SUBCUTANEOUS ADMINISTRATION OF A LOW MOLECULAR WEIGHT HEPARIN (CY 222) COMPARED WITH SUBCUTANEOUS ADMINISTRATION OF STANDARD HEPARIN IN PATIENTS WITH ACUTE DEEP VEIN THROMBOSIS

Abstract
68 patients (pts) with acute deep vein thrombosis (DVT) were randomized to either CY 222 (Choay Institut, Cl, France) (n=33) in a dose of 750 u anti-Xa Cl/kg/day or standard heparin (SH) (n=35), 500 ui/kg/day, both given by 2 daily subcutaneous (sc) injections for 10 days. In SH group, dose was monitored by daily activated partial thromboplastin time to maintain a prolongation between 2 to 3 times the control value ; in CY 222 group dose remained unchanged during the 10-day treatment. Venography was repeated at day 10. Initial DVT localization and derived Marder’s score was similar in both groups (14.1 ± 11.7 in CY 222 group and 14.3 ± 10.6 in SH group, p = NS).The results show that : 1/ no bleeding complication was observed in CY 222 pts, but large hematoma occured in 3 SH pts, 1 patient in each group developed a recurrent pulmonary embolism and 2 others pts (1 in each group) did not undergo control phlebography ; 2/ in CY 222 group, 8 pts obtained complete lysis (CL, thrombolysis more than 90%), 11 partial lysis (PL, thrombolysis between 30% and 90%), and 11 no change (NC, less than 30%) ; 3/ in SH group, 4 pts obtained CL, 15 PL, 8 NC and extension was seen in 2 pts. Thus, phlebographic improvement (thrombolysis more than 30%) was observed in 65% in both groups.In conclusion, these preliminary results suggested that sc administration of CY 222 and SH, both given by 2 daily injections, was equally effective in pts with acute DVT, and CY 222 seemed to be safer than SH.