Estimation of the impact of warfarin’s time-in-therapeutic range on stroke and major bleeding rates and its influence on the medical cost avoidance associated with novel oral anticoagulant use-learnings from ARISTOTLE, ROCKET-AF, and RE-LY trials

Estimation of the impact of warfarin’s time-in-therapeutic range on stroke and major bleeding... Warfarin’s time-in-therapeutic range (TTR) is highly variable among patients with nonvalvular atrial fibrillation (NVAF). The objective of this study was to estimate the impact of variations in wafarin’s TTR on rates of stroke/systemic embolism (SSE) and major bleedings among NVAF patients in the ARISTOTLE, ROCKET-AF, and RE-LY trials. Additionally, differences in medical costs for clinical endpoints when novel oral anticoagulants (NOACs) were used instead of warfarin at different TTR values were estimated. Quartile ranges of TTR values and corresponding event rates (%/patient − year = %/py) of SSE and major bleedings among NVAF patients treated with warfarin were estimated from published literature and FDA documents. The associations of SSE and major bleeding rates with TTR values were evaluated by regression analysis and then the calculated regression coefficients were used in analysis of medical cost differences associated with use of each NOAC versus warfarin (2010 costs; US payer perspective) at different TTRs. Each 10 % increase in warfarin’s TTR correlated with a −0.32 %/py decrease in SSE rate (R2 = 0.61; p < 0.001). Although, the rate of major bleedings decreased as TTR increased, it was not significant (−0.035 %/py, p = 0.63). As warfarin’s TTR increased from 30 to 90 % the estimated medical cost decreased from −$902 to −$83 for apixaban, from −$506 to +$314 for rivaroxaban, and from −$596 to +$223 for dabigatran. Among NVAF patients there is a significant negative correlation between warfarin’s TTR and SSE rate, but not major bleedings. The variations in warfarin’s TTR impacted the economic comparison of use of individual NOACs versus warfarin. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Thrombosis and Thrombolysis Springer Journals

Estimation of the impact of warfarin’s time-in-therapeutic range on stroke and major bleeding rates and its influence on the medical cost avoidance associated with novel oral anticoagulant use-learnings from ARISTOTLE, ROCKET-AF, and RE-LY trials

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Publisher
Springer Journals
Copyright
Copyright © 2014 by Springer Science+Business Media New York
Subject
Medicine & Public Health; Cardiology; Hematology
ISSN
0929-5305
eISSN
1573-742X
D.O.I.
10.1007/s11239-013-1048-z
Publisher site
See Article on Publisher Site

Abstract

Warfarin’s time-in-therapeutic range (TTR) is highly variable among patients with nonvalvular atrial fibrillation (NVAF). The objective of this study was to estimate the impact of variations in wafarin’s TTR on rates of stroke/systemic embolism (SSE) and major bleedings among NVAF patients in the ARISTOTLE, ROCKET-AF, and RE-LY trials. Additionally, differences in medical costs for clinical endpoints when novel oral anticoagulants (NOACs) were used instead of warfarin at different TTR values were estimated. Quartile ranges of TTR values and corresponding event rates (%/patient − year = %/py) of SSE and major bleedings among NVAF patients treated with warfarin were estimated from published literature and FDA documents. The associations of SSE and major bleeding rates with TTR values were evaluated by regression analysis and then the calculated regression coefficients were used in analysis of medical cost differences associated with use of each NOAC versus warfarin (2010 costs; US payer perspective) at different TTRs. Each 10 % increase in warfarin’s TTR correlated with a −0.32 %/py decrease in SSE rate (R2 = 0.61; p < 0.001). Although, the rate of major bleedings decreased as TTR increased, it was not significant (−0.035 %/py, p = 0.63). As warfarin’s TTR increased from 30 to 90 % the estimated medical cost decreased from −$902 to −$83 for apixaban, from −$506 to +$314 for rivaroxaban, and from −$596 to +$223 for dabigatran. Among NVAF patients there is a significant negative correlation between warfarin’s TTR and SSE rate, but not major bleedings. The variations in warfarin’s TTR impacted the economic comparison of use of individual NOACs versus warfarin.

Journal

Journal of Thrombosis and ThrombolysisSpringer Journals

Published: Jan 30, 2014

References

  • Increasing prevalence of atrial fibrillation and flutter in the United States
    Naccarelli, GV; Varker, H; Lin, J; Schulman, KL
  • Evolving models of warfarin management: anticoagulation clinics, patient self-monitoring, and patient self-management
    Ansell, JE; Hughes, R

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