title: Healthcare resource utilization in patients receiving idarucizumab for reversal of dabigatran anticoagulation due to major bleeding, urgent surgery, or procedural interventions: interim results from the RE-VERSE AD™ study.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: a Thomas Jefferson University , Philadelphia , PA , USA.
authors.forename: Charles V
authors.initials: CV
authors.lastname: Pollack
authors.affiliation: b Northwestern University , Chicago , IL , USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Bernstein
authors.affiliation: c Boehringer Ingelheim Pharmaceuticals Inc. , Ridgefield , CT , USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Dubiel
authors.affiliation: c Boehringer Ingelheim Pharmaceuticals Inc. , Ridgefield , CT , USA.
authors.forename: Paul
authors.initials: P
authors.lastname: Reilly
authors.affiliation: d Boehringer Ingelheim Corporation , Ingelheim , Germany.
authors.forename: Fredrik
authors.initials: F
authors.lastname: Gruenenfelder
authors.affiliation: e Leiden University Medical Center , Leiden , the Netherlands.
authors.forename: Menno V
authors.initials: MV
authors.lastname: Huisman
authors.affiliation: f Tuen Mun Hospital , Tuen Mun , New Territories , Hong Kong, PR China.
authors.forename: Chak-Wah
authors.initials: CW
authors.lastname: Kam
authors.affiliation: g Boehringer Ingelheim Pharma GmbH & Co. KG , Ingelheim , Germany.
authors.forename: Eva
authors.initials: E
authors.lastname: Kleine
authors.affiliation: h Duke University Medical Center , Durham , NC , USA.
authors.forename: Jerrold H
authors.initials: JH
authors.lastname: Levy
authors.affiliation: i Rhode Island Hospital, Brown Medical School , Providence , RI , USA.
authors.forename: Frank W
authors.initials: FW
authors.lastname: Sellke
authors.affiliation: j Klinik für Neurologie , Klinikum Frankfurt Höchst , Frankfurt and Universitätsklinikum , Heidelberg , Germany.
authors.forename: Thorsten
authors.initials: T
authors.lastname: Steiner
authors.affiliation: k Boehringer Ingelheim GmbH , Ingelheim , Germany.
authors.forename: Anastasia
authors.initials: A
authors.lastname: Ustyugova
authors.affiliation: l McMaster University and Thrombosis and Atherosclerosis Research Institute , Hamilton , Ontario , Canada.
authors.forename: Jeffrey I
authors.initials: JI
authors.lastname: Weitz
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000191:economics* / Q000627:therapeutic use*; D000925:Anticoagulants / Q000009:adverse effects; D001777:Blood Coagulation / Q000187:drug effects; D001803:Blood Transfusion / Q000191:economics; D003362:Cost-Benefit Analysis; D000069604:Dabigatran / Q000009:adverse effects; D004630:Emergencies; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced / Q000188:drug therapy*; D006490:Hemostatics / Q000191:economics* / Q000627:therapeutic use*; D006801:Humans; D007362:Intensive Care Units / Q000191:economics; D007902:Length of Stay / Q000191:economics; D008297:Male; D008875:Middle Aged; D017059:Models, Econometric; D011446:Prospective Studies; D013997:Time Factors
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000925:Anticoagulants; D006490:Hemostatics; C000594745:idarucizumab; D000069604:Dabigatran
keywords: Healthcare resource utilization; anticoagulation reversal; dabigatran etexilate; idarucizumab; reversal agent