Abstract 18404: Clinical Events Avoided With Apixaban Compared to Current Standard of Care for the Initial and Extended Treatment and Prevention of Venous Thromboembolism
Purpose: The AMPLIFY trial compared apixaban 5 mg BID to low-molecular-weight heparin (LMWH) followed by dose-adjusted warfarin for initial treatment and long term prevention of recurrent venous thromboembolism (VTE) over a six-month period. The AMPLIFY-EXT trial compared extended treatment with apixaban 2.5 mg and 5 mg BID to placebo in previously treated patients over a 12-month period. The analysis reported here evaluated the potential clinical implications of the introduction of initial and extended treatment with apixaban versus current standard of care (SoC).
Methods: A Markov model was developed to evaluate the lifetime clinical impact of initial and extended treatment and prevention of VTE with apixaban (starting at 5 mg BID for 6 months, then 2.5 mg BID for an additional 12 months) versus current SoC (LMWH/warfarin for 6 months with no further treatment). Clinical event rates were taken from the AMPLIFY and AMPLIFY-EXT trials. Background mortality rates were based on US life tables and published literature. Outcomes evaluated were the number of events avoided in a 1,000-patient cohort, number needed to treat to avoid a recurrent VTE event, number needed to treat to harm with an additional bleed, and life years gained.
Results: In a cohort of 1,000 patients, initial and extended treatment with apixaban versus current SoC was projected to result in 63 fewer recurrent VTE events, 13 fewer major bleeds, and 28 fewer CRNM bleeds, resulting in 0.139 life years gained per patient. These results translated to one recurrent VTE event avoided for each 16 patients treated with apixaban with no additional harm in terms of major bleeding events. Assessment of apixaban for 6-month treatment only versus current SoC was also projected to cause fewer recurrent VTEs, major and CRNM bleeds. The majority of the benefit observed in reducing recurrent VTE events was observed during the extended treatment phase when patients continued with apixaban treatment as opposed to stopping anticoagulant therapy with SoC.
Conclusions: Initial and extended treatment with apixaban for prevention of VTE appears to be a superior alternative to current SoC in terms of clinical events avoided, leading to fewer recurrent VTEs, fewer bleeding events, and a projected increase in life-expectancy.
Author Disclosures: T. Lanitis: Consultant/Advisory Board; Significant; Paid consultant to Pfizer/BMS in connection with conducting this research. M. Hamilton: Employment; Significant; Employee of Bristol-Myers Squibb with ownership of stocks. D. Rublee: Employment; Significant; Employee of Pfizer inc. with ownership of stocks. R. Leipold: Consultant/Advisory Board; Significant; Paid consultant to Pfizer/BMS in connection with conducting this study. C. Browne: Consultant/Advisory Board; Significant; Paid consultant from Pfizer/BMS in connection with conducting this study. P. Quon: Consultant/Advisory Board; Significant; Paid consultant to Pfizer/BMS in connection with conducting this study. A. Cohen: Honoraria; Significant; Has received honoraria and research support from Pfizer/BMS.
- © 2014 by American Heart Association, Inc.