Safety of idarucizumab in the reversal of dabigatran at six tertiary care Ontario hospitals

Abdulrehman, Jameel; Zarabi, Sahar; Elbaz, Carolyne; Wit, Kerstin de; Lin, Yulia; Sholzberg, Michelle; Selby, Rita

doi:10.1002/rth2.12535

Cited by 5 publications

(2 citation statements)

References 22 publications

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“…Abdulrehman et al conducted a Canadian cohort study across six hospital sites to determine outcomes post-idarucizumab. 115 During hospitalization, 19 of 85 patients who received idarucizumab died within 2 days, 2 patients had ischemic strokes (2.4%), and 3 patients had VTE (3.5%). These outcomes post-idarucizumab were similar to real-world studies in Denmark and the Netherlands.…”

Section: Direct Thrombin Inhibitorsmentioning

confidence: 99%

A Historical Perspective on the Reversal of Anticoagulants

Salter

Crowther

2022

Semin Thromb Hemost

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There has been a landmark shift in the last several decades in the management and prevention of thromboembolic events. From the discovery of parenteral and oral agents requiring frequent monitoring as early as 1914, to the development of direct oral anticoagulants (DOACs) that do not require monitoring or dose adjustment in the late 20th century, great advances have been achieved. Despite the advent of these newer agents, bleeding continues to be a key complication, affecting 2 to 4% of DOAC-treated patients per year. Bleeding is associated with substantial morbidity and mortality. Although specific reversal agents for DOACs have lagged the release of these agents, idarucizumab and andexanet alfa are now available as antagonists. However, the efficacy of these reversal agents is uncertain, and complications, including thrombosis, have not been adequately explored. As such, guidelines continue to advise the use of nonspecific prohemostatic agents for patients requiring reversal of the anticoagulant effect of these drugs. As the indications for DOACs and the overall prevalence of their use expand, there is an unmet need for further studies to determine the efficacy of specific compared with nonspecific pro-hemostatic reversal agents. In this review, we will discuss the evidence behind specific and nonspecific reversal agents for both parenteral and oral anticoagulants.

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Section: Direct Thrombin Inhibitorsmentioning

confidence: 99%

A Historical Perspective on the Reversal of Anticoagulants

Salter

Crowther

2022

Semin Thromb Hemost

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“…Rationale: Various guidelines have been published that recommend the use of idarucizumab in the setting of dabigatran-associated bleeding or urgent surgery. 27,53,[103][104][105][106] Data on the clinical use of idarucizumab support the efficacy in dabigatran-associated bleeding in various clinical settings [107][108][109][110][111] (compare flow charts urgent surgery, life threatening and nonlife-threatening bleeding).…”

Section: Picomentioning

confidence: 99%

Clinical guideline on reversal of direct oral anticoagulants in patients with life threatening bleeding

Grottke,

Afshari,

Ahmed

et al. 2024

European Journal of Anaesthesiology

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BACKGROUND Anticoagulation is essential for the treatment and prevention of thromboembolic events. Current guidelines recommend direct oral anticoagulants (DOACs) over vitamin K antagonists in DOAC-eligible patients. The major complication of anticoagulation is serious or life-threatening haemorrhage, which may necessitate prompt haemostatic intervention. Reversal of DOACs may also be required for patients in need of urgent invasive procedures. This guideline from the European Society of Anaesthesiology and Intensive Care (ESAIC) aims to provide evidence-based recommendations and suggestions on how to manage patients on DOACs undergoing urgent or emergency procedures including the treatment of DOAC-induced bleeding. DESIGN A systematic literature search was performed, examining four drug comparators (dabigatran, rivaroxaban, apixaban, edoxaban) and clinical scenarios ranging from planned to emergency surgery with the outcomes of mortality, haematoma growth and thromboembolic complications. The GRADE (Grading of Recommendations, Assessment, Development and Evaluation) methodology was used to assess the methodological quality of the included studies. Consensus on the wording of the recommendations was achieved by a Delphi process. RESULTS So far, no results from prospective randomised trials comparing two active comparators (e.g. a direct reversal agent and an unspecific haemostatic agent such as prothrombin complex concentrate: PCC) have been published yet and the majority of publications were uncontrolled and observational studies. Thus, the certainty of evidence was assessed to be either low or very low (GRADE C). Thirty-five recommendations and clinical practice statements were developed. During the Delphi process, strong consensus (>90% agreement) was achieved in 97.1% of recommendations and consensus (75 to 90% agreement) in 2.9%. DISCUSSION DOAC-specific coagulation monitoring may help in patients at risk for elevated DOAC levels, whereas global coagulation tests are not recommended to exclude clinically relevant DOAC levels. In urgent clinical situations, haemostatic treatment using either the direct reversal or nonspecific haemostatic agents should be started without waiting for DOAC level monitoring. DOAC levels above 50 ng ml−1 may be considered clinically relevant necessitating haemostatic treatment before urgent or emergency procedures. Before cardiac surgery under activated factor Xa (FXa) inhibitors, the use of andexanet alfa is not recommended because of inhibition of unfractionated heparin, which is needed for extracorporeal circulation. In the situation of DOAC overdose without bleeding, no haemostatic intervention is suggested, instead measures to eliminate the DOACs should be taken. Due to the lack of published results from comparative prospective, randomised studies, the superiority of reversal treatment strategy vs. a nonspecific haemostatic treatment is unclear for most urgent and emergency procedures and bleeding. Due to the paucity of clinical data, no recommendations for the use of recombinant activated factor VII as a nonspecific haemostatic agent can be given. CONCLUSION In the clinical scenarios of DOAC intake before urgent procedures and DOAC-induced bleeding, practitioners should evaluate the risk of bleeding of the procedure and the severity of the DOAC-induced bleeding before initiating treatment. Optimal reversal strategy remains to be determined in future trials for most clinical settings.

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