Vol. 49 | No. 1 | January-June 2021 Back

Open Access

Comparison of Accuracy of Bleeding Risk Scores in Predicting Bleeding Events in Patients with Mechanical Prosthetic Valve

Romelie M. Tuplano, Sharon Lacson, Maria Johanna Jaluague-Villanueva
Jun 2021 DOI 10.69944/pjc.384d7efd23

Abstract

INTRODUCTION: Individualizing dose alteration of warfarin remains a challenge while optimizing  the benefit from warfarin and avoiding bleeding events. Hence, this study aimed to compare  the accuracy of bleeding risk scores in predicting bleeding events in patients with a mechanical  prosthetic valve. 

METHODOLOGY: This is a prospective cohort study that includes 123 adult patients who  underwent warfarin therapy after mechanical valve replacement done between January 2019  to March 2020. Bleeding risk stratification based on RIETE, HASBLED and ATRIA scorings and  telephone follow-up until 1 year to check for the bleeding outcome were done. 

RESULTS: Bleeding was noted in 23 patients (18.7%). There is no significant difference between  the demographic and clinical profile of patients in the bleeding and non-bleeding group except  for the highest INR obtained during admission for valve surgery. The mean highest INR obtained  in the bleeding group is 4.34 + 2.67 which was significantly higher than in the non-bleeding  group (2.83 + 1.8). Using the scorings, risk stratification for bleeding between the groups was the  same. 

CONCLUSION: There is no sufficient evidence to conclude that RIETE, HASBLED, and ATRIA  are accurate in predicting bleeding events in patients who underwent mechanical valve surgery.  Labile INR is a significant predictor of bleeding events.

References
  1. Bonow RO et al. 2008 Focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease. JACC. 2008, June; Vol 52 No 13: 1-142.
  2. Beyth RJ, Quinn LM, Landefeld CS. Prospective evaluation of an index for predicting the risk of major bleeding in outpatients treated with warfarin. Am J Med. 1998;105:91- 99.
  3. Kuijer PM, Hutten BA, Prins MH, Buller HR. Prediction of the risk of bleeding during anticoagulant treatment for venous thromboembolism. Arch Intern Med. 1999;159:457-460.
  4. Shireman TI, Mahnken JD, Howard PA, et al. Development of a contemporary bleeding risk model for elderly warfarin recipients. Chest. 2006;130:1390-1396.
  5. Gage BF, Yan Y, Milligan PE, et al. Clinical classification schemes for predicting hemorrhage: results from the National Registry of Atrial Fibrillation (NRAF). Am Heart J. 2006;151:713-719.
  6. Ruiz-Gimenez N, Suarez C, Gonzalez R, et al. Predictive variables for major bleeding events in patients presenting with documented acute venous thromboembolism. Findings from the RIETE Registry. Thromb Haemost. 2008;100:26-31.
  7. Pisters R, Lane DA, Nieuwlaat R, et al. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest. 2010;138:1093-1100.
  8. Fang MC, Go AS, Chang Y, et al. A new risk scheme to predict warfarin-associated hemorrhage. The ATRIA (Anticoagulation and Risk Factors in Atrial Fibrillation) Study. J Am Coll Cardio. 2011; 58:395-401.
  9. Donze J et al. Scores to predict major bleeding risk during oral anticoagulation therapy: a prospective validation study. 2012, Nov. The American Journal of Medicine. Vol 125 No 11; 1095-1102.
  10. Hylek EM, Molina CE, Shea C, Henault LE, Regan S. Major hemorrhages and tolerability of warfarin in the first year of therapy among elderly patient s with atrial fibrillation. Circulation AHA 2007 May 29;115(21):2689-96. Epub 2007 May 2.
  11. Jang I, Choo S, Kim K. Warfarin therapy after mechanical valve replacement: a tool for predicting bleeding events. 2017, March; Vol 26 No 2; 215-223.
  12. Vicente FP, Aquino AV, Jacoba KG. The intensity of oral anticoagulation at which thromboembolic complications are effectively prevented without excessive bleeding among adult patients who received mechanical prosthetic heart valve: and experience at Philippine Heart Center.
  13. Apostolakis S, Lane S, Guo Y, Buller H, Lip G. Performance of the HEMORR2GHES, ATRIA, and HASBLED bleeding risk-prediction scores in patients with atrial fibrillation undergoing anticoagulation.
  14. Jeffrey D. Blume. Bounding Sample Size Projections for the Area Under a ROC Curve. Journal of Statistical Planning and Inference 2009; 139(1): http://www.ncbi.nlm.nih.gov/ pmc/articles/PMC2631183/#FD16
  15. Senoo K, Proietti M, Lane DA, Lip GY. Evaluation of the HAS-BLED, ATRIA, and ORBIT Bleeding Risk Scores in Patients with Atrial Fibrillation Taking Warfarin. American Journal of Medicine 2016; 129(6): https://www.ncbi.nlm. nih.gov/pubmed/26482233 (accessed 13 July 2018).
  16. Kaatz, S. et al. Definition of clinically relevant non-major  bleeding in studies of anticoagulants in atrial fibrillation  and venous thromboembolism disease in non-surgical  patients: communication from SSC of the ISTH. Journal  of Thrombosis and Haemostasis. Volume 13, Issue 11. 11  Sept 2015. 
  17. Schulman, S. et al. Definition of major bleeding in clinical  investigations of antihemostatic medicinal products in non surgical patients. Journal of Thrombosis and Haemostasis.  Volume 3, Issue 4. 4 April 2005. 
  18. Rodeghiero, F. et al, ISTH/SSC Bleeding Assessment  Tool: A Standardized Questionnaire and a Proposal for  a New Bleeding Score for Inherited Bleeding Disorders.  Journal of Thrombosis and Haemostasis, 8: 2063–2065.  Supplementary Material to the Official Communication of  the SSC (Last revision: 19 July 2011). 
  19. Bergmark, Brian MD et al. Comparison of Events  Across Bleeding Scales in the ENGAGE AF-TIMI 48 trial.  Circulation AHA. November 2019;140:1792–1801. 
  20. Kaatz, S et al. Definition of clinically relevant non-major  bleeding in studies of anticoagulants in atrial fibrillation and venous thromboembolic disease in non-surgical patients:  communication from the SSC of the ISTH. Journal of  Thrombosis and Hemostasis. November 2015. Volume13,  Issue11. Pages 2119-2126.
License

Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License, which permits use, share — copy and redistribute the material in any medium or format, adapt — remix, transform, and build upon the material, as long as you give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use. You may not use the material for commercial purposes. If you remix, transform, or build upon the material, you must distribute your contributions under the same license as the original. You may not apply legal terms or technological measures that legally restrict others from doing anything the license permits. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit https://creativecommons.org/licenses/by-nc-sa/4.0/.