PENTasaccharide in HIp-FRActure surgery study (2001)


Prophylaxis for VTE after surgery for hip fracture

Close this section


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

Close this section

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)

Close this section


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

Close this section

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

Close this section


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

Close this section


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

Close this section


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

Close this section

Corresponding author

Bengt I. Eriksson, MD, Orthopedics Department, Sahlgrenska University Hospital – Östra, S-41685 Göteborg, Sweden, e-mail:

Close this section

Back To List

Recommend pageBack to top