BRANDJES

Acenocoumarol and heparin compared with acenocoumarol alone in VTE treatment (1992)

Condition

Initial treatment of proximal DVT

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Objective

To compare the safety and efficacy of continuous i.v. heparin plus acenocoumarol with that of acenocoumarol alone in the initial treatment of proximal DVT

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Trial design

Randomized, placebo-controlled, double-blind study
Active treatment: UFH 5000 IU i.v. bolus followed by continuous infusion of 1250 IU/hour (aPPT target 60–90 s) for at least 7 days until the aPTT was in the therapeutic range plus acenocoumarol 6 mg p.o. once daily on the first day followed by 4 mg p.o. once daily on the next day and then dose-adjusted to an INR 2.0–3.0 for 12 weeks (n=60)
Control treatment: UFH placebo plus acenocoumarol (same dosing as above) (n=60)

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Endpoints

Primary efficacy endpoint: composite of documented symptomatic extension of VTE, symptomatic PE or VTE recurrence during a 6-months follow-up 
Secondary efficacy endpoint: asymptomatic extension of VTE (calculated at the end of the first week)
Primary safety endpoint: major and minor bleeding during the first 3 months

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Trial participants

120 consecutive patients between 18 and 85 years of age with documented acute proximal venous thrombosis

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Results

Efficacy outcome: During the 6-months study period, 4 of 60 patients (6.7%) receiving the combined strategy and 12 of 60 patients (20.0%) on acenocoumarol alone experienced a symptomatic extension or recurrence of VTE. In the combination therapy group, 4 of 49 evaluable patients (8.2%) had asymptomatic worsening of VTE, as compared with 21 of 53 patients (39.6%) in the monotherapy group
Safety outcome: Major bleeding occurred in 2 patients (3%) in the combined treatment group compared to 3 patients (5%) in the monotherapy group

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Summary

Efficacy: A combined treatment with UFH and an oral anticoagulant is superior to an anticoagulant monotherapy in preventing VTE extension or recurrence in patients with acute proximal DVT
Safety: Major bleeding complications were infrequent during anticoagulant treatment and comparable in both groups

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Reference

Brandjes DPM, Heijboer H, Büller HR, De Rijk M, Jagt H, Ten Kate JW. Acenocoumarol and heparin compared with acenocoumarol alone in the initial treatment of proximal vein thrombosis. New Engl J Med 1992;327:1485-1489

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Corresponding author

Dees P.M. Brandjes, MD, Department of Medicine, Slotervaart Ziekenhuis, Louwesweg 6, 1066 EC Amsterdam, the Netherlands

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