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Once-Daily Enoxaparin in The Outpatient Setting Versus Unfractionated Heparin in Hospital for the Treatment of Symptomatic Deep-Vein Thrombosis

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Abstract

Background: Once- and twice-daily low-molecular-weight heparin administered in hospital have been shown to be effective and safe for treating deep-vein thrombosis. The aim of this study was to compare the efficacy and safety of deep-vein thrombosis treatment using once-daily subcutaneous enoxaparin in the outpatient setting with intravenous unfractionated heparin in hospital.

Methods: This randomized, parallel-group, open-label study was conducted in 18 centers in 4 countries. In total, 298 patients with symptomatic deep-vein thrombosis who were eligible for home treatment were randomized to treatment with enoxaparin in the outpatient setting (1.5 mg/kg subcutaneously once-daily) or unfractionated heparin in hospital (5000 IU bolus and 1250 IU/hour intravenous infusion) for ≥5 days. Clinical endpoints were assessed during a 6-month follow-up period.

Results: Among all patients treated with enoxaparin, there was a trend towards fewer recurrent deep-vein thromboses (1.3% vs. 5.4%; p = 0.060) and pulmonary emboli (1.3% vs. 4.1%; p = 0.17) compared with patients treated with unfractionated heparin. When considering a post-hoc combined endpoint of deep-vein thrombosis and pulmonary embolism, significantly fewer events occurred in the enoxaparin group than in the unfractionated-heparin group (2.7% vs. 8.8%; p = 0.026). The incidences of bleeding events and adverse events in the enoxaparin and unfractionated-heparin groups were similar.

Conclusions: Once-daily subcutaneous enoxaparin in the outpatient setting is at least as effective and as well tolerated as in-hospital intravenous unfractionated heparin for treatment of deep-vein thrombosis.

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Authors and Affiliations

  1. Prince of Wales Hospital, Randwick, New South Wales, Australia

    Beng H. Chong MBBS, PhD, FRACP, FRCPA, FRCP (Professor)

  2. St. George Clinical School, University of New South Wales, Sydney, Australia

    Beng H. Chong MBBS, PhD, FRACP, FRCPA, FRCP (Professor)

  3. St. George Hospital, Gray Street, Kogarah, New South Wales, Australia

    Tim A. Brighton

  4. Royal Perth Hospital, University of Western Australia, Perth, Australia

    Ross I. Baker

  5. Austin and Repatriation Medical Center, Heidelberg, Australia

    Peter Thurlow

  6. Nepean Hospital, Penrith, New South Wales, Australia

    Choon H. Lee

  7. St. George Hospital, W.R. Pitney Building, Level 2, Gray Street, Kogarah, 2217, New South Wales, Australia

    Beng H. Chong MBBS, PhD, FRACP, FRCPA, FRCP (Professor)

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  1. Beng H. Chong MBBS, PhD, FRACP, FRCPA, FRCP
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  2. Tim A. Brighton
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  3. Ross I. Baker
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  5. Choon H. Lee
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for the ASTH DVT Study Group

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Correspondence to Beng H. Chong MBBS, PhD, FRACP, FRCPA, FRCP.

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Chong, B.H., Brighton, T.A., Baker, R.I. et al. Once-Daily Enoxaparin in The Outpatient Setting Versus Unfractionated Heparin in Hospital for the Treatment of Symptomatic Deep-Vein Thrombosis. J Thromb Thrombolysis 19, 173–181 (2005). https://doi.org/10.1007/s11239-005-1848-x

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  • DOI: https://doi.org/10.1007/s11239-005-1848-x

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