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Abstract
Aims: Patients treated with anticoagulants may experience serious bleeding or require urgent surgery or intervention, and may benefit from rapid anticoagulant reversal. This exploratory analysis assessed healthcare resource utilization (HCRU) in patients treated with idarucizumab, a specific reversal agent for dabigatran etexilate.
Materials and methods: RE-VERSE AD™ (NCT02104947), a prospective, multi-center open-label study, is evaluating idarucizumab for dabigatran reversal in patients with serious bleeding (Group A) or undergoing emergency surgery/procedures (Group B). HCRU outcome measures evaluated in the first 90 patients enrolled were use of blood products and pro-hemostatic agents, length of stay (LOS) in hospital, and LOS in intensive care unit (ICU).
Results: Blood products or pro-hemostatic agents were given to 63% (32/51) of patients in Group A and 23% (9/39) of patients in Group B on the day of/day after surgery. An overnight hospital stay was reported for 82% (42/51) of patients in Group A with median LOS = 7 (range = 1–71) bed-days. For Group B, 92% (36/39) had an overnight hospital stay with a median LOS = 9 (range = 1–92) bed-days. In Group A, 17 patients were admitted to the ICU for at least 1 day with median LOS = 4 (range = 1–44) days; in Group B the number was 15 with median LOS = 2 (range = 1–92) days.
Limitations: The lack of a control group and the small patient numbers limit the strength of the conclusions.
Conclusions: The use of idarucizumab may simplify emergency management of dabigatran-treated patients with life-threatening bleeds and reduce perioperative complications in patients undergoing emergency surgery.
Transparency
Declaration of funding
This study was funded by Boehringer Ingelheim Pharma GmbH & Co. KG.
Declaration of financial/other interests
CVP Jr has received consulting fees from Boehringer Ingelheim, Bristol-Myers Squibb/Pfizer, Daiichi Sankyo, and Janssen, and research support from AstraZeneca. RB has received travel support and fees for consulting, lectures, and serving on steering committees from Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, and Medtronic. RD, FG, EK, PR, and AU are employees of Boehringer Ingelheim. MVH has received honoraria for presentations as well as research grants from Boehringer Ingelheim, Bayer HealthCare, Pfizer, GlaxoSmithKline, and Actelion. JHL has received consulting fees/honoraria from Boehringer Ingelheim, Janssen, The Medicines Company, and Instrumentation Labs, and has served on steering committees for CSL Behring and Grifols. FWS has received consulting fees from Boehringer Ingelheim and CSL Behring. TS has received speaker’s honoraria and consultancy fees from Boehringer Ingelheim, Bayer, Bristol-Myers Squibb/Pfizer, and Daiichi Sankyo. JIW has received consulting fees/honoraria from Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, Bayer, Johnson & Johnson, Daiichi Sankyo, Portola, Ionis Pharmaceuticals, and Merck. JME peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Acknowledgements
Medical writing assistance, supported financially by Boehringer Ingelheim Pharma GmbH & Co. KG, was provided by PAREXEL during the preparation of this article.
Previous presentations
Data have previously been presented at the American College of Cardiology Scientific Sessions 2016, Chicago, IL, USA.
