Global Use of Idarucizumab in Clinical Practice: Outcomes of the RE-VECTO Surveillance Program

Fanikos, John; Murwin, Debra; Gruenenfelder, Fredrik; Tartakovsky, Igor; França, Lionel Riou; Reilly, Paul; Kermer, Pawel; Wowern, Fredrik von; Lane, Deirdre A.; Butcher, Ken

doi:10.1055/s-0039-1695771

Cited by 40 publications

(28 citation statements)

References 21 publications

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“…A study by Fanikos et al report on 359 patients included from 61 international sites in a global surveillance program (RE-VECTO) on idarucizumab in clinical practice [8]. They conclude that idarucizumab was prescribed according to label, but due to study limitations on data collection they did not report clinical outcomes.…”

Section: Introductionmentioning

confidence: 99%

Real-world experience with reversal of dabigatran by idarucizumab

Haastrup

Hellfritzsch

Nybo

et al. 2021

Thrombosis Research

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Section: Introductionmentioning

confidence: 99%

Real-world experience with reversal of dabigatran by idarucizumab

Haastrup

Hellfritzsch

Nybo

et al. 2021

Thrombosis Research

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“…Among the enrolled patients, 97.5% of patients were receiving dabigatran. 57% of the patients received idarucizumab to reverse major bleeding (gastrointestinal bleed-44.4%; intracranial bleed-38.6%), and 36% received idarucizumab for urgent interventions [52]. 95% of patients received full dose of two vials (2.5 g × 2), and only 1% received a second dose similar to findings of the RE-VERSE-AD study in which a second round dosing was required in 1.6% of patients [52].…”

Section: Specific Reversal Agentsmentioning

confidence: 76%

“…e RE-VECTO international surveillance program enrolled 359 patients from 61 sites (Asia Pacific-13.9%, EU-42.3%, North America-43.7%) which licensed and dispensed idarucizumab [52]. Among the enrolled patients, 97.5% of patients were receiving dabigatran.…”

Section: Specific Reversal Agentsmentioning

confidence: 99%

“…57% of the patients received idarucizumab to reverse major bleeding (gastrointestinal bleed-44.4%; intracranial bleed-38.6%), and 36% received idarucizumab for urgent interventions [52]. 95% of patients received full dose of two vials (2.5 g × 2), and only 1% received a second dose similar to findings of the RE-VERSE-AD study in which a second round dosing was required in 1.6% of patients [52]. e study suggested that the 4 Advances in Hematology usage patterns of idarucizumab aligned with its prescribing information, and there was minimal off-label use.…”

Section: Specific Reversal Agentsmentioning

confidence: 99%

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An Update on the Reversal of Non-Vitamin K Antagonist Oral Anticoagulants

Mujer

Manoj

Atti

et al. 2020

Advances in Hematology

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Non-vitamin K antagonist oral anticoagulants (NOACs) include thrombin inhibitor dabigatran and coagulation factor Xa inhibitors rivaroxaban, apixaban, edoxaban, and betrixaban. NOACs have several benefits over warfarin, including faster time to the achieve effect, rapid onset of action, fewer documented food and drug interactions, lack of need for routine INR monitoring, and improved patient satisfaction. Local hemostatic measures, supportive care, and withholding the next NOAC dose are usually sufficient to achieve hemostasis among patients presenting with minor bleeding. The administration of reversal agents should be considered in patients on NOAC's with major bleeding manifestations (life-threatening bleeding, or major uncontrolled bleeding), or those who require rapid anticoagulant reversal for an emergent surgical procedure. The Food and Drug Administration (FDA) has approved two reversal agents for NOACs: idarucizumab for dabigatran and andexanet alfa for apixaban and rivaroxaban. The American College of Cardiology (ACC), American Heart Association (AHA), and Heart Rhythm Society (HRS) have released an updated guideline for the management of patients with atrial fibrillation that provides indications for the use of these reversal agents. In addition, the final results of the ANNEXA-4 study that evaluated the efficacy and safety of andexanet alfa were recently published. Several agents are in different phases of clinical trials, and among them, ciraparantag has shown promising results. However, their higher cost and limited availability remains a concern. Here, we provide a brief review of the available reversal agents for NOACs (nonspecific and specific), recent updates on reversal strategies, lab parameters (including point-of-care tests), NOAC resumption, and agents in development.

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“…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 surveillance program, involving hospital pharmacies in countries where idarucizumab was dispensed from August 2016 to June 2018. 13 So far, this is the largest report on idarucizumab use, including 359 patients from 61 sites in Asia, European Union and North America. The study attempted to characterize the utilization of idarucizumab in 'real-world' clinical practice worldwide, including insight into the clinical profiles of patients receiving the antidote and reasons for its use.…”

mentioning

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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Global Use of Idarucizumab in Clinical Practice: Outcomes of the RE-VECTO Surveillance Program

Cited by 40 publications

References 21 publications

Real-world experience with reversal of dabigatran by idarucizumab

Real-world experience with reversal of dabigatran by idarucizumab

An Update on the Reversal of Non-Vitamin K Antagonist Oral Anticoagulants

Idarucizumab for Reversion of Anticoagulant Effect in Daily Practice

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