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Wiener klinische Wochenschrift

, Volume 124, Issue 21–22, pp 756–762 | Cite as

Outcome of coumarin-therapy in an outpatient setting over a 10-year period

Coumarin-therapy in clinical practice
  • Eva Z. ReininghausEmail author
  • Harald Schmidt
  • Ingrid Lafer
  • Georg Gutjahr
  • Stefan M. Schmidt
  • Bernd Reininghaus
  • Hans-Peter Kapfhammer
  • Vinzenz Stepan
original article
  • 143 Downloads

Summary

Objectives

A retrospective study was conducted on an unselected sample of patients on vitamin K antagonists (VKAs; phenprocoumon, acenocoumarol) in an outpatient setting in Austria. The main objective was to determine whether bleeding and thromboembolic events reported in randomised trials are comparable to the experience in clinical practice. In addition, we focused on differences between the two VKAs and the particular indications for treatment and influences of risk factors.

Participants

Total observation time was 10 years, the number of patients was 599 and the patient years-at-risk (pyr) was 1,856.

Results

Severe bleeding occurred in 1.1 % pyr and the bleeding-related mortality was 0.1 %. Severe thromboembolic events occurred in 2.8 % pyr, with a rate of fatal events of 0.3 %. A significant increase in risk was found in patients older than 75 years concerning bleeding as well as thromboembolic events. Acenocoumarol showed significantly higher rates in life-threatening and fatal bleeding episodes in comparison to phenprocoumon.

Conclusions

The outcome of patients receiving VKA in an office setting is similar to that reported in the literature and the use of VKAs in this setting appears to be safe.

Keyword

Anticoagulants Atrial fibrillation Coumarin Hemorrhage Thromboembolism Phenprocoumon Acenocoumarol 

Therapie mit Vitamin-K-Antagonisten in einer internistischen Facharztpraxis – Ergebnisse aus 10 Jahren

Zusammenfassung

Hintergrund

In einer internistischen Facharztpraxis wurden alle PatientInnen, die innerhalb von 10 Jahren mit Vitamin-K-Antagonisten (Phenprocoumon, Acenocoumarol) behandelt wurden, retrospektiv evaluiert. Es konnten 599 PatientInnen mit insgesamt 1.856 PatientInnenjahren in die Studie eingeschlossen werden. Alle aufgetretenen Blutungen und thromboembolischen Ereignisse wurden erfasst, als auch Unterschiede zwischen den einzelnen Indikationsgebieten und den beiden Vitamin-K-Antagonisten berechnet.

Ergebnisse

Schwere Blutungen traten in 1,1 % aller PatientInnenjahre auf, 0,1 % führten zum Tod. Schwere thromboembolische Ereignisse fanden sich in 2,8 % aller PatientInnenjahre, 0,3 % verliefen tödlich. PatientInnen über 75 Jahre hatten ein signifikant erhöhtes Risiko sowohl für Blutungen, als auch thromboembolische Ereignisse. Acenocoumarol war im Vergleich zu Phenprocoumon mit einer signifikant höheren Rate an lebensbedrohlichen und tödlichen Blutungen assoziiert. Es fanden sich deutliche Unterschiede in den Ergebnissen zwischen den einzelnen Indikationen.

Schlussfolgerungen

Unsere Resultate sind vergleichbar mit denen aus randomisierten Studien, trotz des relativ hohen Anteils an PatientInnen, die bei randomisierten Studien ausgeschlossen worden wären. Insgesamt zeigen unsere Studienergebnisse, dass VKAs in der klinischen Praxis mit einer geringen Rate an Blutungen und thromboembolischen Ereignissen einfach und sicher eingesetzt werden können.

Schlüsselwörter

Vitamin-K-Antagonisten Vorhofflimmerarrhythmie Antikoagulation Thromboembolie Phenprocoumon Acenocoumarol 

Notes

Conflict of interest

There are no actual or potential conflict of interests capable of influencing judgment on the part of any author.

References

  1. 1.
    Ansell J, Hirsh J, Hylek E, Jacobson A, Crowther M, Palareti G. American College of Chest Physicians. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians evidence-based clinical practice guidelines (8th edition). Chest. 2008;133(6 Suppl):160S–98S.PubMedCrossRefGoogle Scholar
  2. 2.
    Levine MN, Raskob G, Beyth RJ, Kearon C, Schulman S. Hemorrhagic complications of anticoagulant treatment: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004;126(3 Suppl):287S–310S.PubMedCrossRefGoogle Scholar
  3. 3.
    Jackson SL, Peterson GM, Vial JH, Daud R, Ang SY. Outcomes in the management of atrial fibrillation: clinical trial results can apply in practice. Intern Med J. 2001;31:329–36.PubMedCrossRefGoogle Scholar
  4. 4.
    Levi M, Hovingh K. Bleeding complications in patients on anticoagulants who would have been disqualified for clinical trials. Thromb Haemost. 2008;100(6):1047–51.PubMedGoogle Scholar
  5. 5.
    Rothwell PM. External validity of randomised controlled trials: “to whom do the results of this trial apply?” Lancet. 2005;365:82–93.PubMedCrossRefGoogle Scholar
  6. 6.
    Mant J, Edwards D. Stroke prevention in atrial fibrillation: putting the guidelines into practice. Drugs Aging. 2010;27(11):859–70.PubMedCrossRefGoogle Scholar
  7. 7.
    Singer DE, Chang Y, Fang MC, Borowsky LH, Pomernacki NK, Udaltsova N, Go AS. Should patient characteristics influence target anticoagulation intensity for stroke prevention in nonvalvular atrial fibrillation: the ATRIA study. Circ Cardiovasc Qual Outcomes. 2009;2(4):297–304.PubMedCrossRefGoogle Scholar
  8. 8.
    Diener HC, Putzki N. “Leitlinien für die Diagnostik und Therapie in der Neurologie”. Georg Thieme Verlag; 2008.Google Scholar
  9. 9.
    Singer DE, Albers GW, Dalen JE, Fang MC, Go AS, Halperin JL, Lip GY, Manning WJ, American College of Chest Physicians. Antithrombotic therapy in atrial fibrillation: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th edition). Chest. 2008;133(6 Suppl):546S–92S.PubMedCrossRefGoogle Scholar
  10. 10.
    Vahanian A, Baumgartner H, Bax J, Butchart E, Dion R, Filippatos G, Flachskampf F, Hall R, Iung B, Kasprzak J, Nataf P, Tornos P, Torracca L, Wenink A, ESC Committee for Practice Guidelines. Guidelines on the management of valvular heart disease: the task force on the management of valvular heart disease of the European Society of Cardiology. Eur Heart J. 2007;28(2):230–68.PubMedCrossRefGoogle Scholar
  11. 11.
    Atrial Fibrillation Investigators. Risk factors for stroke and efficacy of antithrombotic therapy in atrial fibrillation: analysis of pooled data from five randomized controlled trials. Arch Intern Med. 1994;154:1449–57.CrossRefGoogle Scholar
  12. 12.
    Ezekowitz MD, Wallentin L, Connolly SJ, Parekh A, Chernick MR, Pogue J, Aikens TH, Yang S, Reilly PA, Lip GY, Yusuf S, RE-LY Steering Committee and Investigators. Dabigatran and warfarin in vitamin K antagonist-naive and -experienced cohorts with atrial fibrillation. Circulation. 2010;122(22):2246–53.PubMedCrossRefGoogle Scholar
  13. 13.
    Mant J, Hobbs FD, Fletcher K, Roalfe A, Fitzmaurice D, Lip GY, Murray E, BAFTA investigators, Midland Research Practices Network (MidReC). Warfarin versus aspirin for stroke prevention in an elderly community population with atrial fibrillation (the Birmingham Atrial Fibrillation Treatment of the Aged Study, BAFTA): a randomised controlled trial. Lancet. 2007;370(9586):493–503.PubMedCrossRefGoogle Scholar
  14. 14.
    Abdelhafiz AH, Wheeldon NM. Results of an open-label, prospective study of anticoagulant therapy for atrial fibrillation in an outpatient anticoagulation clinic. Clin Ther. 2004;26(9):1470–8.PubMedCrossRefGoogle Scholar
  15. 15.
    Evans A, Kalra L. Are the results of randomized controlled trials on anticoagulation in patients with atrial fibrillation generalizable to clinical practice? Arch Intern Med. 2001;161(11):1443–7.PubMedCrossRefGoogle Scholar
  16. 16.
    Landefeld CS, Beyth RJ. Anticoagulant-related bleeding: clinical epidemiology, prediction, and prevention. Am J Med. 1993;95(3):315–28.PubMedCrossRefGoogle Scholar
  17. 17.
    Go AS, Hylek EM, Chang Y, Phillips KA, Henault LE, Capra AM, Jensvold NG, Selby JV, Singer DE. Anticoagulation therapy for stroke prevention in atrial fibrillation: how well do randomized trials translate into clinical practice? JAMA. 2003;290:2685–92.PubMedCrossRefGoogle Scholar
  18. 18.
    Go AS, Hylek EM, Chang Y, Phillips KA, Henault LE, Capra AM, Jensvold NG, Selby JV, Singer DE. Anticoagulation therapy for stroke prevention in atrial fibrillation: how well do randomized trials translate into clinical practice? JAMA. 2003;290(20):2685–92.PubMedCrossRefGoogle Scholar
  19. 19.
    van Walraven C, Hart RG, Singer DE, Laupacis A, Connolly S, Petersen P, Koudstaal PJ, Chang Y, Hellemons B. Oral anticoagulants vs aspirin in nonvalvular atrial fibrillation: an individual patient meta-analysis. JAMA. 2002;288(19):2441–8.PubMedCrossRefGoogle Scholar
  20. 20.
    Pérez-Gómez F, Alegría E, Berjón J, Iriarte JA, Zumalde J, Salvador A, Mataix L, NASPEAF Investigators. Comparative effects of antiplatelet, anticoagulant, or combined therapy in patients with valvular and nonvalvular atrial fibrillation: a randomized multicenter study. J Am Coll Cardiol. 2004;44(8):1557–66.PubMedCrossRefGoogle Scholar
  21. 21.
    Mant J, Hobbs FD, Fletcher K, Roalfe A, Fitzmaurice D, Lip GY, Murray E, BAFTA investigators, Midland Research Practices Network (MidReC). Warfarin versus aspirin for stroke prevention in an elderly community population with atrial fibrillation (the Birmingham Atrial Fibrillation Treatment of the Aged Study, BAFTA): a randomised controlled trial. Lancet. 2007;370(9586):493–503.PubMedCrossRefGoogle Scholar
  22. 22.
    Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L, RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(12):1139–51.PubMedCrossRefGoogle Scholar
  23. 23.
    Fihn SD, Callahan CM, Martin DC, McDonell MB, Henikoff JG, White RH. The risk for and severity of bleeding complications in elderly patients treated with warfarin. The National Consortium of Anticoagulation Clinics. Ann Intern Med. 1996;124(11):970–9.PubMedGoogle Scholar
  24. 24.
    Wehinger C, Stöllberger C, Länger T, Schneider B, Finsterer J. Evaluation of risk factors for stroke/embolism and of complications due to anticoagulant therapy in atrial fibrillation. Stroke. 2001;32(10):2246–52.PubMedCrossRefGoogle Scholar
  25. 25.
    Schulman S, Beyth RJ, Kearon C, Levine MN, American College of Chest Physicians. Hemorrhagic complications of anticoagulant and thrombolytic treatment: American College of Chest Physicians evidence-based clinical practice guidelines (8th edition). Chest. 2008;133(6 Suppl):257S–98S.PubMedCrossRefGoogle Scholar
  26. 26.
    Marinigh R, Lip GY, Fiotti N, Giansante C, Lane DA. Age as a risk factor for stroke in atrial fibrillation patients implications for thromboprophylaxis: Implications for thromboprophylaxis. J Am Coll Cardiol. 2010;56(11):827–37.PubMedCrossRefGoogle Scholar
  27. 27.
    Kearon C. Balancing risks and benefits of extended anticoagulant therapy for idiopathic venous thrombosis. J Thromb Haemost. 2009;7(Suppl 1):296–300.PubMedCrossRefGoogle Scholar
  28. 28.
    Ost D, Tepper J, Mihara H, et al. Duration of anticoagulation following venous thromboembolism: a metaanalysis. JAMA. 2005;294:706–15.PubMedCrossRefGoogle Scholar
  29. 29.
    Nieto JA, Camara T, Gonzalez-Higueras E, Ruiz-Gimenez N, Guijarro R, Marchena PJ, Monreal M, RIETE Investigators. Clinical outcome of patients with major bleeding after venous thromboembolism. Findings from the RIETE Registry. Thromb Haemost. 2008;100(5):789–96.PubMedGoogle Scholar
  30. 30.
    Colwell CW Jr, Berkowitz SD, Lieberman JR, Comp PC, Ginsberg JS, Paiement G, McElhattan J, Roth AW, Francis CW, EXULT B Study Group. Oral direct thrombin inhibitor ximelagatran compared with warfarin for the prevention of venous thromboembolism after total knee arthroplasty. J Bone Joint Surg Am. 2005;87(10):2169–77.PubMedCrossRefGoogle Scholar
  31. 31.
    Unay K, Akan K, Sener N, Cakir M, Poyanli O. Evaluating the effectiveness of a deep-vein thrombosis prophylaxis protocol in orthopaedics and traumatology. J Eval Clin Pract. 2009;15(4):668–74.PubMedCrossRefGoogle Scholar
  32. 32.
    Johnson R, Charnley J. Treatment of pulmonary embolism in total hip replacement. Clin Orthop Relat Res. 1977;(124):149–54.Google Scholar

Copyright information

© Springer-Verlag Wien 2012

Authors and Affiliations

  • Eva Z. Reininghaus
    • 1
    Email author
  • Harald Schmidt
    • 2
  • Ingrid Lafer
    • 1
  • Georg Gutjahr
    • 3
  • Stefan M. Schmidt
    • 1
  • Bernd Reininghaus
    • 1
  • Hans-Peter Kapfhammer
    • 1
  • Vinzenz Stepan
    • 4
  1. 1.Department of PsychiatryMedical University GrazGrazAustria
  2. 2.Outpatient-office for Internal MedicineGleisdorfAustria
  3. 3.Department of MathematicsUniversity of BremenBremenGermany
  4. 4.Department of Internal MedicineKH ElisabethinenGrazAustria

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