title: Patient-reported treatment satisfaction with oral rivaroxaban versus standard therapy in the treatment of pulmonary embolism; results from the EINSTEIN PE trial.
abstract: BACKGROUND
  Rivaroxaban is an oral, direct Factor Xa inhibitor, approved for the treatment of pulmonary embolism (PE) and deep vein thrombosis (DVT) and the secondary prevention of recurrent PE and DVT as a fixed-dose, monotherapy regimen that does not require initial heparinisation, routine coagulation monitoring or dose adjustment. Approval in this indication was supported by results from EINSTEIN PE, a large, randomised, open-label study that compared rivaroxaban with enoxaparin/vitamin K antagonist (VKA) therapy in patients with acute symptomatic PE with or without DVT.
  
  
  METHODS
  Patient-reported treatment satisfaction was evaluated in a predefined subanalysis of EINSTEIN PE to enable monitoring and optimisation of patient-reported outcomes and, therefore, patient compliance. As part of EINSTEIN PE, 2,397 patients in seven countries were asked to complete a validated measure of treatment satisfaction, the Anti-Clot Treatment Scale (ACTS) throughout the duration of treatment (up to 12 months).
  
  
  RESULTS
  Patients reported greater satisfaction in the rivaroxaban treatment arm as compared with the enoxaparin/VKA treatment arm. Treatment with rivaroxaban was reported as being significantly less burdensome than enoxaparin/VKA therapy, and the benefits of treatment were significantly greater.
  
  
  CONCLUSIONS
  Rivaroxaban treatment resulted in improved treatment satisfaction compared with enoxaparin/VKA in PE patients, particularly in reducing patient-reported anticoagulation burden.
authors.affiliation: Maastricht University Medical Centre, 6200 MD Maastricht, The Netherlands. Electronic address: mh.prins@maastrichtuniversity.nl.
authors.forename: Martin H
authors.initials: MH
authors.lastname: Prins
authors.affiliation: Bayer Pharma AG, Wuppertal, Aprather Weg 18a, 42096 Wuppertal, Germany. Electronic address: luke.bamber@bayer.com.
authors.forename: Luke
authors.initials: L
authors.lastname: Bamber
authors.affiliation: Peninsula College of Medicine and Dentistry, Plymouth, PL6 8BU, UK. Electronic address: stefan.cano@pms.ac.uk.
authors.forename: Stefan J
authors.initials: SJ
authors.lastname: Cano
authors.affiliation: Bayer HealthCare, Montville, NJ, 13342, USA. Electronic address: maria.wang@bayer.com.
authors.forename: Maria Y
authors.initials: MY
authors.lastname: Wang
authors.affiliation: Maastricht University Medical Centre, 6200 MD Maastricht, The Netherlands.
authors.forename: Petra
authors.initials: P
authors.lastname: Erkens
authors.affiliation: Max Ratschow Clinic for Angiology, Grafenstraße 9, 64283 Darmstadt, Germany. Electronic address: rupert.bauersachs@klinikum-darmstadt.de.
authors.forename: Rupert
authors.initials: R
authors.lastname: Bauersachs
authors.affiliation: Bayer Pharma AG, Wuppertal, Aprather Weg 18a, 42096 Wuppertal, Germany. Electronic address: anthonie.lensing@bayer.com.
authors.forename: Anthonie W A
authors.initials: AW
authors.lastname: Lensing
mesh_terms: D000284:Administration, Oral; D065427:Factor Xa Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000627:therapeutic use*; D017060:Patient Satisfaction; D011655:Pulmonary Embolism / Q000188:drug therapy*; D000069552:Rivaroxaban; D013876:Thiophenes / Q000627:therapeutic use*
chemical_list: D065427:Factor Xa Inhibitors; D009025:Morpholines; D013876:Thiophenes; D000069552:Rivaroxaban
keywords: Anti-Clot treatment scale; Coagulation inhibitor; Pulmonary embolism; Rivaroxaban; Treatment satisfaction; Venous thrombosis