Definition of major bleeding: Prognostic classification.
anticoagulants
bleeding
classification
hemorrhage
mortality
Journal
Journal of thrombosis and haemostasis : JTH
ISSN: 1538-7836
Titre abrégé: J Thromb Haemost
Pays: England
ID NLM: 101170508
Informations de publication
Date de publication:
11 2020
11 2020
Historique:
received:
04
05
2020
revised:
25
07
2020
accepted:
31
07
2020
pubmed:
9
8
2020
medline:
15
5
2021
entrez:
9
8
2020
Statut:
ppublish
Résumé
In patients on anticoagulant treatment, the major bleeding (MB) definition released by the International Society of Thrombosis and Haemostasis (ISTH) is widely accepted. However, this definition identifies MBs with highly variable short-term risk of death. The study aims were to derive and validate a classification of ISTH-defined MBs for the risk of short-term death. Consecutive patients admitted for ISTH-defined MB occurring while on treatment with oral anticoagulants were included in the study and divided into a derivation and a validation cohort. Death within 30 days was the primary study outcome. Among 1077 patients with MB, 64/517 and 63/560 patients in the derivation and validation cohort died, respectively. In the derivation cohort, Glasgow coma scale (GCS) <14 and shock were predictors of death; critical site bleeding and hemoglobin decrease ≥2 g/dL, or transfusion ≥ 2 units were not. GCS <14 (hazard ratio [HR], 8.67; 95% confidence interval [CI], 3.93-19.13) was predictor of death in intracranial hemorrhage (ICH) and shock at admission (HR, 4.84; 95% CI, 2.01-11.70) and pericardial bleeding (HR, 11.37; 95% CI, 1.33-97.31) in non-ICH MBs. The predictive value of GCS <14 in ICH and shock and pericardial bleeding in non-ICH MBs was confirmed in the validation cohort. None of the patients with isolated ocular or articular bleeding died. A prognostic classification of ISTH-defined MBs for the risk of short-term death is proposed as "serious," "severe," and "life-threatening" (ICH with GCS <14 or non-ICH with shock) MBs. According to our study, ISTH-defined MBs can be stratified for the risk of death within 30 days.
Sections du résumé
BACKGROUND
In patients on anticoagulant treatment, the major bleeding (MB) definition released by the International Society of Thrombosis and Haemostasis (ISTH) is widely accepted. However, this definition identifies MBs with highly variable short-term risk of death.
OBJECTIVES
The study aims were to derive and validate a classification of ISTH-defined MBs for the risk of short-term death.
METHODS
Consecutive patients admitted for ISTH-defined MB occurring while on treatment with oral anticoagulants were included in the study and divided into a derivation and a validation cohort. Death within 30 days was the primary study outcome.
RESULTS
Among 1077 patients with MB, 64/517 and 63/560 patients in the derivation and validation cohort died, respectively. In the derivation cohort, Glasgow coma scale (GCS) <14 and shock were predictors of death; critical site bleeding and hemoglobin decrease ≥2 g/dL, or transfusion ≥ 2 units were not. GCS <14 (hazard ratio [HR], 8.67; 95% confidence interval [CI], 3.93-19.13) was predictor of death in intracranial hemorrhage (ICH) and shock at admission (HR, 4.84; 95% CI, 2.01-11.70) and pericardial bleeding (HR, 11.37; 95% CI, 1.33-97.31) in non-ICH MBs. The predictive value of GCS <14 in ICH and shock and pericardial bleeding in non-ICH MBs was confirmed in the validation cohort. None of the patients with isolated ocular or articular bleeding died. A prognostic classification of ISTH-defined MBs for the risk of short-term death is proposed as "serious," "severe," and "life-threatening" (ICH with GCS <14 or non-ICH with shock) MBs.
CONCLUSION
According to our study, ISTH-defined MBs can be stratified for the risk of death within 30 days.
Identifiants
pubmed: 32767653
doi: 10.1111/jth.15048
pii: S1538-7836(22)03726-6
doi:
Substances chimiques
Anticoagulants
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
2852-2860Informations de copyright
© 2020 International Society on Thrombosis and Haemostasis.
Références
Schulman S, Kearon C. Subcommittee on control of anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005;3(4):692-694.
Becattini C, Franco L, Beyer-Westendorf J, et al. Major bleeding with vitamin K antagonists or direct oral anticoagulants in real-life. Int J Cardiol. 2017;15(227):261-266.
Eerenberg ES, Middeldorp S, Levi M, et al. Clinical impact and course of major bleeding with rivaroxaban and vitamin K antagonists. J Thromb Haemost. 2015;13:1590-1596.
Brekelmans MP, Bleker SM, Bauersachs R, et al. Clinical impact and course of major bleeding with edoxaban versus vitamin K antagonists. Thromb Haemost. 2016;116:155-161.
Bleker SM, Cohen AT, Buller HR, et al. Clinical presentation and course of bleeding events in patients with venous thromboembolism, treated with apixaban or enoxaparin and warfarin. Results from the AMPLIFY trial. Thromb Haemost. 2016;116:1159-1164.
Bleker SM, Brekelmans MPA, Eerenberg ES, et al. Clinical impact of major bleeding in patients with venous thromboembolism treated with factor Xa inhibitors or vitamin K antagonists. Thromb Haemost. 2017;117(10):1944-1951.
Becattini C, Franco L, Masotti L, et al. Clinical management and outcome of major bleeding in patients on treatment with vitamin K antagonists. Eur J Intern Med. 2016;33:47-54.
Beyer-Westendorf J, Förster K, Pannach S, et al. Rates, management, and outcome of rivaroxaban bleeding in daily care: results from the Dresden NOAC registry. Blood. 2014;124:955-962.
Klok FA, Huisman MV. How I assess and manage the risk of bleeding in patients treated for venous thromboembolism. Blood. 2020;135(10):724-734.
Piran S, Schulman S. Treatment of bleeding complications in patients on anticoagulant therapy. Blood. 2019;133(5):425-435.
Hemphill JC III, Greenberg SM, Anderson CS, et al. Guidelines for the management of spontaneous Intracerebral Hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2015;46(7):2032-2060.
Holbrook A, Schulman S, Witt DM, et al. Evidence-based management of anticoagulant therapy: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012;141(2):e152S-e184S.
Schulman S, Beyth RJ, Kearon C, Levine MN. 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-298S.
Tomaselli GF, Mahaffey KW, Cuker A, et al. 2017 ACC expert consensus decision pathway on management of bleeding in patients on oral anticoagulants: a report of the American College of Cardiology task force on expert consensus decision pathways. J Am Coll Cardiol. 2017;70(24):3042-3067.
Pollack CV Jr, Reilly PA, van Ryn J, et al. Idarucizumab for dabigatran reversal - full cohort analysis. N Engl J Med. 2017;377(5):431-441.
Connolly SJ, Crowther M, Eikelboom JW, et al. Full study report of andexanet alfa for bleeding associated with factor Xa inhibitors. N Engl J Med. 2019;380(14):1326-1335.
Weitz JI. Reversal of direct oral anticoagulants: current status and future directions. Semin Respir Crit Care Med. 2017;38(1):40-50.
van der Hulle T, Kooiman J, den Exter PL, Dekkers OM, Klok FA, Huisman MV. Effectiveness and safety of novel oral anticoagulants as compared with vitamin K antagonists in the treatment of acute symptomatic venous thromboembolism: a systematic review and meta-analysis. J Thromb Haemost. 2014;12(3):320-328.
Makam RCP, Hoaglin DC, McManus DD, et al. Efficacy and safety of direct oral anticoagulants approved for cardiovascular indications: systematic review and meta-analysis. PLoS One. 2018;13(5):e0197583.
Majeed A, Hwang HG, Connolly SJ, et al. Management and outcomes of major bleeding during treatment with dabigatran or warfarin. Circulation. 2013;128:2325-2332.
Berger R, Salhanick SD, Chase M, et al. Hemorrhagic complications in emergency department patients who are receiving dabigatran compared with warfarin. Ann Emerg Med. 2013;61:475-479.
Vanassche T, Hirsh J, Eikelboom JW, et al. Organ-specific bleeding patterns of anticoagulant therapy: lessons from clinical trials. Thromb Haemost. 2014;112:918-923.
Beyer-Westendorf J, Michalski F, Tittl L, et al. Management and outcomes of vaginal bleeding and heavy menstrual bleeding in women of reproductive age on direct oral anti-factor Xa inhibitor therapy: a case series. Lancet Haematol. 2016;3:e480-e488.
Brekelmans MP, Scheres LJ, Bleker SM, et al. Abnormal vaginal bleeding in women with venous thromboembolism treated with apixaban or warfarin. Thromb Haemost. 2017;117(4):809-815.
Green L, Tan J, Morris JK, et al. A three-year prospective study of the presentation and clinical outcomes of major bleeding episodes associated with oral anticoagulant use in the UK (ORANGE study). Haematologica. 2018;103(4):738-745.