Idarucizumab since FDA approval: Use in the real-world

Ebinger, Joseph; Granger, Christopher B.; Zhu, Alexander Y.; Chang, Allison; Henry, Timothy D.

doi:10.1016/j.ahj.2017.08.007

Cited by 6 publications

(6 citation statements)

References 19 publications

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“…To the best of our knowledge, this is one of the largest cohorts of idarucizumab use in the clinical setting. 16,17,[19][20][21][22] Although the study analyzed idarucizumab use exclusively at Canadian centers, the data presented from this study may be generalizable to other developed countries. This was also the only study to capture time from presentation to idarucizumab administration in the bleeding group.…”

Section: Ta B L E 1 Baseline Characteristicsmentioning

confidence: 99%

Safety of idarucizumab in the reversal of dabigatran at six tertiary care Ontario hospitals

Abdulrehman

Zarabi

Elbaz

et al. 2021

Research and Practice in Thrombosis and Haemostasis

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Background Idarucizumab, a monoclonal antibody fragment that reverses the anticoagulant effect of dabigatran, was approved for use in Canada in 2016. Objective Our objective was to assess the safety of idarucizumab among patients who received the drug within the first 3 years of its use in Canada. Patients/Methods We performed a retrospective health records review of all idarucizumab use, excluding use in those <18 years of age, between May 16, 2016, and August 1, 2019, at six Ontario tertiary care hospitals. The primary outcome was mortality. The secondary outcomes were in‐hospital arterial thrombotic event (ATE), in‐hospital venous thromboembolism (VTE), length of hospital stay, and length of critical care stay. Results A total of 85 patients received idarucizumab during the study period for the following indications: 37 (43.5%) for spontaneous bleeding, 28 (32.9%) for traumatic bleeding, 11 (12.9%) for emergency surgeries/procedures, 5 (5.9%) for elective surgeries/procedures, and 4 (4.7%) for other indications. Nineteen patients (22.4%; 95% confidence interval [CI], 14.8%‐32.3%) did not survive their hospitalization. During hospitalization, two patients (2.4%; 95% CI, 0.7%‐8.2%) had ATE, and three patients (3.5%; 95% CI, 1.2%‐9.9%) had VTE. The median length of stay was 8 (interquartile range [IQR], 2.5‐13) days in hospital and 3 (IQR, 2‐5) days in critical care. Conclusions Compared with clinical trial data, we found a numerically higher rate of mortality and similar rate of ATE and VTE among patients treated with idarucizumab in the real world.

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Section: Ta B L E 1 Baseline Characteristicsmentioning

confidence: 99%

Safety of idarucizumab in the reversal of dabigatran at six tertiary care Ontario hospitals

Abdulrehman

Zarabi

Elbaz

et al. 2021

Research and Practice in Thrombosis and Haemostasis

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“…So far, only scarce and sparse data have been published about its use in daily clinical routine. 15 Only small case series have been documented with not enough evidence to understand to what extent the use of idarucizumab can effectively affect the clinical course of patients presenting with acute bleeding or with a need for immediate reversal for urgent surgery. In a small retrospective review, the authors clearly stated that it remained unclear in which clinical situations idarucizumab would be clinically indicated.…”

Section: Clinical Usefulness and Impact On Real Worldmentioning

confidence: 99%

“…In a small retrospective review, the authors clearly stated that it remained unclear in which clinical situations idarucizumab would be clinically indicated. 15 …”

Section: Clinical Usefulness and Impact On Real Worldmentioning

confidence: 99%

“…Indeed, even though an active substance “blocking” the anticoagulant activity (a blocker, not an antidote or a reversal agent) could represent an important aid for some specific situations, the most important approach in actively bleeding patients is to sustain the patients’ conditions and physically “constrain” the bleeding. Furthermore, in those patients undergoing urgent procedures, while available data from the real world so far seem to report large underuse, 15 a recent review of NOACs from the surgical point of view underlines how the use of antidotes/reversal agents is limited to very few patients. 20 This document underlines that the main issue for each surgeon is to precisely measures the patient’s ongoing anticoagulant activity, to reassure the operator before to proceed with a surgical procedure, even an urgent one.…”

Section: Clinical Usefulness and Impact On Real Worldmentioning

confidence: 99%

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Use of idarucizumab in reversing dabigatran anticoagulant effect: a critical appraisal

Proietti¹,

Boriani²

2018

TCRM

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Use of non-vitamin K antagonist oral anticoagulants is spreading in the real world. Despite that, a strong need for antidotes/reversal agents is still reported by several physicians. Idarucizumab is a humanized monoclonal antibody fragment that binds specifically to dabigatran. Idarucizumab was approved in 2015 by the US Food and Drugs Administration and European Medicines Agency for reversal of anticoagulation activity in dabigatrantreated patients. This review briefly summarizes the experimental evidence about effectiveness and safety of idarucizumab. Furthermore, we review the current recommendations and experts’ point of view about the use of antidotes/reversal agents in patients reporting a major bleeding event.

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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.…”

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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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Idarucizumab since FDA approval: Use in the real-world

Cited by 6 publications

References 19 publications

Safety of idarucizumab in the reversal of dabigatran at six tertiary care Ontario hospitals

Safety of idarucizumab in the reversal of dabigatran at six tertiary care Ontario hospitals

Use of idarucizumab in reversing dabigatran anticoagulant effect: a critical appraisal

Idarucizumab for Reversion of Anticoagulant Effect in Daily Practice

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Idarucizumab since FDA approval: Use in the real-world

Cited by 6 publications

References 19 publications

Safety of idarucizumab in the reversal of dabigatran at six tertiary care Ontario hospitals

Safety of idarucizumab in the reversal of dabigatran at six tertiary care Ontario hospitals

Use of idarucizumab in reversing dabigatran anticoagulant effect:&nbsp;a critical appraisal

Idarucizumab for Reversion of Anticoagulant Effect in Daily Practice

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Use of idarucizumab in reversing dabigatran anticoagulant effect: a critical appraisal