title: Management patterns and outcomes of patients with venous thromboembolism in the usual community practice setting.
abstract: OBJECTIVE
  The objectives of this study were to observe a commercially insured sample diagnosed with a venous thromboembolism (VTE) event and treated postevent with warfarin and to detail the thromboembolic and bleeding outcomes in the time periods during warfarin therapy and after discontinuation of such therapy.
  
  
  METHODS
  This retrospective, observational cohort study used medical, pharmacy, and eligibility data from 2 US health plans. Study inclusion required an inpatient diagnosis of deep venous thrombosis (DVT) or pulmonary embolism (PE) between January 1, 1998, and December 31, 2000; warfarin, heparin, or low-molecular-weight heparin within 30 days after diagnosis; no VTE diagnosis; and no anticoagulant use for 3 months preceding diagnosis. A random sample of medical charts was abstracted to validate VTE events and collect prothrombin time/international normalized ratio (INR) result data. Recurrent VTE events, bleeding events, and proportion of time within INR range were captured in the postindex VTE event time period. Univariate and multivariate statistical techniques were used to assess outcomes.
  
  
  RESULTS
  A total of 2,090 patients were identified with a newly diagnosed VTE event (DVT only, 1450; PE with or without DVT, 640). Mean (SD) age was 61.7 (16) years; mean (SD) follow-up time after the index diagnosis was 21.3 (10) months. Overall mean (SD) length of warfarin therapy was 6.6 (6) months. During the follow-up period, 224 patients (10.7%) experienced a recurrent VTE event and 122 patients (5.8%) experienced a bleeding event requiring hospitalization. The cumulative incidence of recurrent VTE events over 3 and 6 months was 9.0% and 10.9%, respectively. Using the chart abstraction subset, patients were within the appropriate INR range 37.7% of the time while receiving warfarin.
  
  
  CONCLUSIONS
  Negative outcomes associated with warfarin therapy-recurrent VTE events and bleeding requiring hospitalization-were experienced by 10.7% and 5.8% of patients, respectively. These data suggest that negative outcomes may be more prevalent in usual community medical practice compared with rates observed in the controlled environment of the clinical trial or specialized anticoagulation clinic.
authors.affiliation: HealthCore, Inc., Wilmington, DE 19081, USA. vwilley@healthcore.com
authors.forename: Vincent J
authors.initials: VJ
authors.lastname: Willey
authors.forename: Michael F
authors.initials: MF
authors.lastname: Bullano
authors.forename: Ole
authors.initials: O
authors.lastname: Hauch
authors.forename: Matthew
authors.initials: M
authors.lastname: Reynolds
authors.forename: Gail
authors.initials: G
authors.lastname: Wygant
authors.forename: Lauren
authors.initials: L
authors.lastname: Hoffman
authors.forename: George
authors.initials: G
authors.lastname: Mayzell
authors.forename: Alex C
authors.initials: AC
authors.lastname: Spyropoulos
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006495:Heparin, Low-Molecular-Weight / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D015994:Incidence; D019934:International Normalized Ratio; D008297:Male; D008499:Medical Records; D008875:Middle Aged; D011655:Pulmonary Embolism / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology; D012008:Recurrence; D012189:Retrospective Studies; D012307:Risk Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D020246:Venous Thrombosis / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology; D014859:Warfarin / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000925:Anticoagulants; D006495:Heparin, Low-Molecular-Weight; D014859:Warfarin