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.
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: Walter Ageno; Alexander S Gallus; Ann Wittkowsky; Mark Crowther; Elaine M Hylek; Gualtiero Palareti Journal: Chest Date: 2012-02 Impact factor: 9.410
Authors: Chaitanya Sarawate; Mirko V Sikirica; Vincent J Willey; Michael F Bullano; Ole Hauch Journal: J Thromb Thrombolysis Date: 2006-04 Impact factor: 2.300
Authors: Jan Beyer-Westendorf; Kati Förster; Sven Pannach; Franziska Ebertz; Vera Gelbricht; Christoph Thieme; Franziska Michalski; Christina Köhler; Sebastian Werth; Kurtulus Sahin; Luise Tittl; Ulrike Hänsel; Norbert Weiss Journal: Blood Date: 2014-05-23 Impact factor: 22.113
Authors: J Bradley Layton; Christoph R Meier; Julie L Sharpless; Til Stürmer; Susan S Jick; M Alan Brookhart Journal: JAMA Intern Med Date: 2015-07 Impact factor: 21.873
Authors: Frederick A Spencer; Joel M Gore; George Reed; Darleen Lessard; Luigi Pacifico; Cathy Emery; Mark A Crowther; Robert J Goldberg Journal: Thromb Haemost Date: 2009-05 Impact factor: 5.249
Authors: Christine Baumgartner; Alan S Go; Dongjie Fan; Sue Hee Sung; Daniel M Witt; John R Schmelzer; Marc S Williams; Steven H Yale; Jeffrey J VanWormer; Margaret C Fang Journal: Thromb Res Date: 2020-03-05 Impact factor: 3.944
Authors: Isa I Valentín; Giselle Rivera; Mariely Nieves-Plaza; Iadelisse Cruz; Jessica Y Renta; Carmen L Cadilla; Juan F Feliu; Richard L Seip; Gualberto Ruaño; Jorge Duconge Journal: P R Health Sci J Date: 2014-09 Impact factor: 0.705