixaban in the treatment of VTE in routine clinical practice had not been evaluated.

Thus, Weycker et al. compared the risk of major bleeding and recurrent VTE in an observational study among patients receiving apixaban vs warfarin for VTE in clinical practice in the USA. In this retrospective cohort, data was analysed from 4 private healthcare claims databases (between March 2014 and June 2017), including 19,676 patients on apixaban and 34,647 patients on warfarin. Patients were adults aged 18 years and over, who had initial VTE episodes and began outpatient treatment within 30 days with apixaban or warfarin plus parenteral anticoagulant bridge therapy. Major bleeding and recurrent VTE were ascertained during a 180-day follow-up period and were compared between apixaban and warfarin patients using Cox proportional hazards models. The crude incidence of major bleeding was 1.6% for apixaban (4.2 per 100 patient-years) vs 2.7% for warfarin (6.7 per 100 patient-years). The adjusted hazard ratio (HR) was 0.71 (95% CI, 0.63-0.82; P<0.001). The crude incidence of recurrent VTE was 2.4 for apixaban (6.4 per 100 patient-years) and 3.8% for warfarin (9.4 per 100 patient-years), with HR 0.77 (95% CI, 0.69-0.86; P<0.001). According to the researchers, this showed a clear difference between warfarin and apixaban regarding effectiveness and safety.

1. Weycker D, et al. Abstract 1298-373. ACC 2019, 16-18 March, New Orleans, USA.
2. Agnelli G, et al. N Eng J Med. 2013;369(9):799-809.
3. Kearon C, et al. Chest. 2016;149(2):315-52.



Posted on 6 June, 201917 March, 2021