Display options
Share it on

Cardiol Ther. 2017 Dec;6(2):261-271. doi: 10.1007/s40119-017-0090-x. Epub 2017 May 19.

Analytical Management of Patients Undergoing Oral Anticoagulant Therapy Could Have a Strong Impact on Clinical Outcomes: A Follow-up Study.

Cardiology and therapy

Vincenzo De Iuliis, Sebastiano Ursi, Gianfranco Vitullo, Irma Griffo, Antonio Marino, Marika Caruso, Francesco Cipollone, Sabrina Capodifoglio, Veronica Breda, Elena Toniato, Alfonso Pennelli, Pio Conti, Stefano Martinotti

Affiliations

  1. CHIETI, SS Annunziata University Hospital, ASL Lanciano-Vasto-Chieti, University of Chieti, Via dei Vestini 31, 66100, Chieti, CH, Italy.
  2. Department of Medical, Oral and Biotechnological Sciences, University of Chieti, Via dei Vestini 31, 66100, Chieti, CH, Italy.
  3. Department of Medicine and Science of Aging, University of Chieti, Via dei Vestini 31, 66100, Chieti, CH, Italy.
  4. Department of Medical, Oral and Biotechnological Sciences, University of Chieti, Via dei Vestini 31, 66100, Chieti, CH, Italy. [email protected].

PMID: 28526929 PMCID: PMC5688967 DOI: 10.1007/s40119-017-0090-x

Abstract

INTRODUCTION: Oral anticoagulant therapy, such as vitamin K antagonists (VKAs), is prominent for the prevention of cerebral ischemic stroke or systemic embolism and all-cause mortality in patients with atrial fibrillation, venous thromboembolism, and mechanical or biological valve. VKA treatment requires monitoring of the international normalized ratio (INR) in order to maintain it in a therapeutic range, avoiding side effects, the main and most significant of which is bleeding. The aim of the present study was to evaluate the event rates of several clinical composite outcomes, such as bleeding, thromboembolic events, and all-cause death.

METHODS: We compared three organizational models distinguished by a total (from 1 January to 31 December 2015 in which PT/INR analysis with the relative internal and external quality controls was performed by the surveillance center) or partial (from 15 January to 15 July 2016 and from 15 August to 15 November 2016, in which the surveillance center had the ability to view only the PT/INR results or all patients analyses, including blood count, creatinine, liver enzymes, etc., respectively) analytical patient management. The present longitudinal follow-up study included 1225 patients, recruited from 1 January 2015 to 15 November 2016 at a surveillance center for the prevention of cerebral ischemic stroke and systemic embolism in Chieti (Italy).

RESULTS: The results show a significant rise of the incidence rate ratio in patients undergoing VKA treatment during the period 15 January to 15 July 2016 compared to the previous one regarding total bleeding, especially for minor bleeding and digestive bleeding; thromboembolic events; and all-death cause.

CONCLUSIONS: These findings show that analytical and clinical data and information should be under the direct supervision and responsibility of the surveillance center. In fact, this approach seems to highlight the best results in terms of safety and therapeutic effectiveness.

Keywords: Atrial fibrillation; Bleeding risk; Clinical outcomes; Oral anticoagulant

References

  1. Int J Immunopathol Pharmacol. 2016 Mar;29(1):112-20 - PubMed
  2. J Am Coll Cardiol. 2014 Dec 2;64(21):e1-76 - PubMed
  3. BMJ. 2014 Apr 14;348:g2116 - PubMed
  4. Int J Immunopathol Pharmacol. 2016 Sep;29(3):354-63 - PubMed
  5. N Engl J Med. 2013 Nov 28;369(22):2093-104 - PubMed
  6. J Arrhythm. 2016 Jun;32(3):163-9 - PubMed
  7. Eur Heart J. 2011 Sep;32(18):2282-9 - PubMed
  8. J Biol Regul Homeost Agents. 2016 Jul-Sep;30(3):863-866 - PubMed
  9. BMC Health Serv Res. 2013 Mar 07;13:85 - PubMed
  10. J Biol Regul Homeost Agents. 2016 Apr-Jun;30(2):477-84 - PubMed
  11. Chest. 2004 Dec;126(6):1938-45 - PubMed
  12. J Biol Regul Homeost Agents. 2016 Apr-Jun;30(2):491-5 - PubMed
  13. Am J Cardiol. 2010 Feb 15;105(4):502-10 - PubMed
  14. N Engl J Med. 2009 Sep 17;361(12):1139-51 - PubMed
  15. J Thromb Haemost. 2005 Apr;3(4):692-4 - PubMed
  16. J Cardiol. 2011 Jan;57(1):95-9 - PubMed
  17. Int J Immunopathol Pharmacol. 2016 Dec;29(4):632-646 - PubMed
  18. Arch Intern Med. 2007 Jul 9;167(13):1414-9 - PubMed
  19. Lancet. 2007 Aug 11;370(9586):493-503 - PubMed
  20. Chest. 2010 Feb;137(2):263-72 - PubMed
  21. Int J Immunopathol Pharmacol. 2016 Mar;29(1):40-53 - PubMed
  22. BMJ. 2011 Jan 31;342:d124 - PubMed
  23. N Engl J Med. 2001 Apr 5;344(14):1067-78 - PubMed
  24. Arch Intern Med. 1990 Aug;150(8):1598-603 - PubMed
  25. Eur J Inflamm. 2015 Apr 1;13(1):40-52 - PubMed
  26. N Engl J Med. 2011 Sep 15;365(11):981-92 - PubMed
  27. Am Heart J. 2008 Jul;156(1):57-64 - PubMed
  28. J Biol Regul Homeost Agents. 2016 Oct-Dec;30(4):1073-1078 - PubMed
  29. Circulation. 2007 Jul 17;116(3):305-15 - PubMed
  30. N Engl J Med. 2011 Sep 8;365(10):883-91 - PubMed
  31. Thromb J. 2014 Feb 18;12(1):5 - PubMed
  32. J Biol Regul Homeost Agents. 2016 Jan-Mar;30(1):141-6 - PubMed
  33. J Biol Regul Homeost Agents. 2016 Jul-Sep;30(3):821-826 - PubMed
  34. Lancet. 1997 Jun 7;349(9066):1641-9 - PubMed

Publication Types