Point-of-care testing INR: an overview

Doris Barcellona 1 , Lara Fenu 1 ,  and Francesco Marongiu 2
  • 1 Department of Medical Sciences “Mario Aresu”, University of Cagliari, Cagliari, Italy
  • 2 Head of the Internal Medicine and Haemocoagulophaties Unit, University of Cagliari, Cagliari, Italy, Phone: +390706754188
Doris Barcellona, Lara Fenu and Francesco Marongiu

Abstract

Oral anticoagulant therapies with the anti-vitamin K drugs (AVK), warfarin, acenocoumarol and phenprocoumon, are employed in primary and secondary anti-thrombotic prophylaxis in patients with venous thromboembolism, atrial fibrillation and cardiac mechanical valves. However, a monitoring test such as the International Normalized Ratio (INR) is required. The periodic monitoring of this therapy entails discomfort for the patients. Telemedicine and telecare can provide significant aid in the management of this therapy allowing patients to perform the test at home or anywhere else with a portable device, i.e. point-of-care testing (POCT), and to send the result to a thrombosis (TC) via web. Patients can receive dose adjustment sent back by the TC. The effectiveness of this type of management is equal or superior to the traditional AVK monitoring in terms of hemorrhagic and thrombotic events. Analysis of the costs with a horizon of 10 years reveals that both self-testing and self-management are cost-effective. The aim of this overview is to describe the pros and cons of the use of POCT as an alternative in the monitoring of AVK. In particular, description of the POCT, decentralization, quality of the therapy, safety and costs will be examined.

  • 1.

    Ageno W, Gallus AS, Wittkowsky A, Crowther M, Hylek EM, Palareti G, et al. Oral anticoagulant therapy: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2012;141:e44S–88S.

    • Crossref
    • PubMed
    • Export Citation
  • 2.

    Stenflo J, Fernlund P, Egan W, Roepstorff P. Vitamin K dependent modifications of glutamic acid residues in prothrombin. Proc Natl Acad Sci USA 1974;71:2730–33.

    • Crossref
    • Export Citation
  • 3.

    Quick AJ. The prothrombin in hemophilia and in obstructive jaundice. J Biol Chem 1935;109:73–4.

  • 4.

    Kirkwood TB. Calibration of reference thromboplastins and standardization of the prothrombin time ratio. Thromb Haemost 1983;49:238–44.

    • Crossref
    • PubMed
    • Export Citation
  • 5.

    Ansell J, Holden A, Knapic N. Patient self-management of oral anticoagulant guided by capillary (fingerstick) whole blood prothrombin times. Arch Intern Med 1989;149:2509–11.

    • Crossref
    • PubMed
    • Export Citation
  • 6.

    Taborski U, Muller-Berghaus G. State-of-the-art of patient self-management for control of oral anticoagulation. Semin Thromb Hemost 1999;25:43–7.

    • Crossref
    • PubMed
    • Export Citation
  • 7.

    Watzke HH, Forberg E, Svolba G, Jimenez-Boj E, Krinninger B. A prospective controlled trial comparing weekly self-testing with standard management of patients on stable oral anticoagulation. Thromb Haemost 2000;83:661–5.

    • Crossref
    • PubMed
    • Export Citation
  • 8.

    Gadisseur AP, Breukink-Engbers WG, van der Meer FJ, van den Besselaar AM, Sturk A, Rosendaal FR. Aanticoagulant therapy through patient self-management and management by specialized anticoagulation clinics in the Netherlands: a randomized clinical trial. Arch Int Med 2003;163:2639–46.

    • Crossref
    • Export Citation
  • 9.

    Cosmi B, Palareti G, Carpanedo M, Pengo V, Biasiolo A, Rampazzo P, et al. Assessment of patient capability to self-adjust oral anticoagulant dose: a multicentre study on home use of portable prothrombin time monitor (COAGUCHEK). Haematologica 2000;85:826–31.

  • 10.

    Barcellona D, Fenu L, Cornacchini S, Marongiu F. Telemedicine can improve the quality of oral anticoagulation using portable devices and self-testing at home. J Telemed Telecare 2013;19:298–301.

    • Crossref
    • PubMed
    • Export Citation
  • 11.

    Health Quality Ontario. Point-of-care international normalized ratio (INR) monitoring devices for patients on long-term oral anticoagulation therapy. Ont Health Technol Assess Ser 2009;9:1–114.

    • PubMed
    • Export Citation
  • 12.

    Christensen TD, Larsen TB. Precision and accuracy of point-of-care testing coagulometers used for self-testing and self-management of oral anticoagulant therapy. J Thromb Haemost 2012;10:251–60.

    • Crossref
    • PubMed
    • Export Citation
  • 13.

    Tripodi A, Arbini AA, Chantarangkul V, Bettega D, Mannucci PM. Are capillary whole blood coagulation monitors suitable for the control of oral anticoagulant treatment by the international normalized ratio? Thromb Haemost 1993;70:921–4.

    • Crossref
    • PubMed
    • Export Citation
  • 14.

    Sølvik UØ, Stavelin A, Christensen NG, Sandberg S. External quality assessment of prothrombin time: the split-sample model compared with external quality assessment with commercial control material. Scand J Clin Lab Invest 2006;66:337–49.

    • Crossref
    • PubMed
    • Export Citation
  • 15.

    Stavelin A, Meijer P, Kitchen D, Sandberg S. External quality assessment of point-of-care international normalized ratio (INR) testing in Europe. Clin Chem Lab Med 2011;50:81–8.

    • PubMed
    • Export Citation
  • 16.

    Kitchen S, Kitchen DP, Jennings I, Woods TA, Walker ID, Preston FE. Point-of-care international normalized ratios: UK NEQAS experience demonstrates necessity for proficiency testing of three different monitors. Thromb Haemost 2006;96:590–6.

    • Crossref
    • PubMed
    • Export Citation
  • 17.

    Jespersen J, Poller L, van den Besselaar AM, van der Meer FJ, Palareti G, Tripodi A, et al. External quality assessment (EQA) for CoaguChek monitors. Thromb Haemost 2010;103:936–41.

    • Crossref
    • PubMed
    • Export Citation
  • 18.

    Barcellona D, Fenu L, Cornacchini S, Marongiu F. Point-of-care (POCT) prothrombin time monitors: is a periodical control of their performance useful? Thromb Res 2009;123:775–9.

    • Crossref
    • PubMed
    • Export Citation
  • 19.

    Pengo V. Monitoring oral anticoagulants: new strategies for an emerging problem. Intern Emerg Med 2006;1:3–4.

    • Crossref
    • PubMed
    • Export Citation
  • 20.

    Testa S, Alatri A, Paoletti O, Morstabilini G, Medagliani MA, Denti N, et al. Reorganization of an anticoagulation clinic using a telemedicine system: description of the model and preliminary results. Intern Emerg Med 2006;1:24–9.

    • Crossref
    • Export Citation
  • 21.

    St John A. The evidence to support point-of-care testing. Clin Biochem Rev 2010;31:111–19.

    • PubMed
    • Export Citation
  • 22.

    Goble JA, Rocafort PT. Point-of-care testing: future of chronic disease state management? J Pharm Pract 2015:pii: 0897190015587696. [Epub ahaed of print].

  • 23.

    Palareti G, Poggi M, Guazzaloca G, Savino A, Coccheri S. Assessment of mental ability in elderly anticoagulated patients: its reduction is associated with less satisfactory quality of treatment. Blood Coag Fibrinol 1997;8:411–17.

    • Crossref
    • Export Citation
  • 24.

    Ward A, Tompson A, Fitzmaurice D, Sutton S, Perera R, Heneghan C. Cohort study of anticoagulation self-monitoring (CASM): a prospective study of its effectiveness in the community. Br J Gen Pract 2015;65:e428–37.

    • Crossref
    • PubMed
    • Export Citation
  • 25.

    Optimal Warfarin Management for the Prevention of Thromboembolic Events in Patients with Atrial Fibrillation: A Systematic Review of the Clinical Evidence [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health, 2011. CADTH Optimal Use Reports.

  • 26.

    Rosendaal FR, Cannegieter SC, van der Meer FJ, Briët E. A method to determine the optimal intensity of oral anticoagulant therapy. Thromb Haemost 1993;69:236–39.

    • Crossref
    • PubMed
    • Export Citation
  • 27.

    Schneeweiss S, Gagne JJ, Patrick AR, Choudhry NK, Avorn J. Comparative efficacy and safety of new oral anticoagulants in patients with atrial fibrillation. Circ Cardiovasc Qual Outcomes 2012;5:480–6.

    • Crossref
    • PubMed
    • Export Citation
  • 28.

    Dallalzadeh LO, Go AS, Chang Y, Borowsky LH, Fang MC, Singer DE. Stability of high-quality warfarin anticoagulation in a community-based atrial fibrillation cohort: the Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. Am Heart Assoc 2016;5:pii: e003482.

  • 29.

    Wan Y, Heneghan C, Perera R, Roberts N, Hollowell J, Glasziou P, et al. Anticoagulation control and prediction of adverse events in patients with atrial fibrillation: a systematic review. Circ Cardiovasc Qual Outcomes 2008;1:84–91.

    • Crossref
    • PubMed
    • Export Citation
  • 30.

    Senoo K, Lip GY. Female sex, time in therapeutic range, and clinical outcomes in atrial fibrillation patients taking warfarin. Stroke 2016;47:1665–8.

    • Crossref
    • PubMed
    • Export Citation
  • 31.

    Wells PS, Brown A, Jaffey J, McGahan L, Poon MC, Cimon K. Safety and effectiveness of point-of-care monitoring devices in patients on oral anticoagulant therapy: a meta-analysis. Open Med 2007;1:e131–46.

    • PubMed
    • Export Citation
  • 32.

    Garcia-Alamino JM, Ward AM, Alonso-Coello P, Perera R, Bankhead C, Fitzmaurice D, et al. Self-monitoring and self-management of oral anticoagulation. Cochrane Database Syst Rev 2010;4:CD003839.

  • 33.

    Bloomfield HE, Krause A, Greer N, Taylor BC, MacDonald R, Rutks I, et al. Meta-analysis: effect of patient self-testing and self-management of long term anticoagulation on major clinical outcomes. Ann Intern Med 2011;154:472–82.

    • Crossref
    • PubMed
    • Export Citation
  • 34.

    Heneghan C, Ward A, Perera R. Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data. Lancet 2012;379:322–34.

    • Crossref
    • PubMed
    • Export Citation
  • 35.

    Sharma P, Scotland G, Cruickshank M, Tassie E, Fraser C, Burton C, et al. Is self-monitoring an effective option for people receiving long-term vitamin K antagonist therapy? a systematic review and economic evaluation. BMJ Open 2015;5:e007758.

    • Crossref
    • PubMed
    • Export Citation
  • 36.

    Matchar DB, Jacobson A, Dolor R, Edson R, Uyeda L, Phibbs CS, et al. Effect of home testing of international normalized ratio on clinical events. N Engl J Med 2010;363:1608–20.

    • Crossref
    • PubMed
    • Export Citation
  • 37.

    Meyer S, Frei CR, Kelly RD. Impact of a new method of warfarin management on patient satisfaction, time and cost. Pharmacotherapy 2013;33:1147–55.

    • Crossref
    • PubMed
    • Export Citation
  • 38.

    Barcellona D, Fenu L, Vannini ML, Piras M, Marongiu F. Antiphospholipid syndrome patients: the performance of Coaguchek XS in the monitoring of Vitamin-K Antagonists. Thromb Res 2012;129:e168–70.

    • Crossref
    • Export Citation
  • 39.

    Pengo V, Crippa L, Falanga A, Finazzi G, Marongiu F, Moia M, et al. Phase III studies on novel oral anticoagulants for stroke prevention in atrial fibrillation: a look beyond the excellent results. J Thromb Haemost 2012;10:1979–87.

    • Crossref
    • PubMed
    • Export Citation
Purchase article
Get instant unlimited access to the article.
$42.00
Log in
Already have access? Please log in.


or
Log in with your institution

Journal + Issues

Clinical Chemistry and Laboratory Medicine ( CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor of over three. CCLM is the official journal of nine national clinical societies and associated with EFLM.

Search