Performance of idarucizumab as antidote of dabigatran in daily clinical practice

Wall, Sake J van der; Rein, Nienke van; Bemt, Bart van den; Kruip, Marieke J.H.A.; Meijer, Karina; Boome, L.C.J. te; Simmers, T. A.; Alings, A. Marco; Tieleman, Robert G; Westerweel, Peter E.; Klok, Frederikus A.; Huisman, Menno V.

doi:10.1093/europace/euy220

Cited by 33 publications

(29 citation statements)

References 20 publications

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“…In nearly half of patients (48%), idarucizumab was administered prior to acute surgery and in 43% because of bleeding. These findings differ from those reported in a Dutch study of real-world use of idarucizumab in 88 consecutive patients between 2016 and 2018 [14]. In the Dutch cohort, 60% had severe bleeding as indication for treatment.…”

Section: Discussioncontrasting

confidence: 96%

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Real-world experience with reversal of dabigatran by idarucizumab

Haastrup

Hellfritzsch

Nybo

et al. 2021

Thrombosis Research

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Section: Discussioncontrasting

confidence: 96%

“…From Montefiore Medical Center in New York, Goriacko et al reported clinical resolution of bleeding in six of seven cases and no adverse events [19]. Further, in the aforementioned Dutch study, they found that effective haemostasis was achieved in 74% of cases following idarucizumab use [14].…”

Section: Discussionmentioning

confidence: 99%

Real-world experience with reversal of dabigatran by idarucizumab

Haastrup

Hellfritzsch

Nybo

et al. 2021

Thrombosis Research

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“…Until recently, only small case series about idarucizumab use have been reported, [9][10][11] and a larger study of a cohort from 20 hospitals in the Netherlands analysed 88 patients (53 with severe bleeding and 35 requiring urgent surgical intervention). 12 Effective haemostasis was achieved in twothirds of bleeding patients and was associated with lower mortality risk. Clinical outcomes were considered similar to those observed in the RE-VERSE AD trial, regarding recurrent bleeding, thromboembolism and a high mortality rate.…”

mentioning

confidence: 99%

“…Indeed, using different definitions which were not possible to evaluate in the RE-VECTO, van der Wall et al found that the use of idarucizumab was inappropriate in 28% of patients, including a significant number of patients with interventions that could have been delayed or those with bleeding complications not considered uncontrollable. 12 Patients in the RE-VECTO surveillance program were rather poorly characterized regarding their baseline characteristics. While the main findings in the RE-VECTO report were broadly consistent to those observed in the RE-VERSE AD, the patient clinical profile in the RE-VECTO program might not be similar to that in the clinical trial, thus compromising the generalizability of the RE-VECTO findings.…”

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confidence: 99%

Idarucizumab for Reversion of Anticoagulant Effect in Daily Practice

Fauchier

Potpara

2019

Thromb Haemost

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The safety and efficacy of nonvitamin K antagonist oral anticoagulants (NOACs) seen in the respective pivotal randomized trials on stroke prevention in atrial fibrillation (AF) 1 have been broadly confirmed by numerous observational cohort-or registry-based reports. [2][3][4] In addition to the convenient practical aspects favouring NOACs over vitamin K antagonists (e.g., no need for continuous laboratory monitoring, limited drug-drug and food interactions, fixed-dose regimen), the availability of specific antidote(s) to reverse their anticoagulant effect has been conditioned for a more widespread and possibly safer use of NOACs. 5,6 Several antidotes/reversal agents for NOACs have been recently developed. 7 Idarucizumab, a specific reversal agent for dabigatran, has been the first to receive approval for clinical use in many countries.The efficacy and safety of idarucizumab for reversing dabigatran anticoagulant effect has been tested in the Reversal Effects of Idarucizumab on Active Dabigatran (RE-VERSE AD) phase III study. 8 In this multicentre, prospective, single-cohort study, 503 patients receiving dabigatran were enrolled to receive idarucizumab 5 g in two consecutive intravenous boluses. The primary efficacy endpoint was maximum percentage of dabigatran anticoagulant effect reversal within 4 hours of the second idarucizumab intravenous bolus. The patients were divided into two groups: those with an uncontrollable or life-threatening major bleeding were enrolled in group A and those needing surgery or another invasive procedure requiring normal haemostasis were enrolled in group B. The two groups were similar regarding most baseline characteristics; diluted thrombin time and ecarin clotting time were prolonged in more than 90% of patients at study entry but normalized rapidly after the first idarucizumab infusion, with 100% reversal within 4 hours after infusion. The reversal was sustained up to 24 hours. Among patients in group A for which the assessment of bleeding cessation could have been performed, 68% had bleeding cessation within 24 hours. For the patients in group B, peri-procedural haemostasis was considered normal in 93% patients. In the follow-up observation, 30-day mortality rates were similar between the two groups (13.5 and 12.6% for groups A and B, respectively). Thrombotic events occurred in 4.8% of the entire cohort.Until recently, only small case series about idarucizumab use have been reported, 9-11 and a larger study of a cohort from 20 hospitals in the Netherlands analysed 88 patients (53 with severe bleeding and 35 requiring urgent surgical intervention). 12 Effective haemostasis was achieved in twothirds of bleeding patients and was associated with lower mortality risk. Clinical outcomes were considered similar to those observed in the RE-VERSE AD trial, regarding recurrent bleeding, thromboembolism and a high mortality rate.In this issue of the journal, Fanikos et al report results of the RE-VECTO study, a global post-approval, European regulatory authorities requested international...

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“…Что касается применения идаруцизумаба в реальной клинической практике, то в последние годы постепенно накапливается опыт его применения у больных как с продолжающимися кровотечениями [13,14], так и перед проведением оперативных вмешательств, в том числе у пациентов с острым повреждением почек [15,16]. Отдельно стоит отметить, что все чаще появляются сообщения об использовании идаруцизумаба для нейтрализации эффекта дабигатрана у больных, которым показано выполнение экстренной тромболитической терапии [17][18][19][20].…”

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Dabigatran and Idaruzizumab. New Opportunities for Improving Patient Safety

2019

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The widespread use of new oral anticoagulants in clinical practice requires improving the safety of medication use, i.e. the use of specific reversal agents, if necessary. Idarucizumab, a humanied monoclonal antibody fragment, is the first reversal agent authorized in our country that binds to dabigatran. Its efficacy and safety have been validated in several clinical trials, and its use gains experience in real clinical practice.

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Performance of idarucizumab as antidote of dabigatran in daily clinical practice

Abstract: Because practice-based data on the usage of idarucizumab for urgent dabigatran reversal is unavailable, we evaluated the appropriateness of idarucizumab usage, its haemostatic effectiveness and clinical outcomes.

Cited by 33 publications

References 20 publications

Real-world experience with reversal of dabigatran by idarucizumab

Real-world experience with reversal of dabigatran by idarucizumab

Idarucizumab for Reversion of Anticoagulant Effect in Daily Practice

Dabigatran and Idaruzizumab. New Opportunities for Improving Patient Safety

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