title: Dabigatran etexilate for thromboprophylaxis in over 5000 hip or knee replacement patients in a real-world clinical setting.
abstract: BACKGROUND
  Thromboprophylaxis is recommended for patients undergoing total hip or total knee replacement (THR, TKR). An international, open-label, prospective, observational, single-arm study in a routine clinical setting was performed to assess the safety and efficacy of dabigatran etexilate 220 mg once daily in patients undergoing THR or TKR, and in subgroups of patients with potentially increased risk of bleeding or venous thromboembolism (VTE).
  
  
  METHODS
  Patients were ≥18 years and required to be eligible to receive dabigatran 220 mg once daily (first dose 110 mg 1-4 h after THR/TKR surgery) according to the European Summary of Product Characteristics. The primary safety and efficacy outcomes were incidence of major bleeding events (MBEs), and the composite incidence of symptomatic VTE events and all-cause mortality, respectively.
  
  
  RESULTS
  In total, 5292 patients (median age 64 years) were enrolled and received dabigatran (2734 THR and 2558 TKR). Median drug exposure was 31 days (THR 34 days; TKR 27 days). Overall incidence of MBEs was 0.72 % (95 % confidence interval [CI] 0.51, 0.98), and this rate was comparable between types of surgery and was not significantly affected by protocol-defined risk factors. The overall incidence of symptomatic VTE and all-cause mortality was 1.04 % (95 % CI 0.78, 1.35); the only significant risk factor was history of VTE events (odds ratio 5.59; 95 % CI 2.53, 11.08). A post-hoc analysis showed that the incidence of MBEs in this observational study was similar to or lower than those reported in previous phase 3 trials.
  
  
  CONCLUSIONS
  Results from this observational study of dabigatran etexilate administered to patients undergoing THR or TKR surgery are reassuring and supportive of those obtained in dabigatran phase 3 trials.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT00846807.
authors.affiliation: Department of Anaesthesia and Intensive Care Medicine, Cochin University Hospital, Assistance-Publique - Hôpitaux de Paris; Université Paris Descartes, Paris, France.
authors.forename: Nadia
authors.initials: N
authors.lastname: Rosencher
authors.affiliation: Department of Anaesthesia and Intensive Care Medicine, Cochin University Hospital, Assistance-Publique - Hôpitaux de Paris; Université Paris Descartes, Paris, France.
authors.forename: Charles M
authors.initials: CM
authors.lastname: Samama
authors.affiliation: Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany ; Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Feuring
authors.affiliation: Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany ; Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
authors.forename: Martina
authors.initials: M
authors.lastname: Brueckmann
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
authors.forename: Eva
authors.initials: E
authors.lastname: Kleine
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Clemens
authors.affiliation: Royal Liverpool University Hospital, Liverpool, L69 3GA UK.
authors.forename: Simon
authors.initials: S
authors.lastname: Frostick
keywords: Dabigatran etexilate; Observational study; Thromboprophylaxis; Total hip replacement; Total knee replacement