SUBCUTANEOUS RECOMBINANT HIRUDIN (HEW-023) VERSUS INTRAVENOUS-SODIUM HEPARIN IN TREATMENT OF ESTABLISHED ACUTE DEEP-VEIN THROMBOSIS OF THE LEGS - A MULTICENTER PROSPECTIVE DOSE-RANGING RANDOMIZED TRIAL

The aim of this multicentre, prospective, randomised, dose-ranging stu dy was to compare the safety and efficacy of subcutaneous recombinant hirudin (HEW 023) against intravenous sodium heparin in acute lower li mb deep venous thrombosis (DVT). Patients were randomized to treatment with either HEW 023 or heparin for 5+/-1 days. HEW 023 was given acco rding to body-weight in three dose groups. Thromboembolic disease was assessed by phlebography and ventilation/perfusion (V/Q) scanning on D ay 1 and Day 5+/-1. One hundred and fifty-five patients were enrolled, of these 121 were evaluable for efficacy analysis. Significantly fewe r patients on HEW 023 developed new V/Q abnormalities during the treat ment period, ip = 0.006). There was no difference between the groups i n thrombus extension or regression, major bleeding complications or se rious adverse events. There were significantly fewer findings of new V /Q mismatch after treatment with HEW 023, and anticoagulant control wa s superior in these patients.