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* From the Clinical Thrombosis Center (Dr. Spyropoulos), Lovelace Health Systems, Albuquerque, NM; Center for Pharmacoeconomic and Outcomes Research (Ms. Hurley), Lovelace Respiratory Research Institute, Albuquerque, NM; and MEDTAP International (Ms. Ciesla and Dr. Lissovoy), Bethesda, MD.
Correspondence to: Alex C. Spyropoulos, MD, Medical Director, Clinical Thrombosis Center, Lovelace Health Systems, 5400 Gibson Blvd SE, Albuquerque, NM 87108;
Objectives: A landmark Canadian randomized controlled clinical trial compared treatment of acute proximal vein thrombosis via low-molecular-weight heparin (LMWH) [enoxaparin] administered primarily at home with IV unfractionated heparin (UH) in the hospital. Results demonstrated equivalent safety and efficacy for home care with enoxaparin with a reduction in cost. Our objective was to validate these findings in the routine practice setting of a US health maintenance organization.
Design: Retrospective analysis of medical and administrative records of health-plan members meeting inclusion-exclusion criteria of the Canadian trial during the period from 1995 to 1998.
Setting: Staff-model health maintenance organization serving New Mexico.
Patients:Persons presenting as outpatients from 1995 to 1996 or from 1997 to 1998 with acute, proximal deep vein thrombosis (DVT) diagnosed by duplex ultrasonography.
Interventions: Initial anticoagulant therapy of IV UH administered in the hospital (from 1995 to 1996 group, n = 64) or subcutaneous LMWH (enoxaparin) administered primarily at home (from 1997 to 1998 group, n = 65), followed by warfarin therapy.
Results: No statistically significant differences were observed in the number of recurrent venous thromboembolic events (p = 0.36) or bleeding events (p = 1.0). Mean ± SD cost per patient was $9,347 ± 8,469 in the enoxaparin group compared with $11,930 ± 10,892 in the UH group, a difference of - $2,583 (95% bootstrap-adjusted asymmetrical confidence interval, -$ 6,147, + $650).
Conclusions:Retrospective replication of the Canadian study in a US routine (managed) care setting found similar clinical and economic outcomes. Treatment of acute proximal DVT with enoxaparin in a primarily outpatient setting can be accomplished safely and yields savings through avoidance or minimization of inpatient stays.
Key Words: economics enoxaparin low-molecular-weight heparin managed care outpatient treatment pharmacoeconomic evaluation proximal deep vein thrombosis utilization
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