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Descriptive analysis of the process and quality of oral anticoagulation management in real-life practice in patients with chronic non-valvular atrial fibrillation: the international study of anticoagulation management (ISAM)

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Abstract

Background/objectives

Expert oral anticoagulation management is the key to good outcomes and is performed variably in different health care systems throughout the world. We set out to assess the quality of anticoagulation management in five countries in patients receiving vitamin K antagonists (VKAs) for stroke prophylaxis in chronic non-valvular atrial fibrillation (NVAF), and to compare the anticoagulation management practices in these countries.

Methods and results

This was a retrospective, multi-centre cohort study in the United States, Canada, France, Italy, and Spain. About 1,511 patients were randomly recruited from representative practices (routine medical care (RMC) in the US, Canada, and France; anticoagulation clinics in Italy and Spain) and data pertaining to their oral anticoagulation care were abstracted from their medical records. The predominant anticoagulant in use was warfarin in the US, Canada, and Italy; acenocoumarol in Spain; and fluindione in France. Documentation of care was poor in the US, Canada, and France, countries where RMC was studied. Percent INRs or time-in-therapeutic range was greater in the two anticoagulation clinic samples compared with the RMC samples.

Conclusion

Oral anticoagulation care varies considerably from country to country. Findings suggest that anticoagulation clinic care (ACC) may provide better outcomes as assessed by international normalized ratio (INR) time-in-range. Physicians tend to under treat more than over treat. Finally, documentation of care is often inadequate.

Condensed Abstract Oral anticoagulation management (routine medical care or anticoagulation clinic care) was retrospectively assessed in 5 countries using a uniform, structured assessment tool. Major management differences were detected, especially between anticoagulation clinic care and routine care. Documentation was often a problem in the latter setting. Less time in therapeutic INR range was noted in routine medical care. Findings suggest that anticoagulation clinic care may provide better outcomes as assessed by international normalized ratio (INR) time-in-range. Physicians tend to under treat more than over treat. Finally, documentation of care is often inadequate.

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Acknowledgements

We express our sincere thanks to the participating physicians and clinics and to the local study co-ordinators (Ole Hauch and Gail Wygant, USA; Amin Haiderali, Canada; Hervé Lamarque and Maud Woessner, France; Alessandra Cheli and Cristina Negrini, Italy; Rosario Marazuela, Spain), and Jonas Carlsson for statistical support. This study was funded by AstraZeneca.

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Authors and Affiliations

  1. Department of Medicine, E113, Boston University Medical Center, 88 E. Newton St., Boston, MA, 02118, USA

    Jack Ansell

  2. AstraZeneca R & D, Molndal, Sweden

    Jennifer Hollowell

  3. University of Padova, Padova, Italy

    Vittorio Pengo

  4. Hospital Universitario de Bellvitge, L’Hospitalet de Llobregat, Barcelona, Spain

    Fernando Martinez-Brotons

  5. Caro Research Institute, Concord, MA, USA

    Jaime Caro

  6. Hôpital Laroboisière, Paris, France

    Ludovic Drouet

Authors
  1. Jack Ansell
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  2. Jennifer Hollowell
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  3. Vittorio Pengo
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  4. Fernando Martinez-Brotons
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  5. Jaime Caro
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  6. Ludovic Drouet
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Corresponding author

Correspondence to Jack Ansell.

Additional information

This study was presented in part at the 8th National Conference on Anticoagulant Therapy, Orlando, Fl, May 2005, sponsored by the Anticoagulation Forum. This study was supported by a grant from AstraZeneca, Molndal, Sweden.

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Ansell, J., Hollowell, J., Pengo, V. et al. Descriptive analysis of the process and quality of oral anticoagulation management in real-life practice in patients with chronic non-valvular atrial fibrillation: the international study of anticoagulation management (ISAM). J Thromb Thrombolysis 23, 83–91 (2007). https://doi.org/10.1007/s11239-006-9022-7

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  • DOI: https://doi.org/10.1007/s11239-006-9022-7

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