Coagulation

Clinicians report real-life experience with NOAC reversal agent


The reversal agent for the NOAC dabigatran is proving its worth in real life emergency situations say researchers who have reported for the first time a series of case reports documenting physician and patient experience with the drug.

While idarucizumab (Praxbind) has been approved for more than a year in Australia, the US and Europe, German researchers who have published the case reports say clinical experience with the agent is limited because clinical situations requiring urgent reversal of the anticoagulant are rare.

They say the short half life of the NOAC, especially when renal function is normal, means restoration of hemostasis can be expected within 12-24 hours after the last dose was taken and that treatment discontinuation, along with supportive measures, may often be sufficient even in patients with moderate-to-severe bleeding.

But in the 11 cases reports published earlier this week showing real life experiences with the drug, researchers say they were able to quickly and easily reverse the anticoagulant effects of dabigatran in a variety of emergency situations.

Most patients described in the cases were aged in their 80’s with poor renal function and previous history of stroke and a number of other comorbidities.

Emergency situations included severe postoperative bleeding, emergency high bleeding-risk surgery, invasive diagnostic testing, intracranial bleeding and and thrombolysis with recombinant tissue plasminogen activator for acute ischemic stroke.

Laboratory coagulation tests were performed in all cases before administration of the reversal agent and the dTT was used to calculate the dabigatran concentration in 5 cases, the researchers said.

In one case a 78-year-old man who was taking dabigatran for NVAF was admitted to hospital in the morning after his wife noticed aphasia, difficulty walking and right faciobrachial hemiparesis.

MRI revealed recent-onset ischaemia and the presence of microbleeds. The patient’s last intake of dabigatran was the morning of being admitted to hospital.

According to the treating physicians, thrombolysis with recombinant tissue plasminogen activator (rt-PA) was indicated. However, laboratory tests showed a dTT of 134 ng/mL so doctors administered an intravenous bolus injection – 5g – of idarucizumab.

Thrombolysis was performed just 20 min later without complications and half an hour after receiving the reversal agent, the patient’s dTTwas below 32 ng/mL and remained under that level during the following three days.

The authors say that patient recovered fully from his stroke and was able to go back to his ‘very active way of life’.

While many emergency departments have yet to use the reversal agent in patients, researchers say that hospital-specific protocols by multidisciplinary teams should be developed and put in place to ensure fast and appropriate use of the agent in the rare cases it might be needed.

The series of 11 case studies are published in the Journal of Thrombosis and Thrombolysis and can be accessed here.

Related stories: 

TGA approves first NOAC reversal agent 

Video explainer: How does idarucizumab (Praxbind) actually work?

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