PEGASUS Study Details
ARIXTRA for prophylaxis in abdominal surgery, including patients with cancer [12]
PEGASUS was a randomized, double-blind, double-dummy trial of abdominal surgery patients at risk for thromboembolic complications. Patients received either SC once-daily injections of ARIXTRA 2.5 mg or dalteparin sodium 5,000 IU once-daily, with one 2,500 IU SC preoperative injection and one 2,500 IU SC first postoperative injection. ARIXTRA was administered 6 hours after surgery.
Surgery was considered high risk if patients were >60 years, or >40 and <60 years with 1 or more additional risk factors for VTE, or were undergoing abdominal surgery with general anesthesia expected to last >45 minutes.
The primary efficacy outcome was DVT detected by mandatory bilateral venography, documented symptomatic DVT, or documented symptomatic PE up to Day 10. The main safety outcome measure was major bleeding during treatment.
The incidence of DVT/PE was 4.6% (47/1,027) for the group treated with ARIXTRA vs 6.1% (62/1,021) for the dalteparin group. The relative reduction in risk was 24.6% (95% CI, -9.0 to 47.9; P=0.144), which met the predetermined criterion for noninferiority of ARIXTRA. Major bleeding was observed in 3.4% (49/1,433) of patients who received ARIXTRA and 2.4% (34/1,425) of patients who received dalteparin (P=0.122). A separate analysis of major bleeding according to time of first postoperative dose of ARIXTRA after surgical closure was conducted. When ARIXTRA was dosed <6 hours after surgery, the rate of bleeding was 3.4% (9/263). However, when ARIXTRA was dosed at least 6 hours after surgery, the incidence of bleeding was 2.8% (32/1,139).