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Self- versus Conventional Management of Oral Anticoagulant Therapy

Effects on INR Variability and Coumarin Dose in a Randomized Controlled Trial

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Abstract

Background

Comparison of self-management of oral anticoagulant therapy versus conventional management has been hindered by use of different methods. We tested the hypothesis that there is no difference in the International Normalized Ratio (INR) variability, INR level, and coumarin dose among patients randomized to conventional management versus self-management.

Methods

The study design included uniform analysis of blinded control blood samples in both treatment arms. Ninety-two patients were randomly assigned to either self-management of oral anticoagulant therapy (including a teaching program for self-management followed by 6 months of independent self-management) or 6 months of conventional management. The endpoints were the variance (median square of the standard deviation) of the INR value, the median INR-value (using a blinded control sample analyzed monthly by a reference laboratory), and the coumarin dose.

Results

Self-management was associated with a statistically significant smaller variance in INR values, a higher median INR value, and a higher dose of warfarin compared with conventional management. No difference was found in the group of patients using phenprocoumon.

Conclusion

Training and implementation of patient self-management leads to a smaller variance in INR values, a higher median INR value and a higher dose of coumarin compared with results obtained for conventionally managed patients.

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Notes

  1. The use of trade names is for product identification purposes only and does not imply endorsement.

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Acknowledgments

This study was financially supported by grants from the Danish Heart Foundation (Grant no. 02-2-3-35-22017), Snedkermester Sophus Jacobsen og hustru Astrid Jacobsens Fond, Fonden til Lsgevidenskabens Fremme (A.P. Møller og Hustru Chastine Mc-Kinney Møllers Fond til almene Formaal), Skejby Sygehus’ Forskningspulje, Elin Holms Forskningspulje, Carl og Ellen Hertz’s Legat til Dansk Læge-og Naturvidenskab and Direktør Jacob Madsen & hustru Olga Madsens Fond. The work was independent of the funders. We are grateful to the Department of Clinical Biochemistry, Skejby Sygehus, Aarhus University Hospital for analyzing the external INR measurements and for quality control of the monitors. The secretaries Annette Strandbo Jensen and Linda Nielsen from the Department of Cardiothoracic and Vascular Surgery were of great help in conducting this study.

Conflict of interest: J. Michael Hasenkam has served as consultant for Medical CV, Inc., Inver Grove Heights, MN, USA, Roche Diagnostics, Basel, Switzerland, and St. Jude Medical, St. Paul, MN, USA. The authors have no other conflict of interest relevant to the content of this study.

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Authors and Affiliations

  1. Department of Cardiothoracic and Vascular Surgery and Institute of Clinical Medicine, Skejby Sygehus, Aarhus University Hospital, DK-8200, Aarhus N, Denmark

    Thomas Decker Christensen, Marianne Maegaard, Vibeke Elisabeth Hjortdal & J. Michael Hasenkam

  2. Department of Clinical Epidemiology and Institute of Clinical Medicine, Aarhus University Hospital, Aarhus, Denmark

    Henrik Toft Sørensen

Authors
  1. Thomas Decker Christensen
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  2. Marianne Maegaard
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  3. Henrik Toft Sørensen
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  4. Vibeke Elisabeth Hjortdal
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  5. J. Michael Hasenkam
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Correspondence to Thomas Decker Christensen.

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Christensen, T.D., Maegaard, M., Sørensen, H.T. et al. Self- versus Conventional Management of Oral Anticoagulant Therapy. Am J Cardiovasc Drugs 7, 191–197 (2007). https://doi.org/10.2165/00129784-200707030-00005

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