A COMPARISON OF RECOMBINANT HIRUDIN WITH A LOW-MOLECULAR-WEIGHT HEPARIN TO PREVENT THROMBOEMBOLIC COMPLICATIONS AFTER TOTAL HIP-REPLACEMENT

Background Patients who undergo total hip replacement have a high risk of thromboembolic complications. Recombinant hirudin (desirudin), a s pecific inhibitor of thrombin, represents a new development in antithr ombotic therapy. We compared the efficacy and safety of desirudin with those of a low-molecular-weight heparin (enoxaparin) for the preventi on of thromboembolic complications in patients undergoing primary tota l hip replacement. Methods Both treatments, which were assigned in a r andomized, double-blind manner, were started preoperatively: enoxapari n on the evening before surgery, and desirudin within 30 minutes befor e the start of surgery. The dose of desirudin was 15 mg subcutaneously twice daily, and the dose of enoxaparin was 40 mg subcutaneously once daily. The duration of treatment was 8 to 12 days. Deep-vein thrombos is was verified by bilateral venography performed at the end of the tr eatment period or earlier, if there were clinical signs of deep-vein t hrombosis. Results At 31 centers in 10 European countries, 2079 eligib le patients were randomly assigned to receive desirudin or enoxaparin. A total of 1587 patients were included in the primary analysis of eff icacy. In the desirudin group, as compared with the enoxaparin group, there was a significantly lower rate of proximal deep-vein thrombosis (4.5 vs. 7.5 percent, P = 0.01; relative reduction in risk, 40.3 perce nt) and a lower overall rate of deep-vein thrombosis (18.4 vs. 25.5 pe rcent, P = 0.001; relative reduction in risk, 28.0 percent). The safet y profiles were similar in the two treatment groups. Conclusions When administered 30 minutes before total hip replacement, desirudin is mor e effective than enoxaparin in preventing deep-vein thrombosis. (C) 19 97, Massachusetts Medical Society.