COLUMBUS

Low-molecular-weight heparin in the treatment of patients with venous thromboembolism (1997)

Condition

Initial treatment of symptomatic VTE

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Objective

To evaluate the efficacy and safety of fixed-dose reviparin compared with adjusted-dose UFH in unselected patients with confirmed DVT, with or without associated PE

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Trial design

Randomized, open study with parallel groups
Active treatment: reviparin 6300 anti-factor Xa IU (body weight >60 kg), 4200 IU (46–60 kg), 3500 IU (35–45 kg) s.c. twice daily for at least 5 days and until the concomitant treatment with a coumarin derivative resulted in an INR >2.0 (n=510)
Control treatment: UFH 5000 IU i.v. bolus followed by 1250 IU/h continuous i.v. infusion (target aPTT 60–85 s) for at least 5 days and until the use of a coumarin derivative induced an INR >2.0 (n=511)

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Endpoints

Primary efficacy endpoint: 12-weeks incidence of symptomatic recurrent VTE complications (DVT and PE)
Primary safety endpoints: major bleeding within 12 weeks of randomization, mortality

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Trial participants

1021 consecutive patients with acute symptomatic DVT, PE or both and who required antithrombotic therapy

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Results

Efficacy outcome: At 12 weeks, the incidence of recurrent VTE events was 5.3% in the reviparin group and 4.9% in the UFH group. The absolute difference of 0.4% indicated equivalence between the 2 treatments. Most episodes of recurrent VTE occurred in the first 14 days and the risk of recurrence decreased over time
Safety outcome: 16 patients assigned to reviparin (3.1%) and 12 patients assigned to UFH (2.3%) had episodes of major bleeding. 12-week mortality rates were 7.1% in the reviparin group and 7.6% in the UFH group

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Summary

Efficacy: Fixed-dose reviparin and adjusted-dose UFH are equivalent in the treatment of unselected patients with confirmed DVT, with or without associated PE
Safety: The incidence of major bleeding was similar with reviparin and UFH

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Reference

The Columbus Investigators. Low-molecular-weight heparin in the treatment of patients with venous thromboembolism. N Engl J Med 1997;337:657-662

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Corresponding author

Prof. J. W. ten Cate, MD, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam Zuid-oost, the Netherlands

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