PENTHIFRA Plus Study Details
ARIXTRA for extended prophylaxis of VTE in hip fracture surgery [11]
PENTHIFRA Plus was a double-blind multicenter trial in which 656 patients undergoing hip fracture surgery were randomly assigned to receive prophylaxis with once-daily SC injection of either 2.5 mg of ARIXTRA or placebo for 19 to 23 days. Prior to randomization, all patients had received ARIXTRA for 6 to 8 days.
The primary efficacy outcome was DVT detected by mandatory bilateral venography or documented symptomatic DVT or PE during the double-blind period. The main safety outcome was major bleeding.
The incidence of DVT for treatment with ARIXTRA was 1.4% (3/208) vs 35.0% (77/220) for placebo, with a relative risk reduction of 95.9% (95% CI, 87.2-99.7; P<0.001). The rate of symptomatic VTE was reduced to 0.3% (1/326) for ARIXTRA, vs 2.7% (9/330) for placebo (P=0.21). This was a relative risk reduction of 88.8% (P=0.02).
Major bleeding occurred in 2.4% (8/327) of patients in the group treated with ARIXTRA and 0.6% (2/329) of those receiving placebo. There was a trend toward major bleeding in the group treated with ARIXTRA vs the placebo group (P=0.06); there were no differences between the 2 groups in the incidence of clinically relevant bleeding (leading to death, reoperation, or critical organ bleeding).