title: Rivaroxaban for the treatment of symptomatic deep-vein thrombosis and pulmonary embolism in Chinese patients: a subgroup analysis of the EINSTEIN DVT and PE studies.
abstract: BACKGROUND
  The worldwide EINSTEIN DVT and EINSTEIN PE studies randomized 8282 patients with acute symptomatic deep-vein thrombosis (DVT) and/or pulmonary embolism (PE) and, for the first time in trials in this setting, included patients in China. This analysis evaluates the results of these studies in this subgroup of patients.
  
  
  METHODS
  A total of 439 Chinese patients who had acute symptomatic DVT (n=211), or PE with or without DVT (n=228), were randomized to receive rivaroxaban (15 mg twice daily for 21 days, followed by 20 mg once daily) or standard therapy of enoxaparin overlapping with and followed by an adjusted-dose vitamin K antagonist, for 3, 6, or 12 months. The primary efficacy outcome was symptomatic recurrent venous thromboembolism. The principal safety outcome was major or non-major clinically relevant bleeding.
  
  
  RESULTS
  The primary efficacy outcome occurred in seven (3.2%) of the 220 patients in the rivaroxaban group and in seven (3.2%) of the 219 patients in the standard-therapy group (hazard ratio, 1.04; 95% confidence interval 0.36-3.0; p=0.94). The principal safety outcome occurred in 13 (5.9%) patients in the rivaroxaban group and in 20 (9.2%) patients in the standard-therapy group (hazard ratio, 0.63; 95% confidence interval 0.31-1.26; p=0.19). Major bleeding was observed in no patients in the rivaroxaban group and in five (2.3%) patients in the standard-therapy group. In fragile patients (defined as age >75 years, creatinine clearance <50 mL/min, and/or body weight ≤50 kg), the principal safety outcome occurred in four (8.9%) of the 45 patients who received rivaroxaban compared with seven (15.2%) of the 46 patients who received standard therapy.
  
  
  CONCLUSIONS
  In Chinese patients with acute symptomatic DVT and/or PE, rivaroxaban was as efficacious as enoxaparin followed by vitamin K antagonist therapy, with a similar safety profile. The relative efficacy and safety of rivaroxaban compared with enoxaparin/vitamin K antagonist were consistent with that found in the rest of the world.
  
  
  BACKGROUND
  EINSTEIN PE, ClinicalTrials.gov NCT00439777; EINSTEIN DVT, ClinicalTrials.gov NCT00440193.
authors.forename: Yuqi
authors.initials: Y
authors.lastname: Wang
authors.forename: Chen
authors.initials: C
authors.lastname: Wang
authors.forename: Zhong
authors.initials: Z
authors.lastname: Chen
authors.forename: Jiwei
authors.initials: J
authors.lastname: Zhang
authors.forename: Zhihong
authors.initials: Z
authors.lastname: Liu
authors.forename: Bi
authors.initials: B
authors.lastname: Jin
authors.forename: Kejing
authors.initials: K
authors.lastname: Ying
authors.forename: Changwei
authors.initials: C
authors.lastname: Liu
authors.forename: Yuxia
authors.initials: Y
authors.lastname: Shao
authors.forename: Zhicheng
authors.initials: Z
authors.lastname: Jing
authors.forename: Isabelle Ling
authors.initials: IL
authors.lastname: Meng
authors.forename: Martin H
authors.initials: MH
authors.lastname: Prins
authors.forename: Akos F
authors.initials: AF
authors.lastname: Pap
authors.forename: Katharina
authors.initials: K
authors.lastname: Müller
authors.affiliation: Bayer HealthCare, Aprather Weg 18a, Wuppertal D-42096, Germany. anthonie.lensing@bayer.com.
authors.forename: Anthonie Wa
authors.initials: AW
authors.lastname: Lensing