ENOXAPARIN IN THE PREVENTION OF DEEP VENOUS THROMBOSIS AFTER MAJOR SURGERY - MULTICENTRIC STUDY

DVT is a very frequent complication of general surgery. Heparin and, m ore recently, LMWHs can successfully prevent post surgical thromboembo lism. One thousand one hundred and twenty-two patients (533 males and 589 females; mean age 62.2 +/- 11.4 yrs) were enrolled in a multicentr e controlled study, to evaluate the efficacy and safety of enoxaparin in comparison to calcium heparin in the prevention of deep venous thro mbosis (DVT) following general surgery. Patients assigned to the enoxa parin and the calcium heparin groups received 1 daily dose of 20 mg (2 000 I.U.) and 2 daily doses of 0.2 ml (5000 I.U.), respectively starti ng 2 hours before the operation. Both drugs were given by subcutaneous route. A Doppler or Duplex Scan diagnosis of DVT was made in 3 (0.5%) patients in the enoxaparin group (2 cases during treatment and 1 pati ent at the end of treatment) and in 6 (1.1%) patients in the calcium h eparin group (5 cases during treatment and 1, bilateral, after the end of treatment). Pulmonary embolism (PE) was ascertained by angiography in 1 patient (0,18%) in the enoxaparin group and in 2 patients (0,36% ) in the calcium heparin one. Hemorrhagic complications occurred in 29 patients (5.2%) in the enoxaparin group and in 34 (6.1%) in the calci um heparin group. Haematomas located in the injection site were report ed in 16.1% and 25.3% in the enoxaparin and calcium heparin groups res pectively (p = 0.0001). Local pain in the injection site at the 5th da y of treatment was reported in 8.4% and 16,6% in the enoxaparin and ca lcium heparin groups respectively (p = 0.0001). These results show tha t enoxaparin, administered by the subcutaneous route, is equally effec tive, but better locally tolerated in comparison to calcium heparin in preventing thromboembolic disease following major surgery.