Lessons learnt from local real-life experience with idarucizumab for the reversal of dabigatran.


Journal

Internal medicine journal
ISSN: 1445-5994
Titre abrégé: Intern Med J
Pays: Australia
ID NLM: 101092952

Informations de publication

Date de publication:
Jan 2019
Historique:
received: 06 02 2018
revised: 22 04 2018
accepted: 27 05 2018
pubmed: 6 6 2018
medline: 21 9 2019
entrez: 6 6 2018
Statut: ppublish

Résumé

Idarucizumab is a specific antidote for the direct thrombin inhibitor oral anticoagulant dabigatran etexilate. It has been used with increasing frequency in Australia since it was granted Therapeutic Goods Administration approval in October 2016. To assess idarucizumab usage, effect on coagulation parameters and clinical outcomes in patients who received idarucizumab in Western Sydney Local Health District (WSLHD). A retrospective audit was conducted of all patients who received idarucizumab in WSLHD between September 2015 and December 2017. Of the 23 patients who received idarucizumab, 17 (74%) had bleeding, and 6 (26%) required urgent surgery/procedure. Thrombin time (TT) or activated partial thromboplastin time (APTT, when TT not available) remained prolonged at 24 h post-idarucizumab infusion in 10 of 20 (50%) patients. Renal impairment at admission was associated with prolonged TT/APTT at 24 h (P = 0.02). Of the six (26%) patients who died during hospital admission, five had raised TT/APTT at 24 h (P = 0.05). Two deaths were due to continued bleeding despite idarucizumab. Only 17% of patients received prohaemostatic treatments, and none received plasma derivatives. Despite assay availability, dabigatran drug level was only measured in eight patients. Idarucizumab helped achieve haemostasis in 15 bleeding patients and allowed 6 patients to undergo urgent surgery. Half the patients had prolonged TT/APTT at 24 h post-idarucizumab, which was more likely to occur in patients with impaired renal function.

Sections du résumé

BACKGROUND BACKGROUND
Idarucizumab is a specific antidote for the direct thrombin inhibitor oral anticoagulant dabigatran etexilate. It has been used with increasing frequency in Australia since it was granted Therapeutic Goods Administration approval in October 2016.
AIMS OBJECTIVE
To assess idarucizumab usage, effect on coagulation parameters and clinical outcomes in patients who received idarucizumab in Western Sydney Local Health District (WSLHD).
METHODS METHODS
A retrospective audit was conducted of all patients who received idarucizumab in WSLHD between September 2015 and December 2017.
RESULTS RESULTS
Of the 23 patients who received idarucizumab, 17 (74%) had bleeding, and 6 (26%) required urgent surgery/procedure. Thrombin time (TT) or activated partial thromboplastin time (APTT, when TT not available) remained prolonged at 24 h post-idarucizumab infusion in 10 of 20 (50%) patients. Renal impairment at admission was associated with prolonged TT/APTT at 24 h (P = 0.02). Of the six (26%) patients who died during hospital admission, five had raised TT/APTT at 24 h (P = 0.05). Two deaths were due to continued bleeding despite idarucizumab. Only 17% of patients received prohaemostatic treatments, and none received plasma derivatives. Despite assay availability, dabigatran drug level was only measured in eight patients.
CONCLUSION CONCLUSIONS
Idarucizumab helped achieve haemostasis in 15 bleeding patients and allowed 6 patients to undergo urgent surgery. Half the patients had prolonged TT/APTT at 24 h post-idarucizumab, which was more likely to occur in patients with impaired renal function.

Identifiants

pubmed: 29869387
doi: 10.1111/imj.13995
doi:

Substances chimiques

Antibodies, Monoclonal, Humanized 0
Anticoagulants 0
idarucizumab 97RWB5S1U6
Dabigatran I0VM4M70GC

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

59-65

Informations de copyright

© 2018 Royal Australasian College of Physicians.

Auteurs

Yvonne Brennan (Y)

Department of Haematology, Westmead Hospital, Sydney, New South Wales, Australia.

Emmanuel J Favaloro (EJ)

Diagnostic Haemostasis Laboratory, Laboratory Haematology, NSW Health Pathology, Westmead Hospital, Sydney, New South Wales, Australia.
Sydney Centres for Thrombosis and Haemostasis, Sydney, New South Wales, Australia.

Leonardo Pasalic (L)

Department of Haematology, Westmead Hospital, Sydney, New South Wales, Australia.
Sydney Centres for Thrombosis and Haemostasis, Sydney, New South Wales, Australia.

Hayley Keenan (H)

Transfusion Laboratory, NSW Health Pathology, Westmead Hospital, Sydney, New South Wales, Australia.

Jennifer Curnow (J)

Department of Haematology, Westmead Hospital, Sydney, New South Wales, Australia.
Sydney Centres for Thrombosis and Haemostasis, Sydney, New South Wales, Australia.
Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia.

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Classifications MeSH