American Journal of Cardiovascular Drugs

, Volume 7, Issue 3, pp 191–197

Self- versus Conventional Management of Oral Anticoagulant Therapy

Effects on INR Variability and Coumarin Dose in a Randomized Controlled Trial
  • Thomas Decker Christensen
  • Marianne Maegaard
  • Henrik Toft Sørensen
  • Vibeke Elisabeth Hjortdal
  • J. Michael Hasenkam
Original Research Article

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.

References

  1. 1.
    Hirsh J, Dalen J, Anderson DR, et al. Oral anticoagulants: mechanism of action, clinical effectiveness, and optimal therapeutic range. Chest 2001; 119 Suppl. 1: 8S–21S.PubMedCrossRefGoogle Scholar
  2. 2.
    Sawicki PT. A structured teaching and self-management program for patients receiving oral anticoagulation: a randomized controlled trial. Working Group for the Study of Patient Self-Management of Oral Anticoagulation. JAMA 1999; 281 (2): 145–50.PubMedCrossRefGoogle Scholar
  3. 3.
    Cromheecke ME, Levi M, Colly LP, et al. Oral anticoagulation self-management and management by a specialist anticoagulation clinic: a randomised cross-over comparison. Lancet 2000; 356 (9224): 97–102.PubMedCrossRefGoogle Scholar
  4. 4.
    Körtke H, Körfer R. International normalized ratio self-management after mechanical heart valve replacement: is an early start advantageous? Ann Thorac Surg 2001; 72 (1): 44–8.PubMedCrossRefGoogle Scholar
  5. 5.
    Horstkotte D, Piper C, Schulte HD, et al. Improvement of prognosis by home prothrombin estimation in patients with life-long anticoagulant therapy [abstract]. Eur Heart J 1996; 17: 230.Google Scholar
  6. 6.
    Fitzmaurice DA, Murray ET, Gee KM, et al. A randomised controlled trial of patient self management of oral anticoagulation treatment compared with primary care management. J Clin Pathol 2002; 55 (11): 845–9.PubMedCrossRefGoogle Scholar
  7. 7.
    Sidhu P, O’Kane HO. Self-managed anticoagulation: results from a two-year prospective randomized trial with heart valve patients. Ann Thorac Surg 2001; 72 (5): 1523–7.PubMedCrossRefGoogle Scholar
  8. 8.
    Gadisseur AP, Breukink-Engbers WG, van der Meer FJ, et al. Comparison of the quality of oral anticoagulant therapy through patient self-management and management by specialized anticoagulation clinics in the Netherlands: a randomized clinical trial. Arch Intern Med 2003; 163 (21): 2639–46.PubMedCrossRefGoogle Scholar
  9. 9.
    Menendez-Jandula B, Souto JC, Oliver A, et al. Comparing self-management of oral anticoagulant therapy with clinic management: a randomized trial. Ann Intern Med 2005; 142 (1): 1–10.PubMedGoogle Scholar
  10. 10.
    Sunderji R, Gin K, Shalansky K, et al. A randomized trial of patient self-managed versus physician-managed oral anticoagulation. Can J Cardiol 2004; 20 (11): 1117–23.PubMedGoogle Scholar
  11. 11.
    Fitzmaurice DA, Murray ET, McCahon D, et al. Self management of oral anticoagulation: randomised trial. BMJ 2005; 331 (7524): 1057.PubMedCrossRefGoogle Scholar
  12. 12.
    Christensen TD, Maegaard M, Sørensen HT, et al. Self-management versus conventional management of oral anticoagulant therapy: a randomized, controlled trial. Eur J Intern Med 2006; 17 (4): 260–6.PubMedCrossRefGoogle Scholar
  13. 13.
    Völler H, Glatz J, Taborski U, et al. Self-management of oral anticoagulation in nonvalvular atrial fibrillation (SMAAF study). Z Kardiol 2005; 94 (3): 182–6.PubMedCrossRefGoogle Scholar
  14. 14.
    Heneghan C, Alonso-Coello P, Garcia-Alamino JM, et al. Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. Lancet 2006; 367 (9508): 404–11.PubMedCrossRefGoogle Scholar
  15. 15.
    Cannegieter SC, Rosendaal FR, Wintzen AR, et al. Optimal oral anticoagulant therapy in patients with mechanical heart valves. N Engl J Med 1995; 333 (1): 11–7.PubMedCrossRefGoogle Scholar
  16. 16.
    Christensen TD. Self-management of oral anticoagulant therapy: a review. J Thromb Thrombolysis 2004; 18 (2): 127–43.PubMedCrossRefGoogle Scholar
  17. 17.
    Fihn SD, McDonell M, Martin D, et al. Risk factors for complications of chronic anticoagulation: a multicenter study. Warfarin Optimized Outpatient Follow-up Study Group. Ann Intern Med 1993; 118 (7): 511–20.PubMedGoogle Scholar
  18. 18.
    Butchart EG, Payne N, Li HH, et al. Better anticoagulation control improves survival after valve replacement. J Thorac Cardiovasc Surg 2002; 123 (4): 715–23.PubMedCrossRefGoogle Scholar
  19. 19.
    Poli D, Antonucci E, Gensini GF, et al. Asymptomatic excessive coumarin anticoagulation is a risk factor for thrombotic and bleeding complications of oral anticoagulant therapy. J Thromb Haemost 2003; 1 (8): 1840–1.PubMedCrossRefGoogle Scholar
  20. 20.
    McGlasson DL. A review of variables affecting PTs/INRs. Clin Lab Sci 1999; 12 (6): 353–8.PubMedGoogle Scholar
  21. 21.
    Awad MA, Selim TE, Al-Sabbagh FA. Influence of storage time and temperature on international normalized ratio (INR) levels and plasma activities of vitamin K dependent clotting factors. Hematology 2004; 9 (5–6): 333–7.PubMedCrossRefGoogle Scholar

Copyright information

© Adis Data Information BV 2007

Authors and Affiliations

  • Thomas Decker Christensen
    • 1
  • Marianne Maegaard
    • 1
  • Henrik Toft Sørensen
    • 2
  • Vibeke Elisabeth Hjortdal
    • 1
  • J. Michael Hasenkam
    • 1
  1. 1.Department of Cardiothoracic and Vascular Surgery and Institute of Clinical Medicine, Skejby SygehusAarhus University HospitalAarhus NDenmark
  2. 2.Department of Clinical Epidemiology and Institute of Clinical MedicineAarhus University HospitalAarhusDenmark

Personalised recommendations