CC BY 4.0 · Thromb Haemost
DOI: 10.1055/s-0039-1695771
Coagulation and Fibrinolysis
Georg Thieme Verlag KG Stuttgart · New York

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

John Fanikos
1  Brigham and Women's Hospital, Boston, Massachusetts, United States
,
Debra Murwin
2  Boehringer Ingelheim Pharmaceuticals, Ridgefield, Connecticut, United States
,
Fredrik Gruenenfelder
3  Boehringer Ingelheim International GmbH, Ingelheim, Germany
,
Igor Tartakovsky
3  Boehringer Ingelheim International GmbH, Ingelheim, Germany
,
Lionel Riou França
3  Boehringer Ingelheim International GmbH, Ingelheim, Germany
,
Paul A. Reilly
2  Boehringer Ingelheim Pharmaceuticals, Ridgefield, Connecticut, United States
,
Pawel Kermer
4  Department of Neurology, Nordwest-Krankenhaus Sanderbusch, Sande, Germany
5  University Medical Center Göttingen, Göttingen, Germany
,
Frederik von Wowern
6  University Hospitals of Skåne – Malmö, Skåne, Sweden
,
Deirdre A. Lane
7  Liverpool Centre for Cardiovascular Science, Liverpool Heart and Chest Hospital, University of Liverpool, Liverpool, United Kingdom
,
Ken Butcher
8  Prince of Wales Clinical School, University of New South Wales, Sydney, Australia
9  Department of Medicine, University of Alberta, Edmonton, Alberta, Canada
› Author Affiliations
Funding The RE-VECTO surveillance program was funded by Boehringer Ingelheim Pharma GmbH & Co. KG.
Further Information

Publication History

28 March 2019

19 July 2019

Publication Date:
30 August 2019 (eFirst)

  

Abstract

Idarucizumab was approved for the reversal of dabigatran in 2015. We investigated whether postapproval usage patterns of idarucizumab in a real-world setting reflect those observed in the pivotal trials. No safety or efficacy data were collected in this medical record-based observational study. RE-VECTO, a global postapproval, international, surveillance program, involved hospital pharmacies in countries where idarucizumab was licensed and dispensed (August 2016–June 2018). Characteristics of sites prescribing idarucizumab and of eligible patients (≥ 18 years old and receiving idarucizumab regardless of prior oral anticoagulant use), as well as idarucizumab utilization data, were collected and analyzed descriptively. Sixty-one sites enrolled 359 patients. Most pharmacies (85.2%) were centralized, and the median idarucizumab units stocked per hospital was 2.0 (interquartile range, 1.0–3.0). Almost three-quarters of patients were elderly (74.9% aged > 70 years), and only four (1.1%) had received idarucizumab before. Nearly all patients were treated with dabigatran (97.5%). There was a low frequency of unapproved dabigatran dosage regimens (3.3%). Life-threatening or uncontrolled bleeding was the most frequent indication for idarucizumab (57.7%), followed by emergency surgery/urgent procedure (35.9%). Of the life-threatening bleeding events, the most frequent were gastrointestinal tract (44.4%) and intracranial (38.6%). Most patients (95.0%) were given the full dose of two vials (2 × 2.5 g) of idarucizumab initially, and very few (1.7%) received a second dose. Of those patients requiring emergency or scheduled/planned surgery/procedures, 25.5% underwent gastrointestinal and/or abdominal surgery/procedures. Real-world usage patterns of idarucizumab provide valuable insights into emergency reversal strategies. Off-label use was minimal.

Authors' Contributions

All authors were involved with designing the surveillance program, provided critical review of the article, and approved the final version for publication.