LEVINE (2)

Treatment of proximal DVT with low-molecular-weight heparin at home vs. standard

Condition

Treatment of acute proximal DVT in outpatientsheparin in hospital (1996)

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Objective

To compare the efficacy and safety of fixed-dose subcutaneous low-molecular-weight heparin given at home with those of adjusted-dose intravenous standard heparin given in the hospital in patients with proximal DVT

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Trial design

Randomized, open study with parallel groups
Active treatment: enoxaparin 1 mg/kg s.c. twice daily administered by the patient at home (hospitalized patients were allowed to be discharged early) for ≥5 days and until the concomitant oral anticoagulant therapy resulted in an INR 2.0–3.0 (n=247)

Control treatment: UFH 5000 IU i.v. bolus, followed by continuous infusion of 20,000 IU in 500 ml of a 5% dextrose solution, with 32 ml administered per hour to target an aPTT of 60–80 s, for ≥5 days until INR 2.0–3.0. The patients were treated in hospital (n=253)

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Endpoints

Primary efficacy endpoint: symptomatic recurrent VTE during 3-month follow-up
Primary safety endpoints: major and minor bleeding during the period of administration of study medication or within 48 hours after its discontinuation
Secondary endpoint: hospital stay

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Trial participants

500 consecutive symptomatic outpatients with acute proximal DVT proven on venography or duplex scan but with no signs of PE

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Results

Efficacy outcome: During the 3-month follow-up, 13 of the 247 patients assigned to enoxaparin (5.3%) and 17 of the 253 patients receiving standard heparin (6.7%) had symptomatic recurrent VTE. 2 patients in the UFH group had PE, and both died
Safety outcome: Major bleeding complications occurred during the period of study-drug administration or the subsequent 48 hours in 5 patients given enoxaparin (2.0%) as compared with 3 patients given UFH (1.2%). 2 of the 5 episodes of bleeding in the enoxaparin group were fatal. Minor bleeding was observed in 2.4% of the patients in both groups
Hospital stay: Of the 247 patients assigned to enoxaparin, 120 were never admitted to the hospital, and the remaining 127 patients spent an average of 2.2 days in the hospital after randomization. The average hospital stay for all patients in this group was 1.1 days, as compared with 6.5 days for the patients receiving standard heparin

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Summary

Efficacy: Treatment of proximal DVT with enoxaparin at home was least as effective as treatment with standard heparin in hospital, with a non-significant trend in favor of enoxaparin
Safety: Rates of major bleeding were low and similar in both treatment groups

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Reference

Levine M, Gent M, Hirsh J, Leclerc J, Anderson D, Weitz J, Ginsberg J, Turpie AG, Demers C, Kovacs M, Geerts W, Kassis J, Desjardins L, Cusson J, Cruickshank M, Powers P, Brien W, Haley S, Willan A. A comparison of low-molecular-weight heparin administered primarily at home with unfractionated heparin administered in the hospital for proximal deep-vein thrombosis. N Engl J Med 1996;334:677-681

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Corresponding author

Mark Levine, MD, Hamilton Regional Cancer Centre, 699 Concession St., Hamilton, ON L8V 5C2, Canada

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