Call for local guidelines on DOAC reversal with non-specific haemostatic agents

Coagulation

By Mardi Chapman

17 Nov 2021

Australian research shows DOAC reversal with off-label, non-specific haemostatic agents is effective – but the risk of a thromboembolic complication needs to be carefully considered in a high-risk patient group.

A retrospective study comprised a medical record review of all 51 patients who were prescribed either a 3 factor-prothrombin complex concentrate (3F-PCC) or activated prothrombin complex concentrate (aPCC) at St Vincent’s Hospital Melbourne between 2017 and 2020.

Patients were included if they had received either of the agents for the reversal of apixaban or rivaroxaban when associated with either a significant bleeding event (70.6%) or prior to an urgent surgery or procedure (29.4%).

Most patients were on anticoagulants for AF (80.6%) and the median age was 76 years.

The study found that all patients achieved effective haemostasis with use of a reversal agent.

All patients who received reversal for a bleeding event, including intracranial haemorrhage and gastrointestinal bleeding, obtained effective haemostasis within 48 hours of presentation to hospital.

As well, all patients who required DOAC reversal for urgent surgery had what was regarded as normal periprocedural blood loss and haemostasis which was maintained throughout their hospital stay without the need for additional surgery.

The study, published in the Internal Medicine Journal, said both haemostatic agents were associated with an improvement in laboratory coagulation parameters.

Patients who received aPCC had a decrease in the median INR from 1.5 to 1.1 (p = 0.000). while patients who received a 3F-PCC had a reduction in median INR from 1.4 to 1.1 (p = 0.065).

The median aPTT was significantly reduced for patients who received aPCC (p = 0.001) and stable for those patients who received 3F-PCC.

Specific apixaban or rivaroxaban anti-Xa levels were only requested for a minority of patients, despite the tests being routinely available at St Vincent’s.

“This may be due to a lack of awareness of the availability and utility of these tests and reflects the need for clinician education and institutional guidelines,” the investigators said.

Four patients developed thromboembolic events during their hospital admission. These included three patients who developed an ischaemic CVA and one patient who developed a DVT.

Of the four in-hospital deaths, one was a patient who developed an ischaemic stroke three days post aPCC administration for an ICH. In another patient who died of poor neurological recovery, it was deemed possible that aPCC contributed to the thromboembolic CVA.

“The study revealed a concerning median time delay of six hours for the administration of the haemostatic agent to patients with significant bleeding,” it said.

“This may reflect a lack of clinician awareness of the availability and utility of these agents and points to the requirement for interdisciplinary collaboration and institutional guidelines.”

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