Dataset Information

Idarucizumab to revert the anticoagulant effect of dabigatran in traumatic acute subdural haematoma: a case report of first use in Latin America.

ABSTRACT:

Background?

Direct oral anticoagulants (DOAC) are an attractive alternative over vitamin K antagonists. They have several advantages in primary and secondary prevention of thromboembolisms due to atrial fibrillation, as well as in prevention and treatment of thromboembolic venous disease. They have fast onset action, do not need laboratory controls in patients with normal renal function, and they have practically no interference with the patient's diet or medications. The strongest objection to their use was the lack of reversal agents that could be used in case of life-threatening haemorrhage or the need for emergency surgery. Dabigatran was the first DOAC to have its own specific reversal agent: idarucizumab, a monoclonal antibody.

Case summary?

We report here the case of a patient undergoing treatment with dabigatran that suffered an expansive subdural haematoma secondary to a cranial injury. The condition was life-threatening and required emergency surgery. Anticoagulation was successfully reversed with idarucizumab.

Discussion?

Emergency surgery in patients in treatment with DOAC is associated with an increased risk of bleeding. With the use of a specific antidote to block the action of the anticoagulant, as in the case of idarucizumab with dabigatran, the risk of complications during and after emergency surgery is reduced. This is the first case report with which the successful use of idarucizumab in Latin America is documented.

SUBMITTER: Izaguirre Avila R

PROVIDER: S-EPMC6601192 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Publications

Idarucizumab to revert the anticoagulant effect of dabigatran in traumatic acute subdural haematoma: a case report of first use in Latin America.

Izaguirre Ávila Raúl R Bahena López José Eduardo JE Cortina de la Rosa Evelyn E Hernández Márquez Miguel Ángel MÁ

European heart journal. Case reports 20190601 2

<h4>Background</h4>Direct oral anticoagulants (DOAC) are an attractive alternative over vitamin K antagonists. They have several advantages in primary and secondary prevention of thromboembolisms due to atrial fibrillation, as well as in prevention and treatment of thromboembolic venous disease. They have fast onset action, do not need laboratory controls in patients with normal renal function, and they have practically no interference with the patient's diet or medications. The strongest object ...[more]

PMID: 31449648

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Project description:Idarucizumab is the first targeted antidote of dabigatran, a direct oral anticoagulant used for prevention and treatment of venous thromboembolism and prevention of stroke in atrial fibrillation. Idarucizumab is a humanized fragment of a monoclonal antibody, which binds dabigatran reversibly with high affinity and, when administered intravenously, immediately neutralizes its anticoagulant effect. It is rapidly cleared by the kidney with captured dabigatran. In Phase I and II trials, no significant adverse events have been reported. Specifically, idarucizumab has no anticoagulant or procoagulant effect by itself. Idarucizumab is currently being evaluated in an ongoing Phase III trial, in patients treated with dabigatran presenting with severe active bleeding or requiring emergency surgery or an invasive procedure and are at high risk of bleeding. The results of the interim analysis confirm the ability of idarucizumab to neutralize dabigatran instantaneously, without rebound effect, except in rare patients with very high baseline levels of anticoagulant. Although not definitely proving clinical efficacy, due to the noncontrolled design of the trial and the heterogeneity of patient conditions, these promising results on an intermediate criterion with strong rationale have led to the approval of idarucizumab for these indications. However, several questions are unresolved. First, activity measurement of dabigatran in blood, useless in current practice, could be useful to guide the treatment and avoid over- or underutilization of the antidote; but so far, it has not been largely available in real time. Second, the translation of anticoagulant neutralization to an effect on mortality and better outcome is highly dependent on the global management of these patients, especially rapid diagnosis, supportive care, and easy access to antidote administration. Although idarucizumab represents a remarkable achievement in drug design and development, whether it will be an important step toward improved safety of patients treated with dabigatran in the real world will have to be demonstrated in the postmarketing phase.

Project description:IntroductionIdarucizumab, a monoclonal antibody fragment that rapidly reverses the anticoagulant effects of dabigatran, was approved in Japan in September 2016, at which time an all-case, postmarketing surveillance (PMS) study was initiated to collect data on idarucizumab in Japanese patients. Interim results were published previously, and the final results are reported herein.MethodsThis multicenter, open-label, uncontrolled, non-interventional PMS study was conducted in Japanese patients who received idarucizumab at the approved dose (2 × 2.5 g/50 ml) and had uncontrolled bleeding (group A) or required an emergency procedure (group B). The primary endpoint was the frequency of adverse drug reactions (ADRs). The secondary endpoint was the maximum extent of reversal of the anticoagulant effects of dabigatran, within 4 h of idarucizumab administration, based on activated partial thromboplastin time (aPTT).ResultsThe final analysis included 804 patients. ADRs during the idarucizumab treatment and post-treatment periods were reported in 17 of 542 patients (3.1%) in group A and 12 of 240 patients (5.0%) in group B. Thrombotic events were reported in 22 patients (4.1%) in group A and 15 patients (6.3%) in group B, and hypersensitivity occurred in four (0.7%) and five patients (2.1%), respectively. Among 793 patients evaluated for effectiveness, 78 in group A and 26 in group B had aPTT data at baseline (immediately before idarucizumab administration) and within 4 h of idarucizumab administration; in these patients, median maximum percentage reversal within 4 h of idarucizumab administration was 100%.ConclusionsThe final analysis from the PMS study confirms previous findings suggesting that idarucizumab can safely and effectively reverse the anticoagulant effects of dabigatran in Japanese patients in clinical practice. The results support the continued use of idarucizumab in Japan.Trial registrationThis study is registered with ClinicalTrials.gov (NCT02946931).

Dataset Information

Idarucizumab to revert the anticoagulant effect of dabigatran in traumatic acute subdural haematoma: a case report of first use in Latin America.

Background?

Case summary?

Discussion?

Publications

Idarucizumab to revert the anticoagulant effect of dabigatran in traumatic acute subdural haematoma: a case report of first use in Latin America.

Similar Datasets

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