1. ARIXTRA® (fondaparinux sodium) in the prevention of venous thromboembolism after hip-fracture surgery
BI Eriksson, KA Bauer, MR Lassen, and AGG Turpie on behalf of the Steering Committees of the Pentasaccharide Orthopaedic Prophylaxis Studies

2. PENTHIFRA: OBJECTIVE AND DESIGN
To compare the efficacy and safety of o.d. s.c. injections of Arixtra® 2.5 mg with enoxaparin 40 mg in preventing venous thromboembolism (VTE) in patients undergoing surgery for hip fracture.
A multicenter, randomized, double-blind, two-parallel-group comparative trial in 1711 patients.
It is important to distinguish venous thromboembolism from thrombosis occurring in placental capillaries, responsible for recurrent pregnancy loss, preeclampsia and other obstetric complications. Although some risk factors are common to these two disorders, they differ in their clinical expression and their therapeutic management.

3. PENTHIFRA: DESIGN R Treatment 7 ± 2 Days Arixtra® 2.5 mg o.d.
start 6 ± 2 hrs post-op R
Enoxaparin
40 mg o.d.
start pre-op
Venogram Day 5–11
Follow up Day 42 ± 7

4. PENTHIFRA: ENDPOINTS Primary efficacy: VTE up to day 11
deep-vein thrombosis (DVT) detected by mandatory bilateral venography, or
documented symptomatic DVT, or
pulmonary embolism.
Primary safety: Major bleeding.

5. PENTHIFRA: EFFICACY RESULTS
1250 (73.1%) patients included in the primary efficacy analysis
Arixtra® also reduced the incidence of:
any DVT by 58.2% (p<0.001),
any proximal DVT by 78.7% (p<0.001)
distal-only DVT by 55.4% (p<0.001).

6. PENTHIFRA: SAFETY RESULTS
Arixtra® N=831 n (%)
Enoxaparin N=842 n (%)
Fatal bleeding
1 (0.1)
Bleeding in critical organ
Bleeding leading to reoperation
3 (0.4)
2 (0.2)
Bleeding with a bleeding index*  2
15 (1.8)
16 (1.9)
*The bleeding index was calculated as follows: [number of units of packed red blood cells or whole blood transfused] + [(pre-bleeding) - (post-bleeding) hemoglobin (g/dl) values]

7. PENTHIFRA: CONCLUSION
In patients undergoing surgery for hip fracture, Arixtra® was significantly more effective than enoxaparin in preventing VTE and was equally safe