VAN GOGH Extension

Extended prophylaxis of venous thromboembolism with idraparinux (2007)

Condition

Extended prophylaxis of VTE after 6 months antocoagulation

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Objective

To evaluate the efficacy and safety of a 6-month extension of VTE prophylaxis with idraparinux in patients who had initially received 6 months of prophylaxis with an anticoagulant

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Trial design

Randomized, placebo-controlled, double-blind phase III study
Active treatment: idraparinux 2.5 mg s.c. once weekly for 6 months (n=594)
Control treatment: placebo s.c. once weekly for 6 months (n=621)

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Endpoints

Primary efficacy endpoint: incidence of symptomatic recurrent VTE (nonfatal or fatal)
Primary safety endpoint: major bleeding
Secondary safety endpoint: clinically relevant bleeding, death from any cause

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Trial participants

1215 patients (age =18 years) with confirmed, symptomatic DVT or PE who had been treated for 6 months with acenocoumarol or warfarin (either in previous VAN GOGH studies or outside these studies)

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Results

Efficacy outcome: During the 6 months of randomly assigned treatment, 6 of 594 patients in the idraparinux group (1.0%) and 23 of 621 patients in the placebo group (3.7%) had recurrent VTE (relative risk reduction 73%; p=0.002). In the placebo group, a higher VTE incidence was observed in patients who had received a vitamin K antagonist before randomization than in those who had received idraparinux (5.9% vs. 0.7%; p=0.004)
Safety outcome: Major bleeding occurred in 11 of 594 patients in the idraparinux group (1.9%) and in none of the 621 patients in the placebo group (p<0.001). Three bleeding episodes in the idraparinux group were fatal intracranial hemorrhages. The incidence of major bleeding was higher in patients who had received idraparinux before randomization than in those who had received a vitamin K antagonist (3.1% vs. 0.9%; p=0.06). The rate for clinically relevant bleeding was 4.5% in the idraparinux arm compared to 1.5% in the placebo group. The mortality was lower in the placebo group (0.6 vs. 1.5%)

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Summary

During the 6-month extension of thromboprophylaxis, the factor X inhibitor idraparinux was effective in preventing recurrent thromboembolism but was associated with an increased risk of a major hemorrhage

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Reference

The van Gogh Investigators; Büller HR, Cohen AT, Davidson B, Decousus H, Gallus AS, Gent M, Pillion G, Piovella F, Prins MH, Raskob GE. Extended prophylaxis of venous thromboembolism with idraparinux. N Engl J Med 2007;357:1105-1112

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Corresponding author

Prof. Harry R. Büller, Department of Vascular Medicine, Academic Medical Centre, Meibergdreef 9, 1105 AZ Amsterdam, Netherlands, e-mail: h.r.buller@amc.uva.nl

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