Highlights from

ACC 2019

American College of Cardiology Annual Scientific Session & Expo

New Orleans 16-18 March 2019

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

A retrospective study of venous thromboembolism (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 efficacy of apixaban in treating and preventing VTE in a real-world setting [1].

Results from the AMPLIFY trial show that the new oral anticoagulant (NOAC) 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, NOACs are recommended over vitamin K antagonists (VKAs) for VTE without associated cancer diagnosis [3]. However, the safety and efficacy 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 versus warfarin for VTE in clinical practice in the United States.

In this retrospective cohort, data was analysed from 4 US private healthcare claims databases (03/2014 - 06/2017), including 19,676 patients on apixaban and 34,647 patients on warfarin. Patients were adults aged 18 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 efficacy and safety.

  1. Weycker D, et al. Safety and Effectiveness of Apixaban Versus Warfarin in the Treatment and Prevention of Venous Thromboembolism. Abstract 1298-373. ACC 2019, 15-18 March, New Orleans, USA.

  2. Agnelli G, et al. Oral apixaban for the treatment of acute venous thromboembolism. N Eng J Med. 2013;369(9):799-809.

  3. Kearon C, et al. Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report. Chest. 2016;149(2):315-52.

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