PENTHIFRA

PENTasaccharide in HIp-FRActure surgery study (2001)

Condition

Prophylaxis for VTE after surgery for hip fracture

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Objective

To compare the efficacy and safety of fondaparinux and enoxaparin for VTE prophylaxis after surgery for fractured hip

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Trial design

Randomized, double-blind study with parallel groups
Active treatment: fondaparinux 2.5 mg s.c. once daily, initiated 6±2 hours postoperatively, second dose given ≥12 hours after the first, treatment for 5–9 days; enoxaparin placebo (n=842)
Control treatment: enoxaparin 40 mg s.c. once daily, first dose given 12±2 hours preoperatively, second dose 12–24 hours after surgery, for
5–9 days; fondaparinux placebo (n=831)

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Endpoints

Primary efficacy endpoint: DVT and PE up to day 11 after surgery
Secondary efficacy endpoints: total, proximal, or distal DVT or symptomatic VTE up to day 11 and symptomatic VTE up to day 49
Primary safety endpoint: major bleeding Secondary safety endpoints: minor bleeding, death, blood transfusion requirement, thrombocytopenia

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Trial participants

1711 patients (mean age 77 years) scheduled to undergo surgery for fracture of the upper third of the femur within 48 hours of admission

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Results

Efficacy outcome: 1250 patients were included in the primary efficacy analysis. At day 11, the incidence of VTE was 8.3% in the fondaparinux group (52 of 626 patients) and 19.1% in the enoxaparin group (119 of 624 patients). The resulting relative risk reduction was 56% (p<0.001). Proximal DVT occurred in 0.9% of patients assigned to fondaparinux and 4.3% of patients treated with enoxaparin (relative risk reduction 79%, p<0.001). The rate of fatal PE was 0.2% in both groups. By day 49, the incidence of symptomatic VTE was similar in the fondaparinux group (2.0%) and the enoxaparin group (1.5%)
Safety outcome: By day 11, major bleeding had occurred in 18 of 831 patients (2.7%) treated with fondaparinux and 19 of 842 patients (2.3%) receiving enoxaparin. The incidence for minor bleeding was 4.1% and 2.1%, respectively. Transfusion requirements and other adverse events did not differ significantly between groups. At the end of follow-up, 38 patients treated with fondaparinux (4.6%) and 42 treated with enoxaparin (5%) had died

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Summary

Efficacy: In patients undergoing surgery for hip fracture, fondaparinux was superior to enoxaparin in preventing VTE
Safety: There were no significant differences between both groups in the incidence of clinically relevant bleeding or death

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Reference

Eriksson BI, Bauer KA, Lassen MR, Turpie AGG, for the Steering Committee of the Pentasaccharide in Hip-Fracture Surgery Study. Fondaparinux compared with enoxaparin for the prevention of venous thromboembolism after hipfracture surgery. N Engl J Med 2001;345:1298-1304

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Corresponding author

Bengt I. Eriksson, MD, Orthopedics Department, Sahlgrenska University Hospital – Östra, S-41685 Göteborg, Sweden, e-mail: b.eriksson@orthop.gu.se

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