Incidence of thrombotic complications related to weight-based dosing of activated prothrombin complex concentrate (aPCC) for reversal of apixaban and rivaroxaban in obese patients

Whitaker, Caitlyn; McKinney, Amanda; Bollig, Reagan; Hieb, Nathan; Roberts, Robert F.; Rowe, A. Shaun

doi:10.1007/s11239-021-02605-1

Cited by 1 publication

(2 citation statements)

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“…Bleeding complication rate, defined as continued bleeding, surgical site bleeding or haematoma expansion on CT was 7%. Primary outcome, thrombotic events, occurred in 6% of cases, which was slightly higher than for PCC administration 98 . Another study showed that nonspecific haemostatic treatment with aPCC vs. PCC to prevent haematoma expansion in patients on rivaroxaban or apixaban-associated ICH had a similar excellent (87%) or good haemostatic efficacy (89%), respectively.…”

Section: Discussionmentioning

confidence: 95%

“…Primary outcome, thrombotic events, occurred in 6% of cases, which was slightly higher than for PCC administration. 98 Another study showed that nonspecific haemostatic treatment with aPCC vs. PCC to prevent haematoma expansion in patients on rivaroxaban or apixaban-associated ICH had a similar excellent (87%) or good haemostatic efficacy (89%), respectively. No differences in thromboembolic events, mortality or transfusion requirements within 30 days were observed.…”

Section: Picomentioning

confidence: 99%

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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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Section: Discussionmentioning

confidence: 95%

Section: Picomentioning

confidence: 99%