title: Treatment of pulmonary embolism with rivaroxaban: outcomes by simplified Pulmonary Embolism Severity Index score from a post hoc analysis of the EINSTEIN PE study.
abstract: OBJECTIVE
  The objective was to assess adverse outcomes in relation to the simplified Pulmonary Embolism Severity Index (PESI) score in patients treated with rivaroxaban or standard therapy in the phase III EINSTEIN PE study and to evaluate the utility of the simplified PESI score to identify low-risk pulmonary embolism (PE) patients.
  
  
  METHODS
  A post hoc analysis of EINSTEIN PE data was performed to assess the efficacy and safety of rivaroxaban in patients with a range of simplified PESI scores. Recurrent venous thromboembolism, fatal PE, all-cause mortality, and major bleeding were stratified by simplified PESI scores of 0, 1, or ≥2 and according to treatment period at 7, 14, 30, and 90 days and at the end of the full intended treatment period.
  
  
  RESULTS
  Simplified PESI scores could be calculated in 4,831 of the 4,832 randomized patients; of those, 53.6, 36.7, and 9.7% had PESI scores of 0, 1, and ≥2, respectively. Among patients with simplified PESI scores of 0 or 1, fatal PE, all-cause mortality, and other adverse outcomes were uncommon within the first 7, 14, and 30 days. Patients with simplified PESI scores of ≥2 had more frequent adverse outcomes. Major bleeding was lower in the rivaroxaban group, particularly in those with simplified PESI scores of 1 or ≥2.
  
  
  CONCLUSIONS
  The findings support using risk stratification with the simplified PESI score to identify low-risk patients with PE.
authors.affiliation: Department of Emergency Medicine, University of Cincinnati, Cincinnati, OH.
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Fermann
authors.forename: Petra M G
authors.initials: PM
authors.lastname: Erkens
authors.forename: Martin H
authors.initials: MH
authors.lastname: Prins
authors.forename: Philip S
authors.initials: PS
authors.lastname: Wells
authors.forename: Ákos F
authors.initials: ÁF
authors.lastname: Pap
authors.forename: Anthonie W A
authors.initials: AW
authors.lastname: Lensing
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015897:Comorbidity; D004636:Emergency Service, Hospital; D065427:Factor Xa Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006470:Hemorrhage / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011237:Predictive Value of Tests; D011379:Prognosis; D011655:Pulmonary Embolism / Q000188:drug therapy* / Q000401:mortality; D012306:Risk; D000069552:Rivaroxaban; D012720:Severity of Illness Index; D013876:Thiophenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000925:Anticoagulants; D065427:Factor Xa Inhibitors; D009025:Morpholines; D013876:Thiophenes; D000069552:Rivaroxaban